• FDA files disturbing report about the Burzynski Clinic


    Sorry for the recent lack of postings. However, I’ve been tinkering with this whole cancer thing again. I had my “big” checkup this past week and was a tad preoccupied, wondering what the docs would find. (OK. It was a tad more dramatic than that. Good thing my long suffering husband loves me.) Good grief, I was poked, prodded, my belly was kneaded like a loaf of bread dough. Then they took my blood. Lots of it.

    Then to pour indignity upon indignity, my doc updated my tetanus! Oh, and if you have whooping cough, come on over. I’m covered for that, too. I’m a walking pin cushion… but was I a cancer-filled pin cushion? That was the big question.

    Well, the results are in. After reviewing THREE pages of blood numbers, I’ve been officially declared “In Remission.” It gets better. They tagged on “Surgically Cured” as well. They’ll drop the first “In Remission” part after five years.

    I hardly know how to react.

    Then my world of skepticism and my current cancer situation collided. A post via Barbara Drescher noted that the FDA has inspected the Burzynski cancer “clinic” of Houston and has reported some disturbing findings. Straight from the FDA itself, here’s the whole report.

    Now, I’d heard of Burzynski. I’d also heard how he routinely “cures” cancer using “antieonplastons” which is evidently a super awesome substance extracted from… urine. His treatments are not FDA approved and are not exactly accepted by the American Cancer Society, Cancer Research UK, Sloan-Kettering Cancer Center, and such.

    My doctors had nothing good to say about Burzynski or his clinic. In fact I heard a story of a local girl with kidney cancer who went to that clinic and wound up back at the local hospital with her cancer clearly advanced PLUS her remaining kidney destroyed by the alternative treatment. It’s the only time I’ve ever seen my GP visibly angry. But I digress…

    Despite this reputation amongst more mainstream physicians, Burzynski continues to attract patients under the guise of performing “research,” although he hasn’t published anything. And now, his “research” methods appear to be quite shoddy. According to the FDA report

    Burzynski (as investigator, the subject of the inspection) “failed to comply with protocol requirements related to the primary outcome, therapeutic response […] for 67% of study subjects reviewed during the inspection.” This means that several patients who were reported as “complete responses” did not meet the criteria defined in the investigational plan, as were patients who were reported as having a “partial response” and “stable disease.” This means that his outcomes figures for these studies are inaccurate.

    He appears to have admitted patients outside the criteria for his study. He evidently engaged in shoddy reporting as well. Plus, we have this:

    The FDA told Burzynski: “You failed to protect the rights, safety, and welfare of subjects under your care. Forty-eight (48) subjects experienced 102 investigational overdoses between January 1, 2005 and February 22, 2013, according to the [trial number redacted] List of Hospitalizations/SAE (serious adverse events) [redacted]/ Overdose [redacted]/Catheter Infection report. Overdose incidents have been reported to you [….] There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects.” [emphasis added] It seems that these overdoses are related to the protocol, which requires family members to administer the drugs via programmable pump on their own. Further, patient records show that there were many more overdoses that were not included in the Hospitalization/SAE/Overdose list.

    Reading on, you can find out how he supposedly destroyed records, skipped “baseline measurements,” “adverse events” were not reported, he didn’t always get consent, AND the clinic was “unable to account for its stock of antineoplastons.

    Good grief.

    Forbes has picked up this story. Skeptical Humanities adds a few more details.

    Imagine having cancer, or taking a loved one, to that clinic. They sell hope, but deliver… well if you want the sensation of a sharp knife piercing your heart, read some of the actual Burzynski patient stories found here. Just make sure you have lots of tissues nearby.

    Category: FYI


    Article by: Beth Erickson

    I'm Beth Ann Erickson, a freelance writer, publisher, and skeptic. I live in Central Minnesota with my husband, son, and two rescue pups. Life is flippin' good. :)