According to Haaretz, Israel’s Health Ministry has agreed to let the Sourasky Medical Center in Tel Aviv charge foreign patients for an experimental stem cell treatment, not approved for use yet elsewhere in the world, to treat arterial lateral sclerosis. The payment for use of the experimental therapy is supposed to fund the treatment of Israeli patients. The treatment has not yet completed full clinical efficacy trials.
The article says the treatment is called NurOwn and is being developed by the Israeli firm BrainStorm. It is now undergoing Phase III clinical trials, which examine its medical efficacy. Normally drugs are not given to patients before their safety and efficacy are thoroughly tested, but the Health Ministry has approved limited use: eight Israeli ALS patients may have it, for free, and five patients from abroad may also receive it — but each will pay more than US$300,000 for the treatment.
The technology is based on research by Tel Aviv University professors Daniel Offen and Eldad Melamed and uses stem cells harvested from the patient’s own bone marrow (autologous transfer). The cells are isolated, propagated in the lab and appropriate ones are injected back into the patient and excrete large quantities of proteins, which are responsible for the growth and survival of nerve cells and their interaction between nerves and muscles. The treatment aims to slow the degeneration of brain tissue.
The article states that the decision has been controversial. It says that last year, the Health Ministry had appointed an advisory committee to examine the issue, but the entire committee resigned in May before completing its task or submitting recommendations. Sources close to the issue, says the article, said that a dispute developed between the committee members and the ministry over charging money for the experimental treatment. Ultimately approval was granted without the committee’s input.
The article says that some European nations enable drugs that haven’t been approved for general use, under special circumstances, and since last year, the US has followed suit with the right-to-try law. President Donald Trump signed a law allowing terminally ill patients who have exhausted all known medical options to avail themselves of unapproved treatments if these treatments have passed their first phase of clinical trials. The law sparked controversy and many ethical questions, which arose because the companies developing the drugs are allowed to select the patients to be treated, and no restrictions have been placed on how much they can charge.
Since September 2016, use approved by the Health Ministry of drugs not fully tested yet has been legal in Israel as well.
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