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Posted on 12-03-2016

BRINGING HOPE TO PATIENTS WITH A TERMINAL DIAGNOSIS

by Wendy Nadherny

The use of the word “terminal” limits one's mindset, while the word “curable” opens up a world of possibility.

Brain tumors are the most common cancers among children, according the the American Brain Tumor Association, which estimates more than 4,600 individuals between the ages of 0-19 will be diagnosed with a primary brain tumor this year. The most serious form of pediatric brain cancer is diffuse intrinsic pontine glioma (DIPG), a rare and aggressive tumor found each year in about 300 children, especially in those ages 5-7. As of 2015, the median survival for children with DIPG is less than 1 year from diagnosis. Because DIPG occurs in the brain stem, it is inoperable and unable to be treated with chemotherapy. The standard recommendation of a six-week radiation regimen can shrink the tumor to extend life expectancy a couple more months.

While conventional oncologists consider certain brain cancers to be terminal, hope lies in venturing outside the box of conventional thinking. This includes researching and evaluating U.S.-based and foreign-based clinical trials using experimental approaches to treat primary cancers and recurrent cancers with immunotherapy or gene-targeted therapy. In April 2016, three interesting FDA-approved clinical trials were open to DIPG patients. One of these was offered by the Burzynski Clinic in Houston, TX. This clinical trial was the only one offered to patients who had declined the standard recommendation of radiation and/or tissue brain biopsy. The trial protocol was designed to test non-toxic antineoplaston (ANP) peptide therapy, which had been used in previous trials to treat DIPG and glioblastoma (GBM) brains with some level of prior success and indicating that DIPG and GBM are in fact “curable.”

The manufacturing and research for ANPs is sponsored by the Burzynski Research Institute (BRI), a publicly-owned biopharmaceutical company working to develop and deliver cancer therapies based on genomic and epigenomic principles. In 1967, Stanislav Burzynski, MD, identified naturally occurring human peptides, which were present in healthy patients and deficient in cancer patients. He concluded that these peptides played a role in preventing the growth of cancer cells. With a PhD in Chemistry, Dr. Burzynski was able to reproduce the peptides synthetically, and he named them antineoplastons. ANP therapy targets over 100 genes that affect tumor cells. ANPs switch off certain genes that cause cancer, called oncogenes, activate the genes that fight cancer, called tumor suppressor genes, and pose no harm to healthy cells.

The most common side effects of the ANP drugs are symptoms resulting from electrolyte imbalances – a higher than normal range levels of sodium and lower than normal range levels of potassium. These symptoms can be managed through regular blood analysis, dietary intake, higher water consumption, and potassium supplementation.

Neil Fachon, 19, an engineering student at Northeastern University in Boston was diagnosed with DIPG at Massachusetts General Hospital on March 3, 2016, and became the first patient to enroll in the new ANP clinical trial that opened on April 12, 2016. On April 20, after passing baseline tests, a vascular access catheter was surgically implanted below Neil's collar bone, and on April 21 he began receiving ANP infusions through a portable pump. That same day, however, the FDA placed a hold on the trial it had given prior approval. Committed to his chosen course of treatment and deeming the FDA objections to be unreasonable, Neil took legal action, through federal court in his home state of Rhode Island, to overturn an FDA decision that failed to acknowledge his rights. On May 17, Neil won a temporary restraining order that was later negotiated into a permanent injunction, and he had sound reasons for wanting to pursue this treatment.

DIPG survivor Jessica Ressel, who received her diagnosis in March 1996 at age eleven, was successfully treated by Dr. Burzynski. Now married and a mother of two, she is one of three long-term DIPG survivors who keep in touch with Neil and provide encouragement. All three of these survivors were treated with ANP therapy at the Burzynski Clinic While seeking to assure his own survival, Neil also wanted to play a role in some promising scientific cancer research. Presently Neil is a trial of one, however, he hopes the FDA will remove the hold or that Right to Try legislation will be passed to allow other DIPG patients to join him and have a chance at life.

Right to Try legislation gives terminally ill patients the right to try investigational medicines that have not yet received full FDA approval. According to the Right to Try website: “Over 1 million Americans die from a terminal illness every year... Many spend years searching for a potential cure, or struggle in vain to get accepted into a clinical trial. Unfortunately, FDA red tape and government regulations restrict access to promising new treatments, and for those who do get access, it’s often too late.”

The FDA drug approval process can take up to 15 years. This is far too long for dying patients to wait, because terminal time lines are measured in months and weeks. Many potentially life-saving treatments awaiting approval in the U.S. are already available overseas, and have been for years, yet most Americans cannot afford to seek treatment abroad. A Right to Try law gives hope back to those who have lost it. It is not just for children diagnosed with DIPG, but for anyone with a terminal illness hoping to get life-saving treatment before it’s too late.

Right to Try is already law in 30 states, including Texas, and under consideration in 16 more, including Rhode Island. On May 10, 2016, the Trickett Wendler Right to Try Act of 2016 (S. 2912) was introduced in the United States Senate: “This bill bars the federal government from prohibiting or restricting the production, manufacture, distribution, prescribing, or dispensing of an experimental drug, biological product, or device that is: (1) intended to treat a patient who has been diagnosed with a terminal illness; and (2) authorized by, and in accordance with, state law. The federal government may not restrict the possession or use of such a treatment by a patient certified by a physician as having exhausted all other treatment options.” People can help move this legislation forward by contacting their senators and representatives.

Neil hopes the sharing of his story will raise awareness about treatment options for brain cancer and about a terminally diagnosed patient's right to chose. People can help move Right to Try legislation forward by contacting their senators and representatives.

Learn more at RightToTry.org.

Learn more about DIPG at http://coryscrusaders.org/resources

Wendy Nadherny Fachon is a health educator, a writer for Rhode Island Natural Awakenings magazine, and Neil's mother. She can provide helpful information to parents of children diagnosed with brain cancer, if they contact her at wendy@netwalkri.com or through facebook.

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