Burzynski Patient Claire F.’s Story

*An appeal to encourage Congress to investigate this follows Claire’s story*

Claire F., mother of two, was diagnosed with invasive ductal carcinoma in May 2007 and underwent the underwent a normal course of therapy in the UK, surgery and chemotherapy. In January 2008, she was found to be in remission. She started dating and fell in love with Chris, an old friend. On Christmas 2009, Chris proposed. They booked a church and planned to marry on her 40th birthday in October. In May, however, a lump appeared in her neck. She tells the story on her website:

My GP put me on antibiotics, thinking the lymph nodes had probably come up due to a cold I had. Unfortunately, the antibiotics didn’t do anything, so I was once again referred to the breast clinic. Another painful biopsy was performed on my neck the very next day. The results of this showed the cancer had returned to my lymph nodes. I had an operation a week later to remove the lymph nodes in my neck. Unfortunately, one of them couldn’t be removed because it is attached to my jugular. Removing it would have caused me to bleed out. A few days after the surgery I had routine CT and bone scans to check for any spread of disease. The scans showed the cancer had spread to my spine and my right lung, as well as my neck. I was told I would be lucky to survive the next five years. I have been back on chemotherapy since July of this year [2010]. They’ve put me on oral chemo this time, which I can take at home and the side effects aren’t too bad.

Claire and Chris went forward with planning the wedding and held it as planned, Claire taking a break from her chemotherapy so that she would be at her best that day. The next day, however, they got her scans from an previous test and learned the cancer had spread. She was on a new treatment but looking ahead:

My Mum has recently heard about a doctor in Houston, Texas, Dr Stanislaw Burzynski, who has been conducting clinical trials into gene therapy for over 30 years and how it can treat cancer without causing the unwanted side effects of chemotherapy. Gene therapy is apparently the way forward in treating, sometimes completely eradicating, cancer cells. My husband and parents are of the opinion that we must try everything possible, otherwise we would never forgive ourselves for not giving it a go. This treatment is groundbreaking but unfortunately very expensive.

We have estimated the costs for treatment, travel and accommodation to be in the region of a staggering $100,000 (approximately £65,000). As none of us have this amount of money to hand, we are planning all sorts of fundraising events. So far, my Mum has managed to raise around £15,000 from family donations, which is amazing and is enough to get me and my Dad to Texas, pay for our accommodation and have all the initial tests and treatments out there. We have to stay there for up to a month the first time we go, hence the costs. Chris and my Mum will stay home to look after the girls.

A major reason we are writing this site is that these patients don’t fall into the trap that the Burzynski Research Institute’s antineoplaston trials are anything like respectable. Antineoplaston therapy is no more gene therapy than is eating a banana. It is at this point that Claire is at her most vulnerable. She has been given 5 years at the most to live, has two girls, and is just married. She deserved to participate in a legitimate clinical trial that had a chance of prolonging her life. The Burzynski trials were appalling parodies of the scientific investigation, ones that seemed designed to rope in as many paying patients as possible. In a recent site inspection following the death of a child, the FDA made the following observations:

Among the newly released observations by FDA inspectors:

  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.
All of that is included in the first observation. The second observation showed that Burzynski failed to maintain the records required by his protocols. Specifically:
  1. “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.
  2. 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.)
  3. 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.
  4. The clinic was unable to account for its stock of antineoplastons.

To summarize. The FDA observed that Burzynski’s success rate was inflated, crucial patient records had been destroyed (as far as we can tell, rendering all of his trials completely unverifiable and unpublishable–if Claire was indeed on a trial, her case would not count toward the scientific understanding of antineoplastons, a costly betrayal), that there were numerous serious toxic events, many of which went unreported for long periods of time, that patients were denied informed consent, that paying patients were allowed on the studies who shouldn’t have been included and that patients who should have been dropped were kept on longer than they should have been, and that Burzynski had violated his own protocol.

On Dec 14 of 2010, we hear from her on her webpage:

Thanks for all the well wishes over the last few days. I got my scan results today. They show that the combination chemo drugs haven’t succeeded in shrinking my tumours. My spine is still stabilised, but the neck & lung lesions have grown slightly (again). So, I am going to be put on a different chemo regime, this one is called Gem-Carbo and it’s intravenous, rather than oral treatment. I’m hoping to start this before Christmas. Next week, I’m going to be having daily radiotherapy to my neck to shrink the lymph node that’s been left there, as it’s now giving me some discomfort. The plus side is that my liver and all my other major organs are clear. My oncologist is referring me to see a doctor in Charing Cross hospital, who is aware of the doctor in Houston and his gene therapy treatments. This will arm me with much more information before I head off to Texas. Could be better news, but it could also be so much worse! Xxx

Her radiation treatment is intense and knocks her down a little. Then, right at the end of the year we hear:

The original plan was for me to travel to Texas yesterday, but a couple of weeks ago, my oncologist sent a referral for me to see a professor at the Charing Cross Hospital in London. There are links between Dr. Burzynski in Texas and the Charing Cross Hospital, so my doctor thinks it makes sense for me to see the guy in London and get armed with as much information as possible, before flying out there. My Mum has also recently discovered that there is a clinic in Zurich, Switzerland, which has doctors working under Dr. Burzynski’s guidelines. I am still waiting for the London appointment to come through. As soon as it does, we will know exactly where I’m going and when, but please rest assured that all the money which has been so generously donated will go directly towards my treatment. If I’m able to go to Zurich instead of Texas, the money we’ll save on travel and accommodation will probably pay for at least an extra month’s worth of treatment, which is fantastic. Better still, I won’t have to be so far away from my husband and children for so long!

This is unusual. This is the first we’ve heard of a Zurich clinic. Nonetheless, Claire’s oncologist is mistaken. The physician, Professor Coombes, it turns out, does not have ties with Burzynski, but with a reputable research institution in Houston, MD Anderson, as we hear on Jan 18th:

Just to fill you all in on Friday’s appointment. It didn’t go as well as we hoped it would, because Professor Coombes is linked to another clinic in Texas, the M.D.Anderson Clinic, as opposed to the Burzynski Clinic which we were hoping to get more information on. Having researched Dr Burzynski more over the weekend, the plan is still to visit him to see what he can do for me. His work is still in the clinical trials stage, which is why he’s not known worldwide (and why it’s so flipping expensive!). I feel a little bit deflated about this, but we’re still going to go ahead. We have to try everything that’s out there. Chris has been in touch with some patients of his who absolutely swear by his work.

And the Burzynski Patient Group rears its ugly head, pulling another desperate family into Burzynski’s clutches. In all the years he’s been in “clinical trials” he should have been able to produce a single finished, published study. Claire deserved better. She deserved MD Anderson. On the 2nd of February, she has her Hickman line put into her chest, which is how her antineoplastons will be administered. The traditional chemo is having a positive effect, however, as we hear on March 4th:

Just got back from my results appointment and the news is good! The tumours in my spine and my neck have stabilised, my brain is clear, I have no new disease anywhere else in my body, the new swelling in my neck is muscle damage from having the hickman line put in (which can be treated with physio) and the best news of all is…. the tumour on my lung has shrunk by 1cm!!! This all means that the new treatment is working and I’m raring to go ahead with the next dose tomorrow. I don’t care how crap it makes me feel, it’s working, WOOHOOO!!!! My Mum was crying her eyes out, God love her. The next step is to go and see Professor Coombes again in London, then it’s Texas, here we come!! Thanks to all of you for the thoughts and prayers, they’re obviously working too! xxx

In the meantime, her family and friends are raising money for Burzynski like crazy. By June, however, she still hadn’t gone out to Texas. She is facing some infection issues and she gets violently ill when she starts Taxol, as we hear on June 13:

Chris contacted the clinic in Texas, just to make sure I can have their treatment whilst on chemo and I can! So I started the taxol today. I feel fine at the moment, just very tired.

Interesting. How would you be able to sort the effects of the chemotherapy from any result the ANP would have? (Answer: you can’t. Worst researcher ever.) She returns from the hospital on July 1. As Claire said:

Two weeks ago, I didn’t even have enough energy to lift my head from my pillow and the team have really got on top of my pain management. So, I am now pain and sickness free and Chris and I have been looking into leaving for Texas in two weeks’ time. Flights, car, accommodation and, most importantly, the Burzynski Clinic are all ready for us. The clinic have had all of my medical notes and have said I am eligible for their treatment. All I have to do now is convince Dr. Shah to reinstate my fit to fly letter and get some insurance, then we’re off! I’d like to say a massive thank you to all of you for the donations and lovely messages I’ve received over the last few weeks. I’m completely overwhelmed by this and the support it has given me has been tremendous for my emotional wellbeing. Most of all, I’d like to thank Christopher Faulkner and my parents for looking after me, my children & my blog (!) and for pulling out all the stops to arrange this potentially life saving trip, whilst keeping a bedside vigil for me.

Claire and her husband meet Burzynski on July 18th:

We had our first appointment at the Burzynski Clinic today and got to meet Dr. Burzynski himself, which was a real honour. Today’s appointment was for consultations with the doctors, blood tests and a meeting with the financial team. [...] The next step is for me to have full body PET and CT scans. These will take place either on Tuesday or Thursday of this week. In the meantime, I am going to be started on tablets tomorrow (tuesday), which are a form of gene therapy. We will also be meeting a nutritional specialist, who will give me a list of what I should and shouldn’t eat whilst on the treatment. I’ve already been told today to avoid sugar, bread, pasta and rice… some of my favourite things! That’s you all up to date for now.

On the 23rd we hear:

After taking just 2 doses of the antineoplaston medicine, I spent all of Wednesday night being violently sick and ended up being carted off in an ambulance during the early hours of thursday with ridiculously high blood pressure and pulse rate. The staff at the emergency room were amazing and they gave me an anti-sickness drug and morphine for the pain. Then they hooked me up to a saline drip for a couple of hours to rehydrate me. I felt better in no time, just very tired and weak. We were handed a bill for $1,250 and put in a taxi back to our hotel. Thank God I took out that insurance policy, hopefully we’ll be able to claim most of this cost back when we get home. Thursday was a write off as I spent most of the day trying to catch up on sleep. I missed my appointment at the Burzynski clinic because of it. Chris phoned the doctor there and they’ve re-schelduled my appointment for Monday, giving me the weekend to completely recover from the sickness. Needless to say, I’m not taking the antineoplaston doses for now.

It’s hard to tell what treatment she is on, honestly. She was on “pills” which suggests she is on sodium phenylbutyrate, but she seems to think that it is antineoplaston (PB is a prodrug for the components in ANP). She has been given a liquid form of it, however. The tumor in her neck was pressing up against her vocal cords, and it seems likely that her swallowing is problematic. It does not sound like she is on a clinical trial. You will notice the huge range of side effects that she is suffering, including high blood pressure and tachycardia–these could be direct results of the massive sodium load that Burzynski’s patients have to carry, which can lead to hypernatremia.

The Clinic starts her on Herceptin and Avastin, both common breast cancer drugs. It sounds like she is taking the chemo cocktail route, wherein chemotherapies that have not been tested together are administered to patients. Burzynski sells this as “gene-targeted therapy.”

On July 18th, Claire’s husband notes what is happening:

Time is passing by, we’ve been here for over a week already and we’ve still yet to get Claire started on any treatment that she can tolerate and give us a plan of action to take back to the United Kingdom to present to our Doctors.

The three drugs that have been proposed by the clinic total at $13,825 per month which works out at roughly £8,413 back home.

Once Claire has been cleared to start this treatment we are hoping to get at least two weeks worth here before returning home and then looking to continue the treatment with the NHS and the clinic working together.

Dr.Rakhmanov ( in charge of Claire ) has already said that he will personally fax the plan of action to Claire’s oncologist and does not believe that Claire should have any problems being treated with two of the three proposed drugs, he does however feel that one of them may be controversial but we will have to deal with that if and when it happens.

Of course, the NHS decides that it will not foot the bill, which means more fundraising. On the 14th of August, we hear about her progress, as she is back home in the UK. She’s had it tough:

On Monday of this week, I had my discharge appointment at the Burzynski Clinic. When we arrived there I was in terrible pain on the right hand side of my back, the pain was so bad that I was in tears and quite short of breath. The nurses saw I was distressed and took me to another room to be put on oxygen. This really helped and I felt better in no time. We had the discharge appt, settled our bill for all the drugs/assistance we’d had so far, had our photo taken with Dr. Burzynski and left the clinic.

That photo was posted on her webpage:

Clairejpg

She goes on:

Half way though the flight, I started to get the same back pain I’d had on Monday. Remembering oxygen had helped me then, I asked the stewardess for some. She obliged and I soon got a little audience! But I didn’t care, it was making me feel better.

That Friday, back home, she got up to answer the door and passed out. After she started coughing up blood, her family took her to the hospital, where she was diagnosed with pneumonia. She was in the hospital until the 28th, and then when she came home, she was leveled by a hospital acquired infection.

On 21 September, Claire died. Burzynski’s treatment does not appear to have done anything, but he got his cut.

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 this never happens again.

Burzynski Patient Kyla F.’s Story

*An appeal to encourage Congress to investigate this follows Kyla’s story*

On 5 September 1996, 22 month-old Kyla F. was having trouble walking and swallowing, and her eye was turning inward. After months of exams, it was determined that she had a diffuse intrinsic pontine glioma, the nearly universally fatal tumor that people think, for some reason, that he can cure. These tumors can rarely be biopsied because they are tangled in the delicate wiring of the brain stem. Kyla’s was the size of an egg when she was diagnosed.

