Category: Uncategorized

Burzynski Patient Eduardo M.’s Story

Though it’s been a while since we’ve posted, we still hear from relatives of people who went to the Burzynski Clinic and realized it for what it is, a wallet biopsy with a snake oil chaser. The pain experienced by families reverberates for decades, a legacy of misery few men have sunk to. We have about a hundred of those stories here, and we have a thousand more names in the hopper. We will be starting up again since Burzynski was found to be sanctionable on over a hundred counts early this year by an administrative law judge. He can still practice, but he’s skating on very thin ice.

EduardoM

Burzynski Patient Eduardo M.

The story of Eduardo M. begins in Argentina, in May of 1998.  It was given to me by Eduardo’s daughter in a series of emails. We’re putting the elements into chronological order, but if a quote is set aside, the language comes directly from an email from Eduardo’s daughter, who wanted her dad’s story told.

I am unsure why I am writing this email to you, after so long… but a deep sadness invaded me when I read after googling the dodgy Polish guy who called himself “Doctor” in Houston.

In the Spring of 1998, Eduardo, who was 58, had had three minor accidents while parking his car. His daughter tells the story:

He visited the ophthalmologist and found that he lost his peripheral vision. My dad was blaming his new glasses for his poor vision, but it was worse.

The ophthalmologist sent my dad immediately for a scan, which showed the tumour in his occipital area (of a size of a chicken egg). My dad had no other symptoms.

A week later [in late May] he had brain surgery in Argentina, with one of the best neurosurgeons (who was trained in the US). He removed 80% of it, but the rest was too deeply ingrained in an area that he could not get to.

The diagnosis was a glioblastoma, the same type of tumor that John McCain has been diagnosed with.

The neurosurgeon said the prognosis would depend on which area of the brain the rest of the tumour kept growing towards (inside or out).

The neurosurgeon recommended radiotherapy, but was not optimistic with the prognosis.

A second cousin of mine lives in Houston and his wife has a friend (a nurse I believe, who used to work at the clinic). She recommended that we [go] there because “she saw miracles”), so there we went!

My dad traveled to the US and started with this “treatment” probably around late June, early July (I would say 4 weeks after the surgery). He traveled with my mum and his brother to the US.

At the beginning we heard this “conspiracy theory” [Burzynski] probably told many people: “the FDA did not approve or support his trials because traditional medicine was going to lose heaps when he is successful…”

And we were so desperate, that you would do ANYTHING (in this case, we believed this guy, who said [he had] had so many successful cases!).

My mum had to go to the hospital with him every day in Houston, to be trained in the use of the machine and changing the bags in the machine. [He] received the antineoplastons treatment. I cannot remember if he had steroids, but he had these bags to be put in the machine constantly.

I remember my dad said there was a map of the world at the clinic then, with little flags everywhere! With his patients’ origin!

I know now for sure the world map with be probably covered in black flags if the guy was truthful…

This sounds pretty much like every other patient case where the patient was placed on antineoplastons. The regimen requires a visit to Houston and training on how to administer the drugs. It takes several weeks, and this arrangement, according to FDA inspectors, led to numerous overdoses over the years. The FDA also noted that Burzynski, the lead investigator, took no action to stop those overdoses from happening.

After the initial surgery he traveled to Texas with hopes of this “experimental treatment”, […] connected to that painful-noisy machine, who filled him up with fluids and made him thirsty until death… after six painful months he died, after being told by that charlatan “we will kill this tumour!”…

The agonizing thirst is a common thread running through the stories from the Burzynski Clinic. The amount of water that patients need to drink is unbelievable, and this in turn impacts their sleep and their quality of life during the treatment. See for instance the story of Burzynski Patient Adam M., who reportedly drank up to 12 liters a day and was still excreting more than he was taking in!

My dad lost four or five weeks in the states, came back with all the bags in coolers, and only worsened day by day.

Of course, Dr. Burzynski’s staff keep ringing us from the clinic in Texas to Argentina every three weeks, and when things started to go downhill very quickly for dad, all we will be told was: “increase the dose!”, we replied that he was TOO SICK to endure anything!.

Three days later after that, [I got a] phone call my dad died…

They called a week later from the clinic. I told them then that my dad died a week ago.

Response?: “Oh!… he died?” “YES, I told you he WAS TOO SICK!!! now leave us alone!” and hung up.

Of course, the bill back then (in 1998) was over US $120,000… They were paid by my uncle… but the question I had was:

Is this guy still around?

Is he still giving false hope to people?

My dad came back with his machine and false hope… He died on 18th October 1998, almost 6 months after he was diagnosed.

I can’t believe that after all these years this guy is still allowed to practice!!! Didn’t he have a timeline to present his findings? It’s been almost 20 years!

I was SO angry at the end when my dad died… but how can you take any action being overseas? When my dad died, we did not get an “I am sorry”, just the question regarding when we would pay the outstanding bill…

I sent the clinic a very angry email, which I never received a response to.

How many people from overseas wasted the last months of their lives suffering away from home, instead of sharing precious time with their loved ones?…

How many people lost it all financially to support this pain-merchant?

I hope he gets what he deserves… which is more than a revoked license.

If his trials were true, he would have cured cancer already!

It’s hard to argue with this logic. Thank you to Eduardo’s daughter. She was very kind to share her story with us.

Burzynski Patient Marie F.’s Story

By the time she had two seizures over Thanksgiving weekend in 2005, Marie F. had been living with a low-grade astrocytoma since 1999. She and her family had been watching and waiting for years, and she had only had an occasional seizure in all that time (as well as a biopsy early on.) The Thanksgiving episodes led to an MRI that revealed the tumor was growing.

In January of the following year, Marie F. started a blog. In an early post, on January 17, Marie gave an update:

It is inoperable because of location, and any attempt to remove it would leave me with severe speech and motor skill deficiencies similar to the mild ones I encountered after my biopsy in 2000. We hesitate in doing radiation and chemo quite yet, leaving that as a last resort, desiring to pursue other options first as God leads.

Her family rallied around her, and she took comfort in her faith.

Early in the morning of the next day, Marie arrives in Houston, where the Burzynski Clinic is located. It appears that she is not going along with the advice of her MD from Johns Hopkins Oncology to have radiotherapy.

Later that day, she shows up at the the Clinic with her husband, who reports their first impression:

The clinic smells like a boy’s locker and I suspect we’re going to have to get use to it. Don’t be surprised if you see Marie walking around with an air freshener around her neck.

Marie then met Dr. Barbara Szymkowski, who took an H&P:

She drilled Marie on her medical history and told us what would happen if she was accepted. She said that Dr. Burzynski would look at the MRI and PET scan and determine whether or not Marie was eligible for the clinical trial (BT-9). She then left for what seemed like hours as we waited, waited and waited. Finally, she stopped by and told us that Dr. Burzynski would be in to see us in 2 minutes (HST). Houston Standard Time (HST) runs a whole lot slower than you can imagine. 10 to 15 minutes later Dr. Burzynski walked in and told us the good news. Marie was accepted!

BT-09 is a controversial study, not only because it was done by Burzynski, but because when the FDA reviewed the Clinic’s studies after the pediatric patient Josiah C. died of a stratospheric blood sodium level while on Burzynski’s drug, antineoplastons, they found that his trials were being carried out by Burzynski, the principal investigator, in what can only fairly be described as catastrophically and categorically incompetent manner.

In the warning letter that was sent to Burzynski in December of 2013, the FDA concluded that, among other things, Burzynski miscategorized his patients’ responses in “for 9 of the 27 subjects whose therapeutic response classifications were reviewed during the inspection”:

a.       Protocols BT-09, BT-10, and BT-21 define each possible therapeutic response (Complete Response, Partial Response, Stable Disease, and Progressive Disease), and include specific criteria you must use to classify a subject as having one of those responses. You assigned therapeutic responses incorrectly for 9 of the 27 subjects whose therapeutic response classifications were reviewed during the inspection. Specifically:
i.    For a classification of Complete Response, Protocols BT-09, BT-10, and BT-21 required:  (1) complete disappearance of all contrast-enhancing tumor on neuroimaging studies, and ancillary radiographic studies if appropriate, for a minimum duration of four weeks; and (2) that the subject be off corticosteroids.  […]
ii.   Protocol BT-09: For Subject 007197, the Tumor Measurements CRF indicates, based on Magnetic Resonance Imaging (MRI) taken on July 25, 2001; September 11, 2001; and November 8, 2001, complete disappearance of all contrast-enhancing tumor for a minimum duration of four weeks. However, the Steroids Report CRF and the Oncology-Hematology Flow Sheet show that the subject was on corticosteroids preceding the July 25, 2001 and September 11, 2001 MRIs; during the period between these MRIs; and up to one week prior to the November 8, 2001 MRI. Therefore, the subject did not meet the criteria for Complete Response.
In the current case against Burzynski, that subject, it appears, became Patient Y (28 patients, A-BB, are mentioned in the second amended complaint against Burzynski).
The FDA also found that:
Study records documenting Antineoplaston overdoses show that expanded access patients and subjects in Protocols BT-09, BT-10, and AD-02 had overdoses.
For all the hooting and hollering that ANP is safe and non-toxic, there sure a lot of overdoses. Lastly, the FDA noted:
the informed consent forms used for Protocol BT-09 also did not contain this information [about possible additional expenses to patients], and subjects were only presented with a billing agreement after they had signed the informed consent forms.
This is interesting in Marie’s case, because, the next stage, after being accepted for treatment is the down-payment:
More paperwork was initialed and signed and finally they releaved us of a ton of money. They’re going to submit the cost to the insurance company but there’s no guarantee that they will pay since the treatment is experimental.
Insurance companies almost never pay for Burzynski’s treatment. Over the rest of the week, Marie will have a port installed in her chest and begin treatment. They anticipate staying 2 weeks.
On the 20th, we hear that they have been seeing a nutritionist who advises an organic dietary ritual and advises Marie against putting a cell phone to her ear. After the nutritionist, we hear from Marie’s husband:
The next 4 1/2 hours were dedicated to training on the catheter and pump along side a nice Amish family. We keep running into them everywhere….they are even staying at our hotel. There is also a 2 year old boy with his family who has been through it all (surgery, radiation, …). His doctors have thrown in the towel so they’re at the clinic.

I was also trained on changing Marie’s dressing, flushing her catheter, and injecting drugs via the catheter. Next week, I get to learn how to draw blood via the catheter. Whoo-hee, I can’t wait!

Marie carries a camera-case looking bag which contains the drugs and the pump. The drugs are administered every 4 hours. She can disconnect in between but we’re not to that point yet. So she’ll carry it all weekend. For now, remembering to take it with her when she goes anywhere is the biggest problem. Sleeping with her buddy should be an experience tonight.

The pump that Burzynski’s ANP patients have to carry with them is a nuisance, according to Marie’s husband:
We’ve named the bag Buddy. I asked one of the other patients what she calls her bag to which she replied “You don’t want to know what I call this thing.” We left it right there.
We hear a little about the other patients at the Clinic:
We went to the clinic this morning to get Marie juiced up again. They increased her dose. It didn’t take too long and we got a chance to meet some of the other patients. There is a 15 year old German girl named Angie. They tried chemo but it caused the tumor to grow faster so their doctor in Germany told them to come here. There was another older German couple and a couple of older American couples.
Soon after this increase in dosage, Marie starts vomiting. According to her husband:
We don’t know if it was due to the increase in meds or the steroid she’s now on. The steroid is taken to reduce swelling in the brain. As the tumor dies the body tries to protect the brain which causes the swelling.

Indeed, Burzynski’s use of anti-inflammatories has made his results difficult to interpret, possibly, as the FDA found, he had patients on huge doses of corticosteroids:

However, for all of the subjects listed above as having been classified as a Complete Response despite being on corticosteroids, their corticosteroid doses were well beyond those needed to maintain physiologic levels. Specifically, these subjects were on doses of Decadron (dexamethasone, a corticosteroid) that ranged from 4 mg/day to 16 mg/day, while the physiologic-replacement equivalent of Decadron is in the range of 0.25 mg/day to 0.75 mg/day.

That’s 64 times the dose that other physicians would expect.

Further, it sounds like the husband is repeating the line that other have heard that swelling is a sign that the patient is getting better (what I think of “the getting better so fast it’s killing you gambit”). Many patients at the Clinic have independently reported that what are in all likelihood symptoms of getting worse are signs of getting better.
On their first Sunday in Houston, Marie is too sick to go to church:
I got Marie home and called the doctor. They had me give Marie 1 cc of Dexamethasone Sodium Phosphate (Decadron) via her catheter. Marie started feeling better and I went out to clean the car. No jokes this time. Once is funny but four times including once in the car and once on the side of the road is not. The vomiting is a result of the swelling in her brain. Decadron is a steroid that reduces the swelling i.e., edema.
On Monday the 23rd, Marie must be feeling pretty miserable as her husband is asking for prayers. It sounds like the tumor is probably progressing unabated, as some of her new symptoms appeared before she started treatment:
Marie’s right hand has progressively gotten worse since she’s been here. It started the day we flew out so we believed it was just stress. She has no strength in that hand. But it has been getting worse since starting treatment so maybe it’s due to the swelling.
Also her neck is aching, perhaps, as her husband speculates, from being forced to lug the 6.5 pound pump around. She’s still fighting nausea later in the day, and they have doubled her Decadron dose. By day 9, they have set up a ritual:

We’ve got the routine down.

  1. Go to the clinic
  2. Get Marie’s vitals
  3. Talk to Dr Weaver
  4. Say Hi to our new friends
  5. Vu takes some of Marie’s blood while I practice preparing the drug bags, flushing Marie and programming Buddy
  6. Vu teaches me something new
  7. I fight traffic all the way to our suite

Today, Dr Weaver upped Marie’s dosage. No vomiting. I now have to replace one of her bags after her first infusion. She’s up to 1100 ml of A-10 and they come in bags of 500 and 1000 ml.

We hear about the insatiable thirst that ANP inflicts on patients. Patients must drink (and expel) enormous amounts of water to keep their sodium levels in check. This interrupts their sleep and can degradethe quality of patients’ lives.

