Non-humanities post here.
One of my vast network of informants has fed me the following CaringBridge update from a Burzynski patient that she is monitoring:
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. I 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. I do not know when the new patients will be allowed again or if any restrictions on current patients will also follow. 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. Apparently, a person who monitors the medicine production had a serious medical emergency. This, along with the FDA auditing has us a little on edge waiting to see how it all plays out. 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.
In the last month, the clinic removed all mention of ANP from their website, and we did not know why. This might explain it. I am nauseated at the thought that their drug out-and-out killed a patient.
Also, it sure looks like they are shipping ANP across state lines, doesn’t it? Looks like the FDA had a birthday present for ol’ Stan too.