FDA delays-denies accelerated approval of antineoplastons

[Guest guest]

December 20, 2011Dear Burzynski Movie subscribers,I have received a lot of emails expressing confusion about the White House’s “response†to our petition. I thought I’d outline their underhanded strategy for you in this email. This entire email will also be posted as permanent record on the film’s website here.My petition to the White House [1] was presented as this:“Antineoplastons are gene-targeted cancer medications that have completed Phase 2 FDA clinical trials in 2009, with permission granted to enter the final Phase of FDA testing. These medicines are the first in medical history to cure inoperable childhood brainstem glioma with a 27.5%-50% cure rate, among other cures. Other gene-targeted cancer medications have been given accelerated FDA-approval without demonstrating a single cure. Antineoplastons, proven to be non-toxic, remain unapproved for public use. For the sake of public health, the results from Phase 2 clinical trials of Antineoplastons need to be publicly acknowledged by the FDA and audited by Congress. These medicines have been in FDA clinical testing since 1995—it's time for the general public to have access to them.â€The White House itself did not respond to the petition, they instead asked the FDA to respond. Not only that, the FDA did not address or respond to the petition itself at all. The entire point of petitioning the White House was to petition the White House. If we wanted to petition the FDA, we would have done that (we didn't do that because we understand that the FDA is a part of the problem). I specifically asked within the petition: "For the sake of public health, the results from Phase 2 clinical trials of Antineoplastons need to be publicly acknowledged by the FDA and audited by Congress." I worded this very specifically to have the results publicly acknowledged. It makes sense for the FDA to not want this data publicly acknowledged by Congress, because if they did this—the American public and the rest of the world would be furious to find out that nothing is being done about a cancer treatment that has been consistently curing certain types of cancer within Phase 2 FDA clinical trials that have verifiably never before been cured before in the history of medicine. FDA (Janet Woodcock) petition response Part 1: Thank you for your petition asking the Obama Administration to accelerate the approval of antineoplastons for the treatment of cancer.My response: Thanks, but no thanks Ms. Woodcock, you failed to address anything that the petition was related to and why it was drafted in the first place. For the sake of this petition response, and it’s purpose, I will be addressing only “childhood diffuse intrinsic brainstem gliomaâ€, as the petition itself stated, in regards to the accelerated approval of antineoplastons.FDA petition (Janet Woodcock) response Part 2: As you know, cancer treatments go through a careful research process to prove that they are safe and effective. The National Cancer Institute (NCI) has recommended that controlled clinical studies be conducted in order to assess the safety and efficacy of the therapy. To date no randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals nor have all of the trials needed to approve antineoplastons as a treatment for cancer been conducted.My response: This is where the FDA uses complicated language to try to fool the uneducated citizen. Ms. Woodcock states, “To date no randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals nor have all of the trials needed to approve antineoplastons as a treatment for cancer been conducted.†To the average citizen not familiar with the drug approval process in the USA, Woodcock tries to make it sound as if antineoplastons have never undergone any clinical trials, and if a substance has not undergone any clinical trials, there can't be anything in the peer-reviewed literature showing their safety or effectiveness.For those that do not understand, a “randomized, controlled clinical trial†is what “Phase 3 trials†are. They are called “randomized†because the patents are sadly placed “randomly†into one of two groups of patients in this clinical trial. The first group consists of the “standard of care groupâ€. In this case, the “standard of care†group for this type of brainstem glioma is “radiation only†(since there has not been any medicines to show enough safety and efficacy to ever be approved for brainstem glioma in children—nor has any substance in history ever shown enough safety and efficacy to have ever been granted randomized trials in medical history for this type of tumor—the only “standard of care†available for it is “radiationâ€). The second group is the “new medicine on trialâ€. The FDA then compares the results of the “new medicine group†to the existing “standard of care†group. If the “new medicine group†fares better than the “standard of care†group, and also shows less side effects, then the FDA will then grant that new medicine approval for market. [2]So, to say “no randomized trials have been conducted†makes the reader believe that the FDA has not overseen any testing whatsoever regarding this therapy. This is entirely untrue. The FDA has supervised and authorized Phase 2 trials of antineoplastons for nearly two decades, and they have since granted permission for “randomized controlled clinical trials†of antineoplastons in 2009 for childhood diffuse intrinsic