And then on the 26th, heartbreaking news about the Amish family Marie and her husband have befriended:

I’m having a difficult time being objective about Marie’s condition. Last night, Martin had an hour long seizure before he was rushed to the emergency room. They found that the antineoplaston infusion had diluted the level of his seizure medication which caused his seizure. I see in his eyes the look of discouragement. It’s hard for a man who has worked all his life to be stuck in a wheelchair having other people do things for him. Today I asked him about his farm in Ohio and he said “Now it’s only 5 acres.” I didn’t press him for more details but I got the impression that it is now smaller because he can’t work it or he had to sell part of it to pay for the treatment. The Amish do not use health insurance instead the community meets any needs.

It is endlessly aggravating to see community after community raising money for Burzynski. Marie’s husband reports that she can’t use her right hand and gets tremors when she is on the infusion.

 

Marie did not sleep well that night, and they experiment with switching up the timing of the infusions. However, she is exhausted and inadvertently sets a fire that morning while cooking an egg. Her husband says that Marie “has lost ALL kitchen privileges until she gets some sleep.”

The change up with the timing of the infusions seems to work, but we see that other patients are feeling wiped out too, probably for the same reasons:

Our friend Martin is doing better also. Angie the 15 year old German girl is still very tired. Doctor Weaver suggested doing the constant infusion like we’re doing but Ute said no. I don’t believe she understood what the doctor was suggesting. After seeing Marie this morning, I think she will try it too.

That’s worrying, that communication may be breaking down for patients. Perhaps, then,  it’s not surprising that Robert Weaver recently faced disciplinary action regarding his ethics and informed consent.

On February 1, there is more dickering with the dosage, and Marie is very fatigued:

Marie was extremely tired today. After going through the tremors last night, I switched her over to the smaller doses. While the smaller doses are easier on her body, they require her to be constantly going to the bathroom. So last night, she was getting up every hour.

 

They are planning to leave the Clinic and promise updates, but we don’t hear anything for 2 weeks. The news is not great:
The first week back was rough. We were still dealing with the effects of the drug and trying to a routine going. Marie is now on 4 hour infusions and seems to be handling the infusions well. She is still struggling getting enough sleep which make for interesting conversation during the day.
Marie is also losing weight. It turns out that she was only on Burzynski’s drug for a few weeks after returning home. Marie died on February 27, 2006. Her husband left an extremely moving tribute to his wife of 25 years.

Burzynski Patient Wilma G.’s Story

It’s heartbreaking every time that someone contacts us about their experiences at the Burzynski Clinic. However, some people have tried to turn their experiences (or their relatives’ experience) into something positive. That is the case with today’s story.

In mid-November, a message appeared in the mailbox of the Skeptics for the Protection of Cancer patients:

I have paperwork and documentation from my aunt who died in 1998 or 1999 about the Burzynski clinic and problems she had. I am happy to mail you a copy if you would like. She passed away in 1999.

Wilma had adenocarcinoma of the pancreas with liver metastases. She’s at the end of her course of treatment of a disease with a horrid prognosis, and one might imagine that she was looking for options. She went to the Burzynski Clinic.

According to the letter about the Burzynski Clinic that was sent to the Better Business Bureau by Wilma’s niece:

My aunt, [Wilma G.], was a patient at Dr. Burzynski’s clinic for a cure for liver cancer in 1997 and continued treatment in 1998. She died in 1998. Now that we are going through her records (her husband recently passed away), we found a file on the clinic, with a lengthy complaint letter detailing miscommunication of the part of the clinic as well as lack of follow through and proper care once the treatments were paid for (upwards of $20,000). There was no other correspondence other than a letter from the clinic stating that they would, “look into it.” This complain letter stated that she was withdrawing from the program due to their inept ability to communicate with her as well as her doctor in Florida. I just felt it was important that this be on file in case other people are interested in the clinic and want to check their reputation.

We reproduce the letter from Wilma to Stanislaw Burzynski in its entirety, and include a link to a scan of the original.

February 10, 1998

S.R. Burzynski, M.D., Phd.

12000 Richmond, Suite 260

Houston, Texas 77082

 

Dear Dr. Burzynski:

My name is Wilma [G.] I met you one day with Dr. [Conde?] just before we left Houston for Florida.

We started your program in mid-November 1997. The second day my temperature was 103.2 and I was taken off the antineoplastons. The next day, my temperature was down to 99.[?] and the medication was resumed. All went very well. I had no symptoms, high energy and had total confidence in your program.

We were told it would be necessary to drink from one to two gallons (preferably water) a day in order to wash the salt contained in the antineoplastons from my system. This would be thru the night as well as during the day. It also translated in being up every 1½ to 2 hours, as well as making it difficult for any food to stay in the digestive system long enough for any nutrition to be extracted before it, too, was flushed out. Consequently, I became weaker and weaker and fatigued from so little rest.

Shortly before the end of November we were discharged to come home. The first part of the [???] was okay; however when we attempted to ask questions relating to our individual needs we were told to please not interrupt because she could not pick up where she left off. It would seem to me it would be more

#2

Dr. S.R. Burzynski, M.D., Phd.

 

important to be sure that each patient (or research client) was carefully informed than to hear a speech that was performed by rote. When I asked specifically about which food to eat and which ones to avoid, I was told no cows milk and very little cheese–these allowable were on the list. She thanked us for being so understanding–her child had been sick during the night and she was sleep-deprived. It never occurred to her that so were we and we were being sent home with less than the adequate information we needed.

After we arrived home, all my energy was gone. I could not get out of a chair without help. I had to be bathed. I could not walk without help. Dr. Kahn was our associate doctor–we had personally talked to him on several occasions and at least he knew who we were.

I went to my personal physician here in Jacksonville because my physical condition was deteriorating so rapidly. She asked if I would like for her to call your office–which she did and asked for Dr. Kahn. She was told he was no longer there and my file had been transferred to Dr. Basil (spelling?). When she was transferred to him (I was in the room she was calling from) he had no idea whether he had the file or what was in it. After locating my and [???] lab reports, he prescribed injections of Solumedrol to be administered by home health nurses. I had just completed a prescription of medrol orally. The arrangements were made by my local physician and treatment immediately began.

I have never been informed that I was being

#3

Dr. S.R. Burzynski, M.D., Phd.

 

transferred to another doctor on your staff. This should not only be a professional requirement but a common courtesy consideration. Your monitor nurse as well as Dr. Kahn called frequently. It would not have even required a special phone call.

Before we came back to Houston after the first of January, we had another CT-scan made. Sending an original to you several days ahead of our arrival. When we arrived at your clinic, we were told the lesions had expanded 37%. There was no explanation as to why this could have happened–just that it was strange. We came home and visited the local oncologist who had originally sent us to MD Anderson. He asked us to have another CT-scan made which we did on 1-19-98. We Fed Exd an original to you immediately and told Dr. Basil it was on the way to him. About a week later he asked if we had sent it. We reminded him of our conversation. He left the phone and came back confirming that you did indeed have it. We told him that local radiologists had found no change in the lesions. We still have received no feedback from you regarding a possible misreading on Jan 1 or of the one on Jan 19. What is the point of sending them to you if no one looks at them?

Enclosed are copies of imaging services consultation reports for the two CTscans referred to above. Also, enclosed is the blood work report from the local oncologist in mid-January. Some of the markers are still way out. I was still very orange and very weak at this time. Dr. Basil prescribed the second week of Solamedrol injections and resuming the

#4

Dr. S.R. Burzynski, M.D., Phd.

 

antineoplastons. I declined for several reasons:

  1. My body was getting weaker and painful
  2. too little or no feedback as to what should be happening versus what was happening to my body.
  3. My body needed a rest from the bombardment and consequent decline it had experienced.

Dr. Basil tells us he has received no lab reports since 1-4-98. Since you have LabCorp personnel on premises, all that is necessary is to request a computer print out in your own lab. LabCorp here in Jacksonville is sending all of the reports to you again.

It appears that the major problem stems from the identity I seem to have at your institute–a sheet of paper with a number from which I’m being diagnosed and prescribed- rather than being  listened to or lab reports and CT scans being read and considered.

We came to you with complete trust and wish so much this were still true. We do not know what our future holds at this time.

Due to all of the above, plus, we wish to withdraw from your program and will appreciate at least acknowledgement.

Sincerely,

Wilma [G]

Five days later, this issue has still not worked itself out, and Wilma sends another letter as she tries to settle her bill.

February 15, 1998

Dr. S. R. Burzynski, MD, Phd

12000 Richmond, Suite 260

Houston, Texas 77082

Dear Dr. Burzynski,

Re: Billing

Enclosed are several itemized statements which we received from you. We assumed you retained copies of them so did not bring the 12-26-97 and the 12-28-97 ones with us when we returned in January. Your staff could not find copies. None of them appear to be accurate.

Here is a recap of what we have paid you [emphasis added–ed.]:

Our Check No. Date Amount
4190 11/11/1997 $435
4191 11/11/1997 $12,000
4224 12/26/1997 $5,425
4240 12/28/1997 $3,050
TOTAL $20,910
LESS PUMP <$4500>
Net to SRB Clinic $16,410

Dr. S. R. Burzynski, MD, Phd

You have shipped no supplies in February or late January. We feel you are paid in full, perhaps more, but who knows.

Please check our account and send us an accounting. We are anxious to have a final billing.

Thank you!

Sincerely,

[Wilma G.]

As Wilma indicated, she included a number of itemized bills, and they are revealing. The allegedly missing patient records is disturbing enough, but seriously, the sheer amount of nickle and diming that goes on at the Burzynski Clinic is staggering. My eyes are drawn to all of the blood oxygen levels that were taken. In the SECOND AMENDED COMPLAINT of the current case against Burzynski is what the TMB alleges are more than 40 medically unnecessary blood oxygen tests.

This is why this site exists. So that patients’ experiences can be put in the context of other stories to build a picture of the Clinic. We’re bigger than the actual Burzynski Patient Group and we have literally hundreds more stories to tell. Special thanks to Wilma’s family for sharing these documents with us.

Burzynski Patient Zackery F.’s Story

Zackery F. was 4-years old when he was diagnosed with an astrocytoma, a brain tumor. Three years into Zackery’s conventional treatment, which included surgery and shunts to relieve the pressure the tumor put on his brain, he had reached the end of the road as far as surgery could go. Surgeons at UCLA said that any further debulking might leave the boy completely blind (as opposed to blind in just one eye) according to an article in the May 5, 2003 Bakersfield Californian.

Zackery’s parents had been there throughout, and according to the same article,  their lives were put on hold. Neither parent worked so that they could be with their son and they had moved the family to Bakersfield, CA for treatment. After a seizure caused by a blocked shunt at the end of April 2003, doctors found that the tumors were growing again. In May 2003 the family started appearing in the papers as they tried to raise money for Burzynski. According to the paper:

Fritz’s goal is for Zackery to be treated by Dr. Stanislaw Burzynski, who uses a natural peptide found in the urine and the blood, which he says reduces cancer growth and tumors.

He gives patients a manufactured form of the substance, called antineoplastons, through an infusion tube or by pills. The National Cancer Institute reported evidence of anti­tumor activity in the medical records of some of Burzynski’s most successful patients.

Fritz hasn’t met Burzynski, but has spoken to him and his staff by phone. Patient testimonials and secondhand information give Fritz hope about the potential benefit of Burzynski’s methods for his son.

While Burzynski is hailed as a godsend by members of the alternative medicine community, many in the mainstream don’t accept or outright reject his work.

His methods are still being studied in clinical trials.

13 years later, Burzynski’s treatment are still in clinical trials. This does not sound like the reporter actually talked to the National Cancer Institute, but maybe heard it second (or third) hand from the family. More recently, NCI has said of antineoplastons (and one must assume this is their current position):

Antineoplaston therapy has been studied as a complementary and alternative therapy for cancer. Case reports, phase I toxicity studies, and some phase II clinical studies examining the effectiveness of antineoplaston therapy have been published. For the most part, these publications have been authored by the developer of the therapy, Dr. S.R. Burzynski, in conjunction with his associates at the Burzynski Clinic. Although these studies often report remissions, other investigators have not been successful in duplicating these results. (Refer to the Human/Clinical Studies section of this summary for more information.) The evidence for use of antineoplaston therapy as a treatment for cancer is inconclusive.

Buyer beware when the drug you are taking has been administered to patients for 40 years and it is still considered “inconclusive.”

The trials that were being carried out with NCI, according to David Gorski, fell through “because of strife between the NCI and Burzynski, who viewed the NCI as trying to sabotage the trial.”

By the 28th of May, according to the Californian, the family has still not raised enough money to take Zackery to the Burzynski Clinic, though they have been working very hard to raise money in the local press and have made some progress toward buying an initial consult:

Over the past month, individuals, local businesses and organizations have donated about $8,000, hoping to help the 7­-year­ old Lamont boy before the large tumor in his brain creates more damage.

According to the report, the initial deposit will be $18,000. Zackery’s dad projects the final cost could be $350,000. In order to attract the attention of Maury Povich, a family friend decides he is going to hitchhike to New York City.

We don’t get another report from the Californian until July 24:

Terrified that the surgery required to remove his son’s brain tumor would destroy his optical nerves, [Zackery’s dad] appealed to Kern County through the news media the past few months for funds for an alternative therapy.

Raising more than $15,000, the Lamont boy received the therapy at the Burzynski Clinic in Houston last month, but [Zackery’s dad] said it only caused his son more problems, leaving the dangerous surgery inevitable.

That was extremely fast. On August 1st, we hear:

All this, after the community raised nearly $20,000 for Zackery to receive an alternative therapy that might spare him from surgery. The alternative, provided by the Burzynski Clinic in Houston, didn’t work or didn’t work fast enough.

We only hear what happened at the Burzynski Clinic from Zachary’s father in an article from April 14, 2007 in the Bakersfield Californian:

June 2003:

The treatments in Texas go terribly wrong, causing Zachery’s tumor to swell and sending the boy into a coma, his father said. [Zachary’s father] uses his remaining $10,000 to rent a Lear jet and full medical staff to rush Zachery back to UCLA.

