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 Miki B.’s Story

The story of Miki B. appeared online early in the skeptical backlash against the Burzynski Clinic, which came about after a chap named Marc Stephens, who had been hired by the Clinic to clean up its reputation on the web, threatened a number of skeptics with legal action in the fall of 2011.  He sent a high school student a picture of his house and threatened to contact his school. This is par for the course among hardcore Burzynski supporters. Skeptics have had their employers and licensing boards contacted. None of these have intimidated the skeptics, of course, because who could live with themselves if they had been silenced? But this case will clearly demonstrate that nobody is safe from the ire of a “true believer,” including Burzynski’s own patients.

We did not know much about Miki other than she was Australian and had breast cancer. We don’t know the stage. She started appearing on twitter in April 2012 talking about the Burzynski Clinic.
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Apparently this booking was for late July. She was traveling from Melbourne to Houston for Burzynski’s treatment. This takes her some 8,900 miles away from her support system (and any chance that she will encounter a neutral voice she will trust). In the meantime, she seems to be researching, though the quality of her sources is in some doubt.

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This is patently false. The genome was not sequenced until 2003, and work had been ongoing since the 1980s. This included 20 research universities and independent labs. Burzynski’s was not one of them. You find no relevant publications in the ’70s from Burzynski to suggest that he was a pioneer of genetic… anything.

We hear from Miki, who goes under the pseudonym Xena, after she has arrived in the states and has been put on what Burzynski calls “targeted gene therapy.” This is a cocktail of drugs that have typically never been tested together for efficacy and toxicity plus sodium phenylbutyrate, a urea cycle drug that Burzynski manufactures and sells at his in house pharmacy.

 

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We only learn how many drugs she has been put on on Halloween:

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By this point, skeptics have been in contact with Miki on Twitter, and it must be said, they were not always nice. There is nothing wrong with contacting a cancer patient who is public about their treatment and asking them about it, or even giving completely unwanted advice, but one should always consider that patients have a lot going on and “bringing the hammer down” is not helpful, nor is it likely to do anything but encourage patients to dig in.

We learn that Miki is in contact with other Burzynski patients. Usually, it seems that most patients get contact information from the Burzynski Patient Group. They are also often on cancer-related message boards irresponsibly promoting Burzynski to the desperate. (Almost by definition, cults recruit the vulnerable.) Of course, this is a biased group and does not give you a sense of the wider picture. That contrast is clear below:

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Miki is experiencing survivorship bias. Of course the people you talk to are doing well. The ones you talk to who didn’t do well, well, they don’t talk back. This was made clear when the Clinic gave a list of patient names and phone numbers to a new patient with pancreatic cancer. The sheet looked like this:

listofdead

Joseph A. was alive, but died well within the expected life expectancy for his diagnosis. Maxine M. had already died when this was given to the new patient. Irene S. would be dead within the month. Joanne S. too was alive but was also dead not a year after starting therapy. This pancreatic cancer patient this was given to, Wayne Merritt, was unable to contact any of them. Wayne, by the way, is still alive, and Burzynski’s fans crow that this is evidence that Burzynski works. They don’t seem to realize that the only difference between these patients and Wayne is that Wayne stopped going to Burzynski. Wayne also alleges that he was given a bait-and-switch by the Burzynski Clinc, a not-uncommon complaint. See, for instance, the cases of McKenzie L., or Kathy B., who made a video of a consult with Greg Burzynski, who should have been able to tell her that she was not eligible for antineoplastons but apparently didn’t. The caption to Kathy’s video read:

I made this video 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.

Crucially, Miki does not know the difference in numbers between the survivors with her cancer and those who died, and then the survival rates of someone on standard therapy. This is how you tell if a treatment is working. Nevertheless, something new is creeping into her tone as she goes into mid-November…

 

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And then:

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We simply don’t know what the setback is. But by January, we get the really bad news that the skeptics were expecting.

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In February, however, we see something that is absolutely chilling and distressingly common. Notice here that we are only seeing one side of a conversation. The other side has been deleted. This will be very important.

 

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This is very bad. Numerous patients on this website have reported that the Burzynski Clinic has given unbelievably unhelpful interpretations of medical scans, and they end up celebrating worsening symptoms. I think that the most clear evidence of this is the case of Amelia S., but we have also seen it in several other stories:

So, who was on the other side of that conversation with XenaRaider? Well, it turns out a truly, truly horrible person tweeting under the pseudonym “@BurzynskiSaves” who promoted Burzynski constantly. Constantly.

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And this is true. Every time that Miki had posted something positive about the Clinic, @BurzynskiSaves would retweet it. But then she started to have questions, and @BurzynskiSaves started treating her like garbage.

