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Category: Uncategorized
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:
- 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.
- Additionally, some patients admitted failed to meet the inclusion criteria for the study.
- 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.
- 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.
- 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.
- 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.
- "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.
- 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.)
- 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.
- The clinic was unable to account for its stock of antineoplastons.
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.
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.
"Today, May 26, 1998, she even stood on her own two feet without support!
Come on. Let's Go
You are and always will be
our Kyla, our hero
Our miracle our sunshine
our hope, our child.
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 satisfactorily published. 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. 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 day, friends 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 October, it 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
(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:
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.
[Her mother] [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
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, 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, saying that she was unable to get any of her local doctors to agree to work with the Burzynski Clinic, whereas the "B. Clinic people are making me feel very pressured like it's my problem."
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 that the "Barbara T." at the Clinic explained that the family needed a FDA form 1572 to proceed. "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, she heard the same message from Dr. Weaver. Dr. Weaver, by the way, was sanctioned in May 2014 by the Texas Medical Board for his behavior at the Burzynski Clinic, including:
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, finding:
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. I turns out that while the staff was "delightful and helpful," Briannah had not had the appropriate type of head scan prior to coming to Houston:
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.
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," [her dad] said.
The treatment begins the same day that article runs. A scan posted in July shows the sheer size of this tumor. It dominates the center of the scan and is a terrifying monster. 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. The Clinic claims they have never seen sodium plummet like this before.
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:
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!!! […].
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, according to the FDA, and as reported in USA Today, patients were found to be on 5 to 65 times the anticipated dose 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, we are informed that the tumor has shrunk by 9%. 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 (which Burzynski is not) 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. The catheter needed to be replaced and a gastric tube has been put in. At the same time, when she goes off of ANP, her sodium plummets. It may be the first time that ANP has actually pushed someone's sodium in the right direction.
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," [her mom] 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, the family were with their pastor at Phoenix Children's when Briannah died.
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," [her mother] said. "That in itself is a miracle, I'm not kidding you."
But eventually, [Briannah's parents] 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," [her mother] said.
It is difficult 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:
- We first noticed this pattern in the story of Amelia S.
- The family of Haley S heard this (also, see the clinic's heartless reaction to a stroke that the child had).
- The Clinic gave the same prognosis to Justin B's family in 2006.
- We see a similar cyst in Leslie S.'s story (2006), and it nabbed Burzynski an extra $7,500 before she died.
- We see it AGAIN–as far back as 1994!–in Cody G.'s story.
- We saw it again in the case of Samantha T.
- We saw it again in the story of Christy M.
- A similar story came from Georgia State Senator Ed G.'s story.
- In the most grotesque horror show we've ever written about, Burzynski himself tells the family of Chase S. the same thing. Poor Chase ended lying in state in his family's front room for months.
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:
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 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 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:
1/3/1990MIDDLETOWNThe 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 [W] 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.
"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."
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.
- 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.
- 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.
- 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.
"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."
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.
[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.
On November 1, 1990, Ryan displayed complete remission.
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.
Burzynski Patient Josia C.'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 [Josia's dad], 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.
(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:
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 [Josia's mom] 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 […] 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:
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, 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." [emphasis added]
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:
- We first noticed this pattern in the story of Amelia S.
- The family of Haley S heard this (also, see the clinic's heartless reaction to a stroke that the child had).
- The Clinic gave the same prognosis to Justin B's family in 2006.
- We see a similar cyst in Leslie S.'s story (2006), and it nabbed Burzynski an extra $7,500 before she died.
- We see it AGAIN–as far back as 1994!–in Cody G.'s story.
- We saw it again in the case of Samantha T.
- We saw it again in the story of Christy M.
- A similar story came from Georgia State Senator Ed G.'s story.
- In the most grotesque horror show I have ever written about, Burzynski himself tells the family of Chase S. the same thing. Poor Chase ended lying in state in his family's front room for months.
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.
[Josiah's parents] 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.
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 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.
Burzynski Patient Ryszard C.'s Story
Ryszard C. was a world-renowned actor known for experimental theater.
Here he is in an interview describing his approach to the body and the exercises that he thought were vital to the success of an actor:
You can see perhaps what led to his early death from lung cancer in the opening frames of that interview.
