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 Patient McKenzie L.’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 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., and Burzynski patient Sen. Ed G. 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.

Today we start looking at the roster of the dead and dying known as the ANP Coalition. This is the collection of patients, mostly children, who came to Burzynski’s aid when his unproven “antineoplaston” chemotherapy was taken off the market following a juvenile patient’s death. The ANP Coalition did help get the trials reinstated, as best we can tell, however, out of the nine patients who have appeared in the Coalition’s pro-Burzynski campaigns, 6 have died. Not all of the patients received ANP, but all of the patients have been used. Only one, as far as we know, is on ANP at this time.

The first patient we will examine is McKenzie L. Hers was perhaps the most extensively covered story of all the ANP Coalition’s new patients. We have some 80 files on her story. It is horrible and long and frustrating, but it’s a story that must be told because it makes staggeringly clear the real harm that sloppy journalism can cause. Everyone here tried to do the right thing, but a selective blindness is pervasive and it has truly catastrophic results.

The first evidence that something is wrong appears on McKenzie’s grandfather’s Facebook page on 28 Nov 2012:

2012-11-26

It turns out, as we hear almost two years later that McKenzie had been walking home from school with her grandfather and

“swayed in a crooked line down the sidewalk and her eyes seemed unfocused. When he asked her what was wrong she told him she was seeing double.”

The diagnosis is Diffuse Intrinsic Pontine Glioma, a tumor in the brain stem. Almost universally fatal. It catches the fifth-grader and her family mid-stride; McKenzie had just received a stellar report card and seems to be athletically inclined, swimming and riding horses. Within two weeks, she begins a long series of visits to the hospital for conventional treatment, radiation and chemotherapy, it seems.

Right out of the gate, the traditional therapy does what it is supposed to, beat back the cancer. It is unlikely to kill off it all, but is only a stop-gap measure. We hear on Jan. 7 that double vision and walking have been a problem, but the problems are lessening. On 20 February 2013, we hear that according to their first MRI after treatment, the tumor has shrunk by 50%.

By October, however, the tumor grows back.

Burzynski first appears on the family’s timelines in January 2013, when McKenzie’s grandfather posts an article about Burzynski, one riddled with inaccuracies and conspiracy theories (get a skeptic’s take on the same Burzynski decision here). In September of 2013, however, with the family running out of options, members of the Burzynski Patient Group begin appearing in the family’s Facebook timelines, especially an enthusiastic chemtrailNew World Order, and fluoride truther.

On 2 October 2013, McKenzie L.’s family goes to Houston looking for a miracle:

Untitled

By the end of the month, there seems to be devotion to the Burzynski cause. At the time, Burzynski’s antineoplaston trials were suspended after the death of a child, Josiah C., whose story was told on the cover of USA Today in November 2013, just after McKenzie’s family seems to have committed to Burzynski’s cause. Neither the Clinic nor the FDA told Josiah’s family that the clinical trial that their son was on had been shut down following his death.

Five days after the expose of Burzynski appeared on the cover of USA Today, Michael Rosenfield of WBZ-TV files a report about a petition that McKenzie’s grandfather has started to lobby the FDA for a compassionate exemption for her to receive Burzynski’s drug. At the time, the compassionate exemption seemed to be the only way that Burzynski could get patients on the drug. All of the trials were closed. The list of Burzynski’s horrific violations seemed too unthinkably long to permit him to continue. Burzynski’s response to the charges was clearly inadequate for the FDA. This is the first point where the media failed to serve the public interest. An 8-month investigation raising profound doubts about whether the “doctor in Texas,” as Rosenfield refers to him, and his “controversial drug,” as Rosenfield refers to it, was completely ignored. Indeed, the absence is conspicuous given the horror with which the article was received. We believe that Rosenfield had a journalistic obligation to report that the FDA had observed that:

  1. Burzynski (as investigator, the subject of the inspection) “failed to comply with protocol requirements related to the primary outcome, therapeutic response […] for 67% of study subjects reviewed during the inspection.” This means that several patients who were reported as “complete responses” did not meet the criteria defined in the investigational plan, as were patients who were reported as having a “partial response” and “stable disease.” This means that his outcomes figures for these studies are inaccurate.
  2. Additionally, some patients admitted failed to meet the inclusion criteria for the study.
  3. Even though patients needed to have a physician back home to monitor their progress prior to enrolling in a trial, the FDA found a patient who began receiving treatment before a doctor had been found.
  4. Patients who had Grade 3 or 4 toxic effects were supposed to be removed from treatment. One patient had 3 Grade 3 events followed by 3 Grade 4 events. Another patient had 7 disqualifying toxic events before he was removed from the study.
  5. Burzynski did not report all adverse events as required by his study protocols. One patient had 12 events of hypernatremia (high sodium), none of which was reported. There are several similar patients.
  6. 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] It seems that these overdoses are related to the protocol, which requires family members to administer the drugs via programmable pump on their own. Further, patient records show that there were many more overdoses that were not included in the Hospitalization/SAE/Overdose list.
  7. “Your […] tumor measurements initially recorded on worksheets at baseline and on-study treatment […] studies for all study subjects were destroyed and are not available for FDA inspectional review.” This is one of the most damning statements, as without any…not a single baseline measurement…there is no way to determine any actual effect of the antineoplaston treatment. This means that Burzynski’s studies–which by last account cost $30,000 to begin and $7000 a month to maintain–are unpublishable.
  8. Some adverse events were not reported to the Burzynski Clinic IRB for years. (One patient had an adverse event in 1998 and the oversight board did not hear about it until 2005.)
  9. The FDA observed that the informed consent document did not include a statement of extra costs that might be incurred. Specifically, some informed consent documents were signed days to weeks before billing agreements, and in a couple of cases no consent form could be found.

This document was available online for anyone access to Google to see. Nonetheless, this is the doctor to whom Rosenfield unquestioningly commended young McKenzie’s eager and vulnerable family. The audience of this report was not informed about the true magnitude and nature of the controversy before the station linked to the petition, which was certainly relevant and available. Michael Rosenfield must share some of the blame for what comes.

Three days later, WMUR files a similar report about the petition. McKenzie’s grandfather, again, appears in the report. The interview with McKenzie’s grandmother is heartbreaking, but reporter Jean Macken does not put their grief and fear in context. And they link to the petition, which has already received at least 9,000 signatures following Rosenfield’s report. Jean Macken must share some of the blame for what comes. Incredibly, WMUR had already reported about a fundraiser for the antineoplaston treatment that DIPG patient Justin B. received. Sadly, Justin died.

The next day, the New Hampshire Union Leader publishes an article called, “Hope for McKenzie; A girl vs. bureaucracy.” It is wretched. For instance:

The FDA exists to improve the health of Americans. It screens and tests drugs so that unsafe ones do not reach the market. But what about people who are terminally ill? If someone is facing imminent death, who cares about possible negative side effects of an experimental drug? The FDA does.

