Burzynski Patient Chase S’s Story

Chase S. was diagnosed with a diffuse pontine glioma, a tumor in the brainstem that is very difficult to treat and is nearly universally fatal within 2 years (though there are occasional spontaneous remissions). We’ll pick up the story in Memphis at St. Jude’s, where he had a biopsy and where the family has learned that Chase will be eligible for treatment at Burzynski’s Clinic. They were offered treatments at U Mass and Duke, but they went to Burzynski first:

“By the time we left Memphis, we had received confirmation that Chase would qualify for entry directly in the trial that we were interested in at the Burzynski Institute in Houston. They gave us an appointment for this coming Tuesday morning to go over the details of the program, and if we choose to proceed, he can begin treatments right away. In order to prepare for this, we were able to schedule a procedure at our local hospital (Beaumont) for Monday morning to install a port / shunt in his chest for the treatments to be administered. The therapy developed by Dr. Burzynski (anti-neoplastons) is rather non-conventional but seems to have a lot of promise for this exact type of condition with minimal side-effects (no long-term physical deficits).”

The family initially might have had a difficult time finding a place to stay because refugees from Hurricane Katrina had been arriving in Houston, but they were set up in an apartment. After their first visit to the Burzynski Clinic, they make a decision boggles the mind for anyone who is on the outside of their situation:

“We have an appointment with MD Anderson in the morning, and unless they come up with some major dissuading information, we’ll keep the “traditional approach” in our back pocket as we head into the Burzynski clinic to get started with the first treatment in the afternoon.”

The decision has been made. The boy has a tube placed in his chest for the administering of the ANP, and he will carry a backpack which has a drug pump forcing ANP into his system day and night.

The appointment at MD Anderson goes as you would expected. The doctors, it sounds like, tried to dissuade the family from making a devastating mistake, but they failed:

“The most pleasant surprise about the MDA meeting was that they weren’t too offended when we mentioned that we were investigating alternative therapies, including the Burzynski Clinic. Although they didn’t expressly recommend it, they couldn’t really provide any legitimate reasons why we shouldn’t pursue it. They indicated that although Burzynski had been reporting successful treatments for quite some time, they hadn’t seen any of his studies published for “peer review”. I happened to have a copy of his Phase II trial study on me, which had been published in Drugs R&D in 2003, and reported very high rates of “complete response” (total remission) and partial response (> 50% reduction), with the majority of participants falling into one of these categories and another 30% having stabilized. They thought these would certainly be very promising statistics if they were in fact for patients with this specific condition (which the report indicated). To that, they simply said they weren’t aware of the results and whether it had been subject to “peer review” (pretty remarkable, given that these practices are < ½ hour drive apart). They also wondered whether some of the reported results from the Burzynski studies were based upon “residual effects” from the radiation that patients had previously received – I didn’t bother rebutting this, but from reading the study, it was clear that the patients who underwent radiation were required to wait at least 8 weeks before starting on antineoplastins (probably to remove this specific potential argument).”

What is not said here is that a Phase II trial alone cannot determine efficacy. It may suggest efficacy–its outcomes may justify scaling up the trials–but the gold standard is a peer-reviewed, controlled, published Phase III clinical trial, something that Burzynski, in 30 years of “tests” has never once completed, which puts him in the running for the Worst Researcher Ever Award. What these physicians are saying is that Burzynski is a quack.

The physicians at MD Anderson, of course, knew what they were talking about, and their comments now seem prescient. First, the report is preliminary and has very few patients in it, so it’s likely too small to draw any efficacy conclusions from. The patients in this article were all drawn from the BT-11 protocol:
StatisticsBT11As I (Bob) wrote in my response to what appears to be the finished study (another patient series, not definitive trial results), which was published in the same journal issue as Burzynski’s article:

The FDA have released the observational notes (form 483s) and other documents from these inspections which specifically refer to BT-11, as well as to studies underway at the BRI concurrently with BT-11 and the BRI Institutional Review Board (IRB) that oversaw all of the studies. They are shocking reading, and detail an unbroken string of abysmal FDA site reviews of the Burzynski Research Institute spanning the last 14 years.2 For instance, a 483 form 2001 noted that “Subjects were started on antineoplaston treatment prior to the protocol-specified interval following prior chemotherapy and/or radiation therapy,” including a patient participating in trial BT-11, who had too recently been treated with etoposide. During the same visit, inspectors observed that “Not all serious adverse events and adverse events are reported to FDA and IRB,” including two patients in BT-11, including one patient who had to be removed from the chemotherapy all together because of recurring pancreatitis. Inspectors also observed a “failure to address and resolve reported patient overdoses in BRI query reports to determine the reason for the possible overdose and to take corrective action to prevent recurrence,” including two patients in BT-11.