When skeptics named the person behind the @BurzynskiSaves account, it immediately went private and nobody could see it. It came back not long after, and soon the entire tone of the account changed to one of sweetness and light. The account, it was clear, had been handed off to members of the Burzynski Patient Group. This was made clear when one started replying to herself:

BJFvhQHCcAAj6v_

This was peculiar, but the fact remains that members of the patient group had the keys to the account. And patients who have fallen out of the thrall of the Clinic have reported similar behavior as that experienced by Miki. Take for instance, the story of Burzynski Patient Cari U.:

As the charges multiplied, I asked Burzynski’s staff and the people leading our activist efforts for background information so I could accurately refute them. Had Burzynski refused help from a leading cancer center? Was he pocketing millions supplied by patients who had given up everything? But I was shunned. “You are beginning to remind us of E.,” I was told. E. had been blacklisted by the group for asking questions that leaned toward “the other side.”

Again, if you question the treatment, you become a threat to their belief and become ostracized. It doesn’t just come from the Burzynski patient group, however. The pancreatic cancer patient above who received a list of the dying as Burzynski’s references, after he made his accusation of a bait-and-switch public, received threatening phone calls from someone pretending to be a lawyer who had been hired by the Burzynski Clinic to clean up its online reputation. (How Marc Stephens, whose nasty letters to the Merritts are included here, got their names and number to do this is one for the ages. This is also why I find people defaming Wayne to be contemptible beyond measure.) Regardless, the patient group has embraced the BurzynskiSaves name, as is seen in this current shot of their Facebook page:

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Many of these people in this group are slated to be Burzynski’s character witnesses in his ongoing legal confrontation with the Texas Medical Board come January.

Miki’s last favorable tweet about Burzynski was in February 2013. She died in June 2014.

Special thanks to research ninjas 1 & 2, the damsel on the dock, and Josephine Jones, who all contributed to this in their own way.

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:

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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:

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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.

Screen Shot 2014-10-29 at 1.13.25 AM

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 Cari U.’s Story

[As Stanislaw Burzynski goes in front of the Texas Medical Board again to face a list of abominable charges in November, and as we expect many of the patients who have defended him in the past to be used as human shields again, we have been bringing you the stories of patients who defended him but won’t be at this hearing. It is indeed a rare pleasure to be able to publish the story of someone who defended him only to discover what type of operation Burzynski runs. Cari U.’s story, which is reprinted here in its entirety, was first published in Health in 1998. We are very grateful for her permission to publish it here and glad to report that she is doing well, cured by what was then an experimental treatment. She experienced two clinical trials, a legitimate one and Burzynski’s, and she offers a rare, crucial perspective on the differences between the two. All footnotes are editorial additions that were not in the original. –eds.]

Diagnosed with incurable cancer, I had to fight the FDA for the alternative treatment I desperately wanted. I won–and that’s when my problems began.

At the end of February 1996, I sat in a large hearing room on Capitol Hill, staring at the elevated seats soon to be filled by the dark-suited members of the Subcommittee on Oversight and Investigations. The topic of the hearing was whether my doctor, Stanislaw Burzynski, could keep treating patients with the drug that seemed to be ridding me of cancer.

Two years before, at the age of 21, I’d been diagnosed with a slow-growing non-Hodgkin’s lymphoma. The diagnosis had come almost by accident. A routine scan following a bout of food poisoning had shown tumors throughout my gastrointestinal tract. After doctors at several oncology clinics said they had nothing to offer me, I began taking Burzynski’s medication, called antineoplastons (derived from the Greek for “against cancer”). After a few months I received good news: Scans revealed the tumors were shrinking. But the likelihood of my being able to continue the treatment was shrinking as well. The Food and Drug Administration had just won an indictment of Burzynski on 75 counts of mail fraud and interstate commerce of an unapproved drug.

I, along with dozens of other patients, decided to protest. Since another patient and I lived in Washington, D.C., we took to Capitol Hill, toting our bags of medicine around to elected officials as we asked for help. Most of the senators and congresspeople listened politely, stiffly said they would look into the matter, and nodded good day. A handful, however, welcomed us into their private offices, served sodas, and spoke with us at length. After such a meeting with Rep. Joe Barton (R-Texas), he called this hearing. Barton is one leader of a new movement to give Americans more freedom of choice on their medical care. He favored a bill to speed approval of drugs for serious illness and had just cosponsored the Access to Medical Treatment Act, a bill that would give patients the right to try any alternative therapy, even an unproven one. Barton wanted our saga to illustrate his point. For us, the hearing was a chance to expose what we saw as a witch-hunt of our doctor.