This reminds me of a number of misadventures that have been documented by those who have inspected the Clinic. I think that the most devastating one is of Burzynski patient Josiah C., who died with a sodium level of 205 (the average is around 135). There was the stroke that Burzynski patient Haley S. had in the front of her brain, which her medical team said was not associated her pontine glioma and was likely caused by Burzynski’s treatment.

We should mention that Zachary’s father is a superhero. Parents often have no choice but to become superheroes when their kids get these awful diagnoses, but Zachary’s dad saved his son’s life. Often you hear Burzynski’s few survivors say, “Well, the doctors said take my son/daughter home to die.” Then they went to Burzynski and “shazam” the patient lived. And because they repeat their stories over and over and cite one another over and over, it sounds like there are more successes than they are. It is a small, intense echo chamber.

However, in this case, the father did hear from the doctors that his son was going to die, and he got another opinion. He did due diligence and fought for his son, who survived his cancer using intense conventional therapies, surgery and chemotherapy. It was clearly not easy for them or consequence free, but Zachary’s dad gave him a life by pursuing conventional treatment.

Zachary is now 20 years old.

 

Special thanks to the TOBPG research ninja, who did a lot of work on this story. 

Burzynski Patient Brandon B.’s Story

Brandon was in third grade when he started having headaches and vomiting in early April 1994. According to a Feb 22, 1996 report in the local paper, the Martinez Record (CA), he was an avid baseball player. During a game on April 28, 1994, one of his eyes shut involuntarily while he was pitching. He didn’t tell anyone because he did not want to be taken out of the game.

The next day, the article goes on, Brandon received a diagnosis of a brain tumor. This was successfully removed surgically, but in November of 1995, doctors found 3 brain tumors, one on either side of his head, just above the ears, and another near his spine. The family started Brandon on chemotherapy around Christmas 1995, but it made Brandon sick. Concerned for his quality of life, Brandon’s parents looked for alternatives to chemotherapy, and they settled on Burzynski’s antineoplaston chemotherapy after “a parent of another cancer patient recommended a doctor in Houston who treated patients with an experimental drug.” One wonders if we detect the dark hand of the Burzynski Patient Group (or its predecessor) guiding Brandon’s family to Burzynski.

 

According to the timeline in the Record article, the family arrived in Houston at some point in late January, 1996. Brandon would have had a catheter installed in his chest to receive the near-continuous stream of ANP. They would probably have spent a couple of weeks at the Clinic in Houston learning how to administer the ANP, and the article seems to be from after they returned home.

It’s sort of baffling that at the same time that the family is going to Burzynski, the future of his treatment was very much while in doubt, as according to the Record article:

This week, a Houston judge is due to decide whether Brandon’s doctor, Stanislaw Burzynski, will be allowed to continue administering antineoplaston to non-­Texans.

The judge was Sim Lake. The reason that Burzynski might not be allowed to continue giving ANP to out-of-state patients was because he was facing dozens of federal charges related to his practice. The infuriating tragedy here is that Brandon’s family’s desperation is being used to generate support for Burzynski:

Currently, the drug cannot be mailed across state lines, though Burzynski is allowed to mail it to patients in other countries such as Brazil, Australia and Canada.

So for now, [Brandon’s family] must fly to Houston whenever Brandon’s medicine needs to be replenished. Their next trip is scheduled for early next month.

However, the [family] fear[s] the Food and Drug Administration is attempting to shut down Burzynski’s practice completely.

The travel and expense involved in Brandon’s treatment takes its toll, they admit.

And to someone who did not know about Burzynski’s behavior, this might be a compelling argument: “Why, if Burzynski can peddle his experimental therapy abroad, why not in the US?” Though the reason is simple (the US FDA is not there to protect people abroad and regulates the commercial distribution of drugs between states), the appeal that the family is making to their community, as so often happens, is met with staggering generosity:

Beginning with Brandon’s classmates and the faculty at Morello Park and extending to other community groups such as Brandon’s youth baseball league and the Martinez Kiwanis Club, an outpouring of emotional and financial assistance has overwhelmed [Brandon’s family]. […]

Terri’s and Steve’s co­workers have also pitched in. Terri’s fellow employees at Walnut Country Pre­school in Concord have provided meals for the [family], who sometimes lack the time and energy to prepare them.

Perhaps most impressive, though, are the sacrifices Steve’s co­workers at Piedmont Lumber are making. So far, they’ve donated 11 weeks of vacation to Steve to use as he accompanies Brandon to Houston, where Brandon picks up his medicine. “You know, we’re teamsters. We’re supposed to be these tough guys who show no emotion,” says Steve. “But they understand what we’re going through and that I need to talk about it.”

Burzynski has thrived too long on this generosity and goodwill.

The ruling, by the way, that led to the mess that we are currently seeing in Texas, as Burzynski faces renewed charges from the Texas Medical Board, was that Burzynski could only administer ANP to patients on FDA-approved clinical trials. According to Burzynski’s lawyer:

[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. (emphasis added)

And a host of other trials were opened as well. Burzynski 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 ended in a credible publication, and the trust of every patient who participated in the trials expecting their suffering and money to go into useful research has since been betrayed.

In an article on the front page of the San Jose Mercury News on 30 September 1996, we learn something of the course of Brandon’s treatment:

The results, [Brandon’s mom] said, led to temporary shrinkage of Brandon’s two tumors. But five months later, the family was forced to reduce the dose of Burzynski’s treatment after Brandon developed metabolism problems, apparently related to the drug. As a result, the two tumors grew and he developed more brain tumors. He has since returned to conventional treatment.

Nevertheless, the family was impressed with Burzynski’s therapy, which totaled $20,000, including travel costs and the treatment. Like other families, [they] were able to raise the money from the community.

“If something will show it won’t damage your child’s life, it’s not going to hurt them and it has a chance of helping or curing them, then any amount of money is worth it,” said [Brandon’s mom], a preschool teacher. “You do what you have to do.”

While he cannot explain the shrinkage, Brandon’s pediatric oncologist, Dr. W. Byron Smith, remains uncertain about Burzynski’s treatment.

“I think the medicine may work in a small percentage of patients with brain tumors, but in truth, I don’t really know that,” said Smith. “The only way to resolve the question is with a head-to-head clinical trial in which you randomize patients between his drug vs. the standard therapy that’s been done.”

A few notes about this passage. First, it’s unclear what the “metabolism problems” are that that are mentioned, but there is a good chance that the antineoplastons, which are the metabolic derivatives of an orphaned urea cycle drug (which Burzynski also conveniently produces), may have messed with Brandon’s sodium levels. Antineoplastons are notorious for raising patients’ sodium levels to dangerous heights, and this side effect likely contributed to the death of Josia C., which was chronicled in a USA Today investigation of the Burzynski Clinic:

In a report sent to the FDA after the [Josia’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%.

The typical sodium level is between 135 and 145. This may or may not have been what caused Brandon to get pulled off of the treatment. But what about the shrinkage reported? Surely that’s slam dunk evidence?

Sadly, no. There are a number of reasons that a patient might appear to have regression. One is actual response. It’s a possibility. However, one must also consider the chemotherapy that Brandon had prior to the ANP treatment. Pseudoprogression can occur when a tumor swells as an initial response to a treatment but then returns to baseline. How do we know it was not that? What type/dose of steroids was Brandon on? Burzynski’s use of anti-inflammatories has made his results difficult to interpret, possibly, as the FDA found, he had patients on huge doses of corticosteroids:

However, for all of the subjects listed above as having been classified as a Complete Response despite being on corticosteroids, their corticosteroid doses were well beyond those needed to maintain physiologic levels. Specifically, these subjects were on doses of Decadron (dexamethasone, a corticosteroid) that ranged from 4 mg/day to 16 mg/day, while the physiologic-replacement equivalent of Decadron is in the range of 0.25 mg/day to 0.75 mg/day.

That’s 64 times the dose that other physicians would expect. Burzynski is also notoriously bad at classifying his own outcomes, as the FDA noted two years ago. How do we know shrinkage wasn’t due to something in Brandon’s diet or environment, if it was there at all? So, there are numerous reasons that Dr. Smith hedges a little before giving Burzynski credit. Indeed, the statement that Smith “cannot explain the shrinkage” is unfair and irrelevant, as it is never anyone’s job but Burzynski’s to provide evidence that ANP works, and the only way to do that is in a randomized trial. This has not yet happened.

Even though the Mercury News story suggests that ANP treatment terminated before the end of September, the next month, in an article in the Pleasant Hill Record on 3 Oct 1996, money is still being raised to pay Burzynski:

The Martinez Community Foundation has given the family of cancer patient Brandon Borman $3,100 from a trust fund created earlier by the foundation.

Foundation officials said that they left some funds in the account at WestAmerica Bank in hopes that others in the community would also contribute.

Brandon’s experimental therapy requires monthly trips to Houston, Texas. Neither the therapy nor the airline expenses are covered by the family’s medical insurance.

On 5 April 1997, we hear in an article from the Contra Costa Times that a ball field has been named after Brandon, but that he is not well:

The cancer has spread now from his brain to his spinal cord, and he takes morphine to control the pain of headaches. But he still plays baseball, and was there for the River Dogs’ season opener March 29.

According to the 1 May edition of the Martinez Record, Brandon threw the first pitch at the season opener at the field named for him.

In the 6 June edition of the Contra Costa Times, we hear that Brandon had been with his family at a camp for kids with cancer over Memorial Day Weekend, when he started running a fever and having seizures. On June 3, Brandon died:

“In typical Brandon fashion, he held on for two hours longer than the doctor said he would,” [Brandon’s father] said. “We think he waited until everyone had left and it was just us. We crawled into bed with him and held him. The last time it’d been just the three of us, in a hospital bed at John Muir, was when Brandon was born.

“He took his last breath and he was gone.”

Burzynski is standing before judges in Houston next month, and we can expect a parade of witnesses who think they have been helped by Burzynski will testify passionately on his behalf. Many of them have defended him in previous trials. For every patient that appears in front of Roy Scudday and Catherine Egan, I hope they remember that each live witness represents hundreds of dead patients (Burzynski claims to have treated more than 8000). Burzynski, it seems, is willing to take credit for outliers, which is, to employ a word the TMB lawyer used in his opening statement, cheating.

 

Burzynski Patient McKenzie L.’s Story

As Stanislaw Burzynski stands in front of the Texas Medical Board to answer for yet another litany of abominations, patients are no doubt gathering to protest in front of the courthouse so they can beg for their lives. Many of his supporters in the past have been then-current patients who were convinced that Burzynski is their only chance at life. Burzynski’s patients often have dismal prognoses and their prospects do not improve when they buy into his medical adventurism. In anticipation of such patients being used as human shields yet again, we are focusing on stories of people who have testified on Burzynski’s behalf, begged for their lives in courts and in the public, but who of course died anyway. These patients, so far, include Burzynski patient Elke B., Burzynski patient Douglas W., Burzynski patient Janet C., and Burzynski patient Sen. Ed G. These patients may not be testifying in the upcoming trial, but their stories are perhaps the most important and are far more eloquent and revealing.

Today we start looking at the roster of the dead and dying known as the ANP Coalition. This is the collection of patients, mostly children, who came to Burzynski’s aid when his unproven “antineoplaston” chemotherapy was taken off the market following a juvenile patient’s death. The ANP Coalition did help get the trials reinstated, as best we can tell, however, out of the nine patients who have appeared in the Coalition’s pro-Burzynski campaigns, 6 have died. Not all of the patients received ANP, but all of the patients have been used. Only one, as far as we know, is on ANP at this time.

The first patient we will examine is McKenzie L. Hers was perhaps the most extensively covered story of all the ANP Coalition’s new patients. We have some 80 files on her story. It is horrible and long and frustrating, but it’s a story that must be told because it makes staggeringly clear the real harm that sloppy journalism can cause. Everyone here tried to do the right thing, but a selective blindness is pervasive and it has truly catastrophic results.

The first evidence that something is wrong appears on McKenzie’s grandfather’s Facebook page on 28 Nov 2012:

2012-11-26

It turns out, as we hear almost two years later that McKenzie had been walking home from school with her grandfather and

“swayed in a crooked line down the sidewalk and her eyes seemed unfocused. When he asked her what was wrong she told him she was seeing double.”

The diagnosis is Diffuse Intrinsic Pontine Glioma, a tumor in the brain stem. Almost universally fatal. It catches the fifth-grader and her family mid-stride; McKenzie had just received a stellar report card and seems to be athletically inclined, swimming and riding horses. Within two weeks, she begins a long series of visits to the hospital for conventional treatment, radiation and chemotherapy, it seems.

Right out of the gate, the traditional therapy does what it is supposed to, beat back the cancer. It is unlikely to kill off it all, but is only a stop-gap measure. We hear on Jan. 7 that double vision and walking have been a problem, but the problems are lessening. On 20 February 2013, we hear that according to their first MRI after treatment, the tumor has shrunk by 50%.

By October, however, the tumor grows back.

Burzynski first appears on the family’s timelines in January 2013, when McKenzie’s grandfather posts an article about Burzynski, one riddled with inaccuracies and conspiracy theories (get a skeptic’s take on the same Burzynski decision here). In September of 2013, however, with the family running out of options, members of the Burzynski Patient Group begin appearing in the family’s Facebook timelines, especially an enthusiastic chemtrailNew World Order, and fluoride truther.

On 2 October 2013, McKenzie L.’s family goes to Houston looking for a miracle:

Untitled

By the end of the month, there seems to be devotion to the Burzynski cause. At the time, Burzynski’s antineoplaston trials were suspended after the death of a child, Josiah C., whose story was told on the cover of USA Today in November 2013, just after McKenzie’s family seems to have committed to Burzynski’s cause. Neither the Clinic nor the FDA told Josiah’s family that the clinical trial that their son was on had been shut down following his death.

