*An appeal to encourage Congress to investigate this follows Claire’s story*
Claire F., mother of two, was diagnosed with invasive ductal carcinoma in May 2007 and underwent the underwent a normal course of therapy in the UK, surgery and chemotherapy. In January 2008, she was found to be in remission. She started dating and fell in love with “C,” an old friend. On Christmas 2009, C. proposed. They booked a church and planned to marry on her 40th birthday in October. In May, however, a lump appeared in her neck. She tells the story on her website:
My GP put me on antibiotics, thinking the lymph nodes had probably come up due to a cold I had. Unfortunately, the antibiotics didn’t do anything, so I was once again referred to the breast clinic. Another painful biopsy was performed on my neck the very next day. The results of this showed the cancer had returned to my lymph nodes. I had an operation a week later to remove the lymph nodes in my neck. Unfortunately, one of them couldn’t be removed because it is attached to my jugular. Removing it would have caused me to bleed out. A few days after the surgery I had routine CT and bone scans to check for any spread of disease. The scans showed the cancer had spread to my spine and my right lung, as well as my neck. I was told I would be lucky to survive the next five years. I have been back on chemotherapy since July of this year . They’ve put me on oral chemo this time, which I can take at home and the side effects aren’t too bad.
Claire and C. went forward with planning the wedding and held it as planned, Claire taking a break from her chemotherapy so that she would be at her best that day. The next day, however, they got her scans from an previous test and learned the cancer had spread. She was on a new treatment but looking ahead:
My Mum has recently heard about a doctor in Houston, Texas, Dr Stanislaw Burzynski, who has been conducting clinical trials into gene therapy for over 30 years and how it can treat cancer without causing the unwanted side effects of chemotherapy. Gene therapy is apparently the way forward in treating, sometimes completely eradicating, cancer cells. My husband and parents are of the opinion that we must try everything possible, otherwise we would never forgive ourselves for not giving it a go. This treatment is groundbreaking but unfortunately very expensive.
We have estimated the costs for treatment, travel and accommodation to be in the region of a staggering $100,000 (approximately £65,000). As none of us have this amount of money to hand, we are planning all sorts of fundraising events. So far, my Mum has managed to raise around £15,000 from family donations, which is amazing and is enough to get me and my Dad to Texas, pay for our accommodation and have all the initial tests and treatments out there. We have to stay there for up to a month the first time we go, hence the costs. [C.] and my Mum will stay home to look after the girls.
A major reason we are writing this site is that these patients don’t fall into the trap that the Burzynski Research Institute’s antineoplaston trials are anything like respectable. Antineoplaston therapy is no more gene therapy than is eating a banana. It is at this point that Claire is at her most vulnerable. She has been given 5 years at the most to live, has two girls, and is just married. She deserved to participate in a legitimate clinical trial that had a chance of prolonging her life. The Burzynski trials were appalling parodies of the scientific investigation, ones that seemed designed to rope in as many paying patients as possible. In a recent site inspection following the death of a child, the FDA made the following observations:
Among the newly released observations by FDA inspectors:
- 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.
- Additionally, some patients admitted failed to meet the inclusion criteria for the study.
- 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.
- 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.
- 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.
- “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.
- 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.)
- 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.
- The clinic was unable to account for its stock of antineoplastons.
To summarize. The FDA observed that Burzynski’s success rate was inflated, crucial patient records had been destroyed (as far as we can tell, rendering all of his trials completely unverifiable and unpublishable–if Claire was indeed on a trial, her case would not count toward the scientific understanding of antineoplastons, a costly betrayal), that there were numerous serious toxic events, many of which went unreported for long periods of time, that patients were denied informed consent, that paying patients were allowed on the studies who shouldn’t have been included and that patients who should have been dropped were kept on longer than they should have been, and that Burzynski had violated his own protocol.