Doctors do. For instance, a patient who is facing immanent death may forego palliative care. They risk having their remaining limited time and their savings squandered by a quack. They may get killed quicker. Their quality of life may decline. The cost of trying to deal with the side effects may escalate. They may become ineligible for trials that might actually have a chance of helping them.

Terminally ill children and adults can get unapproved drugs through a policy called “compassionate use.” But even that takes time. Patients have to apply, and the FDA has to approve the use. It is time that some patients do not have.

In emergency cases, the FDA can get approval for compassionate use or “expanded access” overnight.

McKenzie [L.] is fighting for her life. No one knows how much time she has left. We pray that it is longer than the time the FDA will take to respond to her parents’ request. If you would like to help, you can sign the online petition asking that McKenzie be allowed to take the one drug doctors say could save her life.

This last line is deceptive, making it sound like more than a tiny number of uninformed or self-interested physicians would say that ANP would be the one and only drug that could save her. In fact, as we will see, the family has a hard time even finding a physician who would be willing to administer the drugs. This is factually misleading, emotionally manipulative, and irresponsible in the extreme. The New Hampshire Union Leader’s editors must share some of the blame for what comes.

The same day, 25 Nov 2013, the Nashua Telegraph reports on the family’s attempt to get signatures for the petition and to raise money. This is in the news section, not the opinion section, and the reporter, Dean Shalhoup, does not recommend that readers support the initiative. He just reports. Nonetheless, there are some disturbing lapses in judgment that warranted a little research that was either not done or not included.

[The family was] so intrigued by Burzynski’s apparent success in raising from near zero to around 27 percent the cure rate of patients diagnosed, as was McKenzie, with an inoperable pediatric brainstem tumor that they traveled to Houston about two months ago to meet him. “The man has a success rate with this drug,” [McKenzie’s grandfather] said. “I have been in touch with (cancer) survivors who used this drug.”

Of course, Liz Szabo, by this point, had already made it abundantly clear why one should doubt the value of Burzynski’s testimonials:

Yet independent oncologists say that appearances can be deceiving, and that patients shouldn’t be too quick to credit Burzynski. Experts say there are several reasons to be skeptical of Burzynski’s claims.

• Burzynski often relies on anecdotes, which don’t tell the full story. […]

• Burzynski’s therapies are unproven. […]

• Burzynski’s patients may have been misdiagnosed. […]

• Burzynski’s patients may have been cured by previous therapy.

Also, I should mention that sometimes weird things happen. Flukes and fortune can also, rarely, lead to remissions. Next, the “apparent success” cited was easily shown by a little research to be “illusory success.” For instance, Szabo had just reported that the FDA had found that Burzynski had been:

Inflating success rates in 67% of cases, by inaccurately reporting how tumors responded to treatment.

This fact was available and relevant to Shalhoup’s story. Secondly, Burzynski had not–and has never to date–published a reputable study stemming from the 60+ clinical trials he’d opened in the 1990s. This fact checking didn’t need investigative reporting; Szabo, her colleagues, and her editors had done that. All it needed was a Google search. While this is somewhat better than other reporting on McKenzie’s case, Dean Shaloup must share some responsibility for what comes. He allowed desperate people to parrot poppycock.

The next day, on 26 Nov 2013, New Hampshire Senator Kelly Ayotte issued a press release titled:

“Ayotte Urges FDA to Consider Compassionate Use Request for 12-­Year Old New Hampshire Girl Fighting Brain Cancer”

The entirely Burzynski has routinely benefited from patients who believe that he is their only hope. They go to public officials and beg for their lives, which is a bargain that politicians are not in a position to make. They beg in and outside of courts, in statehouses, and in the halls of Congress for the perversity of paying to be in a clinical trial. I don’t doubt that Sen. Ayotte wanted to do the best thing for her constituent. We ALL wanted McKenzie to live a long life. And once Sen. Ayotte had thrown in with Burzynski’s patient, well, someone in her position is in the awkward position of not being able to retract that support gracefully. I had hoped that what happened to McKenzie would lead to the Senator sponsoring radically increased funding for rare childhood brain tumor research in McKenzie’s memory. Research into these tumors is underfunded and patients deserve more options than quackery. There should never be a patient who has to say that “no other treatment options are available,” to quote Ayotte’s press release.

Of course, Shalhoup had to follow up on the story after Ayotte’s office got involved, but when he did, he included a link and instructions on how to find the change.org petition. This is not to his credit. By the 27th, the petition had received 40,000 signatures, no doubt largely from the people who had been misinformed by these reporters. Quackery thrives when reporters opt to do almost entirely uncritical human interest stories. April Guilmet reported in the Union Leader Correspondent that:

Ayotte noted, however, that there have been documented cases of patients reacting positively for the treatment, while the [L] family noted that some patients in past studies have even had their tumors shrink over time.

Burzynski “documented” cures are just as “documented” as UFO abductions and sightings of Bigfoot. This is why scientists–and the regulatory process–requires a higher standard than mere anecdote for miracle cancer claims. Woe to everyone if every nostrum-pushing quack is allowed to circumvent the regulatory process.

On January 13, Shalhoup, from the Telegraph, reports on how the community has committed to help McKenzie, as is to be expected. Strangers can be endlessly kind, but they need to be informed. They need better information than:

“The FDA recently banned the drug, prompted in large part by Burzynski’s 1995 indictment on multiple charges stemming from allegations he violated the federal Food, Drug and Cosmetic Act.”

No. He beat those charges. The FDA didn’t revisit that case. The immediate cause of the suspension appears to be Josiah C’s death and the subsequent investigation. Again, it was in the USA Today piece. While Shalhoup does give a strong half a sentence to vague, uninterviewed detractors of Burzynski, there is nothing like balance in the article, as, again, the link to the petition and info on how to donate is included.

On 28 January Carol Robidoux at the Nashua Patch published an entirely credulous snippet called, “Saving McKenzie [L]: How You Can Help.”

This article ended:

McKenzie’s grandfather […] said the FDA has proof the controversial treatment, available through a clinic in Texas, has a 33 percent cure rate, versus that of conventional cancer treatment, which has a 0 percent cure rate for the kind of cancer McKenzie is up against.

Watch the YouTube video, uploaded here, in which McKenzie and her grandfather tell their story. Then, go to change.org and sign the petition.

Then, pass it on.