Five days after the expose of Burzynski appeared on the cover of USA Today, Michael Rosenfield of WBZ-TV files a report about a petition that McKenzie’s grandfather has started to lobby the FDA for a compassionate exemption for her to receive Burzynski’s drug. At the time, the compassionate exemption seemed to be the only way that Burzynski could get patients on the drug. All of the trials were closed. The list of Burzynski’s horrific violations seemed too unthinkably long to permit him to continue. Burzynski’s response to the charges was clearly inadequate for the FDA. This is the first point where the media failed to serve the public interest. An 8-month investigation raising profound doubts about whether the “doctor in Texas,” as Rosenfield refers to him, and his “controversial drug,” as Rosenfield refers to it, was completely ignored. Indeed, the absence is conspicuous given the horror with which the article was received. We believe that Rosenfield had a journalistic obligation to report that the FDA had observed that:

  1. Burzynski (as investigator, the subject of the inspection) “failed to comply with protocol requirements related to the primary outcome, therapeutic response […] for 67% of study subjects reviewed during the inspection.” This means that several patients who were reported as “complete responses” did not meet the criteria defined in the investigational plan, as were patients who were reported as having a “partial response” and “stable disease.” This means that his outcomes figures for these studies are inaccurate.
  2. Additionally, some patients admitted failed to meet the inclusion criteria for the study.
  3. Even though patients needed to have a physician back home to monitor their progress prior to enrolling in a trial, the FDA found a patient who began receiving treatment before a doctor had been found.
  4. Patients who had Grade 3 or 4 toxic effects were supposed to be removed from treatment. One patient had 3 Grade 3 events followed by 3 Grade 4 events. Another patient had 7 disqualifying toxic events before he was removed from the study.
  5. Burzynski did not report all adverse events as required by his study protocols. One patient had 12 events of hypernatremia (high sodium), none of which was reported. There are several similar patients.
  6. The FDA told Burzynski: “You failed to protect the rights, safety, and welfare of subjects under your care. Forty-eight (48) subjects experienced 102 investigational overdoses between January 1, 2005 and February 22, 2013, according to the [trial number redacted] List of Hospitalizations/SAE (serious adverse events) [redacted]/ Overdose [redacted]/Catheter Infection report. Overdose incidents have been reported to you [….] There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects.” [emphasis added] It seems that these overdoses are related to the protocol, which requires family members to administer the drugs via programmable pump on their own. Further, patient records show that there were many more overdoses that were not included in the Hospitalization/SAE/Overdose list.
  7. “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.
  8. 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.)
  9. 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.

This document was available online for anyone access to Google to see. Nonetheless, this is the doctor to whom Rosenfield unquestioningly commended young McKenzie’s eager and vulnerable family. The audience of this report was not informed about the true magnitude and nature of the controversy before the station linked to the petition, which was certainly relevant and available. Michael Rosenfield must share some of the blame for what comes.

Three days later, WMUR files a similar report about the petition. McKenzie’s grandfather, again, appears in the report. The interview with McKenzie’s grandmother is heartbreaking, but reporter Jean Macken does not put their grief and fear in context. And they link to the petition, which has already received at least 9,000 signatures following Rosenfield’s report. Jean Macken must share some of the blame for what comes. Incredibly, WMUR had already reported about a fundraiser for the antineoplaston treatment that DIPG patient Justin B. received. Sadly, Justin died.

The next day, the New Hampshire Union Leader publishes an article called, “Hope for McKenzie; A girl vs. bureaucracy.” It is wretched. For instance:

The FDA exists to improve the health of Americans. It screens and tests drugs so that unsafe ones do not reach the market. But what about people who are terminally ill? If someone is facing imminent death, who cares about possible negative side effects of an experimental drug? The FDA does.

Doctors do. For instance, a patient who is facing immanent death may forego palliative care. They risk having their remaining limited time and their savings squandered by a quack. They may get killed quicker. Their quality of life may decline. The cost of trying to deal with the side effects may escalate. They may become ineligible for trials that might actually have a chance of helping them.

Terminally ill children and adults can get unapproved drugs through a policy called “compassionate use.” But even that takes time. Patients have to apply, and the FDA has to approve the use. It is time that some patients do not have.

In emergency cases, the FDA can get approval for compassionate use or “expanded access” overnight.

McKenzie [L.] is fighting for her life. No one knows how much time she has left. We pray that it is longer than the time the FDA will take to respond to her parents’ request. If you would like to help, you can sign the online petition asking that McKenzie be allowed to take the one drug doctors say could save her life.

This last line is deceptive, making it sound like more than a tiny number of uninformed or self-interested physicians would say that ANP would be the one and only drug that could save her. In fact, as we will see, the family has a hard time even finding a physician who would be willing to administer the drugs. This is factually misleading, emotionally manipulative, and irresponsible in the extreme. The New Hampshire Union Leader’s editors must share some of the blame for what comes.

The same day, 25 Nov 2013, the Nashua Telegraph reports on the family’s attempt to get signatures for the petition and to raise money. This is in the news section, not the opinion section, and the reporter, Dean Shalhoup, does not recommend that readers support the initiative. He just reports. Nonetheless, there are some disturbing lapses in judgment that warranted a little research that was either not done or not included.

[The family was] so intrigued by Burzynski’s apparent success in raising from near zero to around 27 percent the cure rate of patients diagnosed, as was McKenzie, with an inoperable pediatric brainstem tumor that they traveled to Houston about two months ago to meet him. “The man has a success rate with this drug,” [McKenzie’s grandfather] said. “I have been in touch with (cancer) survivors who used this drug.”

Of course, Liz Szabo, by this point, had already made it abundantly clear why one should doubt the value of Burzynski’s testimonials:

Yet independent oncologists say that appearances can be deceiving, and that patients shouldn’t be too quick to credit Burzynski. Experts say there are several reasons to be skeptical of Burzynski’s claims.

• Burzynski often relies on anecdotes, which don’t tell the full story. […]

• Burzynski’s therapies are unproven. […]

• Burzynski’s patients may have been misdiagnosed. […]

• Burzynski’s patients may have been cured by previous therapy.

Also, I should mention that sometimes weird things happen. Flukes and fortune can also, rarely, lead to remissions. Next, the “apparent success” cited was easily shown by a little research to be “illusory success.” For instance, Szabo had just reported that the FDA had found that Burzynski had been:

Inflating success rates in 67% of cases, by inaccurately reporting how tumors responded to treatment.

This fact was available and relevant to Shalhoup’s story. Secondly, Burzynski had not–and has never to date–published a reputable study stemming from the 60+ clinical trials he’d opened in the 1990s. This fact checking didn’t need investigative reporting; Szabo, her colleagues, and her editors had done that. All it needed was a Google search. While this is somewhat better than other reporting on McKenzie’s case, Dean Shaloup must share some responsibility for what comes. He allowed desperate people to parrot poppycock.

The next day, on 26 Nov 2013, New Hampshire Senator Kelly Ayotte issued a press release titled:

“Ayotte Urges FDA to Consider Compassionate Use Request for 12-­Year Old New Hampshire Girl Fighting Brain Cancer”

The entirely Burzynski has routinely benefited from patients who believe that he is their only hope. They go to public officials and beg for their lives, which is a bargain that politicians are not in a position to make. They beg in and outside of courts, in statehouses, and in the halls of Congress for the perversity of paying to be in a clinical trial. I don’t doubt that Sen. Ayotte wanted to do the best thing for her constituent. We ALL wanted McKenzie to live a long life. And once Sen. Ayotte had thrown in with Burzynski’s patient, well, someone in her position is in the awkward position of not being able to retract that support gracefully. I had hoped that what happened to McKenzie would lead to the Senator sponsoring radically increased funding for rare childhood brain tumor research in McKenzie’s memory. Research into these tumors is underfunded and patients deserve more options than quackery. There should never be a patient who has to say that “no other treatment options are available,” to quote Ayotte’s press release.

Of course, Shalhoup had to follow up on the story after Ayotte’s office got involved, but when he did, he included a link and instructions on how to find the change.org petition. This is not to his credit. By the 27th, the petition had received 40,000 signatures, no doubt largely from the people who had been misinformed by these reporters. Quackery thrives when reporters opt to do almost entirely uncritical human interest stories. April Guilmet reported in the Union Leader Correspondent that:

Ayotte noted, however, that there have been documented cases of patients reacting positively for the treatment, while the [L] family noted that some patients in past studies have even had their tumors shrink over time.

Burzynski “documented” cures are just as “documented” as UFO abductions and sightings of Bigfoot. This is why scientists–and the regulatory process–requires a higher standard than mere anecdote for miracle cancer claims. Woe to everyone if every nostrum-pushing quack is allowed to circumvent the regulatory process.

On January 13, Shalhoup, from the Telegraph, reports on how the community has committed to help McKenzie, as is to be expected. Strangers can be endlessly kind, but they need to be informed. They need better information than:

“The FDA recently banned the drug, prompted in large part by Burzynski’s 1995 indictment on multiple charges stemming from allegations he violated the federal Food, Drug and Cosmetic Act.”

No. He beat those charges. The FDA didn’t revisit that case. The immediate cause of the suspension appears to be Josiah C’s death and the subsequent investigation. Again, it was in the USA Today piece. While Shalhoup does give a strong half a sentence to vague, uninterviewed detractors of Burzynski, there is nothing like balance in the article, as, again, the link to the petition and info on how to donate is included.

On 28 January Carol Robidoux at the Nashua Patch published an entirely credulous snippet called, “Saving McKenzie [L]: How You Can Help.”

This article ended:

McKenzie’s grandfather […] said the FDA has proof the controversial treatment, available through a clinic in Texas, has a 33 percent cure rate, versus that of conventional cancer treatment, which has a 0 percent cure rate for the kind of cancer McKenzie is up against.

Watch the YouTube video, uploaded here, in which McKenzie and her grandfather tell their story. Then, go to change.org and sign the petition.

Then, pass it on.

Links were included throughout the original. Skeptics did contact Robidoux to try to put what was happening in context. In reply to one skeptic’s email expressing concern, she wrote:

They are going into this with open eyes.
Just as people every day fly to foreign countries for treatments or surgeries that aren’t approved or legal in the U.S., this family has the right to pursue whatever treatment they would like, based on what they’ve tried and what their options are, what’s available, and what offers some shred of hope in a hopeless situation. If it is snake oil, if Burzynski is a fake, there are certainly enough local authorities and national news outlets delving into Burzynski’s claims to bear that out. I see Texas authorities have been investigating him since the 1980s. That’s a long time.
If the family does nothing, McKenzie will die. What they’ve tried already, within the realm of approved treatment – also very toxic to the human body – has not netted any positive results.
People make bad investments every day – in stocks, in get rich quick schemes, in religious organizations that promise healing, in New Age crystals and other remedies. Maybe Burzynski realizes he’s capitalizing on the desperation of people who truly have no other options. Maybe he believes something about his treatment has merit for some percentage of patients. I’m not a medical reporter, or even an investigative reporter, by my own or anyone’s standards.

Her standards clearly mean nothing. She’s in fact wrong about this, as conventional treatment unquestionably had abated some of her symptoms and initially shrunk the tumor as hoped. Orac called out her credulousness on the 30th, and she showed up in the comments:

As the other “credulous” reporter referenced here, I just want to reinforce that the story I wrote was one of several written about a family taking desperate measures to save a child with cancer who had run out of “conventional” treatment options. They were well aware of the quackery charges against Dr. Burzynski, yet were willing to take a calculated risk. It is not my duty as a journalist to tell them they are making a mistake – although I did discuss with the grandfather what I had learned about Burzynski in researching it on background for the story. He knew it all, and had visited the clinic himself. For the poster of this blog to persist in calling me a “credulous” reporter in the context of this blog reinforces to me that he is unable to comprehend that sometimes the elements of a story are not what the story is actually about. I cannot and will not investigate Dr. Burzynski – it was out of my realm of expertise and resources, and has already been done by other investigative health and regional reporters; I will report why a New Hampshire family is feeling so desperate that they are willing to petition the FDA for an unproven and controversial treatment. There was nothing about what I wrote that added credulity to Dr. Burzynski or his method.

The question left unanswered is how a decision can both be calculated and desperate? Robidoux’s staggering lack of self-insight to not realize that a call to “pass it on” might suggest to readers that there was something worth fighting for in Burzynski suggests she is in the wrong business.

On the 30th, we hear from April Guilmet that the family has received the support of Senator Jean Shaheen too. We hear how things were going in mid-December:

In a letter sent to Commissioner Hamburg Jan. 17, both Ayotte and Shaheen urged the FDA to communicate directly with the [L.] family.

In early December, the [L.] family was told that McKenzie would be permitted to start ANP therapy in Texas, provided the family could find a physician willing to monitor her progress locally, [a] family friend […] said.

Burzynski even offered to provide the therapy to McKenzie at no cost, according to her family. [emphasis added]

But just over a week later, further complaints against Burzynski were revealed and the FDA told the family they could no longer issue a compassion exemption.

“It’s come down to this,” said [McKenzie’s grandfather] via his cell phone as he drove on the interstate Tuesday morning. “So now I’m headed out to bang on a couple doors.They may want me to go away but I’m not backing down.”

[McKenzie’s grandfather] said he recently learned that the FDA has made more than 50 claims against Burzynski and at least one of his patients died while being treated.

And despite this, the commitment has been made. The grandfather is crashing through warning barriers that were meant to protect McKenzie and other patients

On the same day, the Skeptics for the Protection of Cancer Patients reached out to the reporter to let her know about our strong reservations about the treatment. We offered documents to substantiate our concerns and gave her contact information of patients who claimed to have been maltreated. She immediately replied that she would like permission to use portions of our letter because:

I think its important to share all sides of this story and there are so, so many.

We consented and appeared in the follow up article a few days later:

Of the Burzynski therapy, the American Cancer Society said last week: “Relying on this type of treatment alone avoiding or delaying conventional medical care for cancer may have serious health consequences.’’

Science blogger Robert Blaskiewicz of the Skeptics for the Protection of Cancer Patients group, said he’s been researching Burzynski for the past two years and is genuinely concerned for [McKenzie’s] well-being, should she ultimately be able to obtain ANP treatment.

“I’m all for patient choice,” Blaskiewicz said. “But I’m also for informed consent. Is [McKenzie’s family] aware of the stories, of the 20-year pattern of patients believing that unambiguous signs of progression are signs of success?”

Dr. David Gorski, an oncologist and the administrator of the sciencebasedmedicine.org website, has likewise devoted much of site to speaking out against Burzynski as well as the anti-vaccine movement and various forms of alternative medicine.

