*An appeal to encourage Congress to investigate this follows Leo’s story*
On Father’s Day 2006, 3-year old Leo D. was wobbly on his feet, and his doctor had his family take him to the emergency room. He was diagnosed with a tumor on his brainstem, which, after surgery, was determined to be a diffuse intrinsic pontine glioma. It’s a horrible diagnosis to receive, and Leo was not expected to live a year. His family kept a comprehensive blog about their experiences.
Initially, the family had three options. Radiation and chemo, just chemotherapy (Thalomide and Carboplatin), or palliative care. He started on steroids immediately.
The first thing that the family does is to go to New York to see some Thai monks, Sifu Keith and Sifu Kevin. They prescribe a weird diet (“For breakfast, Leo was supposed to have Cocoa Puffs with soy milk and pickles, but the diner recommended to us didn’t have these on the menu, so chocolate chip pancakes had to do.”) and ask an evil spirit to leave:
“Afterwards, we were told more of the mystery. In a previous life, Leo was a bystander to lynching of slaves and that one of those slaves wasn’t forgiving him for not helping. The Thai exorcism would be very complicated and we were told that Sifu Keith, who had been doing all the treatments, would have to call his Master in Thailand over night to get help. We were to come back at 8am Sunday to their house again, but that Leo would be fine and live a long life..and have 2 sonds of his own. That statement gave us so much hope that we were willing to believe and do just about anything.
“The family is told the next day:
“…the slave that Leo watched lynched forgave Leo overnight, with some convincing from the Master in Thailand by phone. Marina needed to have more (male) children; we were given a macrobiotic-style diet to follow, but pork was ok; what colors to wear and have at home; good luck charms and trinkets; etc. We don’t know, but one thing was for sure: Leo was walking much better, talking better, stopped drooling, and generally seemed happier, especially given the circumstances. We caught an earlier flight home, which got us back on-time because of delays, filled with hope.”
It sounds like the steroids are doing their job.
Leo started radiation on June 29, the same day they first hear of Burzynski, and he soon started chemotherapy, which made him sluggish and unresponsive, clearly scaring the hell out of the parents. The family is talking to members of the Burzynski Patient Group. According to the family:
“…got a call from Dr. Barbara Szymkowski, who was very nice and described the process. She told me that because Leo had had radiation already, there was a chance he’d have to wait before joining their trial, but she’d check with Dr. Burzynski, himself. She called back later and said an exemption would be requested from the FDA because of Leo’s condition and age. We should hear back by Thursday evening. Having seen the side-effects of chemo, read about the long-term effects of radiation, and remembering the horrific odds we were given, we have decided not to follow Dr. Goldman’s trial. We know we’re taking a huge chance, but the basic statistics/evidence we read on Dr. Burzynski’s web site offered much, much better odds. If that doesn’t work, we can always try one of these horrendous radiation/chemo studies — unfortunately they’ll probably be there for quite a while. Needless to say, the radiation oncologist, et al were very unhappy about our decision. We’re praying for antineoplastons to work. […] The only issue seems to be money. It may cost upwards of $400,000 for a multi-year treatment (in addition to monthly MRIs, weekly blood draws, etc.). Needless to say, we’ll find the money one way or another, since insurance probably won’t cover the cost.”
This is infuriating. Burzynski does not have the studies to back up any claim of efficacy. This is perhaps why he was slapped with a warning letter from the FDA in November of 2012 for marketing his chemotherapy (ANP is chemotherapy) and now no mention of antineoplastons appears on his website. By the fifth, the family has taken Leo off of all treatment except the steroids.
Leo goes into the hospital with an infection. And we see this update:
On the other hand, yesterday (Thursday) I got a call from Dr. Szymkowski asking us to come to Houston for an evaluation (no FDA approval yet). We had an appointment on Monday and she suggested we plan on staying for the 3 weeks. So Houston is out for now because their protocol says no infections.
What about the tumor? No radiation and no chemo, what do we do?
It turns out that the physicians were not just unhappy the family’s decision to suspend conventional treatments, but they formalized their objections with a letter, which was received by the family when Leo was in the hospital:
Dr. Szymkowski says that even if he were undergoing radiation and chemo, they would have stopped that even, so this doesn’t seem like just a little cold. But Dr. Chang doesn’t want to hear about any of this and honestly believes that traditional treatment is all that Leo needs. Marina spoke to him a few days ago and, in summary, he said that even if we wanted to come back to him, he would not treat/radiate Leo. Today he stopped by the hospital and handed Marina a typed letter on Lutheran General letterhead to that effect.