On Dec 14 of 2010, we hear from her on her webpage:
Thanks for all the well wishes over the last few days. I got my scan results today. They show that the combination chemo drugs haven’t succeeded in shrinking my tumours. My spine is still stabilised, but the neck & lung lesions have grown slightly (again). So, I am going to be put on a different chemo regime, this one is called Gem-Carbo and it’s intravenous, rather than oral treatment. I’m hoping to start this before Christmas. Next week, I’m going to be having daily radiotherapy to my neck to shrink the lymph node that’s been left there, as it’s now giving me some discomfort. The plus side is that my liver and all my other major organs are clear. My oncologist is referring me to see a doctor in Charing Cross hospital, who is aware of the doctor in Houston and his gene therapy treatments. This will arm me with much more information before I head off to Texas. Could be better news, but it could also be so much worse! Xxx
Her radiation treatment is intense and knocks her down a little. Then, right at the end of the year we hear:
The original plan was for me to travel to Texas yesterday, but a couple of weeks ago, my oncologist sent a referral for me to see a professor at the Charing Cross Hospital in London. There are links between Dr. Burzynski in Texas and the Charing Cross Hospital, so my doctor thinks it makes sense for me to see the guy in London and get armed with as much information as possible, before flying out there. My Mum has also recently discovered that there is a clinic in Zurich, Switzerland, which has doctors working under Dr. Burzynski’s guidelines. I am still waiting for the London appointment to come through. As soon as it does, we will know exactly where I’m going and when, but please rest assured that all the money which has been so generously donated will go directly towards my treatment. If I’m able to go to Zurich instead of Texas, the money we’ll save on travel and accommodation will probably pay for at least an extra month’s worth of treatment, which is fantastic. Better still, I won’t have to be so far away from my husband and children for so long!
This is unusual. This is the first we’ve heard of a Zurich clinic. Nonetheless, Claire’s oncologist is mistaken. The physician, Professor Coombes, it turns out, does not have ties with Burzynski, but with a reputable research institution in Houston, MD Anderson, as we hear on Jan 18th:
Just to fill you all in on Friday’s appointment. It didn’t go as well as we hoped it would, because Professor Coombes is linked to another clinic in Texas, the M.D.Anderson Clinic, as opposed to the Burzynski Clinic which we were hoping to get more information on. Having researched Dr Burzynski more over the weekend, the plan is still to visit him to see what he can do for me. His work is still in the clinical trials stage, which is why he’s not known worldwide (and why it’s so flipping expensive!). I feel a little bit deflated about this, but we’re still going to go ahead. We have to try everything that’s out there. [C.] has been in touch with some patients of his who absolutely swear by his work.
And the Burzynski Patient Group rears its ugly head, pulling another desperate family into Burzynski’s clutches. In all the years he’s been in “clinical trials” he should have been able to produce a single finished, published, credible study. Claire deserved better. She deserved MD Anderson. On the 2nd of February, she has her Hickman line put into her chest, which is how her antineoplastons will be administered. The traditional chemo is having a positive effect, however, as we hear on March 4th:
Just got back from my results appointment and the news is good! The tumours in my spine and my neck have stabilised, my brain is clear, I have no new disease anywhere else in my body, the new swelling in my neck is muscle damage from having the hickman line put in (which can be treated with physio) and the best news of all is…. the tumour on my lung has shrunk by 1cm!!! This all means that the new treatment is working and I’m raring to go ahead with the next dose tomorrow. I don’t care how crap it makes me feel, it’s working, WOOHOOO!!!! My Mum was crying her eyes out, God love her. The next step is to go and see Professor Coombes again in London, then it’s Texas, here we come!! Thanks to all of you for the thoughts and prayers, they’re obviously working too! xxx
In the meantime, her family and friends are raising money for Burzynski like crazy. By June, however, she still hadn’t gone out to Texas. She is facing some infection issues and she gets violently ill when she starts Taxol, as we hear on June 13:
[C.] contacted the clinic in Texas, just to make sure I can have their treatment whilst on chemo and I can! So I started the taxol today. I feel fine at the moment, just very tired.
Interesting. How would you be able to sort the effects of the chemotherapy from any result the ANP would have? (Answer: you can’t. Worst researcher ever.) She returns from the hospital on July 1. As Claire said:
Two weeks ago, I didn’t even have enough energy to lift my head from my pillow and the team have really got on top of my pain management. So, I am now pain and sickness free and [C.] and I have been looking into leaving for Texas in two weeks’ time. Flights, car, accommodation and, most importantly, the Burzynski Clinic are all ready for us. The clinic have had all of my medical notes and have said I am eligible for their treatment. All I have to do now is convince Dr. Shah to reinstate my fit to fly letter and get some insurance, then we’re off! I’d like to say a massive thank you to all of you for the donations and lovely messages I’ve received over the last few weeks. I’m completely overwhelmed by this and the support it has given me has been tremendous for my emotional wellbeing. Most of all, I’d like to thank [a friend] and my parents for looking after me, my children & my blog (!) and for pulling out all the stops to arrange this potentially life saving trip, whilst keeping a bedside vigil for me.
