*An appeal to encourage Congress to investigate this follows Laurye’s story*
(note: quotations from the Laurye’s family’s website are translated from French)
In September 2002, 2 year old Laurye L. was taken to the optometrist, who diagnosed her as farsighted. In January, doctors carried out some visual tests on her, but it turned out that Laurye’s visual problems were not in her eyes, but in her brain. In early March 2003, her health was clearly deteriorating. On the 11th of that month, her parents received a diagnosis. It was that monster that keeps appearing on this website, the Diffuse Intrinsic Pontine Glioma, a brain stem tumor for which there is no real effective long term treatment and to which most patients succumb.
Three days later, Laurye had surgery to reduce pressure in her head, but the prognosis was the same. The family was discouraged from making Laurye suffer through chemotherapy by their doctors. They did, however, give her cortisone and started 28 radiation sessions, which seemed to slow the growth of the tumor.
The family found a real clinical trial in North Carolina (“a chemotherapy with painful side effects without promise of success”) and they found Burzynski, whose treatment, antineoplastons (ANP), they believed, gave Laurye a 50% chance of a cure. No published studies of ANP exist to substantiate that number, or any number for that matter. In fact, the FDA recently observed Burzynski (as investigator, the subject of a recent inspection):
“failed to comply with protocol requirements related to the primary outcome, therapeutic response [...] for 67% of study subjects reviewed during the inspection.” This means that several patients who were reported as “complete responses” did not meet the criteria defined in the investigational plan, as were patients who were reported as having a “partial response” and “stable disease.”
This means that his outcomes figures for these studies are inaccurate. Given these findings, there is no basis for any percentage given by anyone about the efficacy of antineoplastons to be believed.
The parents describe their rationale:
“The name of the treatment is antineoplastons. [It is] nontoxic, the side effects are very minimal and do not affect the quality of life: excessive thirst which increases the volume of urine, no pain for Laurye. After many confirmations with patients who received treatments from Dr. Burzinski successfully, we chose this option believing that this is the best opportunity available to children with this type of tumor.”
Sadly, this is another case of the Burzynski Patient Group luring another person into Burzynski’s exam room. In August, the family goes on vacation, and Laurye is still well enough to learn to fish with her dad.
They outline their plan. On Nov 24, the family will leave Quebec for Houston. The intravenous treatment will cost them $7,200 for the first year and in the second year, capsules will cost $2,000/month for as long as Laurye is on treatment. Medicare does not cover the treatment, so the family sets up a foundation to fund Burzynski’s treatment.
In Houston, on the first of December, Laurye has a port installed in her chest where she will receive the antineoplastons, which will be pumped nearly continuously for months at a time. Laurye has an MRI the next day, and the family passes the next few weeks, like all other caregivers who come to Houston for ANP, learning how to administer the antineoplastons:
This practice, having patients’ families administer the drug, may have contributed to the over 100 overdoses in the last few years. It does not explain, however, this observation by the FDA:
“You failed to protect the rights, safety, and welfare of subjects under your care. Forty-eight (48) subjects experienced 102 investigational overdoses between January 1, 2005 and February 22, 2013, according to the [trial number redacted] List of Hospitalizations/SAE (serious adverse events) [redacted]/ Overdose [redacted]/Catheter Infection report. Overdose incidents have been reported to you [....] There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects.” (emphasis added)
The family returned to Quebec on December 18th. The family reports:
Since December 3, Laurye is on intravenous injection. She must wear a backpack with 2 medication bags in it 24 hours a day. A small pump, connected by a pipe to the catheter, is programmed every four hours (6 doses per day ). We have to change the bags and reprogram the pump daily. In addition, Laurye has a healthy diet to follow and an MRI every two months. The only side effects are excessive thirst, fatigue, and frequent urination.
The unquenchable thirst and urination are caused by the high sodium load that ANP patients carry. According to the FDA’s findings, one patient experienced 12 episodes of hypernatremia (high sodium), none of which was reported.
The family’s new foundation very quickly holds numerous fundraisers, mobilizing the entire community. According to the numbers on the family’s website, no fewer than 18 fundraisers were planned. Additionally, first nine raised $31,520.75 for Burzynski. It is an outrage that the immeasurable kindness and generosity of entire communities has been squandered on Burzynski’s apparently unpublishable studies.
In February (presumably), we get another update.
Her current situation is stable. Every day is an uphill battle against this deadly disease for the whole family, for friends and especially for Laurye. This unique method of treatment [demands] a exceptionally big commitment of time, energy and courage from us. Currently, Laurye is doing very well. [...] The first months were difficult; before her body adjusted to the treatment, she was tired and irritable but the best is yet to come for our Laurye.
We got the results of the January 30, 2004 [MRI], encouraging news for our daughter. The tumor did not progress. She remained stable.