Contacted this week, Gorski said he believed previous trials of ANP “were designed to let Burzynski treat patients, not find answers.”

Gorski is right. We know almost nothing more about antineoplastons than we did when the trials were opened. We have detailed the unambiguous signs of progression (especially ischemic necrosis, or tumors breaking up in the middle because they have outgrown their blood supply) on this site. All we want is a reputable paper to fact-check us, because if we’re right, this is a potential medical ethics scandal that involves 8 times as many patients as the Tuskegee Experiment:

Also in the article, we also hear about McKenzie’s grandfather’s trip to Washington, D.C.:

[He] met individually with some legislators or their staffs last week, including U.S. Sens. Kelly Ayotte, R-N.H., and Jeanne Shaheen, D-N.H., as well as Elizabeth Warren, D-Mass., Ted Cruz, R-Texas, Rand Paul, R-Ky., Ed Markey, D-Mass., Dianne Feinstein, D-Calif., and Tom Harkin, D-Iowa.

He also attended a meeting with seven FDA officials, though FDA Commissioner Margaret Hamburg was traveling and wasn’t present at the meeting.

“Basically, we told (the FDA) that it would be nice if we could get everyone sitting down at one table with them — doctors, patients and legislators,” [the grandfather said] said. “Because there hasn’t been enough communication here.”

When skeptics said that we had concerns, we were not making things up. We had warned and warned and warned everyone about what was going to happen to McKenzie if the family charged ahead and circumvented patient protections. We were concerned that if the doors were opened for one patient, then the FDA would have no justification for denying the treatment to other desperate people.

This is why we were devastated to hear on March 23rd in USA Today:

The FDA acknowledged Friday that it has agreed to allow [7 Burzynski patients] to use the experimental drug, but only if they can find a qualified, independent physician to administer the drug. Beyond infusing the drug and overseeing their care, the doctor would have to formally apply for expanded access to an “investigational new drug,” as well as get approval from an institutional review board, an independent panel that reviews safety and ethical issues involved in clinical trials.

The FDA grants an average of more than 1,000 requests a year for expanded access.

Burzynski will supply antineoplastons for free, says his attorney, Richard Jaffe. [emphasis added]

The next step is finding a doctor to administer the drug, as pointed out in the Billerica Minuteman on March 27th in an article called: “Help McKenzie [L.] Get Needed Treatments.” Again, links are included to the various petitions and projects that can really only help Burzynski and nobody else. The family is still having a hard time finding someone to sign up to work with Burzynski, as we hear in the Nashua Telegraph on 29 March:

That second hurdle, to date a seemingly insurmountable obstacle, is finding a doctor who would agree to administer the drug, called antineoplastons, or ANP, [McKenzie’s grandfather] said. “They said she can use it if we can find a qualified doctor,” he said. “But who knows what ‘qualified’ means? An oncologist? Do they want a research doctor?”

Essentially, the answer to the last question is yes. Which means, [he said] said, even if there’s a doctor out there who would take McKenzie’s case, he or she would likely have to spend lots of money and jump through a lot of hoops to become qualified.

“We can’t even find a doctor to go that far,” [he] said.

This is another red flag; when qualified researchers are unwilling to sign the papers, you have a problem.

Following a visit to Dana Farber in mid-April, according to a public Facebook page set up of McKenzie, the docs say that she “looked really good.” We don’t hear about progress getting a doctor to sign up with Burzynski until May:

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This doctor is Terry Bennett, who explained his participation in the June 15 Telegraph:

The latest move came several weeks ago in the person of a Rochester physician who battled the U.S. Food and Drug Administration to get access to a similarly expensive drug that he felt confident would stem the cancer that was ravaging his body and buy him some time.

Dr. Terry Bennett said his experience prompted him to come forward when he learned the young Hudson girl and her family were beseeching the FDA to grant a compassionate exception that would allow McKenzie access to ANP treatments. […]

Bennett said it didn’t take long after he met McKenzie to agree to be her “backup” doctor in New Hampshire, as he calls his role.

“I thought, if there’s any way they can make this happen, I’m all for it,” he said.

“We have a (sick) little girl here. I will supervise what goes on here the best I can.”

Though you might think, based on the things said above (in bold), and in keeping with common research practice, that the Burzynski Clinic was going to foot the bill. Nope. The family is being charged the customary $15,000 a month in ancillary charges.

Even though the clinic is providing the medication free of charge it is still going to cost approx. $15,000.00 per month for medical supplies, consultations, & administrative fees that insurance will not cover.

While we expected Burzynski to charge out the nose for this treatment, some people thought it was going to be free including the doctor and the nurse who volunteered their services on that basis. On the same day that McKenzie’s Facebook group announced that she was starting on the ANP…

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….and article by Dylan Morrill appeared at Fosters.com, which revealed in part:

Nearly two months later, Bennett and his employees spent more-than 100 hours filling out the FDA application to become the sponsoring doctor and perform the therapy using Burzynksi’s medicines.

Dye was then contacted through “a friend of a friend of a friend,” and decided to offer her nursing services for free to McKenzie. She took two trips down to Burzynski’s Houston clinic to learn about the therapy.

Both Dye and Bennett are not charging for their services, and they thought that Burzynski would also be working pro bono. In December, 2013, Burzynski wrote a letter to U.S. Sen. Kelly Ayotte’s legislative assistant Dan Auger explaining that he would provide antineoplaston therapy for free if the FDA granted the exemption.

The letter read: “This is to confirm S.R. Burzynski, manufacturer of Antineoplaston A10 and As2-1 infusions is willing to provide these agents for free and for compassionate means.”

Bennett said he was told in May during a phone conversation with Burzynski that the medicine was being donated. It was after that conversation that Bennett decided to sponsor McKenzie.

[McKenzie’s] family also believed that McKenzie’s medicine was being provided for free. But […] McKenzie’s mother, said she received an itemized bill from Burzynski showed up in her mail a few weeks ago.

The family was told that the first month will cost $28,000 and every month after that will cost $16,000.

The family received an itemized bill from Burzynski? I think the FDA would be interested in seeing it. I smell a refund!

“It meets all the criteria for a bait and switch operation,” said Bennett. [emphasis added]

The next day, Bennett appeared in another article, which reported:

Bennett said he will not withdraw his sponsorship of McKenzie, despite the cost of treatment. But he’s extremely upset over what he calls a very disturbing phone call that he received on May 28.

Bennett says a representative of the Burzynski Clinic called him on that date seeking payment for the first month of McKenzie’s therapy. Prior to that, Bennett, who is donating his services, thought Burzynski was doing the same.

Instead, said Bennett, “I’m supposed to be the bag man for all of this. They want me to collect the $30 grand for the family and send it to Burzynski.” [emphasis added]

He later said:

On the other, there’s the opinion of Dr. Terry Bennett of Rochester, who agreed to be the overseeing local physician for the treatment of Burzynski.

“This is a classic bait­-and-­switch operation,” Bennett said of Burzynski in a recent phone interview. “He suckered me and this family into buying into a very expensive treatment plan.”

That second article, by the way,  is titled, “Dr. Feels Misled in Cancer Treatment Costs.” It sort of reminds me of the headline. “Amelia S.’s Family ‘Misled By Clinic’” It reminds me of the gouging of Denise D., who was treated so badly by the clinic. It reminds me of Supatra A’s family, who had budgeted but still found themselves in debt to the clinic. It reminds me of poor Kathy B. who said that she:

made this video [of a patient visit with Greg Burzynski] in anticipation that I would be receiving the antineoplastons. Apparently after spending over 30,000 here I found out that the Antineoplastons are only reserved for brain cancer patients who have already undergone chemo radiation. FDA put this restriction on the Burzynski Clinic, so any other cancer patients are BASICALLY ONLY GETTING THE TRADITIOINAL ALLOPATHIC TREATMENTS OF SYNTHETIC ANTINEOPLASON PILLS THAT DID NOTHING FOR ME.

All of these patients are dead. This is what we are dealing with here. This is why reporters need to do a better job of checking the public record before they endorse a shameless quack.

Registered Nurse Ariel Dye also volunteered her services to help McKenzie. She was the one who, instead of the patient, went down to Houston to learn how to use the ANP pumps and administer the drugs. I suspect that patients being trained to administer the drugs themselves may have contributed to the huge number of overdoses observed by the FDA and that this was a fix to the protocol the FDA demanded that Burzynski never got around to doing. He only had 15 years, after all. In November, we hear about Nurse Dye’s experience at the Clinic. She is scathing:

“I went out there and watched the nurse teach a layperson how to work off a central line. It was nothing,” said Dye, who is an IV-certified RN. “It was crazy to me that they charged this.”

“I got little to no instruction saying (things like) if there are major reactions, this is what you’re going to do in this case, in that case,” she said. “They made it seem like it was this big training program they put me through, but they lied and were looking to make money.”

Dr. Bennett came around fully by this point:

“His claims have no merit. He has never tested any of it realistically,” said Bennett.

On day 2 of the treatment, McKenzie feels pretty good, her grandfather reports. But not long thereafter, a few weeks after the start of ANP treatment, we learn that McKenzie is suffering from side effects of ANP:

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On July 27th, we see that the disease is progressing unabated, which is what you would expect if she were put on snake-oil, and what we have seen so many times:

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At about this time, Burzynski was whacked with a 200-page list of charges against him by the Texas Medical Board. This development was announced at The Amazing Meeting, the premier conference on science in the public interest:

http://www.youtube.com/watch?v=yJGIxDou9v0

In response to this action by the TMB, Fosters.com printed an article “Do Not Take Her Hope Away,” which was entirely irresponsible. For instance, they mentioned Dr. Bennett but not his opinion of the clinic. They did not mention that the tumor had continued to grow, as was to be expected. In fact, by July 31st, we hear how ineffective antineoplastons had been:

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In late September, April Guilmet tells us what has happened:

The ANP treatments cost the family about $15,000 per month.“She had crippling headaches and her blood counts got very low,” [McKenzie’s grandfather] said. “At full dosage, her body just couldn’t handle it.”

[McKenzie] went off ANP in mid-August, he said. Since then, her family has been researching other treatment options. She is currently on a regimen of gene-targeted drugs prescribed by doctors at Dana Farber. The family departed for University of Chicago on Sunday, where they will meet with another team of physicians.

The tragedy of fringe medicine is that her tumor might well have been treated by something with a chance of working instead of antineoplaston. To all the reporters who wondered, “What’s the harm in in treating someone with a terminal illness with….whatever they want?” I refer them to the energy, money, and precious time squandered on this course of treatment.

By September 28th, the family is in Chicago pursuing experimental treatment, and Burzynski is, blessedly, out of the picture.

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They are cutting into the brain stem which is usually a surgical no-go zone (and is why so many of Burzynski patients haven’t had biopsies to confirm radiological diagnoses).

McKenzie died at home on 23 Oct 2014. A radiant light went with her, and hundreds of people McKenzie had touched saw her off.

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To think that all of these powerful people were following McKenzie’s story and for want of critical commentary of the treatment in the media, McKenzie suffered for it.

I think Telegraph reporter David Brooks offered a fair summary of McKenzie’s ordeal in his write up after the funeral, “Alternative Methods are Not Safe Bets,” and he concluded:

It’s hard for an outsider not to feel sympathy for a desperate family struggling to save a loved one.

But we should give more weight to a medical establishment that has doubled the human lifespan, that has created a huge, complicated system of peer review, double-blind tests, treatment protocols which is far from perfect but has done more for your health and mine than has a millennium of hopes and dreams.

Brooks apparently interviewed some of McKenzie’s family in the aftermath:

The treatment over the summer accomplished nothing except making McKenzie sicker for a while, and cost McKenzie’s family and supporters many thousands of dollars, even though it was stopped quickly because of side effects, said McKenzie’s grandfather […] .

But [McKenzie’s grandfather] who says the total cost was “less than $25,000,” thinks the effort was worthwhile and might have succeeded if so many obstacles hadn’t been placed in its path […].

Most frightening is the lesson that the grandfather has apparently taken away from this. According to Brooks:

If somebody else he knew was diagnosed with DIPG, he’d recommend going to Burzynski.

The lack of regret is eerily similar to sentiments of the families of Burzynski patients going back decades. For example, in 1982, The Windsor Star reported that a family member still believed in the treatment “with all my heart” but her sister-in-law Deanne had arrived too late for the six weeks of antineoplaston treatment to be effective.

I hope that when the Texas Medical Board drags Burzynski to stand before a judge in Austin on June 15 the press remembers that treating this issue as a human interest story, such as we have seen in the case of McKenzie L., perpetuates misery and magnifies suffering.

Burzynski Patient Alyssa A.’s Story

In 1993, when she was 5-years old, Alyssa A. was diagnosed with anaplastic ependymoma. She had surgery, radiation, and chemotherapy. As a result of conventional treatment, she had, according to her mother, no evidence of disease until January of 1997. She did, however, have slight facial paralysis damage to the pituitary gland from the treatment. The side effects of conventional treatment can be awful, make no mistake.

The tumor started growing again, and the family, according to a Riverside Press-Enterprise article from 15 February 1997, decided to forego a second surgery. By this time they had decided to go to Burzynski. According to the reporter, who was I’m sure trying to help:

Dr. Stanislaw Burzynski of Houston uses fluids that occur naturally in human blood and urine to treat cancer and the treatment reportedly has none of the side effects of chemotherapy.

By reportedly, they most likely mean, the family reported it. Burzynski’s own informed consent disclaimer (and the long record of testimony here) clearly demonstrates that the treatment can have awful side effects. According to Burzynski:

consent1consent2consent3

But other than that….totally safe? Not a chance. According to the same article:

Family and friends are helping [Alyssa’s family] raise the $16,000 for Alyssa’s treatment by holding a car wash and bake sale at the Harvest Christian Fellowship Church today. Right now Alyssa’s tumor is the size of a green pea. If it grows larger than 2 inches before the [they] raise the money, Alyssa will be excluded from the clinical trials, [her mother] said.

