Houston family fights FDA for experimental treatment

‘It’s hard to fight this war,” said Rabbi Yaakov Cohen of Houston, Texas, about the struggle to save the life of his six-year-old son Refael Elisha, who has brain and spine cancer. Grasping at any and every option to help their son, Cohen and his wife Devorah have launched a petition to  convince the US Food and Drug Administration to grant compassionate use exemption to Refael Elisha for antineoplaston therapy.

According to the American Cancer Society, antineoplaston therapy is a complementary, or alternative, cancer treatment that involves using a group of synthetic chemicals called antineoplastons meant to protect the body from disease. Antineoplastons are made up mostly of peptides and amino acids originally taken from human blood and urine. They were discovered more than 40 years ago, but published clinical trial results are available only for a relatively small number of patients, and there is no convincing evidence that they work. The FDA pulled its approval for this treatment in 2012 pending further clinical trials.

The Cohens are turning to this alternative treatment because Refael Elisha has undergone every possible treatment conventional medicine has to offer, and now his doctors at Texas Children’s Hospital are saying there is nothing more they can do for him.

In addition to petitioning the FDA, the family has pursued alternative and experimental treatments from Israel. “It’s been under the table, Jews helping Jews,” Cohen explained.

However, it has been harder to access antineoplaston therapy, which is offered by the Burzysnki Clinic in Houston.

“Here we are 10 minutes away from the clinic, where it makes the product in its own lab, and we can’t access the therapy,” Cohen said in frustration.

Determined to make the treatment available to Refael Elisha, the family has had people speak to the FDA on their behalf and has sent letters to their elected representatives asking for help. Their petition needs 100,000 signatures by January 2, 2014 in order for it to be reviewed by White House staff and sent to the appropriate policy experts.

“If we reach our signature goal, they have to pay attention to it. But it doesn’t necessarily mean they will approve it,” the father explained.

At the same time, an online fundraising campaign has raised over $54,000 toward a goal of $100,000 to assist the Cohens with expenses.

“Please continue to open your hearts and give to help the Cohens continue the fight against the… cancer that has attacked Refael Elisha. This devoted family is leaving no stone unturned, but they simply cannot do it without you,” reads the message on the fundraising web page.

Cohen, a Los Angeles native who lived 19 years in Israel, and his wife, a Brooklyn native who grew up in Israel, moved with their family from San Antonio to Houston two years ago to join TORCH, a Jewish outreach organization.

Refael Elisha is the fifth of their six children. He was diagnosed with anaplastic medulloblastoma in October 2012 and underwent surgery, proton radiation therapy, and chemotherapy. Refael Elisha lost his ability to walk, talk and eat, but after rehabilitation, he regained the ability to talk. An MRI scan in June 2013 showed that his tumor had been eradicated, but a few months later, another scan revealed three tumors, including one extremely invasive one.

“He’s been in so much pain the last couple of days that we have had to keep him on morphine,” Cohen said of his son. “He has an MRI scheduled for tomorrow, but it doesn’t look like the alternative treatments have been working.”

Cohen and his wife remain hopeful. They already have more than two-thirds of the required number of signatures on their petition and hope more people will sign — and also pray for their son, Refael Elisha Meir ben Devorah.