Links were included throughout the original. Skeptics did contact Robidoux to try to put what was happening in context. In reply to one skeptic’s email expressing concern, she wrote:

They are going into this with open eyes.
Just as people every day fly to foreign countries for treatments or surgeries that aren’t approved or legal in the U.S., this family has the right to pursue whatever treatment they would like, based on what they’ve tried and what their options are, what’s available, and what offers some shred of hope in a hopeless situation. If it is snake oil, if Burzynski is a fake, there are certainly enough local authorities and national news outlets delving into Burzynski’s claims to bear that out. I see Texas authorities have been investigating him since the 1980s. That’s a long time.
If the family does nothing, McKenzie will die. What they’ve tried already, within the realm of approved treatment – also very toxic to the human body – has not netted any positive results.
People make bad investments every day – in stocks, in get rich quick schemes, in religious organizations that promise healing, in New Age crystals and other remedies. Maybe Burzynski realizes he’s capitalizing on the desperation of people who truly have no other options. Maybe he believes something about his treatment has merit for some percentage of patients. I’m not a medical reporter, or even an investigative reporter, by my own or anyone’s standards.

Her standards clearly mean nothing. She’s in fact wrong about this, as conventional treatment unquestionably had abated some of her symptoms and initially shrunk the tumor as hoped. Orac called out her credulousness on the 30th, and she showed up in the comments:

As the other “credulous” reporter referenced here, I just want to reinforce that the story I wrote was one of several written about a family taking desperate measures to save a child with cancer who had run out of “conventional” treatment options. They were well aware of the quackery charges against Dr. Burzynski, yet were willing to take a calculated risk. It is not my duty as a journalist to tell them they are making a mistake – although I did discuss with the grandfather what I had learned about Burzynski in researching it on background for the story. He knew it all, and had visited the clinic himself. For the poster of this blog to persist in calling me a “credulous” reporter in the context of this blog reinforces to me that he is unable to comprehend that sometimes the elements of a story are not what the story is actually about. I cannot and will not investigate Dr. Burzynski – it was out of my realm of expertise and resources, and has already been done by other investigative health and regional reporters; I will report why a New Hampshire family is feeling so desperate that they are willing to petition the FDA for an unproven and controversial treatment. There was nothing about what I wrote that added credulity to Dr. Burzynski or his method.

The question left unanswered is how a decision can both be calculated and desperate? Robidoux’s staggering lack of self-insight to not realize that a call to “pass it on” might suggest to readers that there was something worth fighting for in Burzynski suggests she is in the wrong business.

On the 30th, we hear from April Guilmet that the family has received the support of Senator Jean Shaheen too. We hear how things were going in mid-December:

In a letter sent to Commissioner Hamburg Jan. 17, both Ayotte and Shaheen urged the FDA to communicate directly with the [L.] family.

In early December, the [L.] family was told that McKenzie would be permitted to start ANP therapy in Texas, provided the family could find a physician willing to monitor her progress locally, [a] family friend […] said.

Burzynski even offered to provide the therapy to McKenzie at no cost, according to her family. [emphasis added]

But just over a week later, further complaints against Burzynski were revealed and the FDA told the family they could no longer issue a compassion exemption.

“It’s come down to this,” said [McKenzie’s grandfather] via his cell phone as he drove on the interstate Tuesday morning. “So now I’m headed out to bang on a couple doors.They may want me to go away but I’m not backing down.”

[McKenzie’s grandfather] said he recently learned that the FDA has made more than 50 claims against Burzynski and at least one of his patients died while being treated.

And despite this, the commitment has been made. The grandfather is crashing through warning barriers that were meant to protect McKenzie and other patients

On the same day, the Skeptics for the Protection of Cancer Patients reached out to the reporter to let her know about our strong reservations about the treatment. We offered documents to substantiate our concerns and gave her contact information of patients who claimed to have been maltreated. She immediately replied that she would like permission to use portions of our letter because:

I think its important to share all sides of this story and there are so, so many.

We consented and appeared in the follow up article a few days later:

Of the Burzynski therapy, the American Cancer Society said last week: “Relying on this type of treatment alone avoiding or delaying conventional medical care for cancer may have serious health consequences.’’

Science blogger Robert Blaskiewicz of the Skeptics for the Protection of Cancer Patients group, said he’s been researching Burzynski for the past two years and is genuinely concerned for [McKenzie’s] well-being, should she ultimately be able to obtain ANP treatment.

“I’m all for patient choice,” Blaskiewicz said. “But I’m also for informed consent. Is [McKenzie’s family] aware of the stories, of the 20-year pattern of patients believing that unambiguous signs of progression are signs of success?”

Dr. David Gorski, an oncologist and the administrator of the sciencebasedmedicine.org website, has likewise devoted much of site to speaking out against Burzynski as well as the anti-vaccine movement and various forms of alternative medicine.

Contacted this week, Gorski said he believed previous trials of ANP “were designed to let Burzynski treat patients, not find answers.”

Gorski is right. We know almost nothing more about antineoplastons than we did when the trials were opened. We have detailed the unambiguous signs of progression (especially ischemic necrosis, or tumors breaking up in the middle because they have outgrown their blood supply) on this site. All we want is a reputable paper to fact-check us, because if we’re right, this is a potential medical ethics scandal that involves 8 times as many patients as the Tuskegee Experiment:

Also in the article, we also hear about McKenzie’s grandfather’s trip to Washington, D.C.:

[He] met individually with some legislators or their staffs last week, including U.S. Sens. Kelly Ayotte, R-N.H., and Jeanne Shaheen, D-N.H., as well as Elizabeth Warren, D-Mass., Ted Cruz, R-Texas, Rand Paul, R-Ky., Ed Markey, D-Mass., Dianne Feinstein, D-Calif., and Tom Harkin, D-Iowa.

He also attended a meeting with seven FDA officials, though FDA Commissioner Margaret Hamburg was traveling and wasn’t present at the meeting.

“Basically, we told (the FDA) that it would be nice if we could get everyone sitting down at one table with them — doctors, patients and legislators,” [the grandfather said] said. “Because there hasn’t been enough communication here.”

When skeptics said that we had concerns, we were not making things up. We had warned and warned and warned everyone about what was going to happen to McKenzie if the family charged ahead and circumvented patient protections. We were concerned that if the doors were opened for one patient, then the FDA would have no justification for denying the treatment to other desperate people.

This is why we were devastated to hear on March 23rd in USA Today:

The FDA acknowledged Friday that it has agreed to allow [7 Burzynski patients] to use the experimental drug, but only if they can find a qualified, independent physician to administer the drug. Beyond infusing the drug and overseeing their care, the doctor would have to formally apply for expanded access to an “investigational new drug,” as well as get approval from an institutional review board, an independent panel that reviews safety and ethical issues involved in clinical trials.

The FDA grants an average of more than 1,000 requests a year for expanded access.