After 5 months of treatment on chemotherapy to little avail (and because her age and the placement of the tumor made radiation dangerous), the family began looking for new options. They heard about Burzynski through the father of a little boy, Eric Z., who had the same brain tumor. Eric is now dead.

At the time, March of 1997, Burzynski was allowed to continue to pump antineoplastons into children, but only as part of clinical trials. He opened over 60 “to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future,” said his lawyer. Notice he does not say, “every type of cancer that seemed promising” or “could be helped.” Nope. He wanted to treat these cancers and he did, charging patients tens upon tens of thousands of dollars to participate in his “trials.” Not a single damned one of them has ever been published, and the trust of every patient who participated in the trials expecting their suffering and money to go into useful research was betrayed.

It may be just as well, however, as the trials were incompetently run from every single measurable criterion, from the IRB that, if it were attached to a research university receiving federal dollars, would cause all the clinical research at the university to be shut down. The deficiencies outlined in site observations released in November of 2013 found:

Among the newly released observations by FDA inspectors:

  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.
All of that is included in the first observation. The second observation showed that Burzynski failed to maintain the records required by his protocols. Specifically:
  1. “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.
  2. 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.)
  3. 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.
  4. The clinic was unable to account for its stock of antineoplastons.
And this is not the first time the FDA has inspected his site and found it wanting. This is merely the most recent in a decade-long string of abysmal site reviews.
Of course, we should probably expect as much when Burzynski’s lawyer described the first clinical trial as “a joke” in his memoir.
Kyla started antineoplastons on March 7, 1997. The parents seem to have been told that Kyla might have 2 months. That year, according to her mother’s personal website (cached from geocities):
Kyla started that treatment and has been on it ever since, racking up a bill that is currently 157,500 dollars. As long as she continues to received treatment the money is of little matter. Some parents save for college, we chose to save her life.
To my knowledge, there is no account of Kyla’s life on treatment, however,  on 26 May, 1998, her mother reported at the old version of the Burzynski Patient Group:
On antineoplastons, MRIs of her tumor have shown that it has remained stable, a miracle in itself. A PET scan in November of 1997 showed decreased metabolic activity of the tumor.
This suggests that the tumor hasn’t shrunk. And “stable,” again, is a slippery term that doesn’t necessarily mean “not growing,” only growing very slowly. (Decreased metabolic activity in a tumor, after all, is still metabolic activity in a tumor.) It seems that the tumor is a slow progressing one. In the same update, the mother says that,
“Today, May 26, 1998, she even stood on her own two feet without support!
Did she not usually? There is nothing in this to suggest to me that this was more than a slow growing tumor that may have been allayed by the badly tolerated chemotherapy. Her symptoms may have also benefited from steroids, if she was on them.
Kyla died on Monday, June 14th, 1999 at 7:35 AM.  Her tombstone reads:
Kyla
Come on. Let’s Go
You are and always will be
our Kyla, our hero
Our miracle our sunshine
our hope, our child.
Her mother wrote a poem about her little dancer.
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.

Burzynski Patient Hannah H’s Story

*An appeal to encourage Congress to investigate this follows Hannah’s story*

On Oct 18, 2005, 4-year old Hannah H. began complaining of a headache after her mother took her to skating class. Her mom took her to the doctor who suggested that they go to the hospital to rule out anything serious. By the time they reached the hospital, however, Hannah was slurring her speech and was weak on one side. Very quickly it was determined that she had two brain tumors and one had started to bleed. The first tumor, a benign papaloma in the left ventricle,  was removed with surgery, the other, however, was on the brain stem. According to her mom:

They had to biopsy to see what it was – they had 6 Dr.’s in the operating room and were in there for about 4 hours. She came out of surgery fine with no problems and they were able to get a piece of tumour.

It was a diffuse intrinsic pontine glioma, one of the few diagnosed via biopsy. Hannah was in the hospital through Halloween, as was reported in the Vancouver Sun on Nov 1st.

The family continues conventional therapies (timodal and nemotuzamab) for the next year, but in mid-August 2006, the family is clearly looking for new options. They reached out to Justin B’s family (Justin died in 2007):

We’ve tried the standard treatments and while things have remained reasonably stable, with a few ups and downs, we are always looking out for alternate treatments. We’re hearing lots more about Dr. Burzynski’s treatment and would like to ask you some questions about it

Hannah’s family is talking to other Burzynski patients’ families as well. On 9 Sept, on Leo D.’s page (Leo died the next month), her mother leaves a note:

We have found the same thing with Hannah and the Dexamethazone (what they call Decadron in Canada) we have found that her muscles have gotten way weaker, so her walking is really suffering and her speech has declined a great deal – we are also trying new things to get her off the dex… however we’re finding it really hard to do, we use the liquid and can get her down to .25 of a mg and then we have to go up again because we can’t understand what she’s saying… its been like that for about month now…

On Sept 22, the family announces that they will be flying down to Houston for antineoplaston therapy on the 24th and hope to start treatment on Monday:

Well, we have decided to take our daughter Hannah to Houston and have her treated at the Burzynski clinic. Of the choices offered to Hannah for treatment, this seems to offer the best hope for long term survival. The various chemo treatments had what seemed to be good results for short term survival but Antineoplastons had the better long term numbers.

We’ll be be flying down from Vancouver on Sunday morning and get started on Monday with treatment. we’re making all the necessary  arrangements now and hopefully things will go smoothly.

The statement about long-term numbers is not borne out by the evidence. In fact, there is no good evidence that antineoplastons work. Over 60 trials have been started by Burzynski, but none has been seen through to publication. These are the trials that might have established anything like survival rates, so with no finished, published studies there is no basis for anyone to assert that a “rate” exists. Of course, maybe the clinic was sharing preliminary data, but the problem with that is a recent inspection found that 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.” As a result, his outcome figures for these studies are inaccurate. Furthermore, all the baseline measurements for all patients whose files were reviewed by the FDA were destroyed and not available to investigators. Basically, his results can’t be reviewed. This is part of a pattern of sloppy “research” that stretches back for at least a decade.

The family goes through the customary training period at the clinic, because Burzynski’s treatment requires patients to fend for themselves. This likely contributed to the over 100 overdoses and serious but often unreported toxic events that the FDA uncovered during their inspection. For the record, the FDA told Stanislaw 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]

This would have shut down any research institution that received government funds. We’re talking about entire universities, here, not individual studies. Yet Burzynski still treats patients.

While on treatment, Hannah experiences the overwhelming thirst that comes with ANP’s massive sodium doses, with the attendant side effect of urination, and this causes all sorts of problems and consternation:

We’ve had Hannah on the ANP treatment for almost 2 weeks. Things have been going pretty well with treatment and Hannah hasn’t shown any bad reaction to the medication yet.

We’ve had Hannah in diapers for about 3 weeks and what we’ve had a problem with is all the diaper changes and leaks when Hannah is sleeping. There doesn’t seem to be many times when we are able to get her changed at night and often during the day when she doesn’t have a really big pee and fills her diaper and then leaks. This can only get worse the the projected fluid increase as she continues on the treatment.

Ultimately the family decides to line child diapers with adult diapers. That much fluid is going through the poor little girl.

The family had just returned to Vancouver from Houston when we hear that Hannah has died. She died at the same hospital where she was diagnosed a year earlier. The family thanked the staff of the hospital in Hannah’s obituary. The Burzynski Clinic was not mentioned. I see no mention of any positive results of Burzynski’s antineoplastons in Hannah’s case.

One of the lasting effects of Hannah’s experiences has been the establishment of Hannah’s Heroes, which funds legitimate cancer research and operates to this day. One of the sad facts is that the rare tumor that Hannah had is not well understood and there are not many good therapeutic options. Hannah’s Heroes are trying to fill the research gap in the area of brain stem tumors.

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.

Burzynski Patient Keith G.’s Story

*An appeal to encourage Congress to investigate this follows Keiths’s story*

In January 2007, 29-year old Keith G. started having serious headaches and vomiting. A CT scan of his head showed a large mass. He had emergency surgery, and a week later was diagnosed with a malignant brain tumor, a glioblastoma multiforme, this only 3 months after his brother was diagnosed with a brain tumor. Several surgeries, courses of chemotherapy, and radiotherapy allowed him to fight off the tumor for a couple of years. He married in May 2008. In March 2010, a scan showed that the cancer was back, and this led to more surgery in April. This time the tumor came back very rapidly, was removed again in September, and was found to be grade 4.   They started a variety of oral and IV chemotherapies, but Keith’s wife was looking for other options, as the chemo made Keith very tired. In fact, the family was already looking at the Burzynski movie by 15 June. By August 2011, Keith was well along the road to the Burzynski Clinic.

After they arrived in Houston, Keith and his wife found that their insurance company did not cover antineoplastons (they almost never are because the treatments are unproved and unpromising). As his wife explained in the Limerick Post:

“Treatment is very expensive here as all medical treatment in the US, but we can’t let that stop us.”

This is not the first time that we’ve seen this when folks come to see Burzynski from abroad. The mother of Luna P. said this as well, that treatment in the US is always expensive. But there are compounding issues at play here. First, the expensive chemotherapies are for treatments known to have a chance of working. Second, when people here see that their week at the hospital cost $200,000, they don’t often realize that the hospital only expects to recoup a fraction of what they submit to the insurance company, so they ask for a lot. Patients who are self-pay often get a self-pay price for their care, which is more in line with the market value of the treatment.

Another interesting comment from Keith’s wife in that article:

“It is gene targeted treatment that has seen very good results on brain tumors. It is not a form of chemotherapy and is non toxic.”

This is simply false in every particular. Burzynski has never been able to finish and publish a trial that would give him anything like a cure rate. And it seems like he never will, since a recent FDA inspection of his trials revealed a host of colossal, inexcusable, and profoundly damning deficiencies in the trials, from inflated outcomes in 66% of the patient records examined to all baseline measurements destroyed. You can read about this unthinkable list of violations at the Burzynski Clinic at USA Today and links to the primary documents at thehoustoncancerquack.com. The 3-page list of known toxicities from Burzynski’s own patient consent forms includes:

  • severe or life-threatening increased sodium concentration in blood;
  • risk of death;
  • allergies;
  • difficulty arousing;
  • coma;
  • severe or life-threatening low potassium concentration in the blood;
  • decreased levels of consciousness;
  • upset stomach;
  • low platelet numbers requiring transfusions;
  • severe fatigue interfering with activities of daily living;
  • fever greater than 104F;
  • frequent urination at a rate of urination at least once every hour of more often or a requirement for a catheter;
  • liver toxicity;
  • hallucinations;
  • vomiting;
  • chills;
  • swelling;
  • irregular heartbeat;
  • decreased white blood cell count;
  • slurred speech.

On September 17, “The K Project,” a fundraising campaign for Keith’s treatment, is set in motion.

On September 20, 2011, Keith’s wife sends a note to concerned family back home in Ireland:

… Keith is on a combination of oral drugs at the moment & if a positive response is seen then he will probably be put on to an iv drug called Antioneoplastons. After approx 2 weeks on this he will be allowed to go home where he will continue treatment. Everyone in the clinic are lovely. They are pretty busy & have alot of foreign patients. If anyone is interested there is a movie that some of ye might find good. It’s called. ‘burzynski the movie’ on u-tube. Just look for the full length version.

So I will keep ye all up to date with what is happening over here.

On the fundraiser’s twitter feed, we hear:

After a few days rest K is back into the Texas Clinic today. He is pretty tired but is in good form. He thanks everyone for their support

Sadly, the movie that they are referring to is profoundly misleading, and it is clear that the filmmaker does not understand the patient records that he included, as they demonstrate that the tumor sizes are unrelated to dose or time on treatment. This means that, regardless of the outcome, the antineoplastons are likely not having any therapeutic effect. Most viewers won’t know how to read these files, and it will leave them with a badly flawed perception of their prospects at the clinic.

On September 20th, we get an update:

We really never expected anything like this but it really takes a lot of pressure off us as medical treatment in the US is very expensive & we found out just when we got here our insurance company would not support Keith. So this will be a great help towards his treatment.  We have been in Houston now 3 weeks. We originally thought we would be here for 4 weeks maximum but it now seems we could be here for another 4 weeks but we really are unsure about this.

On September 27th, we get a pair of tweets:

Ks had a hard few days and has been pushed to the limit on a massive collection of Meds. However he is in good form and looking ahead.

After a recent MRI we now know there has been no tumor regrowth and its the same as the last scan a few months ago. This is a good thing too

On October 2, the twitter feed reports that Keith has low phosphorous levels, but they are back to normal on the 4th.

By October 6th, the K project has raised 7,000 euros for Burzynski’s treatment and on the next dayfriends back home have a huge fundraiser for Keith and his wife. The next morning, the account is up to 12,000 euros. In all, about 10,000 euros were raised on a single night. But on the 8th we also hear that Keith is having seizures and that his Keppra is being upped. On the 11th, they announce that he will be seeing a neurologist about the seizures. 