If we are reading this letter correctly and it is representative of what happened, this letter exposes Dr. Chang to potential charges of patient abandonment. David Gorski, an oncologist, surgeon, and researcher, notes that there are specific requirements to fulfill and procedures that need to be followed when “firing” a patient. Firing a pediatric patient is even more fraught with moral and legal obligations and obstacles. Regardless of the ethical implications of transferring a patient into the care of Burzynski, legal obligations need to be met and continuity of care needs to be assured. Dr. Chang is probably lucky that the family did not contact the Illinois state licensing board, as there seem to be no laws allowing the immediate severing the patient-doctor relationship, as is promised in the letter.
This is in every way a bad situation, and I suspect that it is is up to regulators and legislators to make sure that parents can’t get into these fixes.
On July 11, Leo is sputtering and having a very hard time being understood. The family are waiting to go to Houston. Meanwhile, they get another update from the hospital, and the doctors are are still opposed to the family’s decision. They even drop the word “neglect” in there, which is strong stuff, but indicates the seriousness of the situation.
On Monday morning, July 17, 2006, the family is at the Burzynski Clinic.
After countless forms, we were taken to a large conference room and met with Dr. Szymkowski. She explained various aspects of treatment, including an overview of the regimen: 22 hours of infusions per day (4 hours per cycle) via a 2-channel pump. Leo will be getting 2 antineoplastons: AS10 and AS2-1. We aren’t quite sure of the difference yet, although she did explain, and will post here when we “get it.” She said she couldn’t quote an exact prognosis and that Dr. Burzynski, himself, would talk to us shortly. The few things I do remember her quoting were general side-effects and their statistics. Dangerously high sodium levels were present in about 5% of the patients. Dangerously low potassium levels were less frequent. White blood cell counts dropping were even lower than the potassium levels, so we’re talking 1-2% or something like that. The other side effects were the similar to everything: nausea, vomiting, etc. The good thing is that all these seem to be manageable.
Sounds like they don’t understand the treatment. Informed consent is important.
This next paragraph is interesting, but I’d really get a 3rd opinion:
She also told us that Saturday’s MRI did not provide the good news we originally thought. Although the overall size of the tumor has not increased, there was more “enhancement” than before. […] Continuing, she said FDA approval was no longer required because of the disease progression, more “good” news. Internal Review Board approval was still needed, though, and is expected by close of business tomorrow. The most important question was whether there was an issue of “if.” She said there were no “ifs.” Treatment would begin; it was now just the matter of Wednesday morning or Wednesday afternoon.
Now I settle in for rage.
Then we met the man himself: Dr. Burzynski. He looked exactly like the photos we’d seen and said something to the effect of our coming here was for “hope,” which is something the oncologists, radiation oncologists, neurosurgeons, and other medical staff at home and other places can’t provide. He exuded confidence, but not arrogance. He gave us a glossy brochure of a couple of recent studies that showed statistics about antineoplaston treatment in children under 4 with intrinsic brain stem tumors that were presented at a neuro-oncological conference:
- Complete response (no disease): 30%
- Stable disease: 40%
- Progressive disease: 30%
Those numbers are incredible: instead of about 2-5% chance of Leo surviving, their statistics show something like 70% survival! We understand that there are no guarantees, but we’ll take odds like this anytime over the traditional ones!!!
Who wouldn’t? I am so angry that Burzynski is giving people quotes from a study presented at a conference. Jesus, it’s like as far from peer review as possible. And the father is right, they are grasping at a shadow of hope. Again, this family has heard nothing but bad news since the diagnosis. This is a miraculous claim they are hearing. They are vulnerable. They do not have a clear understanding of the likely outcome of the treatment. They are walking into a lion’s den, and it frustrates me to hell that I can’t help them. Here’s another red flag:
Antineoplastons are gene-based therapy, meaning their belief is that there are certain malfunctioning genes that make people susceptible to cancers. Unfortunately there is no genetic test at this point to validate that, but someone’s working on it.
Leo started ANP on the 19th:
After the usual nurses’ visit, we spoke at length with Dr. Weaver and asked dozens of questions…until we noticed he was getting antsy and trying to stand-up. But we kept on and got all of our questions answered. Good thing they’re all pretty patient over there. Of course Leo was approved by the Internal Review Board for treatment under protocol BT-11: PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH BRAIN STEM GLIOMA.
The next weeks are apparently typical, learning to work the pump, draw blood, etc, for when they return to Chicago and have to fend for themselves.