That $16,000 is likely the startup fee for the antineoplaston treatment at that time. In this article, they make no mention of the vast sums that Burzynski typically extracts from people who stay on his therapy for months. They raise $3000 in a few weeks, but then another appeal appears in the same paper of 22 Feb:

[Alyssa’s mom] said the therapy could cost as much as $40,000. The initial therapy, she said, costs $16,000 and follow­up treatments that cost $2,000 per month can run four months to one year, depending on the complexity of Alyssa’s case.

There is scant info about what happens when they go to Burzynski. What we know comes from 2 posts a cancer board hosted by MIT, after Alyssa was off treatment and had at least 2 tumors. On 23 July 1998, the Alyssa’s mother told another person looking into treatments:

Jessica, my name is […] and I have a daughter named Alyssa who has also been to the Burzynski Inst. for antineoplastons my daughter also had problems on the therapy. Alyssa had seizures and went into a coma for three days, but her tumor was shrinking in any event we discontinued that treatment.

How did this happen? We find out in a post from 1 Aug 1998:

I infused her with antineoplastons for ten months with good results. We still owe the man $98K, but after they pushed me to raise the dose of A10 to 200cc, she had seizures and we almost lost her. I did acquire [an] oral form [likely sodium phenylbutrate, which Burzynski also sells and which is the prodrug for ANP] from a patient that did not survive and she is on a safe dose. I have enough to get the job done this time. They are charging ancillary charges but not providing the care. I would not go to Houston again.

So, an overdose that may have put her into a coma for 3 days. Burzynski has historically had a problem not only with overdoses, but also with reporting them and preventing future ones from happening, at least according to the FDA, who during a recent site review found:

  • 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.

 

Poor Alyssa may probably be counted among those patients whose overdose, in her case in 1997, should have triggered changes to the protocol to prevent other patients from “almost losing” their children. But he could not demonstrate that he ever did, and the human wastage piled up until 2013 as the FDA, inexplicably, watched. ONE patient overdose should have triggered these protections.

Not only that, but if the family actually thought that the treatment could “cost up to $40,000,” like they told the newspapers, how could they possibly have had informed consent of the costs?

Alyssa died on 1 March 1999.

What is baffling, however, is how Alyssa’s mom’s memory absolutely does not square with all the press coverage of her daughter’s case. In July of 2014, when the FDA waffled and allowed desperate patients–mostly children–to die on Burzynski’s drug, Alyssa’s mom appeared on facebook extolling the benefits of ANP:

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Non-toxic? By her own account, Burzynski’s drugs nearly killed her daughter. And she does not seem to remember that, even though there were some bad side effects, due to conventional treatment Alyssa was lived for years with no evidence of disease until the relapse. This is simply another example of how anecdotes should not be used as evidence of efficacy. People make mistakes.

 

h/t to the research ninja

Burzynski Patient Laura L.’s Story

Tonight we’re going to take a break from the patients who defended Burzynski in court and discuss one who advocated for him in a different way, on the Burzynski Patient Group website. Indeed, her story only ever appeared on that website, as far as we can tell.

After a few years of back pain, in September 2003, Laura L. started physical therapy because her leg was going numb. On October 11, she had an MRI and it revealed a plasmacytoma and damage to her spine. Before she even had a diagnosis, Laura’s relatives suggested that she go to the Burzynski Clinic:

We made the appointment for October 30th and flew to Houston on the 29th. My bone marrow biopsy was done on the 28th, so I didn’t know I had multiple myeloma until I was in Houston. It’s a good thing I went right away. My oncologist was worried about me leaving. He wanted me to have radiation treatments right away. I got them quickly in Texas.

First point: she had radiation, which is part of the standard treatment for this cancer. That itself makes it impossible to determine whether or not Burzynski’s treatment contributed to Laura’s care in any meaningful way.

Laura does not go on antineoplastons, rather the prodrug for them, sodium phenylbutyrate (PB), which Burzynski manufactures. She is also on a host of other drugs:

When I arrived in Houston, I had to walk with a walker. But I quit using it during the three weeks of treatment at the Burzynski Clinic. I was getting better quickly. My treatment consisted of 30 pills per day of sodium phenylbutyrate (PB), four pills per day of Aminocare A10, 200 mg. of Thalidamide, 40 mg. of dexamethasone for four days and then off for four days. I had radiation every day. I had zometta infusions and I will continue that for a couple of years to heal my bones. I get these just once a month. On the first day at the Clinic, I also had a shot of procrit, because I was so anemic.

With the exception of the PB and Aminocare supplement, both manufactured by Burzynski, so far as I can tell, there is nothing remarkable about this suite of treatments. Thalidomide is often given to MM patients, and dextramethasone is a steroid, which is another common treatment. With radiation and an only slightly abnormal combination of therapies, why does Laura think that Burzynski’s patent medicine in the mix made a difference?

In December, Laura is very near death with a high temperature and wonky sodium level which put her in the ER:

The next day, I had a chest x‐ray, which revealed that I had pneumonia in both lungs. I finally went home on Christmas day and that was a wonderful gift to me. I was very weak, though, and I had a hard time climbing stairs. I started having a lot of back pain and then my bone‐scans revealed more lesions. The Burzynski Clinic recommended I have a stem cell transplant. I was very scared, but I trusted their decision.

This sure suggests that Burzynski’s novel medicine medley had failed. Stem cell transplants are part of the normal treatment regimen for MM as well, a conventional approach. She says:

I just had the stem cell transplant and did well with that. I’ve been home since April 25th, 2004. I am not even sterile. Now, I am only taking the sodium phenylbutyrate pills and I am still getting better. The doctors who gave me my stem cell transplant were very impressed with how much I have improved since my diagnosis, how well I did with the transplant and how I am doing now. I thank God for Dr. Burzynski and his cancer treatment.

The question here is, why? Laura had every conventional treatment in the book and credits Burzynski, whose only innovation giving her almost certainly worthless (and apparently already failed) PB.

After all the conventional treatment, Laura L. lived until 2008, when she died of her disease. Sadly, the Burzynski Patient Group “disappeared” her story. How many others have disappeared from that misleading site over the years? (Quite a few, actually. We’ll remember those patients in time.)

Burzynski Patient Amelia S.’s Story

[Houston Press Readers: This is a re-post of an earlier story that really shows what we’re dealing with at the Clinic. The other story we recommend is Burzynski Patient MacKenzie L.’s story. Just last year, her family fought for him to get his “trials” back, and then horrible things happened to them.]

As Stanislaw Burzynski stands in front of the Texas Medical Board to answer for yet another litany of abominations, patients are no doubt gathering to protest in front of the courthouse so they can beg for their lives. Many of his supporters in the past have been then-current patients who were convinced that Burzynski is their only chance at life. Burzynski’s patients often have dismal prognoses and their prospects do not improve when they buy into his medical adventurism. In anticipation of such patients being used as human shields yet again, we are focusing on stories of people who have testified on Burzynski’s behalf, begged for their lives in courts and in the public, but who of course died anyway. These patients, so far, include Burzynski patient Elke B., Burzynski patient Douglas W.,Burzynski patient Janet C.Burzynski patient Sen. Ed G., and McKenzie L. These patients may not be testifying in the upcoming trial, but their stories are perhaps the most important and are far more eloquent and revealing.

Last week, we posted about the patient who had perhaps the most high profile campaign in the US in recent years. This one is perhaps the biggest in UK in recent years. The case of Amelia S. is a hard one to write about, because it tipped skeptics off to a pattern in the stories that patients at the clinic were telling, that their worsening symptoms were signs of improvement. As you will see, this is a story that Burzynski’s patients have been relating for decades. It’s a long post, but it’s important that you read to the bottom.

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3-year old Amelia S. lived in Reading. In about September of 2011, Amelia started displaying neurological symptoms–wobbliness and a trembling left hand (often drawn into a fist). The family brought her in to the hospital after she started falling down. On Jan 30th, 2012, she was diagnosed with a brain tumor, and on the 1st of Feb it was determined to be a large tumor on the brainstem. Surgery revealed a grade 2 diffuse astrocytoma, which the family was given to understand meant that the core of the tumor was likely grade 3. Doctors were unable to remove much of the tumor, only the 4 biopsy samples.

Amelia’s medical team was honest. The benefit offered by radiation and chemotherapy, on average, could be measured in weeks. These are bad, bad tumors. The family brought Amelia home on the 20th of February, her mobility and speech impaired, opting to spare Amelia the unpleasantness of the chemotherapy and radiotherapy. When they saw Amelia improving (we’re not told what those improvements were–whether they were reduction in tumor size or reduced swelling as she recovered from surgery, for instance), however, family understandably felt obliged to look for other options.

They found Burzynski. Immediately, the enormous price tag of his antineoplaston treatments spurred the family on to raise funds. Amelia’s father began documenting their journey to Burzynski in a couple of places, at ameliasmiracle.com and on a Facebook page of the same name. As a whole, his story is the most moving and insightful account of parental heroism that I have read since I began this project, and I strongly recommend that you read it for yourself.

By the end of February 2012, the family had decided on Burzynski. We were introduced to Amelia on February 28th in a video posted by her father:

Attached to the video was a simple plea:

Our daughter, Amelia, was diagnosed at the beginning of February with a very rare type of inoperable brain tumour. She has only a few months to live. We have a ray of hope – treatment for her is available at the Burzynski clinic in Houston, Texas. This treatment in total will cost around £200,000. We need to raise this money to allow Amelia to have the chance to live a normal life.

From the beginning, the family sought media attention to raise money for the Burzynski Clinic, as we see in a Facebook post. the earliest example of Amelia’s story appearing in the press was in the local Wokingham Times on 8 March 2012. The public campaign was launched. And by 14 March, £45,000 had been raised by the community, enough to get Amelia in the door at the Clinic (recent accounts put that initial consult at $30,000). The Wokingham Times seems to have informally adopted the family and followed their progress closely for the rest of the year. These community fundraisers appear as human interest stories and reaffirm that people are basically kind and generous and trusting. In fact, my first exposure to Burzynski and realization that something was profoundly wrong came after I did a newspaper database search for all of the patients that I could find. Of those patients I could find an outcome for, every patient who appeared in the international press, usually begging for money, with a single exception was dead.

A week before Amelia hit the papers, on the 6th of March, Eric Merola, who made an uncritical hagiography to Burzynski unironically called, Burzynski: Cancer is a Serious Business, interviewed the family about their upcoming trip to Houston for his new movie, a sequel, which comes out soon. He planned to follow Amelia’s progress in the film. On the 17th, as they planned their trip to the US, the family put up a short video for Amelia’s donors:

So, she clearly she packed everyone’s hearts into her suitcase. Such a dear.

They left on the 23th of March for America, having raised a staggering £75,000 for Burzynski. In a Wokingham Times piece, her father stated some of the opposition that the family had met:

Mr Saunders added that he was amazed at the number of people who had suggested the American treatment would be fruitless.

He said: “I was warned about this before we decided to go with the Burzynski treatment – it is like there is a vendetta out against the man.

“It is so strange, and all I keep getting are contacts from patients who have been or are being cured by the treatment, or at the very least have had positive results.”

People for whom Burzynski’s treatments fail tend not get into contact with other patients. We are witnessing what is known as survivorship bias. You can talk to a dozen survivors and have a positive impression of a treatment but fail to take into account the 10,000 failures, which would put a treatment well below the efficacy of chance remission, misdiagnosis, and unrecognized responses to traditional therapies. This is why controlled trials are so important to determine efficacy, so we can sort out the background noise of chance from real effects. It is also an important reason that dependence on patient testimonials is a red flag for quackery.

Amelia has had a hole opened in her chest where a Hickman line has been inserted, where she will receive her ANP. These frequently have complications with infection and clogging.

By the 30th, Amelia has her backpack full of antineoplastons, as we see in a video. Her family will spend the customary 3 weeks or so in the US learning to administer the ANP themselves. They are infused at high doses almost continuously.

Amelia’s dad shares his first impression of the Clinic on the facebook page:

The clinic have been fantastic. I am still amazed that people give them such a bad press. They have literally bent over backwards to get this started for us. The receptionist Irena even has a photo of Amelia behind her desk, she is so lovely!

Well there is a reason, of course. It’s because they apparently tell patients that they can tell brain tumors are shrinking by looking at their urine:

Mr Saunders said: “Every day is a milestone and the clinic is being extremely thorough in its tests – Amelia has regular blood tests and these are all closely monitored to check for signs of all sorts of things.

“Interestingly, they can actually see the early signs of the tumour breaking down by how her body excretes it in her blood and urine. This might be the only time in my life I get excited by seeing this kind of information!

I’m not sure what this is supposed to mean, and before Amelia’s story I would not have even noticed this. I can see why a parent clinging to hope would sieze onto any augury of healing. Remember, this family has not had good news about Amelia since her diagnosis. Little steps, literally, mean the world to them. I contacted research oncologist David Gorski, who studies and treats breast cancer, about this claim, and he replied:

“Oncologists don’t monitor anything in the urine for tumor breakdown, at least not for that tumor. There is such a thing called tumor lysis syndrome, but that’s usually only seen in leukemias and lymphomas as a result of induction chemotherapy that kills a lot of cancer cells really fast, releasing potassium, and a number of other byproducts. However, as I said, you don’t generally see this in solid tumors (mainly because none of them respond nearly as dramatically to chemotherapy as hematological malignancies). It’s also a complication to be managed, because its most frequent result is renal failure. It’s possible that he’s referring to GFAP, which is a biomarker for glioma under study, but I don’t think it’s really been validated as a measurement of response to therapy.”

There are apparently no biomarkers for glioma that appear in urine. Amelia had chronically low potassium at this point in her treatment.

We don’t see a lot of what is going on at the clinic on facebook, where most of the story is told record, but we get a clue on Amelia’s other website:

10th April 2012

I realised I hadn’t updated the news section here for a few weeks, this is largely because we update our Facebook page daily and much of our time has been taken up going to and from the clinic. Every day has been a bit of a rollercoaster here. Amelia has been on antineoplaston treatment for a week and a half and at the end of last week we hit a bit of a wall with the treatment dosage. Amelia got pretty sick so we had to back down on the dose a little. Yesterday she started getting really bad headaches so we have now also put her on a low dose steroid as well. Other than this, she is doing well and responding well to treatment. We think there are some very slight improvements in her coordination of her left hand side. We are continuing the treatment, and the aim is now to increase the dosage more slowly to see how she responds. All in all we are doing well and looking forward to coming home soon!