The family is still in Houston on 19 Octoberit seems, and his story appears in the Western People newspaper. At this point 18,000 euros have been raised for Burzynski. Irresponsibly, the journalist says that Burzynski has “a remarkable success rate, especially among young cancer victims who have suffered miracle-type cures under his care.” James Laffey, if you are going to announce miracles, by god make for damned sure that the miracle healer doesn’t end up on the front page of the USA Today exposed as a quack in front of the world before you commend him uncritically to other desperate people. 

In late October, we hear in the Connaught Telegraph:

Keith and his wife Brenda have to travel to Texas about three times during each year of treatment and are currently there receiving the first stage. Meanwhile, back home a number of fundraising events are kicking into gear over the coming weeks.

The total cost will be about  €75,000. A huge number of events are set up to meet this goal.

The family arrives back in Ireland on the 22nd of October. Four days later, Keith is suffering from a chest infection at the site of the port that he had installed to receive the antineoplastons. This is a known, frequent adverse event associated with antineoplaston treatment. On the 27th, in the Galway Advertiser, his sister notes:

“Keith has been very weak and having frequent seizures but these are now being brought under control. He had an MRI scan not so long ago and it showed no change. This is not a bad thing as his tumour is very very aggressive and the fact it hasn’t grown more is good news in itself as he has been off chemotherapy for nearly three months now.”

Keith died on 16 Dec 2011. According to The Western People:

“On his return from America, Keith developed further complications and his health deteriorated rapidly in recent weeks. He passed away on Friday surrounded by family and friends.”

There is nothing in the public record to suggest that for all the hard work and fundraising by Keith and his friends that Burzynski’s treatment did anything more than give poor Keith an infection.

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 and warning letters–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.

Burzynski Patient Laurye L.’s Story

*An appeal to encourage Congress to investigate this follows Laurye’s story*

(note: quotations from the Laurye’s family’s website are translated from French)

In September 2002, 2 year old Laurye L. was taken to the optometrist, who diagnosed her as farsighted. In January, doctors carried out some visual tests on her, but it turned out that Laurye’s visual problems were not in her eyes, but in her brain. In early March 2003, her health was clearly deteriorating. On the 11th of that month, her parents received a diagnosis. It was that monster that keeps appearing on this website, the Diffuse Intrinsic Pontine Glioma, a brain stem tumor for which there is no real effective long term treatment and to which most patients succumb.

Three days later, Laurye had surgery to reduce pressure in her head, but the prognosis was the same. The family was discouraged from making Laurye suffer through chemotherapy by their doctors. They did, however, give her cortisone and started 28 radiation sessions, which seemed to slow the growth of the tumor.

The family found a real clinical trial in North Carolina (“a chemotherapy with painful side effects without promise of success”) and they found Burzynski, whose treatment, antineoplastons (ANP), they believed, gave Laurye a 50% chance of a cure.  No published studies of ANP exist to substantiate that number, or any number for that matter. In fact, the FDA recently observed Burzynski (as investigator, the subject of a recent 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. Given these findings, there is no basis for any percentage given by anyone about the efficacy of antineoplastons to be believed.

The parents describe their rationale:

“The name of the treatment is antineoplastons. [It is] nontoxic, the side effects are very minimal and do not affect the quality of life: excessive thirst which increases the volume of urine, no pain for Laurye. After many confirmations with patients who received treatments from Dr. Burzinski successfully, we chose this option believing that this is the best opportunity available to children with this type of tumor.”

Sadly, this is another case of the Burzynski Patient Group luring another person into Burzynski’s exam room. In August, the family goes on vacation, and Laurye is still well enough to learn to fish with her dad.

They outline their plan. On Nov 24, the family will leave Quebec for Houston. The intravenous treatment will cost them $7,200 for the first year and in the second year, capsules will cost $2,000/month for as long as Laurye is on treatment. Medicare does not cover the treatment, so the family sets up a foundation to fund Burzynski’s treatment.

In Houston, on the first of December, Laurye has a port installed in her chest where she will receive the antineoplastons, which will be pumped nearly continuously for months at a time. Laurye has an MRI the next day, and the family passes the next few weeks, like all other caregivers who come to Houston for ANP, learning how to administer the antineoplastons:

learning

This practice, having patients’ families administer the drug, may have contributed to the over 100 overdoses in the last few years. It does not explain, however, this observation by the FDA:

“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)

The family returned to Quebec on December 18th. The family reports:

Since December 3, Laurye is on intravenous injection. She must wear a backpack with 2 medication bags in it 24 hours a day. A small pump, connected by a pipe to the catheter, is programmed every four hours (6 doses per day ). We have to change the bags and reprogram the pump daily. In addition, Laurye has a healthy diet to follow and an MRI every two months. The only side effects are excessive thirst, fatigue, and frequent urination.

The unquenchable thirst and urination are caused by the high sodium load that ANP patients carry. According to the FDA’s findings, one patient experienced 12 episodes of hypernatremia (high sodium), none of which was reported.

The family’s new foundation very quickly holds numerous fundraisers, mobilizing the entire community. According to the numbers on the family’s website, no fewer than 18 fundraisers were planned. Additionally, first nine raised $31,520.75 for Burzynski. It is an outrage that the immeasurable kindness and generosity of entire communities has been squandered on Burzynski’s apparently unpublishable studies.

In February (presumably), we get another update.

Her current situation is stable. Every day is an uphill battle against this deadly disease for the whole family, for friends and especially for Laurye. This unique method of treatment [demands] a exceptionally big commitment of time, energy and courage from us. Currently, Laurye is doing very well. [...] The first months were difficult; before her body adjusted to the treatment, she was tired and irritable but the best is yet to come for our Laurye.

We got the results of the January 30, 2004 [MRI], encouraging news for our daughter. The tumor did not progress. She remained stable.

While this does mean that the tumor is not growing quickly, periods of tumor stability are not unexpected even without treatment.

Laurye has not had a winter like other children. We always had to be careful that she did not fall ill. Also, the pump does not react well to cold temperatures so we had to limit her outdoor activities. Laurye changed physically (weight gain and swelling) due to cortisone medication to be given in addition to the current treatment. This is to [prevent?] pain during treatment because [when] the tumor is attacked it can cause a lot of pressure in the head. After the good MRI results, we could reduce the cortisone.

This sounds a lot like a line that patients have been repeating throughout this project, that symptoms of getting worse (in this case, swelling in the brain stem) are often described by patients as if they were signs of getting better. Parents of sick children grasp anything at all that would suggest that their child is getting better, even when it is getting worse. We’ve seen a disturbing pattern of patients reporting that getting worse was getting better. We’ve seen it at least 10 times.

We don’t hear much, honestly, until 2005. A mysterious spot appears on the January MRI and disappears on the Feb 22 MRI. Another MRI is scheduled for April 5. The news is not good:

Laurye past a MRI on April 5 and the tumour increased of 3% and there are 3 spots (8mm, 4mm, 1mm).

Doctor Jurida asked [for] a pet scan to see if there is some activity in the spots. We are very worried. We are waiting for on appointment for the pet scan and with the results we will know more. But what we find weird is that in january there was a spot. Febuary it was gone and know there are 3 of them. [...]

Laurye eyes restarted to cross and her legs are hurting. Can someone tell if they ever have any spots like us and what happened.

We don`t know what to think? Doctor Jurida says that as long as we have some spots we cannot disconnect Laurye? It is going to be 17 months on the I.V. treatment and Laurye is starting to be tired of it.

By May, Laurye is off ANP. On May 22nd, she goes on Temodar, which seems to be a standard treatment for this type of tumor. Laurye’s mother reports in June:

Doctor Burzynski told us that it doesn’t do any good to keep Laurye on the treatment. He is suggesting the capsules of antineoplastons all alone or another possibility, capsule of sodium phenylbutyrate (PB) with a soft chimio.

I would like to know if you heard of the sodium phenylbutyrate capsule and what do you thing of them.

Laurye is loosing her ability`s a little bit every week but the clinic can`t tell me if it is necrosis or other tumours. The only way to know would be a biopsy and it is too dangerous, so we will never know.

They do mention that her only side effects from the chemotherapy is constipation and tiredness. In the same post, we see this:

We would like to take the best decision for Laurye. We decided to start oral chemo (TEMODAR) on may 23, 2005 hoping to stop the tumours if its the case for an undetermined time because we would like to go back to the antineoplaston capsules to prevent the increasing again. What if it is not the tumour increasing and it is necroses due to radiation. She is going to have done chemo for nothing, it doesn`t take the necrosis away. the only way to stop necrosis would be hyper-bar oxygene (HBO).

There is a question i’m asking myself and 2 doctors say 2 different things. Do you think chemo increases [radiation necrosis?]

Laurye’s flame is flickering in these final months. On September 8, an update from a family friend:

A few weeks ago [Laurye] was unable to walk or stand. She was unable to do much but lay on the couch and drink through a straw. Her doctors in Canada said it was due to a bleed, but could not confirm it. Her Decadron was increased and she got up and went to school. She had a PET and we are still awaiting the results. Unfortunately, the increased Decadron dose is no longer working.  Depending on the results of the PET, as to whether or not she will qualify for Hyperbaric treatment. She will have to go to a private clinic because the local MD’s have told her parents to let her go (pass away) and will not authorize any further treatment.

On September 10th, in Le Soleil, we hear:

The battle of the little Laurye [L] against the brainstem glioma, a rare and incurable cancer, is nearing completion. The girl who has awakened the sympathy of the population during two years of valiant struggle now living his last moments.

“Let yourself go, Laurye, I’m ready to let you go.” The voice full of distress, Sonia [C] courageously facing the imminent death of his daughter. “I asked her if she was ready to go to heaven. She said nodding,” tells the mother, experiencing immense pain.

Although Laurye’s awareness is intact, her physical condition has deteriorated significantly in recent days. She first stopped walking and talking and can now no longer eat.

Sonia [C] [was] torn from the bedside of her 5-year old daughter for a brief press conference yesterday afternoon to announce that a few hours, maybe a few days, remained in Laurye’s life. She [thanked] all those who supported the family morally and financially throughout his illness.

In the same article, we hear what the total amount that went to the treatment:

Founded in 2003, the Laurye [L] Foundation has raised approximately $235,000. The director of the Foundation insisted that the remaining approximately $ 10,000 cash will be used to fund research on glioma or will be routed to other foundations that assist sick children.

A staggering sum.

Laurye died on September 10th.

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.

Burzynski Patient Briannah O.’s Story

*An appeal to encourage Congress to investigate this follows Briannah’s story*

At four months of age, after seizures and becoming rigid and immobile, Briannah O. was diagnosed with a exceedingly rare brain tumor, a juvenile pilocytic astrocytoma. The tumor was inoperable and eventually the size of a grapefruit. It’s typically slow growing and while usually benign, it occupies valuable real estate. In the first two months after diagnosis, Briannah had two shunts put in to relieve pressure from fluid accumulating in the brain and had a very, very brief trial with chemotherapy. According to one of Briannah’s websites:

2/11/07
This picture is her after the emergency ventricular tap that Dr. Moss did the evening that we arrived. She was still sedated here.

2/11
I took Briannah to the ER room at PCH Sunday afternoon. She was admitted into PICU. Dr. Moss did an emergency ventricular tap to relieve fluid from her brain that had been building up and causing her such great distress. Dr. Moss also wanted to test the fluid and make sure that there was no infection in it so that Dr. Shafron would be able to continue with the shunt surgery that she needed the next day.

In early 2007, the family was interested in going to the Burzynski Clinic.

Almost immediately, the family started to run into troubles with the Clinic. Brianna’s mother left a post on a message board on May 10:

We are all geared up to go to Houston for treatment but I am running into red tape from both ends. I have been in touch with the Burzynski clinic for 2 weeks now and am not getting any where. None  of my daughter’s doctors here are going to sign any documents that  legally bind them to the clinic and that legally links them to be a  FDA co-investigator! How did you people get this done? I told the B. clinic that my daughter’s doctors will do blood work and monitor  her but will not sign any thing. The B.Clinic people are making me feel very pressured like its my problem and that I need to work it out and yet they have not offered me a solution when I’m sure that they deal with this all of the time. Plus I have spoke with 3 different people and have gotten no where. What do I do now? Can’t I just make an appointment and fly to their and go from there. Can’t a doctor at there clinic do this for them?

The antineoplaston treatment can only be administered, per an agreement with the FDA in the mid-1990s, under the auspices of a clinical trial. Burzynski opened over 60 clinical trials and in the nearly two intervening decades has only finished one and published zero.

One of the problems is that after the training period of a few weeks in Houston, Burzynski shifts the burden of administering the treatments for months onto the caregivers. The fact that the administration of the treatment is in the hands of well-meaning amateurs may have contributed to a finding the FDA made earlier this year:

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]

Because people are administering this treatment at home, they need local physicians to take over the routine tasks of blood work and other local monitoring. It is not at all surprising to see that a patient would have a difficult time finding a knowledgeable physician refusing to work with Burzynski. When she says no doctor is going to “sign any documents that  legally bind them to the clinic and that legally links them to be a  FDA co-investigator,” it is ironic, since according to an argument by which Burzynski managed to cling to his medical license last year:

“Respondent’s ownership of the clinic and his self-designation as the clinic’s chief physician on some forms, his ability to hire and fire everyone, and even that the forms which state that he is in “charge of treatment” (as stated in the informed consent forms for patient A) is only evidence of responsibility under vicarious liability theory, given the fact that the medical records detail exactly what doctors provided services to these two patients and who was involved in the delivery of medical care to these patients.”