Additionally, the files of at least two patients in the BT-11 did not record independent tumor measurements by consultants. In the Establishment Inspection Report, the FDA investigator recorded: “Dr. Burzynski stated that he has been contracting consultant radiologists since approximately 1996. I asked Dr. Burzinski8 [sic] if he reports the consultant radiologists’ evaluations, i.e. tumor measurements. He said no. I explained to Dr. Burzynski that all tumor assessments should be reported in the case report forms. He stated he was unaware of a requirement to report the consultant’s tumor measurements.”

We also have no explanation for why half of the patients were excluded from the final study. Further, a researcher on PubPeer reviewed the paper and found some staggering technical deficiencies. Note that this is not Chase’s story, but is apparently from the same protocol as the article that was given to Chase’s family as evidence:

1. Diagnostic criteria: even though there is no clear cut criteria listed for DIPG, there is a common set of characteristics for defining it. As the acronym implies, it should be DIFFUSE, meaning no evident boundaries between the lesion and surrounding brain tissue. Also, it has to be INTRINSIC, meaning it should be completely embedded in pons, with no main exophytic or extra-axial portion. Other commonly recognized features include little or no contrast enhancement of the lesion and location on the ventral aspect of pons. For my astonishment, figure 2 depicts a mesencephalic focal tumor with cystic areas, typical of a low grade glioma with good prognosis, whereas figure 3 shows an upper pons, lower mesencephalon focal, highly enhancing lesion.

2. Accrual time: why it was so long? What happened to the patients diagnosed between 1994 and 2003? […] This patient series seems to be enriched in older patients and longer pre-diagnostic symptom duration, both factors associated with better survival. This strongly indicates a bias […].

3. Evaluation: once there is irregular contrast enhancement by DIPG lesions, it is simply wrong to evaluate response by measuring it. Period. Hence, no result pertaining response evaluation should be trusted in this paper.

4. Prior treatment: patients with more than one previous chemotherapy treatment should raise suspicion, because tipically DIPG patients do not survive beyond the first progression. So, a second and even a third progression seems highly unlikely. […]

6. Title: there is no such thing as a ‘recurrent DIPG’, once [since?] there are no complete responses to treatment for this disease. It should refer to ‘progressive DIPG’.

Lastly, the Clinic has had a hard time diagnosing convincing FDA investigators that their reported outcomes are consistent with the outcomes defined in the protocols they implement. The FDA observed that Burzynski  “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.” The MD Anderson physicians were right the entire time; Burzynski’s quackery can be smelled clear across town.

About the same time that this was going on, Chase has discovered that in exchange for cooperation in the unpleasant business of being a cancer patient, he can charge his parents money for his blood. Very clever guy!

Sadly, by September it is uncertain whether Chase is getting any meaningful treatment at all at this point, which is distressing to see even all these years later:

We also got a return call from the Nutritional Specialist (Jeanne Wallace) who completed her report and is expressing it to us so we can have a consultation and begin the ongoing monitoring process, with her reviewing Chase’s bloodwork a couple times a week. She agreed with our decision to combine the anti-neoplastins with the homeopathic remedy as well as ongoing nutrition monitoring to boost Chase’s immune system. Overall, she’s very comfortable with the plan and doesn’t see any conflicting issues with the treatments. Chase will begin taking the homeopathic remedy, RUTA 6 and Cal Phos, this weekend after a couple more days of the antineoplastins.

On Tuesday the 6th, we get a report of the sort of care we’ve seen so much of since starting this project. This time, the tech can’t tell that the pump has been malfunctioning:

During Chase’s appointment for the ANP treatment today, we discovered that the IV pump has been malfunctioning (as I suspected yesterday, in reviewing the prior days output, but was shrugged off by the tech). The output cycle today confirmed that only about ½ the dosage programmed was administered for the prior two days. 

