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).

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

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. Go to the clinic Get Marie’s vitals Talk to Dr Weaver Say Hi to our new friends Vu takes some of Marie’s blood while I practice preparing the drug bags, flushing Marie and programming Buddy Vu teaches me something new 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.