Patients, former patients, and their family members arrived in Washington by the dozens, some flying cross-country to attend. I arrived with Michele, with whom I had been lobbying for the past month and who had become a good friend. Seven years earlier Michele had been diagnosed with a rare liposarcoma that, despite numerous tries at chemotherapy and alternative treatments, kept resurfacing. In front of me sat Maria, whom I had befriended in Burzynski’s waiting room last year. She and her two teenage children had traveled to D.C. from Pennsylvania. Maria had an astrocytoma, a brain tumor that had gradually shrunk to a sliver after she went on antineoplastons. On my other side was a father from New Jersey whose 12-year old daughter had been diagnosed with a brain tumor. “Only a couple weeks after she started on antineoplastons she was out of the wheelchair!” he proudly reported to me.

The entire back row of the hearing room swarmed with cameras and reporters. Barton took his seat at the center of the panel and, in his soft drawl, described the hearing’s purpose and announced that FDA officials had turned down his invitation to testify.

Burzynski’s most vocal supporters then paraded in, taking their seats at the front, where they would, one by one, tell their stories. Over the past year I’d gotten to know them: the wealthy businessman and his wife who had transformed their dining room into pro-Burzynski headquarters after antineoplastons cured her of the same type of cancer I was battling; the mother who would bounce her toddler son on her knee as she spoke of how antineoplastons had dissolved his brain tumor; and the decorated policeman whose baby, one of twin girls, also experienced remission from a brain tumor after treatment with antineoplastons, only to die of brain damage caused by her previous long run of chemotherapy and radiation. They all spoke in quivering, choked-up voices, some with tears streaming down their cheeks. Finally the policeman’s remaining twin daughter, her long white-blond hair tied with a bow, asked into the microphone, “Why can’t we throw away the bad medicine and keep the good medicine?”

Anyone who’d ever had cancer or known anyone with cancer began to cry. Anyone who was a parent and could imagine having a child with cancer began to cry. The congresspeople shifted uncomfortably in their seats.

Except for a couple of reporters scribbling on steno pads, I was possibly the only person in the room with dry eyes. Maybe I was unaffected because I had heard the stories a dozen times. But more likely I didn’t cry because I was angry. I was angry that Burzynski’s patients had to keep resorting to tears to get heard. I was angry for all the time and energy I had devoted to fighting off the FDA rather than to getting better. But I was also angry for a reason I was just starting to uncover: that our problems with the FDA could be traced to Burzynski himself.

What I didn’t realize was the scope of our actions. We were affecting the course of alternative medicine as a whole, being used as a voice for the Access to Medical Treatment Act. Yes, I’d like to think every American should have the right to the treatment of his or her choice. Yet I can’t help but see my story as a cautionary tale. Had I only known then what I do now.

I first visited Burzynski’s privately owned clinic in Houston after top specialists at Stanford and Harvard gave me the same advice: Do nothing-a strategy called watch-and-wait. Chemotherapy doesn’t work against slow-growing tumors like mine, they said, and radiation would damage nearby organs. When the cancer’s growth speeded up-in a year, five years, 20 years, no one could say for sure–then a bone marrow transplant might be the route to take. But perhaps, they suggested, if I sat tight for a while, one of the exciting experimental drugs being tested by the FDA would be approved. Unfortunately, I couldn’t get into any of the clinical trials; those spots were reserved for people who had been failed by at least one method of mainstream treatment.

But, at age 21, waiting was not easy. It was unsettling to know I had cancer and was doing nothing about it. Out of frustration, my parents and I began researching alternative treatments, from massive doses of vitamin C to macrobiotic diets to the unproven regimens of doctors from Canada to Mexico.

Given Burzynski’s notoriety, it didn’t take long for us to come across the subject of antineoplastons. We sent away for Burzynski’s materials and also contacted the Lymphoma Research Foundation of America, which, after noting that many people at its support group meetings were Burzynski patients, had compiled a list of those willing to share their experiences. We tracked down a dozen who had used or were using his treatment for the same diagnosis as mine. Amazingly, all said taking antineoplastons had led to a significant decrease in tumor size if not a complete and lasting remission. Over and over they repeated ‘one word: nontoxic. Even if antineoplastons didn’t work for me, I concluded, they wouldn’t cause harm.

I consulted my oncologist, who, after reading the information I provided and speaking with colleagues, took a deep breath and said, “I understand how frustrated you must be and why you would like to try this. I wish there was something here I could offer you, but there isn’t. I can’t tell you to go to Houston, but there is nothing I can find that would make me say, ‘Don’t go.'”