In 1962, Ryszard joined the newly-founded Laboratory Theater in Poland, where experimental theater was being developed. According to the wikipedia page of the Theater's founder, Jerzy Grotowski:
In 1965 Grotowski moved his company to Wrocław relabeling them a "Teatr Laboratorium", in part to avoid the heavy censorship to which professional 'theatres' were subject in Poland at that time. Work had already begun on one of their most famous productions, "The Constant Prince". Debuting in 1967, this production is thought by many to be one of the greatest theatrical works of the 20th century. Ryszard [C.]'s performance in the title role is considered the apogee of Grotowski's approach to acting. In one of his final essays, Grotowski detailed how he worked individually with Ryszard for more than a year to develop the details of the actor's physical score before combining this central element of the performance with the work of other actors and the context of torture and martyrdom intrinsic to the play.
After they stopped working with the Theater, the pair continued to work together. In a tribute to his partner in 1990, Grotowski discussed Ryszard's dedication to the craft:
"We can say that I demanded from him everything, a courage in a certain way inhuman, but I never asked him to produce an effect. He needed five months more? Okay. Ten months more? Okay. Fifteen months more? Okay. We just worked slowly. And after this symbiosis, he had a kind of total security in the work, he had no fear, and we saw that everything was possible because there was no fear."
According to his obituary in the New York Times:
Theater critics cited Mr. [C] in 1969 as Off Broadway's most outstanding creator and the actor with the greatest promise.
For the last four years, Mr. [C] taught acting to advanced students at the Tisch School of the Arts at New York University.
In the 1980s, according to his biographer:
"There is no point in hiding it: during this period, [Ryszard] was drinking even more than usual. Periodically he had to dry out. He smoked several packets of cigarettes a day. Yet [his students] still say he taught them about courage. He was not so much an actor with great talent as an actor with great courage."
He summarized his lessons to acting students:
How to be true in performance, that above all. I struggle to plant in them the principle that Grotowksi handed on to me: we act so much in our daily lives that to make theatre what we need to do is to stop acting. Another very important thing to understand is that an actor must concentrate on his own body. The actor's instrument is not [simply] his voice or his diction, it's his whole body. Theatre can be a combination of all the arts-music, dance, painting, writing, but above all it is moving visual art. (in Torzecka 1992:261)
Ryszard's career is retold in detail at Grotowski.net.
Some said that following his parting of ways with Grotowski, the stress of having lost his professional partner manifested itself as cancer; more likely the hard drinking and smoking paved the way for the disease.
On June 5th, 1990, according to his Burzynski, Ryszard entered the Burzynski Clinic with lung cancer. He died 10 days later in Houston. Ryszard C. was only 53. One of the most important actors of the 20th century, in the estimation of his peers, died away from his home in the care of a quack.
For reliable information about clinical trials, visit clinicaltrials.gov. Please consider donating to St. Jude Children's Research Hospital, the children's hospital that once helped a young friend of mine who is no longer with us. If you want to know about the character that Ryszard trusted in his last days, see the story of Amelia S.
Burzynski Patient Kuly R.'s Story
I'm sad that I only heard of Kuly R. after he had passed away. Kuly and his two brothers formed the band RDB (Rhythm Dohl Bass), a popular British-Asian urban bhangra group I have been listening to ever since I first came across Kuly's name in a post over at A Healthy Dose of Skepticism. If you listen to a clip of their music, you'll recognize the hip-hop influence instantly, but you'll also hear a Punjabi influence, which was new to my ears.
The brothers made their name as performers and producers, and their initial success, brought about by a fusion of eastern and western music, has brought them opportunities to participate in high-profile collaborations with Snoop Dogg ("Singh is Kinng") and Ludacris ("Shera Di Kaum") and the top names in Bollywood music. (About halfway through "Singh is Kinng" you get the sense that these styles work really well together, and it is delightful to hear Snoop rapping about the babes in Mumbai.) They founded their own label, Three Records. The remaining brothers, Surj and Manj, have pressed on. They were a featured act in March 2013 at the first India MTV Video Music Awards, where they appeared with T-Pain.
The family was pretty tight lipped about Kuly's illness; it does not seem that they were public about it, and there are practically no published details. As such, there is not much of a trail to trace here. Patients who end up at the Burzynski Clinic, however, have very similar, at times nearly identical experiences. Also, we have looked at enough cases on this site that minor details can actually be quite revealing. It should be remembered, however, that what follows is really a composite of other patients' experiences. Kuly's case is really more of an occasion to share what we know of these patients rather than a straightforward account of his experiences. We try to indicate where we stray from what we know about Kuly so as to avoid confusion; we invite correction should we get any particulars wrong.
In April 2011 Kuly, the oldest brother, was diagnosed with a brain tumor. We know that he had radiation and chemotherapy. This treatment seems to have stayed the progression of the tumor for the rest of the year. In October 2011, the brothers were planning their India tour, and an BBC interview with them suggests that they are on the verge of superstardom. Kuly is interviewed, and he looks pretty good. The South Asian Times reported his death on May 25, saying, "He was receiving treatment at a specialised clinic in Houston, US, at the time of his death."