While this does mean that the tumor is not growing quickly, periods of tumor stability are not unexpected even without treatment.
Laurye has not had a winter like other children. We always had to be careful that she did not fall ill. Also, the pump does not react well to cold temperatures so we had to limit her outdoor activities. Laurye changed physically (weight gain and swelling) due to cortisone medication to be given in addition to the current treatment. This is to [prevent?] pain during treatment because [when] the tumor is attacked it can cause a lot of pressure in the head. After the good MRI results, we could reduce the cortisone.
This sounds a lot like a line that patients have been repeating throughout this project, that symptoms of getting worse (in this case, swelling in the brain stem) are often described by patients as if they were signs of getting better. Parents of sick children grasp anything at all that would suggest that their child is getting better, even when it is getting worse. We’ve seen a disturbing pattern of patients reporting that getting worse was getting better. We’ve seen it at least 10 times.
We don’t hear much, honestly, until 2005. A mysterious spot appears on the January MRI and disappears on the Feb 22 MRI. Another MRI is scheduled for April 5. The news is not good:
Laurye past a MRI on April 5 and the tumour increased of 3% and there are 3 spots (8mm, 4mm, 1mm).
Doctor Jurida asked [for] a pet scan to see if there is some activity in the spots. We are very worried. We are waiting for on appointment for the pet scan and with the results we will know more. But what we find weird is that in january there was a spot. Febuary it was gone and know there are 3 of them. [...]
Laurye eyes restarted to cross and her legs are hurting. Can someone tell if they ever have any spots like us and what happened.
We don`t know what to think? Doctor Jurida says that as long as we have some spots we cannot disconnect Laurye? It is going to be 17 months on the I.V. treatment and Laurye is starting to be tired of it.
By May, Laurye is off ANP. On May 22nd, she goes on Temodar, which seems to be a standard treatment for this type of tumor. Laurye’s mother reports in June:
Doctor Burzynski told us that it doesn’t do any good to keep Laurye on the treatment. He is suggesting the capsules of antineoplastons all alone or another possibility, capsule of sodium phenylbutyrate (PB) with a soft chimio.
I would like to know if you heard of the sodium phenylbutyrate capsule and what do you thing of them.
Laurye is loosing her ability`s a little bit every week but the clinic can`t tell me if it is necrosis or other tumours. The only way to know would be a biopsy and it is too dangerous, so we will never know.
They do mention that her only side effects from the chemotherapy is constipation and tiredness. In the same post, we see this:
We would like to take the best decision for Laurye. We decided to start oral chemo (TEMODAR) on may 23, 2005 hoping to stop the tumours if its the case for an undetermined time because we would like to go back to the antineoplaston capsules to prevent the increasing again. What if it is not the tumour increasing and it is necroses due to radiation. She is going to have done chemo for nothing, it doesn`t take the necrosis away. the only way to stop necrosis would be hyper-bar oxygene (HBO).
There is a question i’m asking myself and 2 doctors say 2 different things. Do you think chemo increases [radiation necrosis?]
Laurye’s flame is flickering in these final months. On September 8, an update from a family friend:
A few weeks ago [Laurye] was unable to walk or stand. She was unable to do much but lay on the couch and drink through a straw. Her doctors in Canada said it was due to a bleed, but could not confirm it. Her Decadron was increased and she got up and went to school. She had a PET and we are still awaiting the results. Unfortunately, the increased Decadron dose is no longer working. Depending on the results of the PET, as to whether or not she will qualify for Hyperbaric treatment. She will have to go to a private clinic because the local MD’s have told her parents to let her go (pass away) and will not authorize any further treatment.
On September 10th, in Le Soleil, we hear:
The battle of the little Laurye [L] against the brainstem glioma, a rare and incurable cancer, is nearing completion. The girl who has awakened the sympathy of the population during two years of valiant struggle now living his last moments.
“Let yourself go, Laurye, I’m ready to let you go.” The voice full of distress, Sonia [C] courageously facing the imminent death of his daughter. “I asked her if she was ready to go to heaven. She said nodding,” tells the mother, experiencing immense pain.
Although Laurye’s awareness is intact, her physical condition has deteriorated significantly in recent days. She first stopped walking and talking and can now no longer eat.
Sonia [C] [was] torn from the bedside of her 5-year old daughter for a brief press conference yesterday afternoon to announce that a few hours, maybe a few days, remained in Laurye’s life. She [thanked] all those who supported the family morally and financially throughout his illness.
In the same article, we hear what the total amount that went to the treatment:
Founded in 2003, the Laurye [L] Foundation has raised approximately $235,000. The director of the Foundation insisted that the remaining approximately $ 10,000 cash will be used to fund research on glioma or will be routed to other foundations that assist sick children.
A staggering sum.
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.