The scientific evidence for and against antineoplastons was thin. Burzynski had written papers that detailed impressive-looking results in individual patients, but they hadn’t been published in major peer-reviewed journals. Other oncologists who had examined records of brain tumor patients treated with antineoplastons had seen enough to recommend research, but they had looked at only seven cases. (Single-case reports can’t fully account for the fact that some tumors may wax and wane even without treatment.) And then there were the troubles of which I was well aware: Burzynski’s history with the FDA.

Fifteen years ago the FDA sought and won an injunction to stop Burzynski from shipping an unapproved drug across state lines. Two years later the FDA raided his clinic, taking patients’ CAT scans, MRIs, and other records. Burzynski had subsequently appeared before three grand juries but hadn’t been indicted. However, problems with the FDA seemed almost standard for the alternative doctors I researched. Many had resorted to practicing in another country.

Burzynski described antineoplastons as a mixture of peptides and amino acids found naturally in blood and urine that could cure brain tumors, lymphomas, and several other types of cancer without serious side effects. The premise was that antineoplastons reprogram cancer cells by switching off the genes that instruct them to multiply out of control and by switching on the genes that tell the cells to self-destruct.

A Polish-trained physician, Burzynski began treating patients with his mixtures in 1977. Initially he developed antineoplastons using his own urine; eventually he had gallons of urine shipped from public urinals. By the time I visited him he’d treated a reported 2,000 patients and was making synthetic antineoplastons in his own lab in Texas. In most cases antineoplastons weren’t covered by insurance plans, so patients themselves paid the medical bills, which started around $200 a day. I was one of the lucky ones. My insurance agreed to pay half.

I spent most of my first day at Burzynski’s clinic sitting in the large waiting room with three dozen other cancer patients and their families. This waiting room was different from the many others I had visited. Most obvious, it was filled with reporters and TV news crews, their lights bombarding us all. Words were unnecessary, as the youngest children told the story of antineoplastons’ appeal best. The children were victims of mainstream medicine. They wore the tattoos of those failures clearly: half-shaven heads zigzagged with scars; swollen, steroidal faces; and weak, wheelchair-imprisoned bodies. Then the cameras shifted to the children who’d been taking antineoplastons for months or even years. With full heads of hair, they ran and laughed and played with the toys in the waiting room, all the while hooked up to IV bags of antineoplastons.

Another difference was that people talked. No one had spoken in the waiting rooms at Stanford or Harvard or any of the other oncology offices I’d visited. Yet here there was an immediate sense of comradeship, and the common bond, it seemed, was that we all had heard unfavorable prognoses, even death sentences, from mainstream doctors. We needed the support of others who had sought out Burzynski as a last shot.

“I was diagnosed eight weeks ago with a brain tumor,” Maria volunteered the first time I met her. “I was skiing, and I had a seizure right there on the slope.”

“I’m here with my sister, all the way from upstate New York,” an older woman said. “She has kidney cancer and is back with the nurses now. Dr. Burzynski said he didn’t know if the medicine would help.”

I spoke with a man, bald with pasty yellow skin, who’d been diagnosed with a lymphoma. “We followed the advice of the first doctor we saw, and he got a bone marrow transplant,” his wife explained. “But before he was even released from the hospital the lymphoma came back. The hospital just dismissed us. They said, ‘Well, we tried. Just go home and get your things in order.'” The wife was 28, the husband 30.

I cringed when a woman asked me outright, “What brings you here? What were you diagnosed with?” But looking around the room at the people chatting, exchanging phone numbers, making dinner plans, and hugging each other, I realized it was a question everyone asked and got asked. For families who were sacrificing savings, jobs, and even homes to pay for this treatment, the security of friendship was all they had left.

In the waiting room that first day, I scrawled my signature on numerous documents releasing Burzynski from responsibility for anything that might happen as a result of antineoplaston treatment.

When I was finally introduced to Burzynski, he gave me a squinty-eyed smile, the corners of his mouth stretching toward long sideburns. A short man with a heavy Polish accent and a tendency to mumble, he exuded friendliness as he studied my chart. “Usually this treatment has very good success with slow-growing non-Hodgkin’s lymphomas. Every four hours you would get a dosage of two types of antineoplastons. You would get a CAT scan after you had been on the treatment six weeks. The treatment would continue for four months after you have a clear scan because we need to ensure that all of the lymphoma is gone and will stay away.”

I had heard similar promises of a simple cure at other alternative clinics and had fled. Yet the words of the patients I’d spoken with before coming to Houston echoed in my head, compelling me to begin.

