FDA agrees to let patients get controversial drug

FDA trips. They are allowing some cancer sufferers to have access to antineoplastons – an unproven drug promoted by Stanislaw Burzynski, as long as Burzynski isn’t doing the work.

FDA agrees to let patients get controversial drug.

The Food and Drug Administration has agreed to allow a handful of cancer patients to receive unapproved drugs from a controversial Texas doctor, but only if they can find another physician to administer them.

A group of eight contacted the FDA to petition for “compassionate use” of the drug.

Burzynski will supply antineoplastons for free, says his attorney, Richard Jaffe.

One person has found a doctor willing to administer the antineoplastons, but others have not, saying they have contacted dozens of doctors, but a qualified oncologist has not been found who would agree to participate. That’s no suprise. The ANP treatment is called safe and effective by the Burzynski clinic but the FDA does not allow him to say that. It has not been proven. In fact, an investigation of Burzynski ramped up after a child died receiving the treatment. See Burzynski exposed in USA Today

Many doctors are NOT happy that the FDA has done this and they would NOT advise anyone to undergo ANP treatment including Orac who calls this action “stunningly cynical or stunningly naive on the part of the FDA”.

Stanislaw Burzynski and the cynical use of cancer patients as shields and weapons against the FDA: Has the FDA caved? – Respectful Insolence.

Because of the serious problems at the Burzynski clinic, it’s clear there was no way they could allow him to do the treatment. However, there are serious considerations with the treatment that the FDA has apparently ignored or taken far too lightly. On the other hand, if patients wish to undertake this treatment with all the information pro and con available, they should be able to.

More:

Burzynski gets FDA smackdown letters

Burzynski violates federal law with misleading claims about his research

Tip: Bob Blaskiewicz

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  6 comments for “FDA agrees to let patients get controversial drug

  1. Chris Howard
    March 22, 2014 at 10:52 AM

    Will they be tracking the data from these “treatments”?

    Because it seems to me that a major problem with Dr. B is that he had no, or refused to share, his data with anyone, and therefore could not verify any of his claims.

    At the very least we may be able to say that other physicians have administered the treatments and collected data from the trial groups.

    While not a rigorous study it could be useful in establishing, once and for all, the veracity of the claims.

  2. Frederick
    March 22, 2014 at 12:31 PM

    Agree with Chris. The worst thing about that if just a handful of those person survive, it will not be because of ANP, we all know that. But that crook will use them as publicity. And the fact that he do not administer the drug will make it look as more objective test. If i was a doctor, there is no way I will give ANP to my patients, I don’t care how much desperate they are, it is no reason to give them that bad stuff.

  3. Bob
    March 22, 2014 at 2:37 PM

    What’s most likely to happen when they all die is that B’s supporters will say that whoever administered the drugs messed up the protocol. Because it only works when Twinkle Tits dispenses it himself in much the same way Jonas Salk had to administer his polio vaccine personally.

    As far as demonstrating efficacy is concerned, this arrangement simply can’t, as far as I know, shed any light on ANP.

  4. March 22, 2014 at 5:40 PM

    I don’t suppose Burzynski will be signing up for this: http://www.alltrials.net/

  5. neko
    March 23, 2014 at 10:56 PM

    I’m starting to believe that at a certain zen level of apologetics, cynicism and naiveté are not antonyms. They may at times even actually be the same thing though the magic of cognitive soundproofing. I’m sure while taking such crass departures from ethics, the political expedients are telling themselves the press releases about mercy are the gospel truth. It is the right choice for them because the false hope is better than doing nothing when they refuse normal treatment or go into palliative care because there is no good option, and it has the plus of making them look “flexible”.

    That this stuff works is implausible. Who is going to do this testing, this quack’s duckling interns? Isn’t it going to be the same quackery that has left his patients to suffer and die for decades, with no hint of proof it works? Do they have some novel way of administering it they came up with, just now? Are they really ready for a new approach that they can start human trials, just like that?

    Maybe they will insist the patients all do both standard care and get this placebo. If so, it’s a grey area, except we know this stuff is probably harmful on it’s own. How harmful hasn’t been studied enough, because there is no reason to study it, it’s useless. So, more of a charcoal than a grey.

    I am baffled, at times. But I am starting to think a lot of these people enter into a state of transcendental self-deceit to resolve the conflicting motivations they have. It’s not so much they are lying as their truth is the product of a hung jury. Surely they can see this will be perceived as a gross case of them abandoning their role? It’s just a case where they have to let go of keeping everyone happy, and they can’t admit there is no way to build consensus and have integrity at the same time. Worse, they probably have conflated consensus and integrity.

    I have no real clue, but at this point, a lot of people have to have given a pass on this. Big careers ( lives ) are at stake. What could be more important? Just a hunch, a lot of people have bent the rules to get where we are, and there is a nasty paper trail on this.

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