It sure sounds like someone knows it’s a bad idea to take responsibility for patients at that clinic.

The same day as that previous post, Briannah’s mother posted:

I did just speak with Barbara T. in Houston and she did explain about the importance of the 1572 FDA form that they have to have in order to  treat Briannah and I understand that. Now I just need to find a doctor who will be a co-investigator.

“Barbara T” was likely Barbara Tomaszewski, who was Burzynski’s business manager. According to Burzynski’s lawyer, during the period when Burzynski was indicted, she kept the clinic afloat:

“As the patient numbers started to decline, she came up with dozens of ways to cut costs and increase income. Some of the services that had been farmed out, like pharmacy supplies, were brought inside the clinic, and buildings were refinanced. She did whatever she had to do to squeeze or save every dollar she could.” (108)

I wonder how much of the current “everything but the squeal” business model of the clinic is a legacy of this woman?

Later that same day still:

Dr. Weaver with the clinic in Houston called me today. He told me that Briannah would need a doctor here in Arizona to evaluate her condition and get back with them and that it would have to go before their board before they could treat her.

I had no idea how hard it would be to get treatment.

Sure I could go into the problems that the FDA reported about how Burzynski’s institutional review board works, but who has the time? Luckily, there’s an entire Form 483 covered with numerous observations that suggest the board is unable to oversee a trial.

On the 17th of February, Briannah’s story hits the papers, as the family desperately scrambles for funds for Burzynski:

The [O family] and their friends and family are seeking financial help to get Briannah to Houston for the experimental therapy, which uses synthetic organic compounds called antineoplastons.

Dr. Stanislaw Burzynski originally developed the treatment more than 30 years ago, and has treated more than 3,000 patients with the intravenously injected compound, which essentially reprograms the brain tumor cells to die off and stop growing.

The procedure is considered experimental because Food and Drug Administration trials that have been ongoing since the 1990s are still under way. That also means it is a private treatment that insurance won’t reimburse. Just starting the treatment costs $20,000, and it can add up to as much as $200,000 over time.

Preliminary FDA trials show that of 226 brain tumor patients treated, 29.2 percent showed complete disappearance or more than 50 percent shrinkage of the tumor, 35.8 percent showed stabilization, while 35 percent had continued tumor growth, according to the clinic.

One wonders where these numbers came from and if they can be said to represent anything real. It’s hard to know since the FDA observed that 2/3 of the outcomes that they examined during an inspection were inaccurate:

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.”

At the end of April, Briannah has a shunt revision. The next week, she is up and bubbly, apparently healthy enough to travel to Houston:

The gift of little Briannah’s health comes at the perfect time, following a $22,000 anonymous donation to help start an experimental treatment at the Burzynski Clinic in Houston. Another $2,200 has been donated into an account established for Briannah.

But the struggle the [O family] began almost a year and a half ago, when their daughter was diagnosed with an inoperable and life-threatening brain tumor, is not over.

They need a local doctor to agree to be the “co-investigator” for Briannah while she is home from her treatments in Houston. And, in future months, they will need an estimated $7,600 per month to maintain the treatments.

Tammy said she is not a desperate mother grasping at straws, but a mother who has no other options for treating her baby’s condition.

The treatment is considered controversial in some medical circles.

This passage is simultaneously heartening and infuriating. The generosity of strangers is often amazing, and this is one of the biggest anonymous donations that we have seen since we started this website. Nonetheless, I am baffled that hundreds of patients have been looking for media attention to raise money for decades, and not one reporter has gotten off their backside to investigate whether or not their coverage of the issue would be a positive thing for the community until Liz Szabo put in months of legwork for her USA Today report, which appeared a few weeks ago. She and her editors should be congratulated for their brave decision to look more deeply into the Clinic, a courage that was recently honored with high praise from William Heisel on the Annenberg School blog: “Her story in USA Today, Doctor accused of selling false hope to families, is one of the best medical investigations I have read.”

On June 6th, a gallery of the family’s trip to Houston goes up.

On June 11, 2007, Briannah’s mom sent an email to a member of a now abandoned antineoplaston support group, who reposted it. The family had some connections in Houston (I think they lived there before), and after they flew down, spent some time reuniting with friends. Then they visited the Clinic:

Today was our first appointment with the clinic. We met with Dr. Burzynski and his staff of doctors and nurses. Everyone was most delightful and helpful. Dr. Burzynski was very forward in expressing the fact that the tumor Briannah has been diagnosed with is very large and that the therapy is a slow and gradual process.

The day did get hectic as it progressed because of processes that take time. She was evaluated and accepted for treatment.

Briannah has a 1pm appt. Briannah will start the antineoplaston treatment tomorrow.

We were told that the MRI that we had done in Phoenix was not the proper MRI. We are being told that we have to have another one done here and it will cost us out of our pocket because we are out of net work with our insurance! I quickly called Dr. Kaplan, who is Briannah’s nuerologist with Phoenix Children’s. He told me that I didn’t need another MRI. I agreed! Dr. Weaver with Burzynski promply called Dr. Kaplan and Dr. Kaplan promplty answered to help us. He is faxing over a letter to submit to the FDA requesting that they accept the MRI that we submitted so we don’t have to get another one. This is all about FDA protocal.

I have to admit that I got a little upset and was not happy about the MRI situation. I was never told by the clinic in all the times that I spoke with them over the phone that it had to be a specific kind of MRI. I was just told that I had to have an MRI with in 2 weeks of our appointment.

The one that we had done in Phoenix before we left was called a one bang and does not require that Briannah be put to sleep. It also is not as defined as the other ones are that require sedation and dye.

Dr. Kaplan stated that it is to risky to do that to her and that it could put her at risk for respitory infection. I have to say that I  agreed and am so glad that he helped us out with this.

At this point, I imagine that the family spends a couple of weeks learning to be independent caregivers for their daughter. Learning how to use the pump and prepare the bags. They stay with a couple who live near the clinic.

According to the local paper on 16 June:

[Briannah's father] will return to Gilbert on Father’s Day, leaving his wife and their two other daughters in Houston for the first three weeks of the treatment, which could last an undetermined period of time.

“We don’t doubt that the medicine is going to work on her,” Mark [O] said.

The treatment begins the same day that article runs. A scan posted in July shows the sheer size of this tumor:

scan

In August, the family is having a hard time keeping Briannah’s electrolytes under control. Her sodium levels are all over the place, and she’s experiencing the known side effects of antineoplastons:

Briannah’s sodium keeps going up to the high 140′s, so I have to disconnect her from the pump, but then her sodium plummets to the 120′s and will keep going down if I don’t do something. Her potassium is up and down too – 2.5 – 2.7. She has been doing so good for so long, but every time she gets her antineoplastons increased it causes her electrolytes to get out of balance.

She will have a seizure and fever of 102 or more every time this happens. I didn’t rush to the emergency room this time and she came out just fine.

The clinic said that they didn’t have a patient who’s sodium plummets like this before.

The 2 times before that we were disconnected we ended up in the hospital because no one knew what to do with her. She ended up having convulsions because the doctors didn’t listen to me and give her the sodium supplements.

All that needs to be done is give sodium/potassium.

At about the same time the Baby Briannah Foundation is incorporated.

On August 31 she had a scan. Two weeks later, the results are in:

I wanted to be sure and let everyone know including Mel and family that we just received Briannah’s radiology report from her MRI that we recently had done 8/31/07. There is no growth, which means, we have not had any growth in at least four months!!! The previous MRI’s that we had before we started treatment with Antineoplastons did show some growth.

This is the first MRI that we have had done since we started the Antineoplaston Therapy in June 2007. The report also stated that the ventricles remain dilated and have “minimally” improved since the previous study!!! This is great news to us, especially with all that we have been through. It is a small beginning, but it is a start in the right direction [...].

I am so grateful for Dr. Burzynski and his awesome discovery of the Antineoplaston Gene Therapy! I sincerely believe that because of these treatments Briannah is with us today and doing as well as she is.

One wonders how much of the improvement is due to the shunts that were fixed in April and how much this is to be expected from a slow growing tumor. There is also the question of how tumors grow–sometimes periods of stability just happen. Notice that it is not shrinking.

The local paper notes on Oct 8:

But since Briannah began experimental treatment in June in Houston, Texas, the youngest of Tammy and Mark [O]’s three daughters has experienced a lessening in the swelling and gained a lot of baby fat. For the first time, her MRI shows no growth in the tumor.

At this point, we’re going to guess that the improvement that we are seeing is related to steroids. Reduction in swelling? Gaining weight (for a baby that was failing to thrive before)? We’re guessing steroids. Burzynski’s patients are often treated with large doses of steroids. As the Clinic is basically a one-trick pony, there is no reason to suspect they changed their tune here.

Among the other revelations in this article, we learn that the treatment is costing $6,400 a month and that the little girl’s birthday in mid-October will double as a fundraiser. Also given the completely expected toxicities we saw above, the reporter still manages to open a sentence with the line: “The treatment, considered nontoxic….” I don’t think that the journalist did anything wrong, I just think that the family has a distorted view of what toxicity means.  

On the 11th of December, following another MRI:

I just received a phone call from the Burzynski Clinic with the most wonderful news…. Dr. Burzynski has gone over the MRI that we just recently had done and according to the radiologist report they have declared that the tumor has shrunk by 9%! This is only the second MRI that we have had done since we began treatment there.

We will take that!

It’s hard to take anything the Clinic tells a patient seriously when the FDA observed two-thirds of the reported clinical trial outcomes were apparently inflated. I’m not even sure how clinically significant that would be if it is an accurate result, especially as, according to the Szabo story, experts will disagree 40% of the time when when interpreting rare brain tumors. These results were reported uncritically in the local paper on 28 Dec. There is something of a vicious feedback cycle here. One must be completely and totally up front about the prognosis at all points with patients. They deserve that, especially when they are as vulnerable as parents as a child with a brain tumor. They have never had good news. ANY change, even “not getting worse,” is a HUGE victory, and expectations need to be managed. Yet the family reports:

“Right now, little Briannah is going to live a normal and a full life,” said [Briannah's dad]. “We’re just really overjoyed.”

This is, of course, what everyone wants. But is it likely? And when it is reprinted in a paper, it’s difficult to see how that hope could not be massively reinforced, making what comes later all the more devastating.

In Feb 2008, Briannah seems to be having a crisis related to her sodium levels. She may be experiencing salt wasting, which can happen when there is injury to the brain. Via a friend of the family, we learn on Feb 7th:

“Baby Briannah was moved to PICU yesterday because her sodium levels dropped dangerously low. My daughter told me last night that Briannah was on IVs and her sodium level had come up some. Tammy and her husband, Mark, have made what was a difficult decision for them; they have decided to insert a peg (g-tube) for Brianna’s feedings. She has been getting her feedings with an NG tube for about 2 years now. Providing her Sodium level rises to normal today, the Broviac (Catheter) and Peg surgeries are scheduled for 2 PM this afternoon. That will be 3 PM Texas time.”

That night, we get an update on what is happening from Briannah’s mother:

It is 9 P.M. and Briannah is still in the recovery room and will probably be going back into ICU just to be closely monitored.

Placing the broviac catheter was harder than the doctor thought and took longer to place. He had to go up into her jugular vein this time. The G-tube placement went very well.

The reason we were admitted into the hospital to begin with is because her catheter stopped working on us. It would flush and allow you to stay on ANP, but would not draw for blood. We worked with it for several days. We had to have it repaired the week before because it broke and was leaking. We were hoping it would open up some how. We eventually did an x-ray that showed the catheter had flipped up. When we were admitted we disconnected her from her ANP pump. I always tell the doctors to put her on IV sodium asap. Eventually they hooked her up to IV sodium and her sodium’s have come up to 129. They were down to 116 before. She is okay and expected to recover.

This child is clearly not on the path to the full normal life that everyone hopes for. And despite this trip to the PICU, the local paper reports in May:

Since the treatment began, mom Tammy [O] said the youngest of her three daughters has been happier and healthier than ever.

“We’ve been able to enjoy this year,” [Tammy] said. “It’s been wonderful. No trauma. No injuries.”

Further, and perhaps not surprisingly, Briannah’s development has been arrested, though by all accounts she is a happy little girl:

Due to the tumor and a surgery when it was first discovered, she still can’t walk but she actively interacts with her parents and sisters, kicks, sits up and speaks baby talk.

We also learn that the father is turning his DJ business into a fundraising vehicle for Burzynski’s treatment, and in early June, another fundraiser is held at a farm where guests pick peaches to raise money.

In August, we get another optimistic assessment from the local paper, as well as this description of the treatment:

Briannah’s tumor has shrunk 20 percent since she began the nontoxic gene therapy treatment at Houston’s Burzynski Clinic.

The definition of gene therapy that makes this description of antineoplastons accurate would also redefine eating a banana as gene therapy. While the family did share some scans, I can’t find any of the results of this treatment. Further, she is still having some serious issues:

While she’s beginning to briefly sit by herself, doctors don’t know how much Briannah can see, and she also has been having seizures.

It looks like the family took a two hour trip to Sedona right before Christmas.