Kuly might have gone to MD Anderson in Houston, a world renown cancer research hospital. But it really looks like he was at the Burzynski Clinic. We know this because of a message from Geeta, Kuly's wife, which appeared on the Team Hannah website (Hannah was in Houston at the Burzynski Clinic at the time of this message):
The treatment that a brain tumor patient would have received at the Burzynski Clinic at this time is likely straightforward enough that you can back fill some of the story. My best guess is that if they left Houston on the 22nd, they probably arrived at the Clinic around the first week in January 2012. If he was in one of Burzynski's "trials," he and his caregivers would have spent their time in Houston learning to administer the medication.
Kuly was likely being treated with the metabolic byproducts of sodium phenylbutyrate (PB), an unproven form of chemotherapy that Burzynski has been treating patients with for decades. PB is an orphan drug used to treat urea cycle disorders and carries an enormous sodium load. (The amount of water that patients have to drink is unreal, and increased blood pressure, as you might imagine, is dangerous to someone with a brain tumor.) Burzynski originally found these substances in human urine, but he has since industrialized their synthetic production. He hypothesized that the lack of these substances in cancer patients' urine meant that "replacing" them might curer cancer. He labeled them "antineoplastons" (ANP), literally "anti-cancers," and began treating patients, having never gone through the appropriate vetting process. Nobody in the medical literature has ever identified "antineoplaston deficiency" as a cause of cancer. Decades later, there is still no compelling evidence that antineoplaston therapy is any more efficacious than giving a tumor a stern talking to.
Because of a major lapse in the FDA's judgment, Burzynski was allowed to administer this chemotherapy as part of a clinical trial. So what did he do? Open up over 60 clinical trials. And don't take my word for it. Burzynski's lawyer, Richard Jaffee, in his memoir, said that in order 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.
In all the years he has been pumping this failed therapy into patients, he has never published a finished study. If you follow the link above, you will see that all of his trials are abandoned or of unknown status. His research career is a joke. Another red flag is the fact that Burzynski charges his patients to participate in clinical trials, up to $30,000 to start and maybe $10,000/month thereafter, often bleeding the dying dry. This is not a business model that suggests that ANP is likely to ever go to market as a cancer cure.
Sadly, at about the same time that Kuly died, a pediatric patient died, and the possibility that the ANP killed her was strong enough that the FDA put a temporary hold on all new antineoplaston patients. No new patients are getting antineoplastons at this time. An intense investigation of the clinic was carried out by the FDA at the beginning of this year, and I received the observation notes of one part of the inspection through a Freedom of Information Act request. What inspectors observed, in my opinion, was not what one expects of a reputable research institution. We have copies of these inspection notes on this website. If any lab at a government-funded research university had had this type of inspection (and we are still waiting for the final report), all government funds to the entire university would be cut off immediately. Sadly, a child had to die before the FDA took action.
Not two months before Kuly began treatment with Burzynski, a person who had been hired by the clinic to provide "web optimization" services, Mark Stephens, started issuing fake legal warnings to people who openly questioned Burzynski. Among these was a high school student in the UK, who was sent a picture of his house by the Clinic's tough, the clear message being, "We know where you live." These threats against critics were covered extensively in the international press. What was not reported at the time was that the same worker was making nearly identical pseudolegal threats to Wayne Merritt, a former pancreatic cancer patient of Burzynski, and his wife Lisa Marie, herself a breast cancer survivor. Stephens called these cancer patients at home to threaten them (how a web optimization person got their names given the patient privacy laws in this country is certainly curious). The Merritt's story is also shared on this website.
In February 2012, the younger brothers were interviewed by Rolling Stone, when their brother must have been obviously ill, and they did not mention the treatment or give any hint about what they were going through. At this time, if he were still on treatment (and because he died in Houston, I'm going to presume that he stuck with Burzynski all the way through), Kuly would be receiving nearly constant infusions of antineoplastons through a programmable pump that he would be carrying with him. He probably would have felt lethargy because the sheer quantity of water that he'd need to imbibe (I've seen up to 12 liters a day) would have kept him up at night, running back and forth to the lavatory. He probably would have been on a fairly heavy dose of steroids, which might have ameliorated some of the inflammation associated with the tumor and temporarily relieved some symptoms.