Burzynski will supply antineoplastons for free, says his attorney, Richard Jaffe. [emphasis added]

The next step is finding a doctor to administer the drug, as pointed out in the Billerica Minuteman on March 27th in an article called: “Help McKenzie [L.] Get Needed Treatments.” Again, links are included to the various petitions and projects that can really only help Burzynski and nobody else. The family is still having a hard time finding someone to sign up to work with Burzynski, as we hear in the Nashua Telegraph on 29 March:

That second hurdle, to date a seemingly insurmountable obstacle, is finding a doctor who would agree to administer the drug, called antineoplastons, or ANP, [McKenzie’s grandfather] said. “They said she can use it if we can find a qualified doctor,” he said. “But who knows what ‘qualified’ means? An oncologist? Do they want a research doctor?”

Essentially, the answer to the last question is yes. Which means, [he said] said, even if there’s a doctor out there who would take McKenzie’s case, he or she would likely have to spend lots of money and jump through a lot of hoops to become qualified.

“We can’t even find a doctor to go that far,” [he] said.

This is another red flag; when qualified researchers are unwilling to sign the papers, you have a problem.

Following a visit to Dana Farber in mid-April, according to a public Facebook page set up of McKenzie, the docs say that she “looked really good.” We don’t hear about progress getting a doctor to sign up with Burzynski until May:

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This doctor is Terry Bennett, who explained his participation in the June 15 Telegraph:

The latest move came several weeks ago in the person of a Rochester physician who battled the U.S. Food and Drug Administration to get access to a similarly expensive drug that he felt confident would stem the cancer that was ravaging his body and buy him some time.

Dr. Terry Bennett said his experience prompted him to come forward when he learned the young Hudson girl and her family were beseeching the FDA to grant a compassionate exception that would allow McKenzie access to ANP treatments. […]

Bennett said it didn’t take long after he met McKenzie to agree to be her “backup” doctor in New Hampshire, as he calls his role.

“I thought, if there’s any way they can make this happen, I’m all for it,” he said.

“We have a (sick) little girl here. I will supervise what goes on here the best I can.”

Though you might think, based on the things said above (in bold), and in keeping with common research practice, that the Burzynski Clinic was going to foot the bill. Nope. The family is being charged the customary $15,000 a month in ancillary charges.

Even though the clinic is providing the medication free of charge it is still going to cost approx. $15,000.00 per month for medical supplies, consultations, & administrative fees that insurance will not cover.

While we expected Burzynski to charge out the nose for this treatment, some people thought it was going to be free including the doctor and the nurse who volunteered their services on that basis. On the same day that McKenzie’s Facebook group announced that she was starting on the ANP…

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….and article by Dylan Morrill appeared at Fosters.com, which revealed in part:

Nearly two months later, Bennett and his employees spent more-than 100 hours filling out the FDA application to become the sponsoring doctor and perform the therapy using Burzynksi’s medicines.

Dye was then contacted through “a friend of a friend of a friend,” and decided to offer her nursing services for free to McKenzie. She took two trips down to Burzynski’s Houston clinic to learn about the therapy.

Both Dye and Bennett are not charging for their services, and they thought that Burzynski would also be working pro bono. In December, 2013, Burzynski wrote a letter to U.S. Sen. Kelly Ayotte’s legislative assistant Dan Auger explaining that he would provide antineoplaston therapy for free if the FDA granted the exemption.

The letter read: “This is to confirm S.R. Burzynski, manufacturer of Antineoplaston A10 and As2-1 infusions is willing to provide these agents for free and for compassionate means.”

Bennett said he was told in May during a phone conversation with Burzynski that the medicine was being donated. It was after that conversation that Bennett decided to sponsor McKenzie.

[McKenzie’s] family also believed that McKenzie’s medicine was being provided for free. But […] McKenzie’s mother, said she received an itemized bill from Burzynski showed up in her mail a few weeks ago.

The family was told that the first month will cost $28,000 and every month after that will cost $16,000.

The family received an itemized bill from Burzynski? I think the FDA would be interested in seeing it. I smell a refund!

“It meets all the criteria for a bait and switch operation,” said Bennett. [emphasis added]

The next day, Bennett appeared in another article, which reported:

Bennett said he will not withdraw his sponsorship of McKenzie, despite the cost of treatment. But he’s extremely upset over what he calls a very disturbing phone call that he received on May 28.

Bennett says a representative of the Burzynski Clinic called him on that date seeking payment for the first month of McKenzie’s therapy. Prior to that, Bennett, who is donating his services, thought Burzynski was doing the same.

Instead, said Bennett, “I’m supposed to be the bag man for all of this. They want me to collect the $30 grand for the family and send it to Burzynski.” [emphasis added]

He later said:

On the other, there’s the opinion of Dr. Terry Bennett of Rochester, who agreed to be the overseeing local physician for the treatment of Burzynski.

“This is a classic bait­-and-­switch operation,” Bennett said of Burzynski in a recent phone interview. “He suckered me and this family into buying into a very expensive treatment plan.”

That second article, by the way,  is titled, “Dr. Feels Misled in Cancer Treatment Costs.” It sort of reminds me of the headline. “Amelia S.’s Family ‘Misled By Clinic’” It reminds me of the gouging of Denise D., who was treated so badly by the clinic. It reminds me of Supatra A’s family, who had budgeted but still found themselves in debt to the clinic. It reminds me of poor Kathy B. who said that she:

made this video [of a patient visit with Greg Burzynski] in anticipation that I would be receiving the antineoplastons. Apparently after spending over 30,000 here I found out that the Antineoplastons are only reserved for brain cancer patients who have already undergone chemo radiation. FDA put this restriction on the Burzynski Clinic, so any other cancer patients are BASICALLY ONLY GETTING THE TRADITIOINAL ALLOPATHIC TREATMENTS OF SYNTHETIC ANTINEOPLASON PILLS THAT DID NOTHING FOR ME.

All of these patients are dead. This is what we are dealing with here. This is why reporters need to do a better job of checking the public record before they endorse a shameless quack.

Registered Nurse Ariel Dye also volunteered her services to help McKenzie. She was the one who, instead of the patient, went down to Houston to learn how to use the ANP pumps and administer the drugs. I suspect that patients being trained to administer the drugs themselves may have contributed to the huge number of overdoses observed by the FDA and that this was a fix to the protocol the FDA demanded that Burzynski never got around to doing. He only had 15 years, after all. In November, we hear about Nurse Dye’s experience at the Clinic. She is scathing:

“I went out there and watched the nurse teach a layperson how to work off a central line. It was nothing,” said Dye, who is an IV-certified RN. “It was crazy to me that they charged this.”

“I got little to no instruction saying (things like) if there are major reactions, this is what you’re going to do in this case, in that case,” she said. “They made it seem like it was this big training program they put me through, but they lied and were looking to make money.”

Dr. Bennett came around fully by this point:

“His claims have no merit. He has never tested any of it realistically,” said Bennett.