On January 26, a post goes up on another patients’ website:

An optic glioma, the type of tumor that James has, is considered a “benign” tumor. How deceiving that word can be. Too many believe that it means that this tumor will/can do no harm. Yet, I write tonight with tears flowing and a heavy heart because sweet Baby Briannah lost her life tonight to an optic glioma.

(In fact, it looks like she may have died on the 24th.)

As the family described her passing:

With Pastor David Wright with us, the room filled with the sweet presence of the Lord, and Tammy’s ear to her chest, her little heart slowed and then stopped. While her dad and mom were holding her tight and smothering her with kisses, her spirit and soul escaped captivity into the vast glory of the Lord’s presence, and the wonders of heaven. [...]

Briannah, Mark, and I, received such excellent and outstanding care from all of the Phoenix Children’s Hospital staff. I could not have imagined being anywhere else. God had His hand on every event, and it was definitely a chosen destination for us.

The local paper described the last hours in more detail:

The fight included shunts placed in her skull to reduce swelling in her brain and, beginning in June 2007, an experimental gene therapy in which she was administered a synthetic organic compound through a tube.

It seemed to be working. The tumor was shrinking, and the once-emaciated Briannah had reached a normal height and weight, though she was unable to walk or talk.

Everything changed last week, when Briannah’s sodium level plummeted, causing her kidneys to shut down. She went into cardiac arrest twice.

“She left her body twice, and they brought her back after 22 minutes, and the second time after 18 minutes,” [Tammy] said. “That in itself is a miracle, I’m not kidding you.”

But eventually, [Tammy] and her husband, Mark, had to make the decision to take her off life support. “When I got to watch Briannah’s body deteriorate, it got to the point where it was easy to let her go,” [O] said.

It is difficult for me to reconcile the idea that the treatment seemed to be working and the poor little girl’s progression and death. We can say, however, that lot of patients have celebrated their fortunes while on Burzynski’s treatment when they in fact were progressing. One of the most scary things that we have found here is a pattern of descriptions of tumors breaking up on the inside and patients rejoicing, when the fact of the matter is that it is far more likely to be a sign of a tumor outgrowing its blood supply. And we’ve seen this for decades:

On February 2, the family celebrated the life of Baby Briannah, as she was known to the community that rallied around her. Her mother bravely posted an image from her daughter’s services on her website. This makes all the more galling the following post on the website:

staff

Usually, this is where we would put an appeal to donate to St. Jude’s. You may still do that, 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 tothehoustoncancerquack.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 at the FDA so we can fix it and so this never happens again.

Burzynski Patient Ryan W.’s Story

*An appeal to encourage Congress to investigate this follows Ryan’s story*

In August 1989, Ryan W. was diagnosed with a thalamic glioblastoma, a grade IV tumor right in the middle of the brain. His prognosis was grim; his doctors estimated 6-9 months, perhaps, maybe a year with the standard therapy. (When patients exceed these estimates on Burzynski’s treatment, they are often touted by supporters as “successful treatment”, however the actual speed of progression falls on a bell curve, and outliers are to be expected.)

Beginning in October, Ryan was treated with 5 weeks of radiation. That treatment seems to have not had any effect on the tumor, at least according to an MRI in January. At the beginning of the new year, we learn that Ryan seems to be undergoing another trial of radiation and has had some complications, according to an announcement in a regional paper:

1/3/1990

MIDDLETOWN
The Fred Villari Studio of Self-Defense will hold a “kick-a-thon” Friday to raise money for the family of a 10-year-old Marlboro child diagnosed in August with a malignant brain tumor.
Students at the Route 35 studio as well as the Morganville branch are encouraged to attend with family members and friends, according to Anthony Russo, chief instructor at the Middletown studio. The goal is to perform the self-defense style kicks 100 times, and everyone participating is encouraged to solicit pledges of at least 10 cents a kick. Pledges will be recorded on a tally sheet provided for each participant.
Proceeds go to the Ryan Werthwein Fund and will assist the Werthwein family with medical expenses for their son, an identical twin who is currently undergoing a six-week radiation therapy treatment.
Complications from a surgical procedure caused Ryan to lapse into a coma lasting two days, and although he regained consciousness, he suffers from short-term memory loss, according to information prepared by the studio.
In Richard Walters’ 1993, Options: The Alternative Cancer Therapy Bookwhich slathers unearned praise on Burzynski’s antineoplaston treatment and is the most complete record of Ryan’s treatment, Ryan’s mother describes what can be the devastating effects of radiation:
“The radiation burnt out most of Ryan’s pituitary gland, stunted his growth, and hurt his mental functioning,” according to Sharon [W.], the boy’s mother.”
He was significantly shorter than his identical twin brother. According to Walters:
After reading up extensively on alternative therapies, Ryan’s parents decided to forego chemotherapy and take their son to Houston for treatment by Dr. Burzynski. “The doctors really beat us up over not doing chemo. We were discouraged at every turn from pursuing a safe, nontoxic alternative. They also told us Burzynski was a quack,” recalls Sharon.
Antineoplastons are neither safe nor non-toxic, nor can you really consider them to be alternative therapies to chemotherapy, as they are basically derivatives of sodium phenylbutyrate and are chemotherapy by any reasonable definition.
The known toxicities can be found on this recent patient consent form, a central part of any research protocol:
consent1consent2consent3
A recent inspection found that toxic events have often been reported by Burzynski’s patients, but that the Clinic has been slow to act on that information. For instance:

  1. Patients who had Grade 3 or 4 [severe or life-threatening] 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.
  2. 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.
  3. 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] Further, patient records show that there were many more overdoses that were not included in the Hospitalization/SAE/Overdose list.
Ryan’s mother reported at the onset of treatment:
“The American Cancer Society said they have an arrangement with the Hilton to keep rooms available for cancer patients’ families, but when we mentioned Dr. Burzynski’s name, they said to ‘forget it.’ The Corporate Angel Network, which boasts in TV ads how it flies young cancer patients around the country for free, refused to fly our son because the National Cancer Institute won’t let them fly Burzynski’s patients. The system is a disgrace.”
For at least 23 years, top cancer charities in the country have refused to participate in what is happening in Houston. More recently, Burzynski patient Kassidy M. was similarly denied a place to stay at Ronald McDonald House because of her intended course of treatment.
According to Walters’ book, Ryan began antineoplastons in mid-April 1990.
One month after the intravenous infusions were started, there was a major breakdown of the tumor mass, and from then on, it steadily shrank as the therapy continued. “It felt as if a miracle had occurred,” says Sharon. An MRI scan of the brain on May 15-after four weeks of treatment-showed only barely visible tumor remnants.
At this point it seems that poor Ryan has been through two rounds of radiation and some sort of surgical procedure. It’s not unreasonable to suspect that these treatments may have contributed to this progress.
In June, they are fundraising for Burzynski:
RyanW
What is endlessly frustrating is that these drugs were called “experimental” in 1990 and are still “experimental” 23 years later. A major red flag, especially when Burzynski’s lawyer said of Burzynski’s first trial:

[W]e decided to hit the FDA with everything at the same time. All of his current patients would be covered in a single clinical trial which Burzynski called “CAN-1.” As far as clinical trials go, it was a joke. Clinical trials are supposed to be designed to test the safety or efficacy of a drug for a disease. It is almost always the case that clinical trials treat one disease.

The CAN-1 protocol had almost two hundred patients in it and there were at least a dozen different types of cancers being treated. And since all the patients were already on treatment, there could not be any possibility of meaningful data coming out of the so-called clinical trial. It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment. The FDA wanted all of Burzynski’s patients to be on an IND, so that’s what we did.

Walters reports:
On November 1, 1990, Ryan displayed complete remission.
Yet, in 1993, when Walters publishes his book, for some reason, Ryan
continues to receive antineoplaston treatment, but the dosage is gradually being reduced. He wears a miniature infusion pump, carried in a waist pack, that injects antineoplastons through a catheter in his chest twenty-four hours a day. There is no pain or discomfort.
Ryan died in 1994 at the age of 14. This was 20 years ago. Antineoplaston treatment is still considered experimental.

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.

Burzynski Patient Josia C.’s Story

*AN APPEAL TO HELP END THIS FOLLOWS JOSIA’S STORY*

Josia C. was 6 years old when he started experiencing a lazy eye, excessive drooling, headaches and double vision. On 25 Aug 2011 he was diagnosed with a pontine glioma, one of the most dire diagnoses that a parent can hear. Of course, his life in Brooklyn was upturned, and he started under the care of a physician at NY Presbyterian / University of Columbia. The first stage of Josia’s treatment was radiation and chemotherapy, including a clinical trial. You get a sense of the seriousness of the prognosis in one of his dad’s posts in April 2012.

How discouraging, but out of the four other children under the same chemotherapy trail Vernostat, Josia is still alive after 8 month. A brutal Cancer war! I questioned God repeatedly for understanding and clarification.

Pontine gliomas are vicious. Because of the treatment, Josia misses most of the year of school. As he told the New York Daily News:

“I never see the kids at my school anymore, but I think about them,” the precocious 6-year-old told the Daily News.

“When I go back to school, I’m going to say, ‘Yay! I’m going back with my friends! I’m going to play!’ ” Josia said.

Even though the tumor has responded to therapy–shrinking 50%–these tumors are notorious for bouncing back, so in December, according to the family, they sought out the Burzynski Clinic. In March 2012, the family begins raising money in earnest for Burzynski. “Dr. Burzynski offers us hope,” they say in a video appeal:

He offers a treatment, an alternative treatment, for cancer, the same type of cancer that my son has [...] His treatment is called antineoplastons. It’s a combination of peptides that turn on and off switches in your genes that help fight the tumor. The antineoplastons are free of charge. They come at no cost to us. However the medical history review is $500, the consultation fee is $1000, the deposit to begin therapy will cost us $18,000, the monthly deposits $7,600 each month he’s on the treatment. The catheter insertion will cost approximately $6,000.

They approximate that the total cost will be $188,000 for a year of treatment. Yet they say that the ANP is free of cost. Josia’s dad says in the video:

This treatment offers us hope, offers my son an opportunity to grow up, some of the things we enjoyed in life: marriage, prom, first date, having your first child [...]

As you watch the video, you can see the tiredness and desperation in their eyes. And there’s no doubt that they will raise the money. Patients seem to find a way. But as they start this, the family has a strange notion about the efficacy about antineoplastons (ANP):

While clinical trials have shown promise, the American Cancer Society says the effectiveness of the therapy “remains uncertain.”

Chemo and radiation alone offer Josia a 6% chance to survive after five years. Josia’s father contends antineoplastons therapy will vastly improve his son’s odds.

“With this treatment, he’ll have a 26% chance of survival,” said Jose [C.], who works for TD Bank.

So far, the family has raised about $25,000 for the alternative treatment, mostly with the help of Josia’s classmates, teachers and Clinton Hill neighbors.

I want to know where they got this number. It can’t be the clinical trials because they have never been published. Never. Over 60 trials begun. 0 published. The antineoplaston trials at this point were only preliminary–they were only phase II. There was no possible basis for anyone to make this claim to the family. Furthermore, the studies that might have demonstrated the efficacy were fundamentally flawed. According to a recent FDA report, all of the baseline scans for these patients were destroyed, positive outcomes were inflated 66% of the time, not to mention a host of ethical problems, including devastating toxicity data (withheld for long periods of time) and over a hundred overdoses with not a finger lifted to protect patients from it happening again. On that basis, all of those numbers cited by the family are unreliable. Families deserve the best information before they decide to spend $188,000 on unproven treatment. You can see how desperate the family is in this video from the local CBS station, and you have to wonder what is going on in the mind of someone who would tell people this desperate exactly what they want to hear without providing good evidence and then accepting enormous stacks of cash for it.

The family is on the verge of leaving for Houston, when on the 13th of April, a setback:

Things just turned to the worst. Josia’s brain tumor is bleeding. We don’t know how much and it’s leaking blood. It seems like Houston will be out of the question. We don’t know yet. We’ve work so hard to get to this point and now I feel like my world is shattering. God I beg of you I’m on my knees please help us get Josia this treatment. Please after the treatment well know if it work and if it doesn’t then I would be the proudest father of an Angel.

The bleed seems to have dampened Josia’s vital signs, and the doctors give him steroids to take pressure off of his brain:

They are going to give him steroids 10mg this will relieve the pressure in the brain if he regains his vital sign we are out to Texas. ASAP.

The next day he is out of intensive care, and his family is focused on getting Josia to Houston:

He has a feeding tube placed and has gained back his speech and is able to swallow to some degree. We are still going to Texas just not by plane. We are driving there.

The feeding tube is removed on April 16th, and on the next day the family is on the road to Houston. Josia’s dad offers a prayer:

Lord please make a way for us to get to Texas. Keep us safe on this journey. Grant us strength and awareness. Give us the ability to drive this long trip. God you have provide us with the wisdom and knowledge to discover this treatment. You have not blink once and kept both you eyes on us. We are on the road for Josia’s miracle treatment. Doctors have told us that there is no cure no treatment that can save Josia little do they know jesus has already saved us. You have pointed the way and we see it. You have told us you will be with us and you have. You have blessed us with placing people on our path that donated the money to pay for this treatment. Thank you god and keep us safe amen!