The following morning in another clinic, I had a semipermanent IV surgically inserted in one of my largest veins, directly above the heart. The slender white tube was held externally by two stitches and completely concealable under clothes. Back at Burzynski’s clinic I was ushered into a large room filled with leather recliners, a sort of classroom where patients were taught correct administration of antineoplastons. On one wall hung newspaper clippings about Burzynski, one describing how he was called during Jacqueline Kennedy Onassis’s final days of battling lymphoma.1 He was not allowed to bring antineoplastons to her bedside in New York, however, since the first civil trial had ruled he could practice the therapy in Texas only.

Despite the ruling, it was no secret that the majority of Burzynski’s patients were not from Texas. The clinic operated on a “don’t ask, don’t tell” basis. I gave a Texas address of distant cousins to whom my monthly supplies of antineoplastons would be mailed. My cousins would then ship them to me. Many patients had similar arrangements. Others restocked by flying to Texas frequently with several empty suitcases.

I received my pump, attached by thin translucent tubes to my first bags of medicine. The pump looked like an enlarged calculator with a number pad and a digital display. It fit snugly into a blue tote the size of a camera case. The nurse connected the medication to the catheter with a simple, painless twist, programmed the pump, and began infusion of the clear, sticky antineoplastons. Because of their urinelike composition, the medication smelled of an overused public toilet. As Burzynski had promised, I felt nothing as the drugs entered my system.

Over a few days at the clinic I learned how to connect and disconnect the IV bags, change the tubing, and set the pump. I also experienced my first side effects: I couldn’t eat because my stomach was churning, and I was too tired for anything much besides reading in bed. Finally a nurse gave me a shot of an anti-inflammatory steroid, told me my reactions were good-signs of “tumor breakdown”-and, with Burzynski’s consent, sent me home, where I returned to college for my senior year.2

Twelve weeks later my CAT scans revealed the first signs that the tumors had shrunk. I called everyone I knew, relaying the news as tears of relief dripped onto my IV bag. Each scan that followed showed more reduction, and by eight months my scans, read by my radiologist and oncologist in D.C., showed a 35 percent decrease.

Word from Burzynski’s office, though, was that my response was slow, and so I was instructed to increase my dosage steadily. I began feeling the toll: My joints hurt to the point that it was painful to bend, type, or write; I could hardly eat; and I often slept the entire day. Worse, though, was the thirst. No matter how much water I drank, I was always on the verge of dehydration. I complained to my oncologist about all the side effects, and she recorded them. I complained as well to Burzynski’s nurses who called each week to check up on me. They said they, too, were recording them. I didn’t mind that no one suggested remedies. The pain seemed small payment for steps closer and closer to a cure.

Then one day I got a call from someone on the phone chain set up by Burzynski patients, relaying the news of the doctor’s indictment. As I listened to the shaky, panicked voice, I sized up my dwindling supply of antineoplastons. It would last a few weeks. I hurriedly phoned the clinic, asking to have six months of medication reserved for me. The place was in disarray. Some staffers were reluctant to speak freely, fearful the phones were bugged. Newcomers were filling in for the usual receptionist who, after traumatic cross-examination during her grand jury testimony on Burzynski’s behalf, suffered a heart attack while driving home. Because of the commotion and demand, the clinic was allotting each patient a two-month supply of antineoplastons, which had to be picked up in person at the clinic in Houston.

“Only a two-month supply?” I pleaded. “It’s finally working, and that’s not enough.”

Even when a drug is backed by a large pharmaceutical company, the FDA approval process is arduous and expensive. Rather than “innocent until proven guilty,” the premise is essentially “ineffective until proven effective.” And effective means results within precise standards from several phases of trials determining a drug’s safety, whether it works in the test tube, then on animals, then on humans, and then the best possible protocol. Most trials eventually involve not just a drug company but doctors in multiple hospitals working together to test the drug on hundreds if not thousands of patients.

To the FDA, Burzynski was someone who had flouted this system, who by not collaborating with oncologists, a major medical center, or a drug company was refusing to play by the rules. After the injunction in 1983, Burzynski had applied to the FDA to begin clinical trials, but the agency said his application was incomplete. In 1989 Burzynski got the go-ahead for a clinical trial with breast cancer patients, but the FDA says he never submitted any data. Trials were approved again in 1993, this time testing brain tumor patients, but the agency says Burzynski refused to enroll enough patients and the trials were canceled. All the while, at his clinic, Burzynski continued to treat hundreds of patients at a time with antineoplastons.

Shipping an unapproved drug across state lines to patients who aren’t enrolled in a clinical trial is a federal offense. (States regulate medicine within their own borders.) After a decade of trying, the FDA had finally convinced a grand jury that Burzynski was doing just that.

The day after I received the call I skipped work and graduate school, and flew to Houston with my mom. We hauled cardboard boxes filled with IV bags of antineoplastons out of the clinic, into our rental car, and to UPS. Then we met up with the dozens of other patients who had dropped everything to come to Burzynski’s aid. We organized a picket for the following morning at the federal building in downtown Houston.