On day 2 of the treatment, McKenzie feels pretty good, her grandfather reports. But not long thereafter, a few weeks after the start of ANP treatment, we learn that McKenzie is suffering from side effects of ANP:

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On July 27th, we see that the disease is progressing unabated, which is what you would expect if she were put on snake-oil, and what we have seen so many times:

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At about this time, Burzynski was whacked with a 200-page list of charges against him by the Texas Medical Board. This development was announced at The Amazing Meeting, the premier conference on science in the public interest:

http://www.youtube.com/watch?v=yJGIxDou9v0

In response to this action by the TMB, Fosters.com printed an article “Do Not Take Her Hope Away,” which was entirely irresponsible. For instance, they mentioned Dr. Bennett but not his opinion of the clinic. They did not mention that the tumor had continued to grow, as was to be expected. In fact, by July 31st, we hear how ineffective antineoplastons had been:

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In late September, April Guilmet tells us what has happened:

The ANP treatments cost the family about $15,000 per month.“She had crippling headaches and her blood counts got very low,” [McKenzie’s grandfather] said. “At full dosage, her body just couldn’t handle it.”

[McKenzie] went off ANP in mid-August, he said. Since then, her family has been researching other treatment options. She is currently on a regimen of gene-targeted drugs prescribed by doctors at Dana Farber. The family departed for University of Chicago on Sunday, where they will meet with another team of physicians.

The tragedy of fringe medicine is that her tumor might well have been treated by something with a chance of working instead of antineoplaston. To all the reporters who wondered, “What’s the harm in in treating someone with a terminal illness with….whatever they want?” I refer them to the energy, money, and precious time squandered on this course of treatment.

By September 28th, the family is in Chicago pursuing experimental treatment, and Burzynski is, blessedly, out of the picture.

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They are cutting into the brain stem which is usually a surgical no-go zone (and is why so many of Burzynski patients haven’t had biopsies to confirm radiological diagnoses).

McKenzie died at home on 23 Oct 2014. A radiant light went with her, and hundreds of people McKenzie had touched saw her off.

Screen Shot 2014-10-29 at 1.13.25 AM

To think that all of these powerful people were following McKenzie’s story and for want of critical commentary of the treatment in the media, McKenzie suffered for it.

I think Telegraph reporter David Brooks offered a fair summary of McKenzie’s ordeal in his write up after the funeral, “Alternative Methods are Not Safe Bets,” and he concluded:

It’s hard for an outsider not to feel sympathy for a desperate family struggling to save a loved one.

But we should give more weight to a medical establishment that has doubled the human lifespan, that has created a huge, complicated system of peer review, double-blind tests, treatment protocols which is far from perfect but has done more for your health and mine than has a millennium of hopes and dreams.

Brooks apparently interviewed some of McKenzie’s family in the aftermath:

The treatment over the summer accomplished nothing except making McKenzie sicker for a while, and cost McKenzie’s family and supporters many thousands of dollars, even though it was stopped quickly because of side effects, said McKenzie’s grandfather […] .

But [McKenzie’s grandfather] who says the total cost was “less than $25,000,” thinks the effort was worthwhile and might have succeeded if so many obstacles hadn’t been placed in its path […].

Most frightening is the lesson that the grandfather has apparently taken away from this. According to Brooks:

If somebody else he knew was diagnosed with DIPG, he’d recommend going to Burzynski.

The lack of regret is eerily similar to sentiments of the families of Burzynski patients going back decades. For example, in 1982, The Windsor Star reported that a family member still believed in the treatment “with all my heart” but her sister-in-law Deanne had arrived too late for the six weeks of antineoplaston treatment to be effective.

I hope that when the Texas Medical Board drags Burzynski to stand before a judge in Austin on June 15 the press remembers that treating this issue as a human interest story, such as we have seen in the case of McKenzie L., perpetuates misery and magnifies suffering.

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.

Burzynski Patient Rebecca L.’s Story

In January of 2000, according to the New Hampshire Union Leader (24 Apr 2000), 9-year old Rebecca L. became unsteady (she was not skiing well during a family trip, and couldn’t get off the bunny slopes) and she started vomiting.

The Boston Sunday Globe (14 May 2000) tells the story:

For the next few days, Rebecca didn’t feel like going to school. Then, when she did go, her parents received a phone call they will never forget. “Her teacher, who know the signs of brain tumors because she lost both her parents to brain tumors, called us,” [Rebecca’s dad] said. “She was crying when she called us. She said, ‘You’ve got to get her checked out today.'”

When they got to the doctor, according to the Union Leader:

The next day, the doctor told them: “We’re going to be looking for a brain tumor.” The [Ls] were stunned.

Becky was taken directly to the Elliot Hospital and following a CAT scan was transferred to Dartmouth by ambulance, where she underwent an MRI. [Rebecca’s dad] said doctors initially thought she was suffering from a benign tumor on the brain stem and scheduled surgery.

It was not benign. It was a malignant glioblastoma multiforme, and without treatment, Rebecca might have 2 months. She underwent 6 weeks of radiation. And that was about all that could be done. After hearing of two of the patients in area who claimed success on Burzynski’s treatment, they determined to go see him:

The family’s insurance policy with Anthem Blue Cross won’t cover the Burzynski treatment because it’s part of a Food and Drug Administration trial. Their old insurance policy with Tufts would have covered it, [Rebecca’s dad] said.

But he said Blue Cross did more than just refuse to pay for the Texas clinic treatment. “They cut us off from all the support,” he said, and won’t pay for MRIs, blood work or anything else.

While the costly Burzynski treatment offers only a 44 percent chance of success, “I have to try it. If you give up hope, you have nothing,” said [Rebecca’s dad].

The drugs that were supposed to be in trials were Burzynski’s patent medicine, antineoplastons. There is no compelling evidence that the substances originally derived from blood and urine have an effect on cancers. The Boston Globe (14 May 2000) also reported on this:

“The treatment in Boston offers no cure, but down there [in Texas] 44 percent of his patients have a response,” [Rebecca’s dad] said. “It affects their tumor in some way. And, half of that 44 percent are in remission. That’s not bad, going from zero percent chance of living here to 20% down there. When you are talking about your child, I would do it for a 1 percent chance.”

The 20 percent cure rate the father believes is absolute, unmitigated, unsubstantiated bunk. There has never been a trial that established efficacy; there have been zero convincing publications. That number is apparently conjured from the ether. It’s even sadder to realize that when the FDA went in and examined his trial results, they found the recorded outcome did not match the actual response 66% of the time, and apparently it was always inflated. Rebecca’s dad unwittingly lays out exactly why Burzynski has been so successful attracting desperate parents into his office. He oozes hope to the hopeless. How anyone could give that number to this family when they are the most vulnerable is unfathomably cruel.

The cost was sufficient that Rebecca’s father, like those of so many other desperate dying children, went to the media to raise money.  Both the Globe and Union Leader ran the address of the fund that had been established for Burzynski. The Globe quoted Rebecca’s father:

“There are a lot of expenses and I don’t know how we’re going to do this, but we love our daughter and we’re going to do it.”