On the 19th, they make it to the Clinic:

So what did we pay for and for how much.
Consultation with three Medical Doctors that’s including Dr. Burzynski himself. $1,250., We will have the catheter insertion done with an out of network surgeon recommended by the Burzynski Medical Team. This will save us anywhere between $900 to $6,000. The average price $6,000 the awesome and diligent finical team that will be helping us every step if the way told us that our emergency room PPO insurance will cover either the full balance or partial. Either way sounds good to us. Again we are saving every $ we can.

As an antineoplaston patient, the surgery was to put a port in his chest for the near-continuous stream of antineoplastons to be pumped into him. On the 24th, Josia has that catheter implanted in his chest after a short, half-hour surgery.

Josia2

(One thing that you notice as you go through the family’s online record of what they endured–and in the celebrations of Josia’s life–is that he was always smiling. A lovely boy with much spirit.)

On April 25th 2012 Josia begins treatment at the Burzynski Clinic, as you can see from this partial screenshot from their website:

Josia1

The antineoplaston treatment takes time to learn how to administer. It’s fairly complicated, as best I can tell, because it takes families about 2 or 3 weeks to learn exactly what to do to administer the treatment on their own. On the 26th, Josia’s dad needs to fly home, leaving the family (including Josia’s grandma) in Houston:

Tonight I fly back to NYC. I’m so scared of leaving them behind. I know that god will watch over them and even more closely that I am not there with them. I still have my faith that god will heal my son. Please continue to pray for Josia, N., and my wife.

On May 4th, Josia’s mom reports her progress on learning the pump:

Josia is doing so well an I am learning everything well enough that they gave me the weekend off from clinic training an have to do everything at home(hotel) this morning went well and so I drew blood and set bags ready to pump.

On May 9th, the family is reunited in Houston, ready for the ride home. Josia seems to be tolerating the treatment. They are home on the 11th.

There is no public update on Josia  that I can see until the 25th of May, when his dad prays. It’s an expression of pure emotion:

I feel like my heart has broken into a million pieces and Josia is trying to put it back together. God I know you are watching us from above. You felt the pain I feel for my son. My soul worships you and my hands are guided by your holy word. My son gives me hope and keeps my faith strong. I’m not going to fight you for Josia, but as long he is here with me I will give him my all. Josia is a part of me as your son is to you. Please don’t take Josia away from my family just yet. I have faith he will survive this. Cancer is our enemy but you are our shield. Protect Josia and heal him whole. I believe in your name and the holy power to heal. Thank you God, in Jesus holy name I pray. Amen

On June 6th, the family was present at the Make A Wish Wishing Place in Monroe, NJ, where the NY Giants’ rookies appeared. Here is some video from the event, which got a little press coverage. Adewale Ojomo, a defensive end, was touched by the experience:

“It touched my heart,” Ojomo said. “I thought I was tough … these kids are tough. They’re fighting all kinds of illnesses and sicknesses. They inspire me. This was a privilege.”

On June 7, Josia, I presume, has problems swallowing, as a feeding tube is going in. They also head in for an emergency MRI.

Over the weekend of the 11th, Josia was visited by friends.  Josia is still smiling, but in the photos you can tell that he’s had it tough.

On June 15th, an update by Josia’s father:

Please pray for my baby boy. Josia is in a coma. We are headed to the hospital now. Jesus save my son.

There are a number of touching photos posted, and then the somber prognosis:

There are no words to describe the pain Niasia and I are feeling. Josia is in a coma but can still hear us. [F]or some reason god has been preparing me for something. I just did[n't] think it was this. His organs shut down and he is breathing very heavy. He’s still fighting. Josia is more of a man than I could ever be. His strength is unmeasurable.

Liz Szabo, the health reporter for USA Today, told the story of that day like this:

On the last day of his life, Josia [C]‘s parents gave him a choice.

The 6-year-old boy had been fighting an inoperable brain tumor for 10 months. When his mother, Niasia [C], found him in his bed, unresponsive and unable to open his eyes, “we knew there was nothing else that we could do,” she said.

An ambulance took Josia to a hospice room at a local hospital. His parents covered him in a soft, blue-and-white blanket, hugged him and held his small hand for the last time.

“We told him the choice was his, whether to keep fighting or be in peace with God,” said his mother. “He chose.”

Josia’s parents would have paid any price to save him.

A Texas doctor, two months, earlier, had given them one: $25,000 upfront, by cash or check.

Josia died at 2:30 on 15 June 2012. The family posted a touching video that spanned Josia’s all-too-brief life:

At this point, I am seeing no evidence that the treatment Josia was on positively affected him. In fact, the evidence suggests that the antineoplastons may have contributed to his death. According to Szabo:

The FDA’s patience with Burzynski apparently wore out after Josia died.

In a report sent to the FDA after the boy’s death, Burzynski’s staff acknowledged that his last blood sample, taken the day he passed away, showed a blood sodium level of 205 millimoles per liter, a level that is typically fatal. Burzynski’s staff blamed that reading on a “false laboratory report based on a contaminated sample.”

Yet hypernatremia is one of antineoplastons’ most common side effects, known to doctors for two decades.

One of Burzynski’s own informed consent documents — the form that patients sign before they begin treatment — put the risk at 21%.

On July 30, 2012 — six weeks after Josia’s death — the FDA forbade Burzynski from giving antineoplastons to any new children.

Six months later, the FDA expanded its “partial clinical hold,” forbidding Burzynski from giving the drugs to new adult patients, according to the Burzynski Research Institute’s 2013 filing to the Securities and Exchange Commission. About 10 patients who were already receiving antineoplastons were allowed to continue, to avoid interruption of care.

To get a sense of what that means, this is a doctor’s reaction when he heard that Luna P.’s sodium while on antineoplastons had reached 178, as captured on the BBC documentary A Hard Line:

A9kdZhJCAAA3PJO

It is a horrifying, unthinkable outcome. I want to know why when Luna P. had this result, the FDA did not clamp down on him instantly.  It might be because, as the FDA found recently, that Burzynski has not diligently reported toxic events to the FDA promptly as he was required to, failing to report this condition, hypernatremia, at least 18 times. Furthermore, 48 patients experiences over a hundred investigational drug overdoses, and the FDA found that there was:

no documentation to show that you have implemented corrective action during this time period to assure the safety and welfare of subjects.”

For the last 10 years of abysmal, inexcusable failures on the part of the Burzynski Clinic, see this compilation.

Josia’s overdose should have been prevented. It was Burzynski’s job to lift a finger and make it happen. He didn’t, and Josia suffered for it. Burzynski’s explanation for Josia’s overdose, that it was a contaminated blood draw is absurd on the face of it. According to a competent physician and researcher:

I was astounded to see that number [205]. I’ve never, ever seen a sodium level that high. Typically, normal is typically between 135 and 145 mEq/L, with slight variations of that range depending on the lab. Burzynski’s excuse, which I’ve heard at various times as being due to an “improper blood draw” or as described above, is purest nonsense. A bad blood draw typically produces falsely elevated potassium levels, not sodium levels. Unless the technician spiked Josia’s sample with 3% saline or something like that, there’s no way to get the level that high. Josia almost certainly died because of hypernatremia from antineoplaston therapy.

Bad blood draws don’t put kids in comas, Stan, but antineoplastons can, at least according to your informed consent form.

The FDA put an end to the apparently endless, fruitless, and unpublishable antineoplaston trials after Josia died. The FDA should have put the smack down years ago, however. We have documented apparent persistent anomalies in the stories of Burzynski’s patients, most horrifyingly, a long string of patients who remarked that getting worse was getting better, most glaringly in the case of people who reported excitedly that their tumors were “breaking up on the inside.” The patients of other doctors would know that that was likely a sign of progression, that tumors that had outgrown their blood become necrotic and cystic in their centers. Yet time and time and time again over a period spanning decades we see patients celebrating and staying on treatment:

But none of this information was conveyed to the family of Josia, not even–and this is stunning– the fact that Josia’s death had resulted in the end of the ANP trials. According to Szabo:

No one told Josia’s parents about any of this.

Not Burzynski. Not the FDA.

Jose and Niasia [C] had no idea that their son’s death prompted an investigation by the FDA, until they were contacted by USA TODAY.

The [family] had long believed that Burzynski could have cured their son if only they had taken Josia to see him first, before giving him radiation and chemotherapy. They had even hoped to launch a non-profit, A Life for Josia Foundation, to help other children with cancer gain access to Burzynski’s treatment.

Now, this is inexcusable behavior both from the FDA and the Clinic, and especially when the family is still raising money to put more kids on the treatment Burzynski sold to them.

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.

Burzynski Patient Levi G’s Story

On March 23rd 2001, four-year old Levi G. was diagnosed with an inoperable brain stem glioma. It’s a bad, bad diagnosis, an aggressive tumor in a delicate spot. Almost nobody lives (though there are remissions in the literature). There aren’t a lot of great treatments.

Within two weeks of the diagnosis, by April 7th, the family has already suspended radiation because of the side effects and is planning to go to the Burzynski Clinic. The clinic has acquired an entirely unearned reputation for curing this type of tumor in children. The family is already preparing to raise funds.

The family is extremely religious and they are looking for signs for what they should do. Ultimately, they take the advice of strangers at IHOP as a sign of the course they should take for their child:

After a few days of strongly resisting any ideas about “alternative treatments”, I was pouring my heart out to the Lord late at night on the day of the third (traumatic) treatment, asking God for clear direction and an end to confusion, when the phone rang. I let it ring and kept praying. It stopped ringing. In a moment or two, it rang again, and I felt like the Lord was saying, “answer it Jeff!”. So I did. It was the grandmother of a child with exactly the same kind of tumor calling from Cincinnati. Over the next half hour or so she told me all about their experiences with traditional and alternative methods, and how successful the treatments administered by Dr. Burzynski had been. Because of the incredible timing of this call, Jami and I were beginning to reexamine our stand, but the clincher came the next morning on our way home from the fourth radiation treatment.The three of us were sitting at IHOP finishing our breakfast, when two kind people came up to us and just started sharing from their hearts about how God created our bodies to heal themselves. The woman spoke about how her child had many difficulties growing up and how she had turned down the conventional methods in favor of natural alternatives – successfully. She spoke about radiation and chemotherapy, and the destructive effects they have on the body, especially children. Jami and I just looked at each other wondering what this conversation was all about. We had not yet even mentioned that Levi had an inoperable brain tumor. After we spoke about Levi’s situation and our open hearts to whatever the Lord wanted for him, the man began to speak about a doctor that has had great success with brain tumors. He was writing down his name for us to check into, and it was the very doctor we had been researching as an alternative the last few days – Dr. Burzynski at the Burzynski Research Institute in Houston. We were really stunned, because that morning Jami and I held hands and prayed fervently that God would give us an “idiot-proof” sign of His leading (“Lord, do you want us to stop the radiation and do something else? Give us a sign today of the route You want us to take”). God sent us two angels to reveal his will for us. It sure seemed idiot-proof to us.

Apparently, the doctors told them that without chemo or radiation, Levi would have 4-6 months to live. Levi is on steroids to keep the swelling down, but the he is gaining a lot weight because of it. On the 26th of April we hear that the most recent MRI shows the tumor is not growing. They seem to be trying to get on a research protocol at the Clinic.

As you all know we had the MRI done on Tuesday. The tumor is exactly the same size. Praise the Lord for that!! The FDA requires us to wait 6 more weeks before we begin treatment in Houston. We could have begun treatment immediately if the tumor had grown. So, for now we will be going to Columbia today (April 26). We will only be there today and tommorrow. I (Jami) will probably go back next week and possibly stay for the full week next week. The Dr. wants Levi to stay there as long as possible for the treatment that they can only give him there. That’s a bummer because I’ll really miss the rest of my family.

It’s very strange to me that the delay in the protocol to separate the effects of radiation from that of the chemo is being blamed on the FDA. You would think that the Clinic would want a clear, unambiguous picture of whether the drug worked.

At any rate, the family is playing the waiting game, measuring time in weeks until the next MRI to see whether or not the tumor’s progression prompts them to go to Houston sooner rather than later. They don’t have a scan until June 5, and the family is languishing, though the Make-A-Wish Foundation will be sending the family to Disney World in the meantime. They have a marvelous time. His MRI shows a tiny bit of shrinkage:

Levi is doing great! His symptoms are the same. He is still a little chubster and his eyes are slightly crossed. Yesterday, he did great with his MRI. He used to cry and go crazy when they took his blood pressure and did the pulse ox and needless to say the IV was a nightmare. But yesterday he didn’t even balk at it. He cried a tiny bit with the IV but what a long way he’s come. He is now a 30 year old in a 4 year olds body. He’s incredible. [Levi's siblings] are so excited about the shrinking tumor!! HOPE. What a beautiful thing!!

Hope is powerful, overpowering even. But at least they have stayed away from the false hope factory in Houston for a little while longer.