And then we get to the point where Deepak Chopra ends up on a cosmic shit list:

The most important thing is that Chase continues to be in great spirits and is cooperating fully. The doctors at the Burzynski are quite impressed with his progress and quite optimistic about the results that we’ll be able to achieve. We’re also making great progress with the homeopathic remedy that we received from India (Ruta 6 and Cal Phos). […]  We also spoke directly with Deepak Chopra (world renowned leader in holistic medicine) on Friday evening and he was quite supportive of our approach – he really wouldn’t change anything with what we’re doing, other than to recommend a couple of specific approaches to meditation / prayer, which we’re anxious to use.

Deepak Chopra?!?! The guy can’t form a coherent sentence! All the alt meddlers with their hands in the pockets of the truly desperate are revolting. It’s so frustrating watching this from afar and knowing what happens.

On the other hand, Chase seems like my kind of kid!

On a side note, since Chase has been eating so many fruits and vegetables lately, naturally he’s been having increasing amounts of gas. He thinks this is great – at any time, he can walk up to mom and say, “I have a present for you” and make a loud toot, which invariably sends him off laughing hysterically. When [Chase’s sister is] around, she gets a kick out of his new “talent” too – they’re both at an age where this is just great humor.

The effects of the ANP are becoming evident as he nears the maximum dose:

Overall, he continues to be in great spirits, but certainly has his ups and downs. This is understandable, particularly since his doses of ANP are really getting up there – he’s now at 220 ml x 6 doses per day of #1 and 35 mll per dose on #2. That adds up to a lot of extra fluid pumping through his system, in addition to the average of 5-6 tall bottles of water that he drinks per day (2-3 during the night). We’ve got him set up with a urinal in his room, which makes things much easier and we’re investigating an easy to use catheter so he won’t even have to get up.

Back home in Detroit, the family gets news that Chase’s tumor has shrunk by 5-10%. (I don’t know what effect the biopsy had, and he seems to be on steroids at this point, so who knows what that signifies?)

Chase starts school at the end of September, and in October, the family starts “Rife Therapy,” which I’d never heard of but raises every red flag there is and seems to have caught the attention of quackwatch):

So now we’ll be kicking into gear the next dimension of Chase’s recovery plan – rife treatments. The machine we purchased from Energy Wellness will transmit electro-magnetic waves at specific frequencies designed to interfere with the tumor and stimulate the breakdown as well as the detoxification of the body. 

The family seems to be held in the thrall of their nutritionist and any other shonk who stumbles by:

After corresponding via e-mail for the past couple of months, yesterday we were finally able to meet Dr. Prasanta Banerji, who is widely recognized as the leading Homeopath in India. [W]e were able to fly in and out of Kansas City to meet Dr. Banerji during a visit on his 5 stop tour of leading US cancer research centers to report on the latest results of his remedies. He examined Chase, reviewed his recent blood tests, MRI results, etc. and is very confident that his homeopathic remedy will be successful in eradicating this tumor.

Dr. Prasanta Banjeri deserves to be hogtied. (Here’s a rundown of homeopathy.)

Through the holidays, Chase seems to slip, bit by bit, while the parents fuss over his nutrition. He develops some sort of stomach condition, but I don’t see any record of them taking him to the hospital at all until the end of January:

Unfortunately, his luck ran out by Tuesday of this week. We had difficulty with the IV tubes leaking over the weekend and that seemed to set the stage. [Chase’s mom] ended up spending 4 hours with Chase in the emergency room from 1-5 am trying to get someone to correctly change his port access and that just ran them both down on energy. Then Chase ended up with nausea again with a fever for a couple of days and had to stop all treatments and miss school. This created an even greater burden for [his mom] to wait on him hand and foot through this period. When we got the results of his bloodwork, we could see why he didn’t want to tolerate treatment or eat much – his potassium was the lowest it’s ever been and his sodium was off the chart (probably due to dehydration related to the fever). […]

Sodium off the chart? We’ve heard of this before, in the story of Luna P.

In mid February, the parents report that Chase’s face is sagging and the his vision is getting “cloudy,” but the parents announce that “Chase is Staying On Track!” It’s very sad. When the tumor seems to be growing, the family decides to make a pilgrimage:

We are now planning a trip to Medjugorje right after Easter to take Chase to the area where Our Lady has appeared and there have been many miracles reported. We continue to have strong faith that Chase is on his way to a full recovery and we’re excited about the unfolding of this miracle. 

Up to this point there has been nothing like progress for Chase while he has been on the ANP treatment. Instead, we see tumor growth, and increasing number of symptoms, and fatigue. These parents just can’t see it. In April, Chase starts to lose some mobility on his right side, and at the end of the month, the parents take him to Hungary for a miracle.