The wealthy businessman and his wife, the mother and her saved little boy, and the decorated policeman, as well as other patients, relatives, and friends, paraded around and around, shaking homemade signs and chanting, “FDA, go away! Let us live another day!” Parents pushed their-children in wheelchairs. The children chanted through puffed-up cheeks and waved signs as best they could with swollen hands.

Our efforts appeared to succeed, as the clinic stayed open. I returned to D.C., where Michele and I, along with lobbyists working on Burzynski’s behalf, took to Capitol Hill every week.

Now that I was being quoted in the press, I started receiving calls from members of Congress, reporters (from as far away as London), and even interested scientists. Some were anonymous tips on who our friends were on the Hill. But others wanted to keep me abreast of allegations against Burzynski that were surfacing. One caller had heard that Burzynski had been given an opportunity to affiliate with the prestigious M.D. Anderson Cancer Center in Houston but had balked. Another claimed that Burzynski’s annual take-home pay topped a million dollars.

As the charges multiplied, I asked Burzynski’s staff and the people leading our activist efforts for background information so I could accurately refute them. Had Burzynski refused help from a leading cancer center? Was he pocketing millions supplied by patients who had given up everything? But I was shunned. “You are beginning to remind us of E.,” I was told. E. had been blacklisted by the group for asking questions that leaned toward “the other side.”

Burzynski’s patience was waning, too. When a New York Times reporter asked him why a top medical journal had never published findings on his drugs, he responded, “To hell with them.” He went on to compare himself to Albert Einstein and Louis Pasteur and said, “[Treatments like mine] have never happened before in medical history, so if the New England Journal of Medicine refuses to publish my paper, why should I waste my time with these fools?”

There, in black and white, my doctor was admitting he’d lost interest in making his treatment more scientific. All this time I’d campaigned on Burzynski’s behalf, I had cast him as a victim of the FDA and its conventions. But now I wondered whether it was actually the other way around. Might Burzynski be getting in the way of science more than it was getting in his way?

Taking a chance on this insight, I telephoned acquaintances at the FDA. They said that in trying to set up clinical trials in 1993 Burzynski withheld information, was evasive and hard to work with, and had only six patients in the trial until a judge ordered him to enroll more. Their message: Your doctor is the one making it difficult. Then I phoned Burzynski’s clinic and spoke with the clinical trials director, Dean Mouscher. He had no medical training. After his father had become a patient of Burzynski’s for a brain tumor, Dean had felt the calling. “Do you know how much paperwork the FDA wanted?” he asked me. He explained how the agency kept asking for minuscule, nitpicky information, how the clinic would have had to hire extra help to meet the FDA’s demands, how it had a limited staff. He said the FDA also had to okay every new patient and was turning away people who needed treatment but didn’t fit the guidelines. Mouscher’s answer in effect confirmed the FDA’S view: The clinic wasn’t willing to follow the rules.

Still, our political efforts had shaken the FDA, and soon after Barton’s hearing the agency agreed to approve a new set of clinical trials on antineoplastons, enrolling each and every one of us-an unprecedented break with the usual practice of studying only patients who fit specific protocols.

But Burzynski was still facing trial on mail fraud charges. Ironically, as he was scheduled to appear in court for illegal shipment of antineoplastons, he was at the same time legally sending them to all 400 of his patients around the country as part of the FDA-sponsored trial.

As the court date neared, our campaign gained more momentum. Patients bought angel pins for “Dr. B.” and his staff to wear. TV news shows covered our effort. “If you convict the doctor,” asked Ted Koppel on “Nightline,” “are you sentencing his patients to death?”

Meanwhile, my side effects worsened. Burzynski’s staff of doctors continued to tell me my increasing pain wasn’t a sign of toxicity but was more “tumor breakdown,” evidence that the high doses were working. To assuage my pain, they filled me with prescription painkillers, steroids, and anti-inflammatory agents, toxic medications to counteract effects of the “nontoxic” treatment.

Nothing helped. I rarely slept since the medication forced me to get up nine or ten times a night to go to the bathroom. Because antineoplastons contain a lot of sodium, the more I upped my dosage, the more thirst became the center of my life. I would drink a gallon of water during the day and go through another gallon at night. And I was still thirsty.

My regular oncologist was also growing frustrated since she had no basis on which to judge my progress in conjunction with my increasing side effects. She didn’t know what to expect, what was typical, or how long to continue therapy before deeming it unsuccessful. Burzynski seldom had answers to these questions. Although the clinic’s nurses called me regularly (daily when the FDA tightened its reins), I was losing confidence that my reactions were being analyzed and compared with those of other patients.

