We are writing to request your urgent attention to a matter that involves the exploitation of cancer patients, their families, and their communities.
For nearly 40 years, Houston cancer doctor Stanislaw Burzynski has been treating cancer patients with an unproven chemotherapy he calls “antineoplastons.” Following an agreement in the 1990s with the FDA, he has recently only been able to administer the drug under the auspices of clinical trials. For this questionable treatment, he charges patients exorbitant fees (often hundreds of thousands of dollars) to participate in a trial, and he claims to cure the most difficult, almost uniformly fatal pediatric brain cancers. His claims are not supported by science and evidence; despite opening more than 60 trials in the last 15 years, he has not published the results of a single completed clinical trial.
On Friday, November 15, 2013, many concerning issues about Dr. Burzynski were detailed in a front-page exposé in USA Today, including his past use of antineoplastons as an AIDS and Parkinson’s treatment. Sickeningly, critics of the Clinic have found a pattern going back 20 years of patients publicly celebrating unambiguous signs of disease progression as signs that antineoplastons were working.
The FDA recently released site inspection notes about Stanislaw Burzynski’s clinic. Their findings were horrific:
-- Burzynski “failed to protect the rights, safety, and welfare of subjects under your care.”
-- “Forty-eight (48) subjects experienced 102 investigational overdoses“
-- Burzysnki allowed overdoses continue: “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.”
-- All baseline tumor measurements were destroyed: “Your [...] tumor measurements initially recorded on worksheets at baseline and on-study treatment [...] studies for all study subjects were destroyed and are not available for FDA inspectional review.” Without any measurement there is no way to determine any actual efficacy of the treatment, making Burzynski’s claims unsupported and unpublishable.
-- Burzynski’s reported success rates are inflated: He “failed to comply with protocol requirements related to the primary outcome, therapeutic response [...] for 67% of study subjects reviewed during the inspection.” Nonetheless, these inaccurate outcomes are used to convince dying patients antineoplastons can save them.
Other issues cited by the FDA included:
-- Paying patients who failed to meet the inclusion criteria for the study were admitted to Burynski’s trials;
-- Burzynski did not report all adverse events as required by his study protocols, and many exhibiting toxic effects were not removed from treatment;
-- Adverse events were not reported in a timely fashion (in one case 7 years);
-- The FDA received two different versions of a pediatric patient's records during an inspection, especially significant because the child apparently died of a known side effect of antineoplastons.
Shockingly, these observations were made after a decade of abysmal site reviews by the FDA. Currently, Burzynski’s trials are subject to a partial clinical hold, which means Burzynski is still treating patients already on his protocol.
We are asking that you:
-- Encourage the FDA to dissolve the Burzynski Research Institute’s clearly deficient Institutional Review [ethical oversight] Board and to place a permanent hold on any more cancer patients receiving antineoplastons;
-- Investigate how Burzynski has been allowed to conduct experiments on pediatric cancer patients while repeatedly cited for violating rules designed to prevent uncontrolled human experimentation.
-- Investigate why the FDA allowed this abysmal researcher to advance to phase 3 clinical trials without publishing a single phase 2 trial;
-- Protect cancer patients from abuse through legislation and FDA oversight reform.
Please help end a medical ethics scandal that involves eight times as many patients as the Tuskegee Experiment. I look forward to your response on this important matter.