In early May, he’s deteriorated more.

In June, the tumor is growing, and Chase is feeling headaches and nausea and other symptoms related to the growth of the tumor and then we hear this. He can’t move his arm or stand on his own. The parents turn to Quantum Healing, which is “imagining” the tumor is getting better. They seem to think that the only problem is that the tumor isn’t being absorbed:

We’re also continuing to use the visualizations / quantum healing approach (focused mainly on seeing Chase’s white blood cells attacking and breaking down the tumor). We have another MRI scheduled for next Friday (6/16) which will provide another very important update on our progress, followed by consultations with his Oncologist and the Burzynski Clinic to determine the next course of action. 

Chase’s next MRI is a tale of woe, and the parents get some news that there is necrosis inside the tumor. What this means is uncertain, but we’re starting to see a pattern in the news that Burzynski’s patients get.

We were fortunate to be able to meet with the Radiologist right away and get his impressions. Unfortunately, the tumor was somewhat larger, which is quite concerning and obviously the reason for the increased neurological symptoms; however, there was a very significant change in its characteristics. We had been told after the previous scans that there seemed to be some necrosis (accumulation of dead tissue) but this time it was extremely obvious – there were two quite large “blisters” or pockets of fluid inside the tumor. The Radiologist described these as pretty clearly necrosis, but wasn’t sure this would be good news, since he’s not familiar with the results to expect from anti-neoplastons and the other treatments that we’re doing. 

We got the feedback from the Burzynski Clinic today, after they reviewed the CD of the MRI as well. Dr. Burzynski was gracious enough to give us a direct consultation to discuss his impressions. He seems to think this is very likely good news – indicating that the tumor is starting to break down and typically the next step would be that the liquid in the blisters would dry up and eventually collapse or shrink. However, there were some areas of enhancement in the scans around these blisters which could also be an indication of higher grade activity (i.e. malignancy). If this is the case, we would need to stop antineoplastons right away and quickly develop an alternative plan (such as radiation or immunotherapy targeting this cell type). Alternatively, this enhancement could just be confirmation of the blood supply being cut off to these areas of the tumor which would be great news. (emphasis added)

Necrosis in the center of a tumor usually means that the tumor has outgrown its blood supply; in this case, it almost certainly means that the ANP is doing nothing to arrest the growth of the tumor. We first noticed patients reporting this as good news in the story of Amelia S, but soon we were aware of many others:

Chase is in the ER in mid-June because he can’t breathe, his vocal cords are paralyzed and he is suffering from swelling in the brain. The family interprets this as Chase getting better so fast it’s hurting him:

All indications are that this tumor is indeed breaking down; however, until it actually shrinks, the pressure that is building-up is extremely concerning since it is affecting Chase’s vitals. This is essentially the “healing crisis” – the tumor is breaking down at a rate faster than his body can resorb the fluid or byproduct of the dead tumor.

In a few days, Chase can’t breathe on his own for more than an hour. They give him a tracheotomy to assist his breathing.

The family seems intent on bringing Chase home as soon as possible, and this starts to lead to problems with the hospital and ICU staff, who see it as dangerous:

SATURDAY, JULY 01, 2006

Chase is Extremely Anxious to get Back Home!Things seem to be going fairly well in terms of Chase’s recovery from the surgeries. He’s been visited by both surgeons that past two days and they don’t see any issues. Nevertheless, the hospital administration is insisting that he needs to stay at least until Monday (actually they’re trying to push us to stay until Wed). We reluctantly agreed to Monday, so that we can let the ENT specialist change the trach and train us on that procedure, but assuming that goes well we’re pushing to get out that day. 

Once the ICU staff realized we weren’t going to accept anything else, they had a patient advocate come and meet with us to try to convince us it would be in Chase’s best interest. We responded that of course, if something concerning should come up with Chase’s condition, we would reconsider. But as far as we’re concerned, those chances just increase the longer we stay in the hospital. We really need to get him back to his familiar surroundings with some stability and on the treatment plan that is working to heal him.

This is hard to continue to write about because I know it really happened. The family is now taking up quantum healing even more than before.