brainstem glioma. > [23] <- Don't miss reviewing this source ;)The FDA knows this, and this was not what the purpose of the petition was about. It’s purpose was to tell the FDA that we want the results of the Phase 2 clinical trials audited by Congress and to then share with the world the results from the Phase 2 clinical trials, which show that antineoplastons are the first substances in history to have ever cured this type of tumor—ever—with a minimum 30% overall cure rate.It’s not like this information is secret, you can see from the following sources for yourself the results from antineoplastons’ Phase 2 trials for this cancer type—we just want these results publicly acknowledged by Congress and announced for the world to know and understand:2007 [3]: http://www.cancer-therapy.org/CT/v5/B/PDF/42._Burzynski,_379-390.pdf2006 [4]: http://www.ncbi.nlm.nih.gov/pubmed/16484713?dopt=Abstract2003 [5]: http://www.ncbi.nlm.nih.gov/pubmed/12718563?dopt=AbstractIt is also public record that no other treatment in history has ever cured this type of cancer:2008 [6]: http://www.ncbi.nlm.nih.gov/pubmed/172781212005 [7]: http://www.ncbi.nlm.nih.gov/pubmed/15565574Another element that the FDA does not want the public to know is this: Since antineoplastons were granted “randomized trials using antineoplastons for brainstem glioma†in 2009, the FDA is forcing these children to also undergo radiation in addition to antineoplastons in these new "randomized trials" within the "new medicine group", which means all of these children will be deaf, have their pituitary glands destroyed (which will stunt their growth permanently), and will also likely make them a non-functioning bed-ridden vegetable. Another thing the FDA would not like you to know is this: No hospital in the USA is allowing these Phase 3 antineoplaston "randomized" trials to be conducted, because they know they will never accrue a single patient due to radiation being forced into the "new medicine group". [23] What parent would put their child through that? Would you? [24] The FDA knew exactly what they were doing when they were forced to grant antineoplastons their first “randomized controlled trialâ€â€”the FDA knows that forcing the kids to simultaneously receive radiation in addition to antineoplastons in the "new medicine group" would halt the trial from even starting at all. The FDA's mafioso tactics in this case has once again proven successful in their efforts to keep antineoplastons from reaching the market—in turn preventing the public from having full access to them. The FDA does not at all care that the therapy has cured an upward of 30% of patients treated of this disease without the inclusion of radiation. So, in an apparent effort to thwart the success of antineoplastons in Phase 3 randomized trials, the FDA is mandating radiation into the "new medicine group", even though they know what it will do to these children, and even though they know radiation is not necessary to cure any of these kids while using antineoplastons. Their very own data shows it. They verified it. It was the FDA’s own data that proved antineoplastons to be safe and effective enough to be granted “randomized phase 3 trialsâ€. [23]In summary, it has been proven impossible to conduct Phase 3 randomized trials of "childhood brainstem glioma" due to the FDA forcing all kids who undergo this therapy to have their brains fried by radiation treatment at the same time. Even if 30% of the kids are cured, they will be deaf, they will be stuck in the body of whatever age they started treatment, and they will likely be an non-functioning vegetable for the rest of their life. Does this sound like an agency that is looking out for the health and well-being of its public? Or does this sound like an agency that doesn't want to see this medicine available to the public? This is the reason I started this petition, and no other. We want the world to know what the verified cure rate is for antineoplastons in this type of cancer, to help the world understand, and to make sure they are eventually granted accelerated approval. Accelerated approval is our only option, since "phase 3 randomized trials" are impossible to conduct due to the FDA's barbaric radiation mandate. So, you might be asking, “what is accelerated approval?" Accelerated approval was something that Dr. A. Kessler [8 (timecode 4:18-6:14)] started in 1996 under the idea of pushing important drugs through without them having to be subjected to “phase 3/randomized trials†in the name of “public healthâ€. This was specifically for drugs that show promise for diseases that have no good or any existing treatments for them. What could be more fitting for this than “brainstem glioma†in children? There is no medicine on the market at all for this treatment, only radiation. The FDA doesn’t care that antineoplastons are the first to cure it. And frankly, it seems it is out of their control anyway since over 50% of their drug evaluation money comes from PhRMA thanks to the drug user fee act of 1992 [9]. If PhRMA has the ability to push unsafe and ineffective drugs through accelerated approval in the name of profit, what will stop them from preventing a competing medicine like antineoplastons from getting a fair chance in the testing process? I appears that we are witnessing exactly that—right now before our eyes—we are witnessing the "privatization" of our federal government agency: The Food & Drug Administration.

