Six-year-old Refael Elisha Cohen is battling brain and spinal cancer. His parents have tried everything, but nothing has caused the cancer to show signs of slowing down. Now they are embarking on the final phase of their battle, but not against the cancer — against the Food and Drug Administration.
Rabbi Jacob Cohen is Elisha’s father and though doctors have given up hope, he hasn’t. Not only have he and his Israeli-born wife Devorah tried every medical treatment they’ve been able to access, the devoutly religious couple who have five other children have also relied on prayer and Jewish traditions.
They gave their son a new first name, Refael, which is the name of the angel of healing.
“If you change the name, you change the destiny,” Rabbi Cohen told a local TV station.
But the Cohens have one more medical option, a rare and highly controversial treatment offered only at a single clinic just blocks from the Cohen’s Houston home.
“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 laments.
The treatment is called antineoplaston therapy and it is not approved by the FDA because there have been no full-scale clinical trials. The therapy uses peptides and amino acids originally derived from human urine and blood.
A doctor named Stanislaw Burzynski developed the treatment in 1967 and opened his Houston clinic 10 years later. He claims to have cured numerous patients, but critics say that without the type of randomized control studies considered necessary to know if a drug is actually effective, his methods do not meet scientific standards and there is no real evidence that the treatment has any effect on tumors.
Researchers at the National Cancer Institute evaluated six cases presented by Burzynski in 1999 and found that the tumors treated with antineoplaston therapy showed no evidence of shrinkage. But a mere six cases, the NCI admitted, is too small a sample to determine whether a drug works or doesn’t.
Nonetheless, for the Cohens the Burzynski clinic offers at least a shred of hope for their son. They need 100,000 signatures by Jan. 2 on a petition to get the FDA to even consider granting a “compassionate use” exemption that would allow Elisha to receive the controversial therapy.
“If we reach our signature goal, they have to pay attention to it,” said the rabbi. “But it doesn’t necessarily mean they will approve it.”