So, she’s been up and down. The steroids are a recurring feature of treatment and can very quickly reduce inflammation in a way that leads to improvements of the type that the family is reporting. You see it a lot on this website. It’s hard not to think of John D., who experienced worsening symptoms while under treatment (and on steroids), which was met with joy on the part of the staff:

I want to mention that the IV nurse told mom today that she’s been there for 10 years & has seen this before & many times, the more severe symptoms that are seen as a result of the therapy is really a good sign that it’s working better. I know this nurse & she is very honest & helpful. She also runs the class they run every week for new patients.

On April 19th we hear that the family is preparing to return home, and on the Wokingham Times page where it is announced, we see that damned picture again, patients literally at death’s door, posing in front of the Burzynski Clinic. We get the update that they have arrived back in England on the 22nd. Amelia’s dad talks about the fundraising (truly amazing acts of generosity by the whole community) and how grateful he is for the immense support that the family has received. (Amelia gives her own thank you’s in an adorable little video a few days later.)  He speculates on the road ahead:

I have come home from Houston with a strange kind of feeling. Perhaps a little apprehension, a bit of fear, a dose of happiness and a shot of hope. We still feel that every day is a roller coaster. We may be sitting on a ticking time bomb, and it may still be that any day we might lose Amelia. Every day truly is so precious, and it is a joy to watch her and her little sister back together again, albeit in a different way, a more careful one, where we have to watch them all the time.

The next day, it sounds like Amelia is having the unquenchable thirst that comes with ANP:

Amelia has been OK today, she was a bit sick earlier but we think this was because she drank too much too quickly – she was fine shortly afterwards. We’ve been getting used to life again at home and putting everything in place we need to.

And we hear that she is due for her first post-treatment MRI:

As far as the MRI goes, I just want to make a point that we aren’t expecting a lot to have happened with this next scan. As part of the medical trial we are required to get a scan done every 4 – 5 weeks – and these things take time to show any change. It is very likely the tumour may be the same or have grown slightly. This is fine and we expect this, and clearly if it has shrunk then great – but we aren’t expecting it to have done.

Tumors on which chemotherapy is working should probably not be growing at all. It’s the definition of “working.”

On the 25th:

Today has been a busy day. Unfortunately Amelia was pretty sick this morning – those of you who have been following our journey will know that we are trying to increase Amelia’s dose of drugs and it sometimes has side effects, this seeming to be the most common. She was fine afterwards and has been eating for the rest of the day.

We had an appointment at the hospital at lunchtime and ended up spending most of the afternoon there so we could get everything sorted. The doctors here are being very cooperative – but I must emphasise that they are recommending different treatment (chemo) and we have consistently turned this down. We have not found a single person with a DIPG tumour that has had any effect with chemo – so continue to find it strange that this is offered. Our plan is to continue the antineoplaston treatment for as long as required. We realise this is being frowned upon by the doctors here – but ultimately we are trying the only thing we found that had credible results.

Credible results would have been publication and replication of his trials. Burzynski can’t seem to complete his trials, much less publish them (which is odd given that he has the test agent already developed and the tumors he is working have outcomes comparatively rapidly). If trial completion were a batting average, he’d be at .015 and his trial publication average would be .000.

By May 4, Amelia is a celebrity. They have raised £160,000 (!) and she is meeting and hanging out with celebrities. And the paper has clearly been reading Amelia’s dad’s updates. Also, her dad’s website announces:

Well we have now been back from Houston for a few weeks – and Amelia has continued to slowly improve with both her walking and speech getting better. The Burzynski clinic were brilliant – we were made to feel so welcome and Amelia really made an impression on everybody there!

We had an MRI scan on Monday that revealed her tumour has stopped growing. Considering she has had no treatment other than the antineoplaston therapy from the Burzynski clinic, we are really pleased (and impressed) that the treatment seems to be working so quickly. We are now continuing the treatment and increasing her dose such that we try to get her to the ‘target’ dose for her weight.

This tumor “stopped growing” news is taken as validation that the treatment is working, so much so, that the Wokingham Times irresponsibly reports that result.   According to her dad:

1. Amelia has been on treatment for less than 4 weeks.
2. She is not on full dose yet, and has some way to go to get there. This is a slow progress, perhaps taking another month or so to achieve this (or more).
3. She has a low grade tumour. Any response will be slow. In other kids where the treatment has worked it has taken many months to show response.
4. She is still on steroids.
5. Her previous scan showed a 13% growth in 7 weeks.

So, having now had several opinions of the scans, I can confirm that Amelia’s tumour has STOPPED GROWING. This is amazing news and we are over the moon that this is the case. For this tumour type, in this short time, with a tumour of the size of Amelia’s, this is an incredibly good result. This is an INCREDIBLY hard tumour to do anything with, one of the hardest to treat and normally very lethal. In most circumstances Amelia would no longer be here (in February there was no way we thought we’d get to May with her) so to have the thing stable is fantastic news.

A few important points. It’s a low grade (slow growing) tumor. This does not seem to have been a PET scan, which would give  a sense how of active the tumor was–to see if it had in fact “stopped.” And initial responses to chemotherapy (and ANP is chemotherapy by every definition) correlate poorly to outcomes, which is, of course, the final goal that everyone involved is keenly interested in. Of course, the Clinic doesn’t convey that information:

I also had a good chat with our doctor in Houston earlier. Again all sounding very positive, and we have again increased Amelia’s dose tonight […] The clinic sound very positive that Amelia’s tumour stopped growing so quickly. Let’s just hope we have more positive news on the next scan in June.

On 12 May, we get an update about Amelia’s progress:

Amelia was on top form today, she was pretty tired after the wedding but perked up and during doses, when we unplugged her from her backpack, she was really bubbly. Later in the afternoon she was doing some proper walking – unassisted. I think we have now realised that a lot of the walking problem now is just her confidence. She was walking almost normally, and certainly the same or better than she was before her operation. Fantastic.

So, they are at point zero, which considering where they have been is wonderful from the family’s perspective, but it doesn’t tell us that the ANP is working of if she has just recovered from surgery to her brain stem and is now on steroids. And this may be important, as dad mentions on the 20th:

She really has improved. We’ve both noticed significant improvements in her speech, mainly in the quality of her pronunciations and also the speed and which she speaks. Slow speech is a classic symptom of her tumour location, so any improvement is a good sign here. This might be the steroids causing this improvement so we have to be careful, but we have a lot of fingers crossed we’ll be taking her off the steroids within the next few weeks if we can get her second bag to target dose. We’ll see.

On the 21st:

Amelia has been a bit groggy, fairly lethargic and pretty reluctant to do a lot. […] Because of the lethargy, the doctor in the US has recommended increasing her steroid dose very slightly. We’ll see if this improves things – if it does then this is a good sign. It does all tie in with us increasing her dose, which is now at maximum on her larger bag. No wonder.

Also on the 21rd, just over a year ago, the fundraiser reaches its goal of £200,000, and the tally continues to climb. In the intervening time, however, we hear that Amelia has had some complications with the Hickman line, which has been replaced because of a tear:

She is doing well otherwise, and we’ll be resuming her treatment tonight. She is now walking by herself, her coordination and balance have all improved and her speech is much better. It looks like the treatment is definitely helping her.

In early June, dad is rattled by the deaths of patients Billie B. and Supatra A., who had the same tumor as Amelia, and for a few days he rails against skeptics. Apparently some have been contacting him and criticizing him. This is wrong, in my opinion. Cancer patients have enough on their plate.

On the 21st, we hear that the tumor remains stable:

Firstly we are waiting on a further interpretation from Dr Burzynski, but as we suspected from our own view of the scans this morning, Amelia’s tumour remains stable. In other words, there is no change since the last scan.

The family accepts this as a sign that they have stayed the brain tumor:

We are 100% sure that without antineoplastons, Amelia would either be in a hospice by now or dead. She has a grade 2 tumour, on scans it appears as a grade 3, and it is very large and in a very dangerous part of the brain. Even a few mm of growth would cause a significant impact on her quality of life at this size. We are all walking on a knife edge. Dr Burzynski’s treatment is undoubtedly keeping her alive. I actually want to wave this in the face of all the skeptics we came across along our journey.

It’s worth noting that the tumor hasn’t shrunk. Small victories–including just not dying–are huge when your child has one of these tumors.

Amelia has her 4th birthday on the 22nd of June, and it is celebrated in the papers.

Again, we see that the steroid dose is being increased on June 25th to control the symptoms of the disease:

We have been advised by the clinic to increase her steroid intake back to how it was last week to see if we see an improvement in her. We will then try in a couple of weeks time to reduce it again but at a slower rate, reducing it by 0.25mg instead of 0.5mg per day. The steroid intake is a tricky issue as they are essential and help reduce the symptoms of this awful disease (headaches, tiredness), however long term steroid use is not good and cause side effects such as weight gain, muscle problems.

We still haven’t seen anything that looks like clear evidence of improvement past diagnosis; it sounds like the symptoms return when the steroids are tapered. She seems to be doing pretty well on this dose of steroids, going to school. (Her last day of nursery school is 11 July.)

On July 15th we hear:

Well – we have had a pretty good weekend. I had a truly amazing conversation last night. Purely by chance I’ve been contacted by the mother of another little girl, who is almost the same age as Amelia, who is receiving the same treatment (for longer), with the same tumour (DIPG) and her tumour just shrunk. By 36%. We are so, so pleased. There is so much hope in our hearts now.

I’ll just briefly mention how frustrated we still are to read so much crap on the internet about Dr Burzynski. I feel like we are ‘insiders’, in a way, and know how the whole thing works now. These doubters clearly don’t. The lady I spoke to last night was told her daughter would die. When she went to Burzynski, her doctor shut her off. Refused to speak. Thank God she chose to follow her heart, and not that doctors advice. She might just have saved her daughters life. There is no doubt this works, and we want it in every hospital in the world. We’ll keep spreading the word until it is.

This child, sadly, is now dead.

By August the tumor has not shrunk, but Amelia has been coping very well. A few weeks earlier she had a wonderful day at the zoo. She’s still a little wobbly on her feet and in the pictures her family put on the Facebook page, you can tell that her face is not symmetrical, but by God she’s enjoying her life, which is an immense thing in itself. On the 6th however, she gets pale and sick; when her blood work is done, they find that her potassium and magnesium are way down, though they stabilize her.

On August 8, we hear:

One of the many things I have said throughout this year is that I hope that maybe, one day, I can learn that another child has had success with this treatment because of the inspiration they gained from Amelia. I know of one little girl, Chey, who is waiting to go to the clinic right now. But due to some complications with the FDA and the clinic, there are some delays – but we are all hoping she will get there very soon. We felt so welcomed by the Burzynski clinic and everything we saw there made us puzzled why so many people don’t believe in it.

We just found out exactly what happened. According to an SEC filing:

In a letter dated June 25, 2012, the [Burzynski] informed the FDA of a serious adverse event which may have been related to the administration of Antineoplastons.  On July 30, 2012, the FDA placed a partial clinical hold for enrollment of new pediatric patients under single patient protocols or in any of the active Phase II or Phase III studies under IND 43,742.  The FDA imposed this partial clinical hold because, according to the FDA, insufficient information had been submitted by the Company to allow the FDA to determine whether the potential patient benefit justifies the potential risks of treatment use, and that the potential risks are not unreasonable in the context of the disease or condition to be treated.

According to the mother of patient Alynn H., her understanding was that a child had died (link is password protected). We have not heard anything else, only that the ANP trials, almost a year later, have not started up again and that the partial hold remains.

On August 13, Amelia’s dad posts a video about Amelia’s life since diagnosis. This write up an unusually long post for this blog, and I haven’t done justice to the support the family has received from their community or the sheer number of people who pitched in to help the family, and this video gives a sense of that:

On the fifteenth, we hear that the family is understandably anxious for the tumor to shrink:

Incidentally, we are well aware that a stable tumour is good. Mondays scan was one that we went into thinking ‘if it is stable then great’. I’ve had a few people come up to me and ask “is the tumour shrinking?”. Now I know people mean well – but it is a little like me walking up to somebody and saying “have you won the lottery yet?”. In other words, frustrating. I smile, say no, it will take time, and move the conversation on.

So far, the tumor’s behavior has been utterly unrelated to the dose of the antineoplaston chemotherapy. On Aug 25, we hear that Amelia is tired on treatment and that she has had a progression of symptoms:

We are still looking to increase her dose slightly as she has gained a little weight since Houston so she should be able to tolerate an increased dose (or at least we hope so). We will probably have to increase her steroids in line with this, but we have been considering this anyway as she seems to have become a lot more wobbly lately. We know from the MRI that the tumour hasn’t grown so an increase in her steroids should help this.

Now, I’m not sure how this was verified. The definition of a “stable” tumor can actually accommodate some growth, so, we can’t know exactly what is happening. And we hear from the family a few days later that they have come to a hard realization:

On the 27th, we hear:

Firstly, Amelia hasn’t quite been herself unfortunately. She has been very reluctant to walk, a lot more tired, slow and pretty lethargic. She was sick on Saturday night also. We are reasonably confident we have probably gone too far with the steroid reduction so we have actually increased these slightly again today. We decided we would rather have a happy and more alert Amelia than one who doesn’t want to do too much – so we made this decision today in coordination with the Burzynski clinic. We’ll see how she does. There is a small chance it is the tumour growing, but much more likely given the scans we have that this is due to swelling of the tumour caused by the treatment. Time will tell. […]

The symptoms we are seeing right now are a direct result of the tumour, hopefully due to it swelling, and the steroids will fix this. They are also what we would see if it has grown.