Claire and her husband meet Burzynski on July 18th:
We had our first appointment at the Burzynski Clinic today and got to meet Dr. Burzynski himself, which was a real honour. Today’s appointment was for consultations with the doctors, blood tests and a meeting with the financial team. […] The next step is for me to have full body PET and CT scans. These will take place either on Tuesday or Thursday of this week. In the meantime, I am going to be started on tablets tomorrow (tuesday), which are a form of gene therapy. We will also be meeting a nutritional specialist, who will give me a list of what I should and shouldn’t eat whilst on the treatment. I’ve already been told today to avoid sugar, bread, pasta and rice… some of my favourite things! That’s you all up to date for now.
On the 23rd we hear:
After taking just 2 doses of the antineoplaston medicine, I spent all of Wednesday night being violently sick and ended up being carted off in an ambulance during the early hours of thursday with ridiculously high blood pressure and pulse rate. The staff at the emergency room were amazing and they gave me an anti-sickness drug and morphine for the pain. Then they hooked me up to a saline drip for a couple of hours to rehydrate me. I felt better in no time, just very tired and weak. We were handed a bill for $1,250 and put in a taxi back to our hotel. Thank God I took out that insurance policy, hopefully we’ll be able to claim most of this cost back when we get home. Thursday was a write off as I spent most of the day trying to catch up on sleep. I missed my appointment at the Burzynski clinic because of it. [C.] phoned the doctor there and they’ve re-schelduled [sic] my appointment for Monday, giving me the weekend to completely recover from the sickness. Needless to say, I’m not taking the antineoplaston doses for now.
It’s hard to tell what treatment she is on, honestly. She was on “pills” which suggests she is on sodium phenylbutyrate, but she seems to think that it is antineoplaston (PB is a prodrug for the components in ANP). She has been given a liquid form of it, however. The tumor in her neck was pressing up against her vocal cords, and it seems likely that her swallowing is problematic. It does not sound like she is on a clinical trial. You will notice the huge range of side effects that she is suffering, including high blood pressure and tachycardia–these could be direct results of the massive sodium load that Burzynski’s patients have to carry, which can lead to hypernatremia.
The Clinic starts her on Herceptin and Avastin, both common breast cancer drugs. It sounds like she is taking the chemo cocktail route, wherein chemotherapies that have not been tested together are administered to patients. Burzynski sells this as “gene-targeted therapy.”
On July 18th, Claire’s husband notes what is happening:
Time is passing by, we’ve been here for over a week already and we’ve still yet to get Claire started on any treatment that she can tolerate and give us a plan of action to take back to the United Kingdom to present to our Doctors.
The three drugs that have been proposed by the clinic total at $13,825 per month which works out at roughly £8,413 back home.
Once Claire has been cleared to start this treatment we are hoping to get at least two weeks worth here before returning home and then looking to continue the treatment with the NHS and the clinic working together.
Dr.Rakhmanov ( in charge of Claire ) has already said that he will personally fax the plan of action to Claire’s oncologist and does not believe that Claire should have any problems being treated with two of the three proposed drugs, he does however feel that one of them may be controversial but we will have to deal with that if and when it happens.
Of course, the NHS decides that it will not foot the bill, which means more fundraising. On the 14th of August, we hear about her progress, as she is back home in the UK. She’s had it tough:
On Monday of this week, I had my discharge appointment at the Burzynski Clinic. When we arrived there I was in terrible pain on the right hand side of my back, the pain was so bad that I was in tears and quite short of breath. The nurses saw I was distressed and took me to another room to be put on oxygen. This really helped and I felt better in no time. We had the discharge appt, settled our bill for all the drugs/assistance we’d had so far, had our photo taken with Dr. Burzynski and left the clinic.
That photo was posted on her webpage:
She goes on:
Half way though the flight, I started to get the same back pain I’d had on Monday. Remembering oxygen had helped me then, I asked the stewardess for some. She obliged and I soon got a little audience! But I didn’t care, it was making me feel better.
That Friday, back home, she got up to answer the door and passed out. After she started coughing up blood, her family took her to the hospital, where she was diagnosed with pneumonia. She was in the hospital until the 28th, and then when she came home, she was leveled by a hospital acquired infection.
On 21 September, Claire died. Burzynski’s treatment does not appear to have done anything, but he got his cut.
Usually, this is where we would put an appeal to donate to St. Jude’s. You may still do that, if you like, but we are now actively campaigning for an investigation into how the FDA decided to allow Burzynski not only to continue his ridiculous trials, but to actually get a phase III trial after a decade of abominable site visits. Go to thehoustoncancerquack.com and you will find the resources you need to put primary documents–the FDA inspection notes–into the hands of your representatives so they can conduct an investigation. All appeals to understand this made to the FDA have failed, so now we need to press the issue onto the committees that oversee the FDA. Please help us uncover what went wrong so we can fix it and this never happens again.