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:

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.