It really, really looks that her wellness is linked directly to how much steroid she is receiving. And here’s another example of something that is…desperately, desperately wrong at the Clinic. The patient is being told that the tumor is swelling because of the treatment. How is it that only at the Burzynski Clinic that getting worse is indistinguishable from getting better? Second point: this is a tumor on the brainstem. If a possible side effect were swelling of the thing pressing against the brainstem, you’d expect that to be on the informed consent form, right? The type of thing that would be among the “serious side effects,” right? It’s not, at least not in a version of the consent form used after Amelia had started ANP:

consent1 consent2 consent3consent2consent3

(Burzynski’s supporters who have been saying that the treatment has no long-term side effects would do well to look at that first paragraph. The paperwork that every patient signs says it can have exactly that.)

On September 5th, we see a candid moment on the facebook page. The parents are committed to seeing this therapy through, but the father has that lingering awareness that this nothing the tumor has not shrunk:

Whether we have returned to a feeling of optimism or not remains to be seen. I still feel uneasy about the fact that we are so far on without the tumour shrinking. It is frustrating, because we have worked SO hard with the treatment – our entire lives are ruled by it and it is almost a full time job sorting it all out – we just share it between us and make it happen. We just know to be patient, and we 100% know it can work.

At this time, Amelia was returning to school (she had already been going to nursery school on treatment). And the way it appeared in the press, and certainly how I and other skeptics read it, it was being promoted as, “See? This treatment is working enough to let this little girl go back,” a human interest story (The Mirror’s coverage was profoundly disgraceful–suggesting UK doctors “refused to treat” Amelia, whereas when you look above you see that in fact: “The doctors here are being very cooperative – but I must emphasise that they are recommending different treatment (chemo) and we have consistently turned this down”), and by god it was good to hear that Amelia was having a great time, but there’s a lot more going on than is contained in the articles. On the 5th we see how much support was needed to get Amelia in. This was not the return of a healed child that everyone took away from the coverage:

“There has been a LOT of organising around this, far more than getting a healthy child to school. We’ve arranged our nanny, we’ve had to work around the school timetable, we’ve had meetings with the school and the teachers and the hospital nurses and made everything happen. The school have been absolutely fantastic every step of the way – we literally cannot fault them.”

On the 8th, we see on the Facebook page:

“On Monday we have a physiotherapist coming to look at her to see if she can get her walking again. I tried a little walking with her today and she is really, really trying. You can see she struggles, like her brain doesn’t know how to do it but the conscious Amelia that we see and know does. It’s a bit like trying to write with the wrong hand – you know what to do but you can’t quite make your hand write as well as the other. She tries to walk, but can’t quite make it all fit.”

This is not a child improving.

September 10, on they were visited by Eric Merola for his utterly uncritical documentary about Burzynski. More on that in a moment.

On the morning of the 15th, Amelia woke up crying with a pain in her head. She went off treatment for a day or so and got better, not trembling, perhaps speaking a bit better. One wonders if she is not experiencing relief from the hypernatremia that can appear alongside such massive sodium doses and can have such side effects.

Amelia has a great couple of days in late September (and she really takes to her school!), and her dad talks about how the awful waiting game goes in between MRIs, which I have learned is how time is measured by cancer patients:

I’ve said this many times before, but the really frustrating thing for me is not having anything really tangible that tells you this is working, until we get the scan image in front of us. This means an 8 week wait between scans when you really have no idea what is going on, and if she gets worse like she did a few weeks back then I think you naturally assume the worst. Then she gets better, and you relax a little!

The October MRI shows no change. But later that month, the family is trying to come to grips with what life will mean in the likelihood that Amelia is not with them. It’s a beautiful post, and I hope you read it. It’s immensely sad and healthy and you can’t help but feel the full force of their grief and fear. This family is mentally preparing themselves for a horrible future, and this makes what happened next absolutely inexcusable by any measure.

By November 19th, Amelia’s right hand is immobilized, a clear progression, and the family gets the results of a recent scan:

What I don’t want to do is get ours, and everybody else’s hopes up about things. I could not bear thinking that this is working and then to be told it isn’t. (emphasis added)

What I will elude to is that the Burzynski clinic feel that there is a cyst forming inside Amelia’s tumour, very slowly. This does seem apparent on the scan images but we want to make sure this has grown over the longer timeframe. A cyst will form where there is cell breakdown, so clearly is a good thing from a ‘killing the tumour’ viewpoint, but possibly bad in that you then have fluid in a very difficult place to get to. We’ll address that little hurdle if we get to it being a problem in the first place.

This sounds exciting (it is), but we are really trying to be careful about getting too much so. Amelia has got worse, although she has had some improvement over the weeks before her MRI. This could be due to a number of factors and we know the tumour has not grown.

Another point with this is that the tumour isn’t shrinking, but if a cyst is forming then it might be some time before the tumour does shrink. We’ve always said that due to Amelia’s tumour being very slow growing, we have more time on our hands more than most kids who get this.

When this news was released on the family’s Facebook page, followed by rapturous confirmation the next day, it was brought to the attention of Orac at Respectful Insolence, who gave an honest medical opinion:

It pains me greatly to do this, because, no matter how I write this, it will be perceived as trying to take away the hope for Amelia’s survival that the Saunders family holds. Such is not my intent, by any stretch of the imagination. However, these “cysts” almost certainly represent areas of ischemia (low blood flow) leading to tissue death as the tumor outgrows its blood supply. This is a phenomenon commonly seen in advanced malignancy. I know this because tumor angiogenesis ia one of my areas of research interest. […]

Sadly, then, seeing “cysts” growing in Amelia’s tumor most likely says nothing one way or the other about whether or not it’s responding to Burzynski’s antineoplastons. That’s assuming that Burzynski’s interpretation of the scans is even correct, which I wouldn’t bet money on. Most likely, these “cysts” indicate that there is no therapeutic effect. I take no pleasure in saying this, but most likely this is true.

Amelia’s dad was understandably upset and actually responded to Orac on Nov 29th, but the day after Orac posted, the family updated their followers:

We know that some people doubt what we are doing. We understand that it is in human nature to question, and many people will not just take something on faith alone. But, ultimately, this is our choice. And that choice seems to be paying off.

Yesterday I sent a CD with the latest MRI scans on to our local oncologist and I’ll be waiting for their opinion. We’ll consider this, and then continue until the next scan and see if the cystic formation that we have been shown grows in some way. I don’t want anyone to think we just take things at face value and accept them – we consider what we see, what we are told, and get as many opinions as we can. We can see with our own eyes though that something has changed with the tumour and we hope this continues. Amelia’s tumour hasn’t enhanced or progressed, so we know it is unlikely to be anything other than cysts, but we will get that second opinion for sure.

Amelia had a magical week. She won a community award, the “Child of Courage” award, and was literally the star of a Nativity play with her friends. The reality of Amelia’s situation soon came upon the family, however. On 2 December:

The truth is, Amelia isn’t getting any better neurologically. We live with her every day and we see it. She is very slowly deteriorating and I think we would be putting our own heads in the sand if we didn’t accept this. On one hand we have the Burzynski clinic who believe the tumour is beginning to die. We are getting opinions here about this theory and we’ll very likely need another scan of a different type in early January to back this up. Everything is based on opinions – and nobody agrees, which makes it all very hard on us.

And the final assessment from the Great Ormond Street Hospital:

We had our meeting at Great Ormond Street yesterday and, sadly, they just don’t have anything for us. We kind of knew this before we went – but wondered if they might have a trial that we could take part in. Unfortunately they don’t.

They felt that Amelia is in the latter stages of the disease, and that what is called ‘progression’ has already started. This means her tumour is growing, the cancer is spreading and we don’t have a huge amount of time left. Again we had already guessed this was happening but it was good in a way to have another opinion of this.

Were it just a one-off bad interpretation of an MRI on the part of the Burzynski Clinic, we might have been able to write this off as a simple mistake. But it’s not. Not by a long shot.

Had Burzynski not used this line on the family who had given him by far the most publicity of any other in years, this recurring theme might have slipped by unnoticed. But it’s clear that this is not just a coincidence, it’s an M.O. predicated on false hope that strings parents and patients along. And it’s been going on for decades! And it leaves patients utterly crushed and confused. The few skeptics who have been working these stories in their spare time have found case after case of patients thinking that getting worse is getting better (a partial, growing list can be found in this post). Consider that the cases written up at this website represent 1/10th of the total cases we’ve been able to find and will be bringing to you, that we have only found a small fraction of cases, mostly from the most recent years, and that this guy has been operating for over 35 years! My god! Imagine what that means!

In light of this, when Eric Merola, in his new movie, says in a series of title cards:

Two months after this interview, Amelia’s tumor began to swell and fill with fluid.

There was confusion and disagreement among between their local radiologists and the radiologists in Houston, [sic] about why this was happening–

So her parents decided to discontinue antineoplaston therapy.

[Then he cuts to a picture of Amelia’s obituary and says,]

“Amelia passed away with her parents by her side on January 6, 2013.”

…it is fundamentally dishonest. There was no confusion. There was the right diagnosis and Burzynski’s diagnosis, a story that’s been spun for decades to desperate parents, and it’s a goddamned disgrace that Merola suggests that the parents’ evidence-based decision could have been related in any way to the outcome.

Instead of the usual plea for a donation to St. Jude Children’s Research Hospital, which researches children’s tumors and provides care for free, we’d like to ask you to make a donation to Naomi House, the children’s hospice center that cared for Amelia’s family in the last days and which seems to be the family’s preferred charity.

If you want to take action, protect the vulnerable, and put reliable information in front of patients who might be looking into this Clinic, the Skeptics for the Protection of Cancer Patients (facebook page here) have put up guidelines about how to boost good information into Burzynski’s search results.

Burzynski Patient Priscilla P.’s Story

Priscilla P. had driven a school bus in numerous cities around the country. In November 1998, she was diagnosed with ovarian cancer. She had radical surgery, a complete hysterectomy and removal of her gall bladder, appendix and lymph nodes. Following that, she endured a year and a half of chemotherapy.

On 8 June 2000, her story appeared in the Atlanta Journal Constitution, raising awareness of a fundraiser for Burzynski:

The chemo slows the cancer, but it’s still growing. But [Priscilla] is upbeat, determined and not about to give up. Her bright blue eyes are animated as she explains Dr. Stanislaw Burzynski’s experimental treatment program in Houston, where she has been accepted as a patient. The treatment is called antineoplaston therapy. Very basically, antineoplastons act as a biochemical microswitch, turning on tumor ­suppressing genes to stop tumor growth.

“My son read about it in People magazine,” she said. “Basically, you have an infusion or take a pill which only attacks cancer cells, without destroying healthy cells. It teaches the cancer cells to die. . . . He’s had over 3,000 patients with great results and very good results with soft sarcomas, which is what I’ve got.”

There’s only one snag to the scenario, and that, of course, is money.

Of course. he has no track record–no basis to claim ANY results with sarcomas because he has never published a respectable account of his treatment. And there is similarly no evidence that ANP is a “biochemical microswitch,” an unnecessarily sciency term if I’ve ever seen it. The article continues:

Since the clinical trial has not yet been approved by the FDA, insurance companies won’t pay for the treatments, which would total about $50,000 for a five-­month program. Like most people, [Priscilla] doesn’t have access to those kinds of funds, and the clinic requires up-­front payment of $20,000 before treatment can be started.

“I can’t understand why insurance won’t pay,” said [Priscilla]. “The cost is a bout the same as chemo, and it would only be for five months, where the chemo can go on indefinitely. . . . Less than five percent of patients are able to go for these kinds of clinical trials because of the money situation, but this is how cures are found. If they don’t have the people to do the trials, how can they hope to find a cure?”

I hate to have to disagree with a patient, but this is NOT how cures are found. Respectable researchers secure funding on the basis of the merit of their ideas, their track record, their ability to convince knowledgeable peers at research foundations to sponsor their research, or their ability to attract investors. Disreputable quacks hit up the dying for cash and bleed the desperate dry, never publishing anything convincing.

Part of Priscilla’s mission, it seems, was to spread the gospel of Burzynski, and she and her family repeated his talking points to the press, who dutifully reprinted it without critical comment, which is deeply irresponsible. I guess fact-checking is something that other newspapers do.

Education of the public is part of what they hope to accomplish as well, said [Priscilla’s daughter].

“I just want people to be aware that these kinds of treatments are available, but people can’t use them because they don’t have the money, and insurance won’t pay,” said [Priscilla’s daughter].

“The other thing is that people like my mom get accepted after everything else is exhausted. She’s had a year and a half of chemo, and she’s completely run down by it. What would have happened if she went (for the treatment) right after surgery? She may have been completely cured by now. If they could go immediately when diagnosed, rather than after chemo brings them to death’s door, how much more effective would that treatment be?”

In all probability, the fact that Burzynski’s patients usually have had prior treatment has lengthened the lives of his patients, as there is no evidence that his treatment does anything. It also gives Burzynski a bogus out for whenever a patient dies: It was the prior treatment that killed them.

On the 22 June an update appears. The fundraiser was successful and raised enough money for Burzynski that he’d let her start.

After the second month of treatment doctors will know whether or not it is effective. If it is not, [Priscilla’s daughter] plans to donate the rest of the money to another candidate for the treatment. The obstacle of money is almost overcome, but now there is a challenge of finding a place to stay during the treatment. [Priscilla’s daughter] is looking into several possibilities, including the Ronald McDonald House, but hopes a local resident with ties to Houston will help. Right now, [Priscilla] is being treated at Kennestone Hospital for blood clots in her lungs.

The Ronald McDonald House has denied Burzynski’s patients housing in the past because of who their doctor is. Think about what that says about the doctor.

An update appeared on November 23 in the AJC. She’s on treatment, and the family is still raising money for Burzynski:

To fund an experimental cancer treatment in Texas, she is selling cookbooks at Curves for Women, a Woodstock business on Main Street that features exercise and health routines for women. The $10 cookbook features low-­fat recipes for busy people and was written by Dawn Hall. The treatment costs  $9,200 a month and lasts five months. [Priscilla], 58, undergoes a 24­-hour­ a ­day infusion of anticancer medication and ingests several dozen pills daily.

Priscilla died of her ovarian cancer on 23 August 2001.

For reliable information about clinical trials, visit clinicaltrials.gov. Please contribute to St. Jude’s Children’s Hospital, which cares for sick children even if they can’t pay.

(Tip of the hat to the Research Ninja, whose hard work made the recent flurry of posts available. Many more to come.)