Seems like a wishful dream. After over 35 years, could the world finally be rid of The Burzyński Clinic’s use of antineoplastons?
Well, there does appear to be cause for optimism.
Antineoplastons (ANP) are at best an unproven cancer treatment. ANP therapy is not licensed as a cancer treatment by the US Food and Drug Administration (FDA), so the Burzynski Clinic offers treatment only as part of a clinical trial. However, patients have to pay many tens of thousands of dollars for the privilege of being on the trial – a highly unusual situation in clinical research.
Furthermore, the scientific community expects the results of clinical trials to be published in the medical literature. So far, Burzynski’s team have not published any results since 2006, which raises questions about exactly what kind of clinical trials they are running, and when we might expect to see the detailed analysis of their results.
Recently bloggers were left puzzled by the removal of references to Antineoplastons from the Burzyński Clinic website. This may go someway to explaining why.
Protect the Patient
Firstly, thanks must go to MedTek on twitter for finding this information. In an unusual step, I won’t be providing a direct link to the source. This is because the source is that of a ‘journal’ run by the parents of a young girl undergoing treatment. I see no value in naming the parents or child involved. Their plight, while directly effected, doesn’t lend any value to points below. You’re free to contact me if you feel this isn’t a good enough reason and I’ll explain in more detail.
You can, however, see an edited screenshot on Josephine Jones’ site.
A post on the site gave us some potential good news, along with some horrific news.
In the most recent entry to the site, posted on 6th February 2013, the parents provide some insight into the goings-on at the Burzyński Clinic.
They make mention of a current audit by the FDA at the clinic:
“The Burzynski Clinic is going through some issues right now. They are in the process of getting audited for the past month by the FDA. The FDA has also gotten approved to continue their audit for another month.”
This is an interesting development. Along with a recent FDA warning letter, asking for the removal of promotional information relating to Antineoplastons, this may go so way to explaining the sudden disappearance of the therapy from their site.
No more admission
They continue with some insight into recent patient admittance to ANP trials:
” believe it was August, the FDA stopped new pediatric patients because a child had went into a tumor related coma and did not get enough water during treatment, thus spiking the sodium level to a fatal level. Now, in January, for reasons unknown to me, the FDA has suspended new adult patients from the ANP as well.”
If true, this is both good news, with the suspension of all new patient admissions, both paediatric and now adult, but also terrible news, as a poor child didn’t get enough water during treatment and died. How a child could be allowed to die of dehydration is beyond me. This seems to demonstrate a complete lack of patient supervision during a critical time in treatment.
Though the reasons for suspension of clinical trails maybe various, the death of a child is not the way anyone wants to get there.
End to the production of ANP?
It would also appear that the clinic may feel the end is near for the production of ANP:
“Friday, the Burzynski Clinic shipped us 3 months of ANP, where they normally only ship 2 weeks. They are being proactive and making sure we have the meds she needs just in case any medicine production is stopped.”
While the journal claims the person in charge of production has had a “serious medical emergency”, it seems unlikely that only one person would be responsible for this. For example, this one person probably takes holidays or is susceptible to a serious medical emergency! It seems more likely that they are being cautious and ensuring patients get their doses.
Phase III Trials
The last section of the journal seems a little bizarre:
“Even though this is bad news for the clinic, there is silver lining because when this is finished, the clinic should be moving into Phase 3 of the clinical trail and hospitals and doctors should be able to start prescribing the ANP and doing clinical trials of their own. To my knowledge, Dr. Burzynski has the only medicine not sponsored or picked up by a pharma company. I think that’s why things don’t work like they do for normal drug approval.”
The parents seem to have been sold the notion that Phase III trails are imminent and that the treatment of their daughter will lead directly to this. I don’t think this seems all that plausible. It strikes me as an unethical sales technique.
They appear unaware of the process for FDA approval and trial registration regulations. They speculate that because Dr. Burzyński’s treatment hasn’t been “picked up by a pharma company” that this is the reason it’s approval process being different. This of course, is not true. The treatment, despite many attempts by others, has never proven to be a viable cancer cure, thus will never be “picked up by a big pharma company”.
It’s a real shame and I do feel truly sorry for these parents. They’ve bought all that they’ve been told and clearly believe this will be the miraculous cure they’ve been looking for. I wish them and their beautiful daughter all the luck in the world.
So, if true, some interesting developments coming out of Texas. We wait to hear if any other information is forthcoming from any other sources. It would be fantastic news, indeed.
I do advise the relevant caution. This is one source. Not verified and with no reference. We await more information.
I have emailed both the FDA and the Burzyński Clinic this morning, asking for clarification regarding these issues. I will update you if I hear anything.