By the 26th Leo is experiencing the effects of being on ANP, the tiredness that comes from getting up constantly to pee and drink water. This is universal, as best I can tell, and after months of this, yes, you can detect a palpable decline in the quality of life based on the treatment alone. By July 30th, this 3-year old is drinking 3 qts. of water a day.
It’s clear that they are raising money as a “treatment fund” is mentioned. While they are there, kids from Oregon and Italy come to the clinic. The same diagnosis as Leo. As the family prepares to leave Houston, they apparently run up against the ol’ court order that says Burzynski can’t ship ANP across state lines…and then somehow that barrier disappears and gets a tracking number…:
The shipping person tried to tell Granpa how things worked around there — that he wouldn’t ship the first batch (i.e. we had to take it with us). That was his first and last mistake, since the Doctor’s orders were clear, meaning the supplies would be shipped to us, without questions. I guess the person in shipping was at least bright enough to quickly understand with whom he was dealing and shut-up. I’ll have Granpa get the tracking number from him tomorrow. 🙂 We left the building about an hour after this process started, with Leo absolutely ravenous. This is the one day we didn’t bring food with us, of course…
That the Clinic seems to be shipping this drug is evident from the next post, on the 4th of August:
Granpa got the tracking number from the shipping department, which sent the supplies and antineoplastons home yesterday.
There was a quick detour to the ER when Leo is screaming in pain at the Clinic after his pump kicks in. The nurse’s reply?
Nurse Louise said she was too busy to help at that moment and that we would have to wait for some time for her to have a good look, but she didn’t know how long — maybe 15 minutes, maybe 3 hours. So we left knowing either Leo would be ok or in an emergency room.
They go to the hotel, and again, when the pump kicks in, Leo is in pain. They go to the ER. It turns out the needle was no longer in the vein, but pumping ANP directly into his chest.
Their last day at the Clinic is Aug 8.
On the 11th, back home, the father reports that another patient, Justin B., who I have already written about, has had great news about the ANP working. Justin has since died. The other patient, Gus L., I can find no continuing record of. The family ups his steroid because Leo is having more headaches and his arm is not working so well.
On Aug 19, Dr. Dr. Szymkowski from the Clinic calls. They are upping the steroids again. (Leo is still not walking.) She delivers this message:
First, if the symptoms get better, that may be a sign that there’s just increased intracranial pressure from all the antineoplaston fluid that’s being pumped into Leo, which causes more swelling. The antineoplastons seem to cross the blood-brain barrier and at the current doses he’s getting 1,260mL of A10 and 90mL of AS2-1, for a daily total of 1,350mL. Obviously not all of this gets into his brain, but probably enough to cause some swelling. Second, if the decadron doesn’t seem to help too much with the symptoms, that means “something” is happening with the tumor…
For the first time, I heard the following in relation to Leo. She said the tumor may be breaking down. Unfortunately in the same sentence she said that it may also have increased its own evil activity. The evil portion seems unlikely because these symptoms occurred virtually overnight and even this aggressive tumor doesn’t grow that fast. Logically (but no one said these damned tumors are logical) that gives us hope for the best-case scenario: the antineoplastons are working.
It’s depressing because, in hindsight, we know what’s happening. And then that same damned story again:
Leo’s symptoms aren’t getting any better. In fact, maybe they’re again a bit worse, like the drooling that’s slightly started and the coughing while drinking. I honestly believe that it’s because something good is happening with the tumor. We were told several times that things may get worse before they get better because the tumor first breaks-up. That causes more swelling. Then the cancerous cells die and get cleaned-up by the body, which of course reduces swelling.
Or it’s growing and you are getting bad advice. I have seen this again and again and again. Burzynski’s staff have been feeding people this line for decades: getting worse is getting better. See the cases of Evan W, Justin B, Georgia M, Cody G, Leslie S, Domenica P., Chase S, and Andrea W. Think of Amelia S. Again, I think of the nurse told John D.:
“[…] 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.”
As the symptoms are getting worse, the Clinic has the first post-Houston scan done early, on Aug 29th. That same day, Leo’s dad mentions Chase S, whose case is the worst, absolutely the worst case I could imagine. It’s what opened my eyes to how bad alternative medicine can be.
On the 30th, they hear that the tumor has decreased 6%:
IMPRESSION: There appears to be slight decrease in size of the pontine glioma compared to 07/15/06 with slightly less compression of the fourth ventricle and minimally decreased size measurements. There is a slightly different contrast enhancement pattern of the tumor compared to prior exam of uncertain significance.
