The Burzynski Clinic in Texas which sells false hope to the sick and desperate has recently been told by the FDA to stop misleading the public. Dr Burzynski’s Antineoplastons “treatment” is being marketed by his clinic despite not having the approval to do so within the United States.
Promotion of an investigational new drug is prohibited underFDA regulations at 21 CFR 312.7(a), which states, “A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent isto restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.”
OPDP requests that you immediately cease the dissemination of violative promotional materials for Antineoplastons such as those described above. Please submit a written response to this letter on or before November 1, 2012, stating whether you intend to comply with this request, and explaining your plan for discontinuing use of such violative materials.
Despite all the marketing promotions on the Burzynski Clinic website Antineoplastons have never been proven to be efficacious. The FDA is allowing the Burzynski Clinic to experiment with the drug to produce evidence that it works. So far no conclusive evidence has been found to support Antineoplastons but that won’t stop a crook like Burzynski from charging people for his “treatment”.