Exasperated and unable to control my nausea, I found myself back in the office of the gastroenterologist who had originally diagnosed the lymphoma, begging for help. He immediately ordered biopsies, tests he said should have been required months before.

He was right. For what showed up in the biopsies was that the cancer cells had turned aggressive, spreading fast. From all my research, I knew what that meant: The lymphoma was now much more dangerous, but was also likely to respond to chemotherapy. In a couple of weeks I had stopped antineoplastons, moved to be closer to my parents, and, at Northwestern Memorial Hospital, begun six rounds of standard chemotherapy.

Standard. Just the word relaxed me. I snuggled into the comfortable arms of an established scientific therapy, where I was fully informed of my exact protocol, not to mention any and all anticipated effects gleaned from years of research and painstaking documentation.

People laugh when I tell them that despite losing my hair, chemotherapy was simple. Now I realize I was comparing the treatment to all I had been through while taking antineoplastons.

Though the chemotherapy was not completely effective, its failure finally made me eligible for a spot in a clinical trial on the promising treatment called monoclonal antibodies. The therapy was touted as a magic bullet, infusing human antibodies and doses of radiation directly to cancer cells, eliminating the toxicity and side effects that normally accompany cancer treatments. Conducted at Northwestern, this was just the sort of trial that the Stanford and Harvard specialists had advised me to watch-and-wait for.

Suddenly I was experiencing the drug development process as it was meant to be. At Northwestern I was grilled relentlessly on my symptoms, poked and prodded, and bombarded with tests. Yet after my experience with Burzynski I felt grateful to be monitored so closely. When the next patient complained of a side effect, I knew the doctor could research the exact day, the exact hour, I’d experienced the same problem. With Burzynski, the patient after me who complained of a side effect like mine was probably told: “It’s tumor breakdown.”

In two weeks the treatment was complete. A few months later I heard the words I’d waited three years for: “There is no sign of lymphoma anywhere.”

Burzynski’s criminal trial began in February 1997. The media, swamped the courthouse. Patients launched rounds of letter writing, took out huge newspaper advertisements, and raised hundreds of thousands of dollars for the legal defense. In May, when my local newspaper ran a photo of a smiling Burzynski trailed by the little boy who was saved, I knew without reading the story that Burzynski had been acquitted.

Two years have passed since I stopped using antineoplastons. I still catch my former doctor on television news and tabloid shows. He is always posed the same way, standing authoritatively next to MRI brain scans, pointing out the changes. First scan, deadly tumor. Second scan, after treatment, no tumor.

Every now and then a desperate patient sees my name in an old newspaper article and calls, seeking information about Burzynski, just as I had done with patients before me. I am never quite sure what to say. Such hope and yearning wait on the line, it is not right to squelch it. I think of Maria, who is still infusing antineoplastons for the remaining sliver of her brain tumor but who is alive and relatively active years past her prognosis for survival. This person on the phone does not have a brain tumor, though; she has ovarian cancer, something that Burzynski, I assume, would say he’s not sure antineoplastons can be effective on. But he’d be willing to try.

Willing to try. How can someone facing death disregard those words from a doctor? A part of me wants to tell the caller just to enjoy what’s left of her life, not to bother with long shots that might make those last months miserable and cost her family’s savings or her house. But I can’t say that. Even if the chance of antineoplastons working is one in 100, what if I’m discouraging that one?

My response would be so much simpler had Burzynski lived up to his responsibility as a scientist and healer by working with others to collect statistics on his medicine. But he didn’t.

After I discontinued his treatment, I requested that a copy of my records be sent to me. Flipping through page after page of recent daily entries, I read, “Condition unchanged… Patient doing well,” “Patient feels good.” I checked the name at the top; it was mine, although I couldn’t remember a single time in the past six months I had felt “good.”

The FDA released preliminary data from the clinical trial earlier this year showing that more than half of the treated patients had high levels of sodium in their blood. The condition may have contributed to seven deaths. Burzynski disputed the finding.

The wealthy businessman and his wife were among the patients at another congressional hearing this spring. This time they rallied passionately for the Access to Medical Treatment Act, which is currently being decided in Congress.

I can see both sides of the argument, for I have lived them. I believe in letting cancer patients try unproven treatments; had I been free to try monoclonal antibodies when I was first diagnosed, the lymphoma might have been wiped out in a few months rather than a few years. Yet when I look closer, the proposed law scares me. It means any doctor could claim to have a cure and prey on people desperately seeking help. It removes incentives for alternative doctors to conduct trials and contribute to science.3

I don’t know who’s right. But I do know that for 15 years the FDA and Burzynski have chased each other, spending precious time and money on legal battles rather than on contributing to science. Had everyone involved focused on what was truly important, antineoplaston therapy could have been proven or disproven as a viable treatment by now.