And they did it. They raised over $100,000 for Burzynski. The stunning generosity of communities is Burzynski’s cash cow, and he milks it over and over. In March of 2001, the Union Leader filled in some of the gaps about the fundraising:

Their insurer would pay none of the bills, so the family let Becky’s plight be known. Fundraisers included a Christian music concert at Veterans Park, a golf tournament at Tory Pines and a NASCAR fundraiser at the Pinardville Athletic Club.

A phenomenal effort. We don’t get a play-by-play about what happened with Rebecca’s treatment. We get a summary from her father:

For a while they worked, said her father […]. “The money, if people donated, it was so worth it. We had a whole year with her. Every day was treasured,” he said […]. She took a turn for the worse in November, and doctors said nothing else was possible.

Yet another family reporting that the treatment was working before it wasn’t. There are endless cases of this on the website. We don’t see what “working” means here. Not growing? Shrinking? Unknown.

It’s difficult to explain why the father credits the treatment with the year, as it is exactly what the doctors at Dana-Farber said the radiation might give her before the family even went to Burzynski, as reported in the Globe on May 14, 2000:

Clipboard01

Sadly, the intervening year can’t reasonably be credited to Burzynski, no matter what the family believes, though it is wonderful that they did have a year together before the end.

On February 22, 2001, teenaged singer Aaron Carter performed in the area, and a local radio station managed to get tickets and a back stage pass for Rebecca. The encounter was described the next day in the Union Leader:

Before the show, he met with 10-­year ­old Becky [L], a wheelchair-bound Manchester girl with inoperable brain cancer. Her meeting with him was quiet ­­ she was really too shocked to speak.

“I like your nails,” he said to her. She grinned . She’d had them done for the show.

Then he wrote “Becky” on his palm and said, “I might even mention your name on stage.”

And when it was time for the thin, towheaded superstar to go, he told her, “You better enjoy the show.”

“I will,” she said back. He “adiosed” and ran toward his backstage area.

Becky’s mother […] said her daughter acted like any other teenage girl this morning.

“She couldn’t wait to start getting ready,” she said. “She knows every word on his CD these days.”

The following Tuesday night, her breathing became erratic.

The nurse gave her sedatives, then pain relievers. Before Becky closed her eyes, she and her father exchanged their last words.

“I asked her if she was still in pain. She shook her head she was,” he said.

[He] stayed up until 5 a.m., and went to bed after the hospice nurse said it could last for days. His wife […] checked on Becky at 6 a.m.

She died before 7.

Rebecca L. died at home on Feb 28, 2001.

Burzynski Patient Janet C.’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.

Janet C. was diagnosed with neuroblastoma at age five. According to her father, who testified for Burzynski in front of Congress in 1998, two years after her diagnosis:

Over a period of 17 months beginning on February 28, 1996 she has suffered through 10 months of very aggressive chemotherapy, 6 days of ablation chemotherapy, 3 days of total body radiation therapy. Twice each day. And then a very gruesome bone marrow transplant resulting in the doctors telling us on February 17 and 18, 1997 that our daughter had only hours to live […].

She was discharged, in remission only to incur 3 life threatening secondary infections. She has been in relatively good health since August 1997. That may sound like good news, but this disease has 93% rate of recurrence which results in death. Most medical journals do not give survival rates after 2 years. They know what happens.

At this point, we need to understand that Janet has been put in remission by grueling yet effective conventional chemotherapy. She had been given more time, but that is, understandably, not enough for a parent who will see anything but a child living a full life to be a failure. It is at this point, when she is remission, that the family starts looking at Burzynski’s treatment. At this point, in order to receive antineoplastons, Burzynski’s unproven treatment, originally isolated from human urine and blood, Janet will need to be on a clinical trial.

It sounds like Janet’s dad had an awful time getting a timely response or even acknowledgement from the FDA that his daughter’s case was being considered for a clinical trial. This is not to the agency’s credit and is a part of the Congressional record. Once everything is filed, of course, as is usually the case, the reply was back very quickly, according to Janet’s father:

The protocol package was sent to the FDA via fax. It was returned to the Doctor’s office, disapproved in less than five hours. The Doctor’s office called and said the FDA had disapproved the protocol and would not allow the Doctor to treat Janet prophylactically. I was shocked by this response from the FDA.

The important thing here is that Janet’s dad wanted to treat the disease prophylactically. This poses some methodological problems for a clinical trial. Let’s say that Janet doesn’t progress. Does that mean that the antineoplaston worked? Or does it mean that she was one of the 7% who happened to not relapse? Well, you can’t in principle know. But the situation here is even less secure, and it’s understandable to see why the FDA would slap the proposal to pump ANP into Janet down so quickly. It’s not even meant to be used as a prophylactic treatment, but only for present disease. This radical departure from normal protocol more than justifies rejection of this particular proposal (not that Burzynski has ever been particularly scrupulous about adhering to protocols):

The father despaired:

The morning after I called Mr. Zimmerman at this home I received a call from Mr. David Banks, also from the FDA. I cried and begged both of these men to at least give my daughter a fighting chance at life. My pleas fell on deaf ears. Mr. Banks sent me a write-up apparently from the Journal of the American Medical Association by a Dr. Green. It was dated 1992 I recall. It was a smear of the treatment I was seeking and the Doctor who invented it.

I called Mr. Banks back He told me to cal a Dr. Blaney at the Texas Children’s Cancer Center. I was referred to a Dr. Stacey Berg. WE discussed janet’s cancer. Dr. Berg stated that a patient in remission was not eligible to participate in the clinical trial for obvious reasons — nothing to measure.

And there you have it. An eminently reasonable explanation. Further, they explained what one of the most important medical journals had to say about Burzynski. Though to the desperate, that gets waved away as a “smear.” The father goes on to say that this Dr. Berg said that Janet had nothing to lose by going on the ANP. If true, it’s a bad thing to say to a patient’s father. What happens if Janet is in the 7% who do not relapse and she has a toxic event like Josia C’s? Prophylactic treatment might possibly kill her for nothing (presumably safe and effective doses for prophylactic treatment hadn’t been figured out anyway). Or what if she is in the 7% and has one of the numerous toxic events the FDA observed to have been ignored or unreported in Burzynski’s studies in 2013? Quality of life or life itself could easily be lost. With no reason to expect that antineoplaston would have any prophylactic effect, why submit a child (a protected class of patient) to unknown dangers?

Not only did the family appear before the House committee to testify for Burzynski, but the father went on TV with John Stossel to make his case to the public.