There is a chance that Burzynski had Kuly on what he calls, "personalized gene-targeted therapy," which uses a commercial genetic test as a type of "medical palm reading." This is Burzynski's only medical option right now, and we suspect that the majority of his patients end up on this (even if they have been attracted by antineoplastons). Untested combinations of off label chemotherapies are sold to the patients on the basis of this gene test. But this therapy, at least until the FDA shutdown of the ANP trials, was reserved for patients who did not have brain cancer (though when the ANP fails a patient, which is a lot, the Clinic seems to try to get the patients to sign up for this similarly expensive course of treatment).
The experiences of patients on antineoplastons often follow a similar course: the tumor appears to stop growing on the MRIs, which are administered and sent to the Clinic for evaluation every 6 weeks or so. While patients always seem elated about the progress that they are making early on in the treatment, in fact solid tumors tend to grow very quickly at first, but the time that they take to double in size increases, which leads to a Gompertzian growth curve, an elongated s-shape with rapid growth in the middle.
At the same time that these tumors temporarily level off, 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 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:
- We first noticed this pattern in the story of Amelia S.
- The family of Haley S heard this (also, see the clinic's heartless reaction to a stroke that the child had).
- The Clinic gave the same prognosis to Justin B's family in 2006.
- We see a similar cyst in Leslie S.'s story (2006), and it nabbed Burzynski an extra $7,500 before she died.
- We see it AGAIN–as far back as 1994!–in Cody G.'s story.
- We saw it again in the case of Samantha T.
- We saw it again in the story of Christy M.
- A similar story came from Georgia State Senator Ed G.'s story.
- In the most grotesque horror show I have ever written about, Burzynski himself tells the family of Chase S. the same thing.
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. (Around the time this was happening, such swelling was not listed on the ANP consent form as a possible serious side effect. See Even strong side effects during initial doses have led to whoops of joy from the nurses there, as was the case in John D.'s story. We sincerely hope that Kuly's family did not have the same experience that so many other people have had; if they did, we hope they realize that they weren't the only ones. A biography of Kuly's wife (pdf) notes that there was a time where "Kuly's health appeared to be improving." I've heard that so many times, but why does this "improvement" never seem to lead to an extension of life?
Kuly died in May 2012, according to the sad RDB press release:
The international music fraternity has faced a saddening loss with Kuly of music band RDB, passing away on 22nd May 2012 in Houston, Texas, USA. The popular music group member sadly lost his battle with cancer at the young age of 35 years old.
His wife was by his side when he died. What is most curious to me is that Kuly died in Houston. It seems to me that most of the international patients tend to die in their home country. Once the caregivers are trained, they continue treatment at home, monitored by local physicians. Furthermore, the Clinic has no beds. Burzynski besides not being a board certified oncologist also has no hospital privileges. So, I am surprised to see that after they returned home in January (presumably to Bedford, UK), that they were back in the US in May, and apparently back at the Clinic. One possible scenario is that after ANP had irrefutably failed, even from the perspective of the family, is that, like Adam M., he was offered the other, "gene-targeted" treatment, which necessitates returning to Houston to begin treatment again:
We don't know what we are supposed to do next. We have discussed a few options, but they all look so awfully wrong. The Burzynski clinic is encouraging us to come back to Houston so he can start gene-targeted therapy. It just feels wrong. First of all, we need to come up with $30,000 to start the other treatment, not to mention all the expenses of going down there. It makes both of us nauseous just thinking of going back to that place and starting over. The monthly cost of the treatment is over $20,000.
The other possibility is that the family traveled back and forth more frequently between the US and the UK than the typical patient. (In the BBC interview, the brothers note that home is whatever plane they are on.) They seem not to have had to raise money like so many of Burzynski's other patients in the UK. It occurs to me that if this scenario is true, the timeline may be even less certain, as they may have met Hannah during one of any number of trips. So, keep in mind that while the case of Kuly is speculative, the general story that I've told holds true for so many of the 550 patients we've collected on this website.
Kuly has not been forgotten. Soon after his death rocked Bollywood, is colleagues recorded tributes. He is on the Brampton Walk of Fame. His brothers have said that they have retired his position at the record label and that nobody will "sit in his throne." His wife has made brain tumor research her preferred charity, and she has raised a lot of money, most notably through the Street Spice event in March of this year. On an old fundraising page (the charity it linked to has since merged with another charity), Geeta notes:
As well as his passion for music, the concept of 'Seva' (selfless giving) and education were very important parts of his life. A humanitarian, Kuly always wanted to give back to society and encouraged others to do the same. Along with a zest for life and charity, he also always wanted to continue learning and expanding his horizons.
For reliable information about clinical trials, visit clinicaltrials.gov. Please consider donating to St. Jude Children's Research Hospital, the children's hospital that once helped a young friend of mine who is no longer with us.