On the 2nd of July, Levi’s mom posts a very touching reflection from on how cancer changes everything :

It’s 11:30 at night. Everyone is sleeping. I was just thinking how the Lord gave me a gift tonight that most people might not appreciate as much as I do. Tonight, I had a “NORMAL” thing happen. Levi wanted to sleep in his room tonight. He hasn’t done that since he was diagnosed. I walked him up to his room, (just like I used to). I tucked him in and we prayed together, (just like we used to). I started to walk out of the room, (just like I used to). He said, “Mom, will you sing some songs?” (Just like he used to). One thing was different. ~ ME! ~ I used to hate when he asked me to sing. That may seem harsh but since I have 4 to tuck in, pray for, love on and talk to about the issues of the day…. extra curricular night time activity is not good. Especially with Levi. He would hold his chubby finger up in front of his face and say just one song mom. So, I would sing one song. Then I would start to leave the room and he would start to cry and say noooo, that wasn’t the song I wanted. So, I would sing another song. Again, it wasn’t the song he wanted to hear… It took around 45 minutes and 10 songs to get him to sleep. When he was sick, I would have given just about anything to hear him say, “mom, will you sing just one song?” It’s been a long time, but tonight, June 30, 2001 I heard those words I longed to hear again. It was BEAUTIFUL.. I would have sung to him all night long but he fell asleep after only 2 songs.

By August 1, Levi has started favoring his left side again and he was very ill. It seems he had contracted a virus and was not having much success fighting it off. On the 12th of August we get a peek into some of the types of alternative medicine practices the family is trying:

It’s been a while since I’ve updated you because we’ve just been so incredibly busy. I wish I could bring good news this update but it’s not that great. You remember the virus that Levi had 2 weeks ago? Well, he’s gotten over the virus however, he still throws up his medicine everytime we give it to him. So, that means he is not getting what he needs to de-toxify his body. He is still favoring his left side, he gets really tired and is extremely emotional. I know that the Lord is not surprised by this bump in the road. There is a good reason for this. We just can’t see it (yet). We are looking into a nutritionist right now. I have been cooking foods that increase the ph in the body (which is what Levi needs) but it’s really hard to think up new things. The kids are soooo sick of steamed asparagus. They used to love it but 3 nights a week is a bit much I must admit.

On the 18th we hear that the family is planning a trip to Houston:

Levi is doing the same. Which is not that great. He is still favoring his left side a lot. He barely uses his left hand and even holds it up with his right hand so that it doesn’t flop around. He gets very emotional at times and cries randomly. We have an MRI scheduled for the 22nd of August. If the results show that the tumor is bigger or even the same then we will be leaving for Houston, TX. Our tentative plans are to leave on the 25th. [Levi's dad] will come back after 4 or 5 days and [...] I will stay for 2 more weeks. I must say I look ahead with dread.

On the 22nd, horrible news:

Unfortunately we don’t have good news this time. With a heavy heart I must tell you that, according to today’s MRI report, Levi’s tumor has taken on renewed vigor. The doctor says it is 20-30% larger now than compared to the original MRI back on March 23rd, even though we all know it was shrinking as of the MRI in June, as well as by all outward evidence until just a few weeks ago.Plans are proceeding to go to the Burzynski Research Institute Clinic in Houston, Texas on Saturday where a new round of special treatments will start.

The day before they leave for Houston, Levi has surgery. Surgeons put a broviac line into his chest.  This is done in preparation for the antineoplaston treatment, which would be pumped into the arteries day in and day out throughout the course of treatment. Levi is a little confused, even a little panicky about this new thing sticking out of him, but his mother keeps her composure and calms him. Her online diary, however, reveals how she really feels:

I find myself “making” memories. I am sometimes afraid that is all I will have soon. I have been struggling with my thoughts. I look at him sleeping and see his chest move up and down with each breath. My thought is, I should enjoy watching this, someday soon, his chest might not move up and down with life. When I touch him and his body is so warm, my thought is, soon his body might not be warm. What will I do if I touch him and his body is cold. Then I can’t function the rest of the day. I just cry all day. I know these are morbid and horrible thoughts but that is where my mind has been lately. Our pain level is contingent on Levi and his symptoms. When he is somewhat “normal” we are okay. But when his symptoms worsen, we fall into desperate thoughts.

According to Levi’s father (who could not stay down there too long):

Our first appointment with Dr. Burzynski was on Monday the 27th. Levi’s treatment actually began on Tuesday and the only side effects he has had is that he is very tired and lethargic, and this was expected. The doctors have been gradually increasing the dosage volume every day so that his body can handle the “peptide fragments” circulating through his bloodstream. They want Levi to be able to attain to the 160cc dosage every 4 hours of the A10-type antineoplaston. Right now he is at 50cc.We are staying in a hotel room (clean, safe and pleasing to Jami – there is a treadmill in the exercise room), 5 minutes from the clinic. Levi has appointments 7 days a week for about 3 weeks. The first week was very trying because our appointments would last 4-5 hours. The kids would get frustrated because they would have to stay contained with us while we were learning how to administer the IV bags, tubes, flushing, programming the pump, etc. We have learned how to do everything by ourselves now so the remaining visits should not be that difficult. They are regularly checking Levi’s blood for any imbalances.

This seems fairly normal. The Clinic routinely turns out the patients on the trial to fend for themselves. While the family was at the Clinic, however, the World Trade Center was attacked. We hear about it all when the family reunited days later:

We’re Home!!!!! It was the longest 3 weeks of our lives. We started our journey home Thursday at about 1:00 pm. We drove for about 7 hours. (Of course we didn’t get as far as we would have liked to because we had to stop so often to eat. Levi is on steroids again and can’t think about anything but food. He gained 8 pounds in 3 weeks) [...]  It was the sweetest reunion!!!. [...] We were all crying. It was the most wonderful moment!!! I dreamed and cried often while in Houston about holding my boys again. It was even better than I had imagined. We were together FINALLY!!!!! When the attack came to America on Tuesday I had a panicked heart. I felt like I had to get home IMMEDIATELY. It felt as if the world were crumbling around me and I couldn’t be with my family. I went to the doctors and told them that I HAD to get home!! But they said NO.  [...] Levi’s handling his new treatment pretty well. He is extremely tired and emotional. It’s kinda hard for him to get around because he’s attached to an I.V. bag all day long. He is also having a hard time getting used to his “new” body. It’s much larger than it was just 3 weeks ago. He was sitting on the potty the other day and he leaned forward, when he did his belly scraped the toilet seat. He moaned. I said, what is it? He looked up and said. “I’m fat!” Poor little man.

The steroids are really taking their toll on him. The family’s lives have been turned into one of caretakers, as the family attends to the constant demands of the treatment:

Well, we’re getting settled in and trying to get used to the extra daily activities. We have to get I.V. bags ready and change catheter tips, change the dressing on Levi’s broviac (tube in his chest), give oral medicine…. Sometimes it takes us over an hour just to get the I.V. bags ready. I must say it’s quite comical. I’ll be cooking dinner, putting football pads in, helping with homework, talking on the phone… priming I.V. bags all at the same time. It’s kinda weird to have medical equipment spread out on the kitchen table while I’m doing my other daily duties. Everyone is already used to it. They all help out. They take turns flushing out Levi’s tubes. It’s an honored position to be able to push the syringe in. Levi has the power to choose who will be “the one.”

Of course, there is the unquenchable thirst that comes with the antineoplaston treatment, and the impact that it has on patients, robbing them of sleep and degrading the quality of their remaining life:

Levi is doing okay and only okay. He is so heavy right now he can hardly move. I can’t tell if he’s having side effects from the steroids or the tumor. I must say that I have developed a deep hatred for decadron (the steroid). I really miss his original little body. He now weighs 52 pounds when just 3 weeks ago he was only 40 pounds. He wakes up every hour and a half to go to the bathroom because of the huge amounts of fluid going into his body. So, Jeff and I rotate nights to sleep. Levi sleeps in our room on a pallet. When he wakes up to go to the bathroom we have him go in a hospital urinal because it’s just easier than getting him up and into the bathroom with the I.V. bag. We thought about just letting him wear a pull-up (diaper) but he wouldn’t hear of it.

Burzynski’s patients are often on large doses of steroids. And then bad news from the Clinic:

I just found out that Levi’s doctor in Houston (Dr. Bestak) died of a massive heart attack on Saturday. I just saw him on Thursday. I am in shock. I also talked to a guy that we met in Houston at the clinic. His father was getting treatment for a brain tumor… he died last Monday. My heart sunk when I heard.

On September 29th we get a sense of Levi’s deterioration and a look into the mindset of a family suffering so much in such turbulent and uncertain times:

Things are pretty much the same with Levi. He is still very heavy and immobile. He is still obsessed with food because of the steroids. He sometimes wakes up in the middle of the night just to ask if it’s almost time for breakfast. He still wakes up every hour or two to go to the bathroom. He is such a sweet little man. Last night he tried to go to the bathroom by himself so he wouldn’t have to wake us up. I woke up to him crying with frustration because he couldn’t do it. He has very little use of his left arm and leg and gets off balance. But what a precious angel he is to try to let us sleep.

We’re in a waiting period right now. I liken it to our country. It’s an anticipatory time of wondering what tomorrow will bring. Will we attack the enemy or will they attack us again? Will the tumor get bigger or will the treatment work? We’re just sitting around waiting

On October 3rd, we get an indication that the only thing that is having any effect on Levi and his tumor is the decadron when they try to taper his steroid dose:

We had a little “bump in the road” yesterday. Levi was having a bad headache all day. When I took him to the doctor his vital signs were bad. His blood pressure was 122/90, his respirations were 52. When Jan (doctor/friend) checked his eyes she could tell that there was pressure in his brain. So, we went to the hospital to get an emergency CT scan and an X-ray. Jan and I were thinking that maybe I had come down on the steroids a little too quickly and it was causing this reaction. He also has a cold so the combination could cause swelling in his brain. I was really nervous because he was drooling and slurring his words, he was falling a lot and his left hand was hurting now because it was drawing up so tight. But the CT scan didn’t show any acute change, the chest X-ray was good and the blood work was normal. What a relief! So, now we’re just working on getting rid of the cold and we’ll have to up the steroids again. We’ll schedule the MRI a little earlier than originally planned. So, it will probably be sometime next week. …yesterday constituted a bad day…

On the 12th, we hear about more deterioration:

The MRI was Wednesday. The tumor is basically the same size, maybe a tad bigger the radiologist said. That was good news to us. His symptoms are basically the same. He is just so heavy (he is 60 lbs now). He is in a wheelchair now because he can only walk a few steps (very wobbly steps) before he is exhausted.

We have had a few “setbacks in hope” in the last few weeks. The neurosurgeon told me that we needed to decide if (in an emergency situation) we want to have a shunt put in or not. In other words: Do we want to just cut to the chase and let the inevitable (death) happen sooner since a shunt will only buy time. When he said that I was shocked. I couldn’t believe we were at this point of decision making.

So the antineoplastons have not stayed the tumor. This is important.

On the 18th we get another update, continued and quickening worsening of symptoms:

On Monday the 15th we had a rough day. The whole night Levi was frustrated. When I would stand him up to go to the bathroom he couldn’t stand. He has been having trouble for a while. But it was different; it was much, much worse. He would put his left leg down and fall, immediately. It was completely useless. When we got up in the morning he was really slurring his words badly. I couldn’t understand anything he was saying. Somewhere around 10:30 am he started saying he had a headache. Usually when he has headaches they only last a few minutes and then they’re gone. But this time it lasted more than an hour and he was wrenched in pain, he wouldn’t even touch his head. I made a few calls and started packing us a bag just in case we had to stay the night. I must admit at this point I was wondering if we’d ever leave the hospital. He had gotten so much worse overnight. I was afraid of what the day would hold for us. Jeff came home and we went to the emergency room. [...]

What happened next is as infuriating and inexcusable as it is predictable:

The next day we talked to the doctors at the clinic in Houston and found some answers. According to them the tumor was breaking down. When it breaks down it causes swelling which causes pressure. We had to up the decadron (steroids) a little to keep the swelling down so that he could tolerate a higher dose of the treatment. They told us before this that he would get worse before he got better. But at this rate I wonder if he’ll ever get to the “better” part.

According to the patient, the doctors at the Burzynski Clinic told them that his slurring and drooling and inability to stand was IMPROVEMENT. Not only that, but that it is the tumor breaking down. This is not the first, second, or the fifth time that we have seen worsening symptoms described as improvements. Patients often report excitedly that their tumor is “breaking up on the inside” or that a fluid filled cystic region has opened up in the middle. These are almost universally embraced by Burzynski’s patients as evidence that the tumor is dying and that ANP is working. Unfortunately, this is far, far more likely to be because the tumor has actually outgrown its blood supply and is dying in the middle. Every competent oncologist knows this is probably a dire development, yet Burzynski’s patients seem to believe that this is good news. We have found the same story repeated over at least 20 years:

This is part of a larger pattern which is every bit as disturbing, patients reporting that worsening symptoms are signs of getting better, which may be comforting but is self-defeating and always ends badly. The claim seems to be that the tumor is swelling because the drugs are killing it, or that the immune system can’t keep up with all the remains of the tumor, or something. This is exactly the case that was made to Levi’s parents. Now if the Clinic knew in 2001 that the tumor growing on your brain stem might swell because of treatment, you’d think that this would appear as a side effect in a patient “consent” form over a decade later. But it doesn’t:

consent1consent2consent3

“Your tumor might squeeze your brain stem” should be under “most common serious side effects” (we’ve seen it so much in patients’ last days that it should be listed there), but you would be wrong. It’s nowhere. Nowhere does it say that your tumor might get bigger. This is unexcusable and THIS MUST END!

5 November, Levi is in a pitiable state:

Yesterday he was very lethargic. Last night we were playing a board game and he just stared at me the whole time, as if he were looking right through me. [...]