STOSSEL: Consider Janet [C]. While she looks healthy, Janet has a form of cancer that’s likely to kill her before she becomes an adult. Her parents want to take her to this Texas clinic, run by Dr Stanislaw Burzynski. He has a treatment that might help her. It’s now being studied by the Food and Drug Administration. But only the FDA gets to decide who can be treated, and the agency turned Janet down. They say it’s not safe if people pursue medical treatments the government hasn’t sanctioned. […]

LYLE [C]: My daughter has a terrible disease called neuroblastoma cancer. I know what the survival rates are, which is essentially zero, and I’m trying to do something that may save my daughter’s life. We have absolutely nothing to lose and everything to gain.

We know, of course, that these last statements are not, strictly speaking, true. Further, there is no mention of the fact that the father wanted to give the drugs in a way that they are not being studied to be given or any sense of real risks that actually exist, which a desperate father would be willing to overlook. By April 15th, 1999, when the interview with Janet’s dad aired, we know that the FDA had caved to the pressure of the Congress. Again. Janet got the antineoplastons.

According to the page that used to be up at the Burzynski Patient Group, but has disgracefully been removed:

Janet is now 8 years old, and she continues to be in remission. After only 6 months of antineoplaston therapy, it is still not certain if she has beaten the odds against cancer. It is known, however, that she and her family have won the fight to decide for themselves how they can best save their child’s life.

[Lyle C.] says, “This was and still is the greatest struggle of our lives. I spent 42 years of my life defending this country, 26 years as a soldier and 16 years as a civilian employee. I find it ironic that I served the same government that attempted to deny my daughter a treatment that may very well save her life.”

It apparently did not save her life. Janet died on October 21, 2001 at age 11.

For other patients who testified for Burzynski over his lamentably long career, see the cases of Elke B. and Douglas W.

Burzynski Patient Douglas 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 going to start 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.

Douglas W. was a Burzynski superstar. He was a helicopter crew chief in Vietnam and then became a corporate jet pilot. On June 26, 1994, according to a March 6, 1996 report in The Oregonian, Douglas received a bad diagnosis. He had a brain tumor, a glioblastoma. According to the report:

[Douglas’s] life gave way to surgery, 33 radiation treatments and four months of conventional chemotherapy. The worst still was to come.

In January 1995, [Douglas] and his wife, Lola, heard bad news from their oncologist: The tumor still was growing. The doctor told [Douglas] he had three or four months to live.

At this point, Douglas turned to the Burzynski Clinic and went on antineoplaston treatment. It was not cheap:

In the past year, his quest for life has taken him close to the center of a national medical controversy. He’s spent $75,000 traveling to Texas and paying for chemotherapy that his insurance wouldn’t cover.

Antineoplastons are the almost certainly ineffective chemotherapy that cancer quack Stanislaw Burzynski has kept “experimental” for 4 decades. Though the experiments have led to no reputable publications, he sure has managed to charge hundreds of patients top dollar for the drug derived initially from human urine and blood. Essentially, Burzynski posits that cancer is caused by a lack of “antineoplastons” in the blood, that cancer is basically an antineoplaston deficiency syndrome. No other physician on the planet recognizes this as a cause of cancer, and no competent physician says there is evidence of this alternative immune system that is supposed to take care of cancer.

Regardless, the reason why Douglas is a superstar is revealed in the next few paragraphs of the article:

Eleven months after he started a chemotherapy unapproved by the Food and Drug Administration, [Douglas] is in full remission. […]

Last week, [Douglas] testified before a congressional subcommittee investigating the Food and Drug Administration’s obligation to patients with life­ threatening illnesses. He appeared on “Nightline” with Ted Koppel in defense of Stanislaw R. Burzynski, a Texas doctor who has been giving unorthodox chemotherapy to cancer patients.

In fact, according to the transcript of the May 19, 1995 Nightline episode, Douglas was used as an example of “desperation”:

DAVE MARASH, ABC News: [voice-over] The first thing you feel in the waiting room of Dr. Stanislaw Burzynski’s Houston, Texas cancer clinic is the desperation.

DOUG [W.] My name is Doug [W.], and I’m from Estekay [sp?], Oregon, which is southeast of Portland, and I’ve got a- I don’t know what it is, but it’s a brain-

WIFE: It’s a glio- it’s a glioblastoma.

DOUG [W.] : -glioblastoma, stage IV.

Back to the Oregonian article, where we see some surprising endorsements:

[Douglas] is in the spotlight because his tumor, an aggressive, advanced stage of glioblastoma, no longer makes a blip on a brain scan. His remission amazed his doctors in Portland.

Dr. Gerald L. Warnock, a diagnostic radiologist with the East Portland Imaging Center, has evaluated four or five of [Douglas’s] brain scans in the past year. He said the most recent scan, in January, was totally clear of a tumor.

“I have never seen it happen before,” said Warnock, who has evaluated about 50 patients with brain tumors.

He said [Douglass’s] remission could be a delayed reaction to his conventional treatments, a miracle, or the result of antineoplaston, the drug administered by Burzynski.

Warnock said he is skeptical of unconventional treatments.

“One case doesn’t make a doctor a hero,” he said.

Still, Warnock is impressed with [Douglas’s] remission, because he’s seen his brain scans, both before and after antineoplaston.

“If I had a relative with that particular type of tumor, I think I would send him down there,” he said.

Dr. Bruce Dana, a medical oncologist who treated [Douglas] with FDA approved anti­cancer drugs, also is impressed with [Douglas’s] remission. He said he has never seen a glioblastoma disappear after earlier scans showed it growing.

By any measure, these doctors are being irresponsible. Going to the press with a data set of one person is irresponsible, especially when the stakes are so high, namely a treatment for an intractable tumor. This is not the last time we’ll hear from Dr. Warnock, however.

Of course, we have seen too much weirdness with Burzynski’s charts in the past (we’re thinking of the time that the FDA got two different sets of records, one from Burzynski’s IRB and a different one from the Clinic, about a child whose death sparked a federal investigation–whoops!) for us to accept the interpretations of anyone who has received records from the Clinic. This is a major reason that the definitive study of ANP can’t possibly come from Burzynski’s outfit. They have shown themselves endlessly incapable of maintaining charts and running clinical trials.

Douglas was out among the 75 patients protesting outside the courthouse as Burzynski faced federal charges in February 1996:

Doug [W], a patient of Burzynski’s, expressed hope that Lake will allow continued treatment. After being on the unorthodox treatments since last summer, [Douglas] said his brain cancer has disappeared.

“I had done everything my doctors in Portland told me to do and then after 33 treatments of chemotherapy and radiation, they told me to give up hope. They said I only had two to three months to live. But I wasn’t ready to give up hope. That’s why I came here.”

On the 29th of February, Douglas was in Washington, D.C. and had five minutes in front of a House committee as patients were paraded in front of congressmen and cameras to beg for their lives.