Let’s take a quick look at some of the cancer medicines recently given "accelerated approval" by the FDA:

Avastin (breast cancer) 2008: The FDA granted accelerated approval for Avastin in the treatment of advanced breast cancer in 2008. The results that allowed it to be “acceleratedâ€: Only 11.3 months of “Progression-free survivalâ€. [10]The FDA took it off the market for this condition in November 2011 because it doesn’t work at all if not properly prescribed [11] (or at least for the oncological world who simply does not understand how to prescribe this gene-targeted medicine—which is pretty much all of them). But don’t feel bad for the company that owns it, they made their fortune from it already for this condition, making up for 17% of the entire company's sales. [12]Avastin (Glioblastoma brain cancer) 2009: The FDA granted accelerated approval for this medicine for Glioblastoma. The FDA’s reasoning was “People with this type of brain cancer have had no new treatments in more than a decadeâ€. [13] Well, what about “brainstem glioma†patients? They haven’t had a new treatment for that condition—ever. But it gets better. Only 58 patients were treated in a single Phase 2 study. The median “response duration†was a mere 3.9 months. That is a “responseâ€, not a cure, or even any real extension of life at all. Antineoplastons have a 30% cure rate in "brainstem glioma", not a “response rateâ€. During this single Phase 2 arm of 58 patients that got Avastin accelerated approval for Glioblastoma—none of them were cured. Avastin is a gene-targeted therapy, which can only target certain specific genes. Oncologists do not test the patient to even see if they have these genes. Dr. Burzynski does, as demonstrated in this short film here. [14]Antineoplastons have an upward of a 9% cure rate for Glioblastoma. [15] [16] [17] Most of the public could care less about “response ratesâ€â€”they want to see actual cures. But, if “response rates†are important, how about the total of 368 patients treated with antineoplastons in Phase 2 trials for Glioblastoma where 40.5% of them had a stable disease? [15] That is of course if we care about “response†vs. “cureâ€.Temodar (Anaplastic Astrocytoma brain cancer) 1999: In 1999, the FDA granted accelerated approval for Temodar for Anaplastic Astrocytoma brain cancer. Only 12 of 54 patients “respondedâ€, with only 9% of them being “cured†[18]. As the film shows [19], Antineoplastons have a 25% cure rate for this condition. [20] And, unlike Temodar which is a poisonous chemotherapy—the 25% of patients cured of Anaplastic Astrocytoma using Antineoplastons can actually one day have children. Like most toxic chemotherapies, Temodar impairs or destroys a person’s ability to remain fertile, among other hideous side effects. [21] Again, what about the 30% cure rate for “brainstem gliomaâ€? Why does Temodar get favored for accelerated approval based on inferior 9% results in their Phase 2 trials?Afinitor (ubependymal giant cell astrocytoma (SEGA) brain tumor): In 2010, the FDA granted accelerated approval for Afinitor after a single Phase 2 study of only 28 patients. 32% of the patients experienced a 50% reduction of their tumor, none of their tumors went away completely. [22]

FDA (Janet Woodcock) response Part 3: The timely review and approval of safe and effective new treatments are central to the U.S. Food and Drug Administration's (FDA) mission to protect and promote the public health. In fact, over the past 12 months, FDA approved 35 new medicines, including three cancer drugs that were approved in less than six months. This is among the highest number of approvals in the past decade. Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin's lymphoma in 30 years; and the first new drug for lupus in 50 years. The approvals came while drug safety standards have been maintained.