By the end of August, Chase is now experiencing tremors on his left side. Burzynski, however, keeps pumping them full of unwarranted optimism:

The feedback from the Burzynski Clinic is that the changes in Chase’s tumor are consistent with what they would expect as it is going through the degradation process. Although the conventional doctors haven’t seen this before, Dr. Burzynski has and he’s confident that things are progressing in the right direction with Chase’s recovery. He is particularly pleased that there was no more mass in the lesion with an increase in the amount of fluid / necrosis.

Abominable. Then we see the most depressing paragraph in the history of medicine on the 1-year anniversary of Chase’s diagnosis:

Well, needless to say, they didn’t know much about the character of our little Trooper! He’s been quite a fighter and an inspiration the whole way. He’s done all we could ask to defeat this terrible condition. The files posted on his Yahoo group show what Chase’s current protocol entails, which tends to change on a weekly basis, with the input of his Nutritionist, Naturopath, Energy Practitioner, Homeopath, the Burzynski Clinic, etc.

Not one person on this list is capable of helping Chase. By September, it’s hard to see anything that looks at all like life in the kid. And then, in early October, this:

THURSDAY, OCTOBER 05, 2006

We Overcame Ludicrous Charges by Protective Services

Last night, I was shocked to come to our front door to find a group of police officers along with two representatives from Protective Services claiming that they had a court order to remove our children due to allegations that we were conducted medical procedures that were endangering Chase. […]

When I explained that everything that we’ve done has been under the supervision and guidance of licensed medical practitioners and provided documentation to substantiate this, their response was that “it doesn’t matter, we have a signed court order and we have to remove your children” […].

Well, as expected, when we provided our documentation to the court, the Prosecutors Office declined to even pursue any charges and requested immediate dismissal of the case, which the Circuit Judge agreed to do.[…]

It is safe to say that if I had been following their blog at the time, Child Protective Services would have been called long before this.

At any rate, a neurologist came to test Chase and found him simply unresponsive:

MONDAY, OCTOBER 23, 2006

Chase Rejected his Doctor and Defied Medical Logic

Last Friday, Chase’s Neurosurgeon came over to assess his shunt site and drain the excess fluid. We were anxious to show the doctor how much more responsiveness Chase has had lately but he didn’t seem to want to cooperate. Over the course of about an hour, Chase wouldn’t budge or indicate the slightest response. Even when we did the breathing test again, he barely took one shallow breath over a few minutes, which was really concerning. 

Of course, the Neurosurgeon took the opportunity to remind us that he was pretty certain that Chase could not be responsive since he is essentially brain dead. Although this wasn’t surprising, it was nonetheless very frustrating because we know otherwise, particularly given Chase’s recent improvements.

After the doctor left, I went back to see Chase and told him I was worried about him. When I asked if he was OK, Chase pulled up his leg (as he has in the recent past to communicate). I was extremely relieved (although frustrated with his lack of cooperation – I can’t blame him for not liking the docs who are trying to convince us to “give it up”).[…]

At Christmas, the family is still exuding an aggressive, unjustified hope that he will come around, that he is just “sleeping.”

In January, the family starts talking to an “intuitive.” That there are people around who are willing to enable this completely disordered thinking is just heartbreaking:

FRIDAY, JANUARY 19, 2007

Chase is Connecting with [his mother]

Over the past couple of months, we’ve been using a very gifted “intuitive” to help us communicate with Chase. He seems to be very comfortable conveying telepathically his needs and desires as well as how he’s doing with the various treatments. We’re continuing to do everything we can to support Chase in his recovery while keeping him comfortable and “connected”, according to his suggestions. […]
During a recent session, Chase conveyed that he wanted mommy to learn how to “connect” with him with the help of our intuitive. Apparently, he wants her to be able to capture his thoughts in order to write a book that would help other families and children in dealing with these kind of situations. Ironically, for the longest time [Chase’s mom] had an intuition or calling to write a book, but didn’t think it would come so soon. Chase is very excited that she’s receptive to working with him and developing her ability to “connect” in this special way.

By March, Chase has been moved to a hospital again, where he contracts infection after infection after infection. There is no response and he is essentially lying in state. Eventually, he contracts a blood infection he can not fight.

Chase died on 17 September 2007.

It’s hard finding anything redeeming about this story. In the end, even Burzynski was a (comparatively) minor player in what happened. ANP clearly did nothing to allay the tumor’s growth or the progression of the disease. The whole story is one of protracted, agonizing decline and false hope abetted by quacks, mystics, and opportunists of all sorts. It was a horrible piece to have to write, but people like this and those who depend on them need to be protected from quackery.