White House Responds to Petition for Refael Elisha Cohen

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rafael-elisha-cohenThank you for your petition. The situation faced by the Cohens — and all families facing childhood cancer — is heartbreaking.

As you may know, the Food and Drug Administration (FDA) is responsible for ensuring that drugs and other medical products sold in the United States are safe and effective. Drugs that haven’t yet been approved for marketing are called “investigational new drugs.” When those drugs show promise, the FDA may allow patients to enroll in clinical trials of those drugs or — in cases when joining a trial isn’t possible and there are no comparable or satisfactory treatments — to be able to use those drugs through expanded access.

This is often referred to as “compassionate use,” but it’s not without risk. Since the treatments are still being investigated, it isn’t known if they are safe or effective. Indeed, there’s the risk that the treatment could be not only ineffective, but make a patient’s condition worse.

In cases like Refael Elisha’s, the drug company that produces the treatment in question works together with the patient and, in some cases, with the patient’s doctor, to request approval from the FDA to treat the patient with the investigational drug. The same standards that prevent the White House from interfering with the outcome of an agency’s independent adjudications or research also apply in cases like Refael Elisha’s. The decision whether to allow compassionate use depends on a number of factors, including what the agency knows about the safety and effectiveness of the proposed treatment. The patient, his illness, his treating physician, and the drug company are all involved in that decision.

We are confident that FDA will rely on its expertise and scientific judgment as it evaluates Refael Elisha’s case.

The FDA provides a variety of resources should you want to learn more about compassionate use or want to request approval from FDA:

You may also contact the FDA’s Office of Health and Constituent Affairs for information and assistance.

{Noam Amdurski-Matzav.com Newscenter}


18 COMMENTS

  1. Even after decades, Burzynski has never published any of his clinical trials to attempt to really demonstrate efficacy of antineoplastons. Instead, he relies on a propaganda campaign

    Anyone who is interested, please see the USA Today expose of Burzynski:
    http://www.usatoday.com/topic/68a3147f-f33a-4db3-a0c9-792c559da370/Stanislaw-Burzynski/

    I hope someone in the Jewish community can investigate how so many people were fooled.
    http://scienceblogs.com/insolence/2014/01/22/stanislaw-burzynski-and-the-cynical-use-of-cancer-patients-as-shields-and-weapons-against-the-fda/

  2. The FDA wasn’t paid off enough from the drug company inorder to allow it on market….it’s only a question of time. in the meantime, many natural methods are available that one should research….

  3. So what did they say? In simplified English? It sounds like typical White House gibberish!
    E.B. White, one of the greatest writers of all time was apt to say, “When writing, employ the 3 S’s – Simplify, Simply,& Simplify!

  4. this white house petition is 1 piece of garbage, every petition we jews signed, they responded NO, No to Rubashkin, NO to Pollard, NO to Jacob Ostreicher & now NO to Elisha Cohen

  5. What has the white house ever done in response to any of these petitions besides answer as to why they cannot get involved?

    Hashem Yerachem!

  6. I wonder how much a frum lady appreciates having her picture shown in public. Matzav – sensitivities please! – Ours and Hers.

  7. I hope he has a Refuah shleima and Arichas yumim

    Did u expect any different from the White House? It’s full of corruption !

  8. The comments here are awesome. By awesome I obviously mean PATHETIC! You guys are a joke and even a bad administration can make good decisions. There’s nothing more anti-semitic than crying anti-semitism every moment.

  9. Anyone familiar with the system knows that petitions to the White House to interfere in this type of situation is predictable. Burzynski knew that, no doubt. I’m nearly sure that the petition was his idea in the first place, knowing it would fail to help Refael Elisha. But it would help his agenda immensly: getting massive public support at a time his (true) image has been exposed. He took advantage, not only of the Cohens, but of our community and our love and devotion to each other. He played us all. Don’t blame this one on the government. The blame lies with Burzynski.

  10. Matzav- Please stop censoring truthful comments and respectful legitimate opinions. If you have some sort of censoring policy, then you need to be upfront about it and acknowledge when a comment has been censored.

    In addition, the Matzav censoring policy appears to be arbitrary and capricious. How do you decide what is censored?

    Thank you.

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