Burzynski to continue trials as FDA says ‘OK’

Disappointing, short-sighted, rather stupid, and not consumer friendly. That’s how I would characterize this latest news that discredited, controversial, and quackerific Dr. Stan Burzynski is allowed to pursue trials. The only positive in this is HE WILL ACTUALLY DO TRIALS which is better than he’s done before. We’ll see.

FDA gives controversial doc green light to restart work.

The FDA has lifted restrictions on a clinical trial run by Stanislaw Burzynski, who was the subject of a USA TODAY investigation last year. Burzynski, 70, has wrangled with state and federal medical authorities for nearly 40 years over his claims that he has discovered natural substances that can fight certain cancers.

Stop right there. 40 years. 40 years and he hasn’t come up with anything definitive, it’s all questionable (and expensive) and of poor quality. That should tell you something, FDA and prospective patients. He’s shown nothing comparable to conventional trials to suggest his treatment actually works.

In a statement issued Friday, the Burzynski Research Institute says it is planning to launch a large, definitive trial — called a Phase 3 study — of patients with newly diagnosed brainstem tumors.

The FDA’s decision “marks an important step in the development of antineoplastons for the treatment of various forms of brain tumors,” the institute said in its statement.

Put up or shut up, Stan. So far, you’ve been full of it.

When hundreds of respected medical professionals and knowledgeable citizens give you plenty of evidence to support that someone is a “snake oil salesman” and the “worst kind of predator”, you ought to listen. This decision is disappointing. FDA fail.

More on Burzynski:

Burzynski exposed in USA Today.

Burzynski violates federal law with misleading claims about his research.

Burzynski gets FDA smackdown letters.

One in a long line of those who were duped by cancer treatment ploy of false hope

Forbes contrasts Burzynski’s clinic with respected medical center

Burzynski gets warning from FDA: Stop promoting your treatment as “safe” and “effective” 

Burzynski and company sued by former patient 

  10 comments for “Burzynski to continue trials as FDA says ‘OK’

  1. Lagaya1
    June 25, 2014 at 3:25 PM

    How can a “real” study charge the participants? They’re betting their money on it working…doesn’t sound like a very good model for a non-biased study to me. So when the patient dies, anyway, the family will blame it on the government for delaying treatment too long, or some such excuse. I’ve never heard of legitimate studies that charge participants.

  2. kompani101
    June 25, 2014 at 3:27 PM

    Having worked in an industry that the FDA was everything, Pharmaceutical R&D, for more than 20yrs, I cannot understand them allowing Burzynski to pull the wool over their eyes time and time again. At this rate the guy will be dead and gone before any action is taken. In his wake will be a desperate record of needless deaths, suffering, hardship and disappointment from his former patients, their families and friends. Terribly bad form FDA.

  3. Kochanski
    June 25, 2014 at 4:43 PM

    Sheesh, is there nothing we can do to stop Burzynski? Why in the world would the FDA allow him to do more trials? I am disgusted.

  4. Brandon
    June 25, 2014 at 5:35 PM

    It appears that Burzynski’s lobbying efforts paid off once again.

  5. June 25, 2014 at 6:49 PM

    What IRB is he supposed ot use for this? His has essentially been shut down due to ethical violations.

  6. Bob Blaskiewicz
    June 25, 2014 at 9:40 PM

    There are pay to play IRBs. Which shouldn’t be.

    • June 26, 2014 at 2:37 AM

      Even so, a company that makes its business as an IRB will still not want to pass ineligible patients, which would count out a significant proportion of past victims. And this does seem to be only a Phase 3 trial, the previous one never accrued a single patient.

      I strongly suspect that the FDA are simply avoiding a restraint of trade lawsuit here, but the description is accurate: this would probably be definitive. Which is, of course, why it will never be published, because the answer will be definitively that ANPs do not work, as all previous investigations have found.

  7. Peter Robinson
    June 26, 2014 at 2:34 AM

    Have the FDA explained the grounds on which they have allowed this to go ahead? What part of the FDA has made this decision? Who was involved? Do the rules allow for trials paid for by patients? Do the insurance companies cover this? Are there any routes for challenging the decision?

    Perhaps a case for a really concerted bombardment of the FDA and politicians to challenge this?

  8. James G
    June 26, 2014 at 2:41 AM

    He’ll continue to drag his feet, and continue to be cited for failing to keep appropriate records, and he will continue charging people ridiculous fees for what appears to be, for lack of credible evidence otherwise, snake oil.

    What bothers me most here, is that he’s going to be treating newly diagnosed patients, who might stand a chance with conventional treatment. In the past it sounds like many of the people he treated had already lost hope, and looked to him as their last chance.

    If there were evidence, say from a phase II trial, that suggested the treatment might work, then perhaps it would be worth the risk, but does he even have that?

  9. Ben Radford
    June 26, 2014 at 12:04 PM

    I think the best course of action at this point is to make sure that the people who approved this are very clearly identified in print, their names and signatures are fully documented, and they are aware that they will be held fully and publicly accountable for however this turns out. They may not care, but they may take another look when they realize that their legacy is tied to this fiasco.

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