But go ahead anyway

An under-reported item – USA Today seems to be the only source even mentioning it: the Food and Drug Administration has lifted restrictions on a clinical trial run by Stanislaw Burzynski of the eponymous clinic.

Burzynski — hailed as a maverick by his fans but derided as a snake oil salesman by mainstream doctors — has long claimed to have achieved dramatic success in hard-to-treat cancers, especially brainstem tumors that are usually considered fatal. According to the National Cancer Institute, however, Burzynski has not produced proof that his drugs save lives by publishing a randomized, controlled trial in a peer-reviewed journal.

But now the FDA says all is forgiven, because Burzynski answered all their questions.

Some cancer specialists say they’re disappointed by the FDA’s decision and concerned for the safety of young patients. Critics also say they’re concerned about the financial impact on dying patients or their families, who often organize elaborate fundraising efforts to obtain the $100,000 or more needed to pay for Burzynski’s experimental treatments, which are not covered by insurance.

“This puts patients at risk,” says Peter Adamson, chairman of the Children’s Oncology Group and chief of clinical pharmacology and therapeutics at the Children’s Hospital of Philadelphia. Research has shown that antineoplastons can cause serious and even life-threatening side effects. “Exposing patients to ineffective therapies does not offer a meaningful prospect for benefit and only exposes patients to risk.”

Also, charging for them is not the usual way of doing things, as I understand it.

So a shitty piece of news that’s almost completely ignored by the news media.


  1. quixote says

    This may be arguing ahead of the evidence. Quote from a recently published study (pdf) by Burzynski with a tiny sample size of 15:

    A complete response was documented in 2/15 (13%), partial response in 2/15 (13%), stable disease in 3/15 (20%). Progression-free survival at six months was 47% and overall survival (OS) at one year was 33.3%…. A small group of patients suffered reversible Grade 3 and 4 toxicities including hypernatremia 2/19 (11%) and decrease of neutrophils 1/19 (5%). There were no chronic toxicities.

    The sample size is too small to draw strong conclusions, but I gather the prognosis without further treatment for children with a recurrence of the disease is much less than 47% survival at six months. That kind of result for such a ferocious cancer is commonly taken as a sign to do heaps more work and to generally get rather excited.

    So he’s not exactly a Lorenzo’s Oil-type quack.

    What’s odd is that he’s treating patients outside the parameters of any study, if I understand the USA Today article. But that’s illegal. Which is not the same as being a quack. If the drug is approved for other purposes, then it’s not even illegal. Just off-label prescribing. So, at least to me, the merits of what’s going on here aren’t clear.

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