Stanislaw Burzynski and the the cancer clinic that bears his name have been the subject of concern in the medical community for years. His practices are well outside the mainstream, and he makes extravagant claims for his costly treatments.
The centerpiece of Burzynski's treatment is a drug he refers to as "antineoplastons". They have never been approved by the FDA for the treatment of cancer, and the only way Burzynski has been able to sell and administer them is under the auspices of "clinical trials." Normally, a trial enrolls a certain number of patients, tracks data, and then publishes them. Despite decades of giving antineoplastons, Burzynski has failed to publish any data (that is, human clinical trials data. He has published case reports and "test tube" results). It's also quite outside the norm for patients to be charged tens of thousands of dollars to participate in clinical trials. This can, as you might imagine, create a bit of a conflict of interest.
English: Burzynski Institute Logo (Photo credit: Wikipedia)
Many of us in the medical community and been concerned about Burzynski's extravagant promises and what are, in my opinion, misleading statements about what he has to offer. For example, his website announces, "Medical expertise based on over 40 years of clinical experience and research" which, given his publishing record, seems an exaggeration at best. (One could also argue that the slogan displayed on his website ("First, DoNoHarm!") is also a bit mendacious given the facts discussed below.)
Earlier this year, the FDA finally visited the Burzynski Clinic to take a peek around. Through FOIA request, a number of bloggers have been looking over the documents for a few months, but now they have been released publicly. The findings are very disturbing and paint a picture of a clinic that fails to follow even basic practices to protect patients. Among the published observations:
The Clinic, "...failed to comply with protocol requirements related to the primary outcome, therapeutic response...for 18 of 27 (67%) of subjects reviewed during the inspection." This included incorrectly listing patient as being in remission (having a "complete response" to treatment); incorrectly listing patients as having a "partial response" to treatment. This is terrifying. Incorrectly assessing a response to treatment gives patients false hopes and makes data look more favorable than they really are (some might call this "massaging the data", but in this case the "data" are real people with cancer).
Some of his patients had been treated with chemotherapy just before being enrolled in Burzynski's studies, which was explicitly forbidden by the research protocols (another way data can be massaged). The protocols also required MRI or CT evidence of the tumor, which in at least one case wasn't present.
The Clinic failed to set up required follow up with the patient's usual physician. This could lead to cancer patients "falling through the cracks".
The FDA report also observed that patients were treated despite having dangerous side effects that would require removing them from the study. According to the report, the protocol requires that "Patients should be removed from treatment for a third episode of Grade 3 or 4 toxicity or for any Grade 4 toxic effect that is truly life threatening or is not easily and rapidly reversible." The FDA observed that several patients were not properly terminated from the study despite life threatening electrolyte problems (high sodium levels). The Clinic also failed to properly report severe adverse events, such as swelling in the brain and pneumonia.
Finally, to add insult to injury, the Clinic failed to properly inform patients of costs before enrolling them, potentially leaving patients with huge, unanticipated medical bills.
The FDA observations paint a horrifying picture, one that no amount of fancy furniture, smiles, and houseplants can cover: if true, these observations show a clinic taking money from patients improperly and performing experimental treatments on them without many of the required safety measures.
Without informed consent, that is, a knowledge of what to expect from a clinical trial, a patient cannot make a reasoned choice. These sort of practices leave patients at the mercy of charlatans, quacks, and even "mad scientists" who might use them as experimental subjects in ways they aren't aware of. These sorts of practices were dealt with shortly after the horrors of World War II by the Declaration of Helsinki, protecting people subject to medical experimentation.
According to the Declaration of Helsinki,
It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.
What this says about Dr. Stanislaw Burzynski I'll leave to the reader's interpretation.
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Bloggers of special note in keeping on the Burzynski story include Bob Blaskiewicz,Tim Farley, and David Gorski.
Bob and David have given some some excellent presentations. For more information, please check them out.