My response: To say “The timely review and approval of safe and effective new treatments are central to the U.S. Food and Drug Administration's (FDA) mission to protect and promote the public health,†is simply not true based on their response to this White House petition. Perhaps that means all of the public except those children who are unlucky enough to be diagnosed with brainstem glioma. Perhaps those kids do not matter to the FDA or qualify as “the publicâ€. Then to go on and boast about their 35 new approved cancer drugs in only 12 months, I can’t think of a bigger slap in the face to the “public health†of the American people on behalf of our newly privatized FDA.FDA petition (Janet Woodcock) response Part 4: A report released last month by FDA, FY 2011 Innovative Drug Approvals, shows faster approval times in the United States when compared to the FDA's counterparts around the globe. Of the 35 approvals in FY 2011, 24 occurred in the United States before any other country in the world, and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines.The Administration remains committed to the timely approval of safe and effective drugs to improve the treatment of cancer and other illnesses.My response: If “The Administration remains committed to the timely approval of safe and effective drugs to improve the treatment of cancer and other illnesses,†then why are they ignoring—or worse—denying their own data regarding antineoplastons in the treatment of childhood diffuse intrinsic brainstem glioma? It seems the pharmaceutical grade medicines known as "antineoplastons" are disqualified from playing the FDA's approval game, even though their results are far more superior than any other cancer therapy our planet has ever seen. Janet Woodcock is the Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. You can click here to contact her

yourself.In solidarity, Merola

NOTE: This article was written by Merola, the director of the documentary Burzynski: Cancer Is Serious Business. Mr. Merola and his documentary are not affiliated with the Burzynski Clinic, or The Burzynski Research Institute, Inc. Mr. Merola is an independent investigative journalist working on his own, and is not in any way supported by The Burzynski Clinic. SOURCES:1. https://wwws.whitehouse.gov/petitions/%21/petition/antineoplastons-cancer-drugs-fda-trials-1995-results-publicly-audited-congress-gain-final-fda/M1hH28lk2. http://www.medterms.com/script/main/art.asp?articlekey=395323. http://www.cancer-therapy.org/CT/v5/B/PDF/42._Burzynskihttp://www.cancer-therapy.org/CT/v5/B/PDF/42._Burzynski,_379-390.pdf4: http://www.ncbi.nlm.nih.gov/pubmed/16484713?dopt=Abstract5. http://www.ncbi.nlm.nih.gov/pubmed/12718563?dopt=Abstract6. http://www.ncbi.nlm.nih.gov/pubmed/172781217. http://www.ncbi.nlm.nih.gov/pubmed/155655748. (Timecode 4:18-6:10): http://www.youtube.com/watch?v=1buiXWr_QTQ9. http://www.boston.com/yourlife/health/diseases/articles/2007/02/26/taking_back_the_fda/10. http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-avastin-combination-paclitaxel-chemotherapy-first-line-advanced-852.html11. http://www.fda.gov/NewsEvents/Newsroom/ucm279485.htm12. http://www.wikinvest.com/stock/Roche_Pharmaceuticals_(RHHBY)13. http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-avastin-brain-cancer-glioblastoma-has-progressed-following-prior-1342.html14. http://www.youtube.com/watch?v=hCrsn8ziGWU15. http://www.burzynskiclinic.com/images/Pub_SRB_2006_Targeted_Therapy_for_Brain_Tumor.pdf16. https://www.burzynskimovie.com/index.php?option=com_content & ;view=article & id=80 & Itemid=3717. https://www.burzynskimovie.com/index.php?option=com_content & ;view=article & id=81 & Itemid=3718. http://clincancerres.aacrjournals.org/content/11/19/6767.full19. https://www.burzynskimovie.com/index.php?option=com_content & ;view=article & id=58 & Itemid=3720. https://www.burzynskimovie.com/images/stories/JodiRec/Statistics%20for%20Anaplastic%20Astrocytoma%20-%20Newly%20Diagnosed.pdf21. http://www.drugs.com/pro/temodar.html22. http://www.novartis.com/newsroom/media-releases/en/2010/1457419.shtml23. Email from the FDA verifying the permission on begin Phase 3 trials for childhood brainstem glioma24. Childhood brainstem glioma patient Ressel interview with medical records

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