Instead, the cancer patient loses. And it shouldn’t take a brain surgeon, or an oncologist or the commissioner of the FDA to figure this out.

Footnotes:

  1. This article apparently appeared in a tabloid.  OnassisIf this in fact happened, unless the Clinic had specific permission to release patient information, this would seem to be a big violation of patient privacy. It strikes us much in the same way the Clinic ghoulishly latched onto the story of Brittney Maynard, a cancer patient who made national news after electing physician-assisted suicide. According to a report in USA Today on 14 February 1994, when asked if Jackie was taking alternative therapies (which she was known to be interested in) her spokesperson replied, “I don’t believe so. She has great confidence in her doctors.”
  2. Nurses at the Burzynski Clinic have said things like this for some time, apparently. According to a 2000 article in US News and World Report which covered the story of Burzynski Patient Andrea W., who had a different tumor:Over the following six weeks, [Andrea’s mother] says, her daughter suffered side effects ranging from disorientation and high fevers to constant thirst. She and her husband […] repeatedly complained to clinic personnel. Each time, she says, “the nurses were jubilant. They said this [side effect] was a sign the tumor was breaking up.”Andrea was dead within the week. Burzynski’s staff have been feeding people this line for decades: getting worse is getting better. See the cases of Evan WJustin BGeorgia MCody G,  Leslie S, Domenica P., and Chase S. Think of Amelia S. And then think of the nurse who told John D.:“[…] 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.”Now we can add Cari U. to this list of patients who were misled.
  3. This is precisely the problem with so-called “Right to Try” laws. One such law just passed in Texas this summer.

Again, and as always, special thanks to the skeptical research ninja whose tireless work has made this article possible.

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 Carol M.’s Story

As we prepare for Burzynski’s upcoming hearing in front of the Texas Medical Board in November, and anticipating that people who happen to have survived Burzynski’s and support him unquestioningly will rally for him as they have in the past, we are telling the stories of patients who have supported him in court, in the political arena, and in the media to find out what happens to patients who defend him. So far we have written about Burzynski patient Elke B., Burzynski patient Douglas W.Burzynski patient Janet C.Burzynski patient Sen. Ed G., McKenzie L, and Alice C. 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.

In September 2011, Carol M. was diagnosed with stage IV, triple negative, inflammatory breast cancer. This is a very bad diagnosis, and the median survival time for patients diagnosed with stage four IBC cancer, according to the American Cancer Society, is about 21 months, which means half of patients live 21 months past diagnosis. The “triple-negative” means that the tumor will not respond to receptor targeted treatments, though it is responsive to other chemotherapy. It’s aggressive and very likely to recur.

As Carol tells the story on April 25, 2012, because she had a younger relative die the previous year of the same disease:

[W]e decided to look for a treatment other than the traditional protocols. A friend recommended Suzanne Somers’ book, Knockout, and, with no other treatment beforehand, we went straight to the Burzynski Clinic. I feel kind of like a poster child for Dr. B.’s Clinic.

She also watched Eric Merola’s uncritical patient exploitation film, Burzynski: Cancer is a Serious Business, which is staggeringly unconvincing to experts, but is eagerly received by the desperate. Suzanne Somers’ medical advice is absurd and dangerous.

As stage IV suggests, by the time the cancer was detected, it had spread through her body. Later we hear that she is watching a large tumor in her breast, two lymph nodes, a tumor in her abdomen, and one on her rib.

In October 2011, Carol is in Houston at the Burzynski Clinic. The regimen she describes is what the clinic sells as “gene-targeted therapy,” but is basically just an untested chemo cocktail with a sodium phenylbuterate chaser. This is the same witch’s brew that was recommended by the Burzynski boys to 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.

We don’t hear what chemotherapies she is using. Breast cancer patient Denise D. ( a truly heartbreaking story) was on Xometa, Xeloda, Zolinza, Tarceva. Real drugs. So maybe we should not be completely surprised that after two months of chemotherapy, in December of 2012, the tumor is responding. A few of the tumors are not visible and there no new nodules on her scan. This is not a miracle; this is chemotherapy.

She signed a petition on Burzynski’s behalf in March, where she describes herself as “stable.”

In June, she reports she is in remission:

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Of course, she has been on chemotherapy, so I don’t know why she is giving Burzynski undue credit.

Then in July, something ominous. Absolutely no details, however:

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On July 30, bad news.

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Carol M. died on Jan 22, 2013, about 16 months out from diagnosis, about five months short of the median survival.

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