I know that all they heard was “decreasing.” It’s really not significant, especially when you have some chemo, some radiation and a bump in the steroid dosage. Leo develops a bad case of thrush, a fungal infection in his mouth (due to the depressed immune response caused by the steroids?). And the poor child seems to not be getting any better:
When I got home, Leo wanted me to hold him, which I did. He’s been pretty “floppy” for a little while, like a newborn whose head and entire body need to be supported all the time.
The poor kid’s been through so much that even faint, fleeting exertion on his part is seen as progress. Scared parents pay so much attention to every little thing. OnSeptember 9, the father mentions:
In our own analysis of Leo’s physical condition, it seems to us that decadron has caused Leo’s state, possibly more than the tumor:1. He started to dislike walking after we started him on decadron after the initial diagnosis in mid June. The radiation people lowered the dose from 10mg to 8mg within a week, but since it had been such a short period of time, there was nothing to gain in either direction.In Houston his dose was immediately increased back to 10mg and he stopped walking and talking normally, but he was still able to move around and stand.2. Once we got home, because of headaches, his dose was again increased by 2mg, to 12mg daily. After this, he basically stopped moving, making “normal” sounds, and sometimes has trouble holding-up his head, etc.3. Naturally all the other side-effects, like the weight gain/water retention/sleeping trouble/etc., got worse as well.
Leo’s back in the hospital on Sept 12th having an infected port removed and replaced. On the 23rd his thrush comes back hard, making drinking nearly impossible and ANP has to stop. On the 28th, the first results of another MRI:
By the time we got home, Dr. Kroin faxed me the preliminary results, read by a different doctor than the first MRI. These were more confusing than usual and partly said good stuff and partly not so good stuff, so on average there’s no change. I spoke to Dr. Barbara of course, who said not to rely on these kinds of things especially when read by a different doctor. She said they all see and measure things differently, which was obvious. Consistency is key. Dr. Khan at the Burzynski Clinic would be working on measuring and analyzing the MRI and we’d get a final, signed copy sometime Friday afternoon. He’s the radiologist that’s read all of Leo’s MRIs down there, along with Dr. Dolgopolov. So the wait continues…
On the 30th, the family is considering a feeding tube, since Leo isn’t eating (thrush).On October 2, Leo has a feeding tube and we hear that he has been off ANP for about 3 weeks. Leo is still in the hospital on October 8th. The dad’s frustration is all that is left in his posts. Leo’s digestive tract is not working like it should and he seems to have an unidentified bleed somewhere, which lands him in the PICU, and we hear that his responsiveness is really way, way down:
Obviously this is extremely disturbing to everyone following Leo, and of course us. The other bit of bad news, his mental state, hasn’t really improved. His eyes react to light and he generally reacts to pain. I’m sure he can hear us because his eyes sometimes open wide.
A staff meeting at the hospital is called on Oct 11th to consult about the case:
The 12pm meeting among the doctors happened at 2pm. Unfortunately the specialists that needed to be there weren’t. Drs. Kroin and Battle, a palliative care nurse, a care coordinator, and Clint from Clinical Ethics were present. We weren’t sure exactly why Clint was there, but he left after 10 minutes anyway because he had to be somewhere else. In a nutshell, we realized that Leo really needs an oncologist to follow him. I told the doctors that we don’t need an oncologist’s treatment (i.e. chemo and radiation) or his personal opinions. But we do need his experience and knowledge, especially to anticipate problems and take measure to avoid them. We will be more than happy to discuss Leo’s tumor treatment, but as long as that discussion centers on the facts of antineoplastons. Dr. Battle said she’d try to get someone for us as soon as possible and we believe she’ll come through. She and Dr. Kroin have been there all along, continue to do so, and we can’t thank them enough for at least trying to help and watch Leo.
On the 12th, Leo’s out of intensive care. As they start feeding him again, he apparently in intense pain. On the 17th, he’s home. It looks like they are planning to start ANP again on the 21st. On the 23rd, Leo died.
It’s hard to see how the ANP had any effect on the progression of this disease. I’m just broken over this. I am so, so sad for Leo’s family and hope that they have found something like peace.
Usually, this is where we would put an appeal to donate to St. Jude’s. You may still do that, if you like, but we are now actively campaigning for an investigation into how the FDA decided to allow Burzynski not only to continue his ridiculous trials, but to actually get a phase III trial after a decade of abominable site visits. Go to thehoustoncancerquack.com and you will find the resources you need to put primary documents–the FDA inspection notes–into the hands of your representatives so they can conduct an investigation. All appeals to understand this made to the FDA have failed, so now we need to press the issue onto the committees that oversee the FDA. Please help us uncover what went wrong so we can fix it and so this never happens again. Find out about real clinical trials by visiting clinicaltrials.gov.