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And here’s why Burzynski and his legal team use patients as human shields. Because patients channel their whole being, their entire hope into the campaign to keep their doctor, who they are allowed to believe is the only thing keeping them alive.

The next time Douglas appears in the media, it’s in the Peoria Journal Star on 5 July 1996, which opened:

Just months after Douglas [W.] went on national television and before Congress to praise an unproven drug for obliterating his brain tumor, he got a shock: The cancer was back.

[Douglas’s] trauma illustrates the contention swirling over “antineoplastons. ” Are they the wonder drugs that desperate patients insist? Or are patients the victims of a fraud charged in a federal indictment of the drugs’ creator, Dr. Stanislaw Burzynski? “There is a long history of promises of miraculous treatments, and they unfortunately generally don’t pan out,” said Dr. Richard Klausner, director of the National Cancer Institute.

[…]

[Douglas] even stands by Burzynski, abandoning antineoplastons only when his brain tumor tripled in size. “We believe that treatment did work with Doug for a year,” said his wife, Lola [W], of Estacada, Ore.

It is sad, but entirely to be expected, to see that Douglas supported Burzynski after a clear failure. They believe the treatment works, but from the outside it is impossible to distinguish between a tumor growing steadily but slowly for a year and a tumor growing like crazy only in the last weeks. This is why we need trials. This is why patient testimonials are veridically worthless.

And we’re not the only ones who question the value of Burzynski’s treatment. Dr. Warnock, the radiologist who said that it looked like he would consider sending a family member to the Clinic after he saw Douglas’s scans, has had a come-to-Jesus moment:

The biggest question is how patients fare over the long term.

Take [Douglas], whose brain scans showed in January that his tumor was gone. In April, it was back. Triple antineoplaston doses failed.

[Douglas’s] doctor cannot explain the initial disappearance. But the relapse and a second patient who had “a flagrant progression of the tumor in 60 days” make him “extremely skeptical,” said Dr. Gerald Warnock.

We suspect Warnock has learned to not speculate wildly in public and that’s why he doesn’t explain the initial disappearance. Doctors and other medical professionals who work with Burzynski’s patients have reported being stung when they see what giving him the benefit of the doubt leads to. Take Dr. Bennett, who treated a girl in New Hampshire earlier this year:

Bennett’s decision [to treat the girl] was based, in part, on a newspaper article that said Burzynski had agreed to donate the medicine required for [ML’s] treatment. But what Bennett didn’t know is that Burzynki planned to charge the family for the clinical costs associated with the therapy.

[ML’s grandfather] said the first month’s bill is expected to be $28,000. Every month after that is expected to cost $16,000. The treatment usually lasts eight to 12 months.

Bennett says a representative of the Burzynski Clinic called him on that date seeking payment for the first month of [ML’s] therapy. Prior to that, Bennett, who is donating his services, thought Burzynski was doing the same.

Instead, said Bennett, “I’m supposed to be the bag man for all of this. They want me to collect the 30 grand for the family and send it to Burzynski.”

Elsewhere, Bennett said that the arrangement “meets all the criteria for a bait and switch operation.” And still elsewhere, he said:

“This is a classic bait-and-switch operation,” Bennett said of Burzynski in a recent phone interview. “He suckered me and this family into buying into a very expensive treatment plan.”

[…]

Bennett has become dismissive of Burzynski’s alleged treatment.

“His claims have no merit. He has never tested any of it realistically,” said Bennett.

And the IV-certified nurse who visited the Burzynski Clinic was apparently not impressed either:

Bennett noted as an example training for Ariel Dye, a registered nurse from Derry who oversaw the intravenous injections of [ML], which cost many thousands of dollars but provided nothing of value. Neither Bennett nor Dye were paid for their help.

“I went out there and watched the nurse teach a layperson how to work off a central line. It was nothing,” said Dye, who is an IV-certified RN. “It was crazy to me that they charged this.”

“I got little to no instruction saying (things like) if there are major reactions, this is what you’re going to do in this case, in that case,” she said. “They made it seem like it was this big training program they put me through, but they lied and were looking to make money.”

Nonetheless, in the same article, and despite the fact that ML reportedly had a bad reaction to the drugs, her grandfather still supports Burzynski:

But [ML’s grandfather] thinks Burzynski has shown at least anecdotally that his treatment has more promise than anything developed by mainstream medicine.

“If he had more funding, he could come up with answers, but nobody wants to do trials with him,” said [ML’s grandfather], who blames Burzynksi’s patent for the opposition. “Because one individual has controlling interest over this, they can’t make any money from this man.”

[ML’s grandfather] also thinks that if the FDA had allowed [her] to be treated at Burzynski’s clinic in Texas, rather than requiring it to be done in New Hampshire under the oversight of a local doctor, she might have done better.

“I don’t believe any of that nay-saying stuff. I’m not going into this blindly,” said [ML’s grandfather], talking about the months of reading and work and meetings he has held on the topic. If somebody else he knew was diagnosed with DIPG, he’d recommend going to Burzynski.

Even though knowledgeable professionals who have nothing to gain from seeing Burzynski shot down and who clearly want to help cancer patients in any way they can, once they have actually worked with Burzynski very commonly come out entirely disillusioned, the targets of Burzynski’s scheme, the fundraisers and family’s and patients, often cling harder to the Clinic, because the alternative is perhaps too horrible for the healthy mind to contemplate.

According to Douglas W.’s obituary in the Sept 8, 1996 Oregonian, Douglas died on the 6th of September, mere months after he appeared before Congress as an apparent cure to testify for Burzynski. He was 48.

For the stories of other patients who have testified for Burzynski but subsequently died, see the cases of Elke B. and Janet C.

Burzynski Patient Elke B.’s Story

As Stanislaw Burzynski heads to court again to answer charges made by a variety of patients to the Texas Medical Board, he is doubtlessly preparing by getting the testimony of current and former patients. In anticipation of this pony’s one trick, we are going to start 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.

Our first patient is an MD and stage-IV breast cancer patient who testified in court for Burzynski in 2012, named Elka B. She was receiving chemotherapy from Burzynski:

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Elke’s obituary, which ran in early November of this year (and is lovely–you should certainly read it, as she was a staggeringly kind and generous person), encapsulates the desperation that Burzynski’s patients and their families feel:

By the time Elke’s cancer was discovered, it had spread throughout her body. Doctors gave her a 5 percent chance of living five years, [her husband] said. She lived for 12.

At one point, [her husband] took Elke to a clinic in Texas, where out-of-pocket costs ran in the tens of thousands. “I don’t care if I have to live in a barn with you,” he told her. “I just want you to live.”

We should note that we do not know how long Elke was at the Burzynski Clinic, only that she was under treatment not even two years ago.

Elke will not be testifying for Burzynski in the upcoming trial.

For more patients who have testified for Burzynski and who are now dead see: Douglas W’s story and Janet C’s story.