(Later the mother mentions that Levi is having “seizure days.”)

The last couple of days have been hard for us. We’ve just been sad. I mean what else can you be but sad when you watch your four year old boy struggle to eat, go to the bathroom, play a game. Everything is difficult for him. Yesterday [Levi's sister] had a new pink dress on with white tights and black patent leather shoes. She looked down at herself and said, “Mommy, I look beautiful today, I want to dance.” Then she turned and looked at Levi and said, “Levi, I want to dance with you.” Usually, Levi would have been so excited about the offer. But this time he looked at her with an irritated smirk and said, “I can’t dance, I can’t walk.” But then she couldn’t understand him so she had to say “what?” about 3 times. Needless to say he was in tears by the end of that conversation.

Levi turned 5 on the 15th of November. He thought that they were going to take out his broviac line for his birthday:

About two weeks before his birthday he made a comment to me that makes me believe his “big day” was a disappointment to him: I said, “Are you excited about your big #5 birthday?” He said, “Yeah, because I won’t have this (pointing to his broviac tubes).” I had to be the bearer of bad news and tell him that the tubes would have to stay. His bottom lip poked out and his shoulders fell in huge disappointment. For some reason he thought that since it was his birthday we would take out the broviac and he would be “done” with it, he would be “regular” [...] again. Oh how I wished and dreamed. But the battle goes on, it is no respecter of “special days.”

The very next day, Levi’s condition deteriorates greatly:

Yesterday Levi went into what appeared to be a coma. Jami called 911; the paramedics and fire truck were there in minutes and transported him to the nearest hospital, where they decided to “Life-Flight” him to Emory. There he got a CAT scan, which indicated no change since the previous one (good news). They say he did not slip into a coma, but are theorizing other causes for the loss of normal body functions. Presently (1:50 PM) Levi is in intensive care and considered critical, he has fluid in his lungs and needs help in breathing.

It makes you want to know exactly who told this family that their son was improving.

On November 20th, Levi’s grandfather reports the that the doctors believe Levi has less than a week to live.

On the 24th, the grandfather reports:

I just spoke with Jeff at the hospital, where they had just finished a meeting with the doctors and decided not to reintubate him when they remove the ventilator, even though they know (humanly speaking) Levi will most likely not be able to breathe on his own – the only “life-support system” they are interested in is the non-artificial one that God provides!

The decide to bring him home, and his parents update the site to tell the story in more detail:

On the Saturday before Thanksgiving we had a wonderful morning. We all just stayed home together. There was no place we had to be and that is a rare thing for us. Levi wasn’t feeling that great and wasn’t hungry at all which was really different. In the early afternoon he threw up. We knew this was really bad and meant that the ventricles (which bring fluid from the spine to the brain) were swollen and blocking the flow. He was still coherent though so I was hoping maybe it was just a virus. I put on some shorts and a T-shirt and got in the tub with him and held him in my lap because he was “wobbly”. Jeff went to get him a drink and  [Levi's brother] and I were just talking to him. All of a sudden he said “Uh oh, Uh oh, I feel funny” and immediately stopped breathing. [Levi's brother] ran to get Jeff. We carried his sweet little limp body to the bed and were trying to get some sort of response out of him. He started to breathe off and on but very sporadically. He began to throw up again, and again. We were terrified. As I was on the bed holding him Jeff laid down (prostrate) on the floor and began to cry out to God. “Please Lord, have mercy on our son, Please God don’t take him…” We called the ambulance and they were there in probably 3 minutes. They rushed him to Gwinnett Medical Center because it was the closest. Then they Life-Flighted him from there to Egelston Children’s Hospital. We were so afraid. After this long eight month battle was it all over now? I was so weary from the constancy of the practical side of the “fight” but I would do it all over again and again if I was given the choice.

After meeting with the doctors on Saturday we decided to transport Levi home with no order to resuscitate. There was no reason to believe (naturally speaking) that Levi would live through the night. We told the hospital staff that it was our desire to get him to our house so he could die at home (and in no pain). [...]

[...] Levi is opening his eyes, he is responding to questions by nodding his head (he cannot talk) he is moving his right arm and leg occasionally and breathing on his own with much help from an oxygen mask. There is not much more to tell.

He does survive the extubation, and while he rallies for a bit, late in the morning of December 20th, we receive this post:

So far it has been a rough one. Yesterday Levi had a really bad day: difficulty breathing, not eating all day and just generally frustrated with his situation. We had a group of prayer warriors come last night and it was an incredible time of the Lord meeting us there. Levi was breathing much easier and seemed fine. We went to sleep at about 12:30am. I woke up at about 2:00am to Levi’s loud and labored breathing. We’ve been up ever since. [...]

Levi is still breathing with extreme difficulty. His color is bad…. the natural mind can’t help but think the worst.

Levi died on December 20th at 1PM, nine months after his diagnosis, well within the normal range of people with his diagnosis. The antineoplastons did nothing more than make him suffer unnecessarily.

Thankfully, it seems that the era of antineoplastons is over for the time being. Last year, a child died while on the treatment, but for some reason this was reported to the FDA and reported in an SEC filing. They have suspended the clinical trials of antineoplastons. If Levi was on one of the clinical trials, it has never been published. Dozens of trials were opened, according to Burzynski’s lawyer’s memoir, to “make sure Burzynski could treat new patients”,

[...] Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future. [...] We heard that the FDA had to put together a fifty-person task force to review all of the protocols Burzynski submitted.

NONE of Burzynski’s clinical trials has EVER been published. Every patient who ever paid to be in a trial has been betrayed. Every one of them who thought that their treatments and suffering was contributing to the treatment of horrible diseases has been betrayed. How many hundreds of the most desperate patients, the most sick and vulnerable people imaginable, have been betrayed by the Clinic’s apparent inability to publish a single completed study?

By god, how much longer must we tolerate this shameful presence?

Please consider giving to St. Jude’s, a children’s hospital that turns away nobody and helped a young friend of mine who is no longer with us. Find out about real clinical trials by visiting clinicaltrials.gov.

Burzynski Patient Sharie M’s Story

In October 2009, medical administrative secretary Sharie M., a wife and mother of four, was diagnosed with glioblastoma multiforme, a devastating brain cancer with a very high mortality rate. Initially, Sharie underwent conventional treatment, including three surgeries to reduce the size of the tumor (debulking) in the months immediately following the diagnosis. This kept the tumor at bay. In July of 2010, however, Sharie’s tumor was returning.

It seems that at this time, they started looking into the Burzynski Clinic and because the treatment is so expensive, they started raising money through the local paper:

“Dr. Burzynski has developed a series of peptides that attach to a sodium molecule and they reconfigure the DNA of cancer cells so that it allows the cancer cells to live a normal life and die, as opposed to living and spreading,” said Mike [M].

“They’ve got a track record of 74 percent of brain tumor success,” he added. “That means it’s either eliminated or stopped the growth for years.”

Mike [M] said the results Dr. Burzynski has achieved are encouraging.

“The statistics from this clinic where we’re at, many times, are three and four times better than the statistics you get from normal oncology,” he said. “But statistics are statistics and that’s why it’s a clinical trial. The proof is in the pudding, they say.”

74% brain tumor success? I want to know where they got that number. It’s inflated above even the ludicrous number that Amelia S.’s story received. In an interview with their local newspaper, Amelia’s mother said that the number they were given was a “complete lie“:

The parents of Pride of Reading Child of Courage winner, four-year-old Amelia [S] who died in January, say they were told she had a 54 per cent chance of survival with the clinical trial in Houston, Texas.

However mum Chantal [S], 36, believes the actual figure was just one per cent.

A BBC Panorama investigation shown on Monday questioned whether the Burzynski Clinic was “selling hope” to families.

In it, Mrs [S] said: “I think that’s wrong [54 per cent figure]. I think that’s a complete lie. I think one per cent is a more accurate figure.”

It sounds as if Sharie is on one of the antineoplaston trials:

Sharie [...] began the treatment over Labor Day weekend. And while it allows her to be at home, it requires her to be on an IV-drip 24 hours a day, seven days a week, as well as thrice-weekly blood drawings to monitor vitals — all for eight to 12 months.

Mike [her husband] said it’s “livable” and that it seems to be working.

“Since the treatment started”, he said, “MRIs showed reduction in tumor size, which is not anticipated by current standard treatment.”

While I am delighted that it sounds at this point Sharie is doing well, I wish I could see those MRIs. How big is the reduction? Is she on steroids? Is the center “breaking up,” a sign of progression–a likely indicator that a tumor has outgrown its blood supply–that has been consistently been reported by the Burzynski patients we’ve looked at as signs of improvement? This is just a reminder that we can’t take patient reports–especially the ones coming from Burzynski’s patients–as reliable evidence of efficacy. Sadly, such patient reports are the sandy foundation of Burzynski’s entire practice.

They have already been to Houston at this point. Sharie would have gone through the multi-week training course at the clinic in Houston because Burzynski made patients fend for themselves. During this time the family is separated, spending the little time they have together apart.  Worse, their insurance is only of limited help:

“They typically will cover medical expenses, traditional blood testing, MRIs — those kinds of things. But the treatment won’t be covered,” Mike [M] said. “The clinical trials may cover the cost of the medication, but the pump, the office calls, the staffing, the supplies — those things are at our expense. So it should be somewhere in the $7,000- to $8,000-a-month range, with a $20,000 initial payment to get started.”

A legitimate researcher would not demand payment up front at all. This family is putting their mother’s life on the line for what will, if successful, make Burzynski a unfathomably rich man. They should not be paying a nickel to be his lab rats. Of course, hundreds of patients have been in his over 60 trials trials, and because every single one of those patients expected their doctor to publish his results, I consider every one of them personally betrayed by Burzynski, as their suffering and generosity has led to exactly zero completed, published trials.

In anticipation of the heavy expenses, the family starts raising money for Burzynski. They sponsor a pancake breakfast at the beginning of November 2010. According to a local television report, Sharie was too sick to attend the event. Nonetheless, some 1500 people showed up to support her. The Burzynski Clinic does not only capitalize on the vulnerable, but exploits the generosity of entire communities. The family’s expenses to date were met at this time.

In September of 2011, her son reports that she is “doing better.” I have no information about what happened to her in the intervening time. I do know, however, that the family opened their farm to local schoolchildren to teach them about agricultural science, an ongoing project that the family continues in honor of Sharie.

Sharie died on Jan 1, 2012. Her passing was commemorated by 600 friends a few days later at St. Boniface’s Catholic Church, where her life was celebrated.

The trial Sharie participated in, the one she and her community paid to participate in, was never published. Indeed, no more patients are being accepted into the trials as of last year, following an investigation into a child’s death. That was followed by a series of devastating findings about the Institutional Review Board (charged with independently reviewing and overseeing trials) by FDA inspectors, which peeled back any pretense of genuine research. Among the findings:

  • “The IRB [Institutional Review Board] used an expedited review procedure for research which did not appear in an FDA list of categories eligible for expedited review, and which had not previously been approved by the IRB. Specifically, your IRB routinely provided expedited approvals for new subjects to enroll under Single Patient Protocols.” [2 adults and 3 pediatric patients are mentioned]
  • “The IRB approved the conduct of research, but did not determine that the risks to subjects were reasonable in relation to the anticipated benefits (if any) to subjects, and to the importance of the knowledge that might be expected to result. Specifically, your IRB gave Expedited Approval for several Single Patient Protocols (SPP) without all the information necessary to determine that the risk to subjects are minimized.” [4 examples follow]
  • “The IRB did not determine at the time of initial review that a study was in compliance with 21 CFR Part 50 Subpart D, ‘Additional Safeguards for Children in Clinical Investigations.’ Specifically, an IRB that reviews and approves research involving children is required to make a finding that the study is in compliance with 21 CFR Part 50 Subpart D, ‘Additional Safeguards for Children in Clinical Investigations.’ Your IRB approved research involving children without documentation of the IRBs finding that the clinical investigation satisfied the criteria under Subpart D.” [3 examples follow and there is a note that this is a repeat observation that had been found in an Oct 2010 Inspection.]
  • “The IRB did not follow its written procedure for conducting its initial review of research. Specifically, the IRB is required to follow its written procedures for conducting initial and continuing review. Your IRB did not follow your written procedures for conducting initial and continuing review because these subjects received IRB approval via an expedited review procedure not described in your Standard Operating Procedures. If your IRB would have followed your own SOP for initial and continuing review, the following subjects would have received review and approval from the full board rather than an expedited review.” [2 adults and 3 pediatric patients are listed.]
  • “The IRB has no written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any unanticipated problems involving risks to human subjects or others. Specifically, your current SOP-2012 v2-draft doc does not describe the requirements on Investigators on how unanticipated problems are reported to the IRB, Institutional Official, and the FDA, such as time intervals and the mode of reporting, or otherwise address how the prompt reporting of such instances will be ensured.”
  • “The IRB has no written procedures [in the SOP-2012 v2-draft doc] for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any instance of serious or continuing noncompliance with theses [sic] regulations or the requirements or determinations of the IRB.”
  • “A list of IRB members has not been prepared and maintained, identifying members by name, earned degrees, representative capacity, and any employment or other relationship between each member and the institution.” (BurzynskiForm483Feb2013)

For a complete list of the massive number of violations in the last decade at the Burzynski Clinc, click here (warning, enormous pdf.)

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.