The FDA is effectively signing the death warrant of more patients by denying them access to Dr. Burzynski’s antineoplaston cancer treatment—for no rational reason whatsoever. Please help. Action Alert!
Over the years, we’ve covered the FDA’s attacks on Dr. Stanislaw Burzynski, the trailblazing cancer doctor best known for his discovery and development of antineoplastons (ANP), which are peptides and amino acid derivatives that activate tumor-suppressing genes. Independent research has confirmed antineoplastons to be an effective cancer treatment.
As we’ve reported in the past, the conventional medical establishment has, through a succession of relentless attacks, slowly choked off patient access to antineoplastons. In July 2012, after years of failed legal attempts to shutter the Burzynski clinic completely, the FDA told Dr. Burzynski he could no longer accept children for treatment with antineoplastons during the current FDA trial. In January 2013, this ban was extended to adults. This means that under current FDA restrictions, no new patients can be treated with antineoplastons. Terminal cases who could be saved will instead die.
Since the FDA has formally forbidden new patient access to antineoplastons, the only hope of dying patients is to convince the FDA to grant a “compassionate use” or “single-patient protocol” exemption via its expanded access rule. This rule allows for the case-by-case use of an experimental or unapproved drug outside of a clinical trial if a patient has a serious or immediately life-threatening disease or condition, and has no other treatment options left.
For an individual patient to be granted access to an experimental drug in the expanded access rule, a doctor need only conclude that the experimental drug does not pose a greater risk than the disease itself. Despite this rule, the FDA has, on a number of occasions, refused to grant access to antineoplastons for patients for whom the treatment is the last shot at living. In one tragic case, a five-year-old diagnosed with aggressive brain cancer died while waiting for the FDA to approve ANP treatment. The FDA eventually did grant the child compassionate use, but by that time he was already brain dead.
In May of this year, a patient with glioblastoma (GBM) was denied access to Dr. Burzynski’s treatment because the FDA judged that “the potential benefits [did not]justify the potential risks of the treatment.” GBM is a highly malignant form of brain cancer and extremely difficult to treat. Apparently death is less risky for these patients than a natural and effective treatment which has a long history of safe use.
What is both confusing and astonishing is that the FDA representatives who denied the request did not challenge the fact that the antineoplaston treatment has no significant additional side effects when compared to standard cancer therapies. The FDA’s main point of contention seems to be that they consider antineoplastons to be an ineffective treatment for GBM, hence they see no perceived benefit to the treatment. The actual effectiveness of the treatment is not in doubt, however, having been used for many years, but that is supposed to be determined by the current FDA-approved trial.
The government actually agreed to the trial—but only if antineoplastons were combined with conventional chemotherapy, just to muddy the results and protect chemo’s primacy as a cancer treatment. And given the government’s attitude, one can only wonder if the results of the trial will ever see the light of day.
Why then is the FDA denying patients access to a potentially lifesaving treatment when nothing else works? These are exactly the kinds of situations that compassionate use and expanded access were made for—patients with no other options who want access to experimental treatments. But rather than give patients one last chance, the FDA effectively signs their death warrant by denying access to Dr. Burzynski’s antineoplaston treatment. This has to stop.
A public outcry against this madness can make a real difference and save lives. Last March, after a similar ANH-USA grassroots campaign to grant dying patients access to Dr. Burzynski’s treatment, the FDA quietly granted eight patients compassionate use exemptions.
Action Alert! Write to the FDA and ask why the agency is yet again denying patients’ access to treatments that could save their lives—a treatment the FDA has admitted carries no significant side effects compared to other therapies for the same diseases. Please send your message immediately.