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It is often argued that the most heinous crimes that can be committed in our society are those committed against children. Defenseless children, who rely on the greater values and morality of society to provide for their safety, their growth and development.

But what happens when the government stands between parents and the possible cure for their child’s terminal illness? Take the following case for example. (The full story of Braiden Norton can be found on his Website, www.BraidenNorton.com.)

“Six years ago, 10-year-old Braiden was enrolled in a clinical trial for his incurable brain tumor. The ‘experimental’ drug Antineoplaston (ANP) was the sole treating agent. Braiden had been in full remission for the last two years and had suffered no toxic side effects.

Last December, an MRI revealed that Braiden has a reoccurrence of the tumor. Reoccurrence of aggressive brain tumors after treatment is very common; it is the reaction of the FDA that was unexpected!

The FDA is refusing to allow Braiden to go back on ANP even though the treatment has already proven its efficacy through his previous remission. The FDA has no legitimate rationale for sentencing Braiden to die. The FDA’s response to his father, who asked to place his son back on ANP, was to recommend that Braiden receive experimental radiation and chemo treatments. Both are known to be ineffective for Braiden’s type of tumor.”

FDA Denies Hope for Dying Children

The FDA is the sole federal agency charged with the authority to grant compassionate use or “expanded access” for the terminally ill to experimental and as-of-yet unapproved drugs. This emergency access is meant to provide terminal patients like Braiden some possibility of hope when conventional treatments offer no curative possibilities.

The reality is that the FDA couldn’t care less about your welfare or last chance at hope. The FDA’s decision-making process is designed to be a regulatory bureaucratic nightmare that is virtually impossible to understand or successfully navigate through, especially when every minute wasted allows an aggressive tumor more time to grow. Clearly preventing Braiden from receiving a treatment that has already shown to be effective is not in the child’s best medical interest  so why is the FDA making this decision?

There is an FDA Compassionate Use process that should enable patients immediate access to potentially lifesaving medications, but the FDA is blocking any avenue that these children have to ANP. The FDA’s compassionate expanded access process, while meant to look reasonable, is nothing short of a nightmare when parents try to use it.

The story of ANP brings to light some very interesting anomalies with respect to how cancer is dealt with in the US, both medically (called “standard of care”), and with respect to the FDA’s new drug approval process. ANP is a self-infused anticancer agent that can be dispensed on an out-patient basis.

When it is successful, the patient can continue to live a fairly normal life as side effects tend to be relatively benign and short term. This makes the treatment much more desirable over conventional treatments, which would certainly lead to economic misfortune for the cancer industry if patients knew and understood the difference between these two types of treatments. Instead of fast-tracking ANP for the good of all, the FDA seems bent on curtailing its use whenever possible.