The parade of bad press and trouble for Stanislaw Burzynski is sweet music to proponents of science-based medicine as Dr. B gets his ass handed to him by the FDA.
The Food and Drug Administration has issued a strongly worded warning letter to a controversial Houston physician, Stanislaw Burzynski, who was the subject of a USA TODAY investigation last month.
Burzynski – hailed as a maverick by his fans but a snake oil salesman by mainstream doctors — has long claimed to have dramatic success in hard-to-treat cancers, especially brainstem tumors that are usually considered fatal. According to the National Cancer Institute, however, Burzynski has never produced definitive proof that his drugs save lives by publishing a randomized, controlled trial in a peer-reviewed journal.
In letters to Burzynski and his research institute posted online Wednesday, the FDA says that Burzynski inflated success rates for experimental drugs that he calls antineoplastons. The FDA also says Burzynski failed to report side effects and to prevent patients from repeatedly overdosing.
Here is the warning letter. The highlighted parts are as follows:
1. You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].
2. You failed to protect the rights, safety, and welfare of subjects under your care [21 Cfr 312.60 and 21 CFR 312.305(c)(1)].
3. You failed to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60, 21 CFR 50.25(b)(3), and 21 CFR 50.27(b)(1)].
4. You failed to adhere to requirements for all expanded access uses with respect to maintaining accurate case histories and retaining records in a manner consistent with 21 CFR 312.62 [21 CFR 312.305(c)(4) and 21 CFR 312.62(b) and (c)].
In other words, YOU FAILED. (CFR stands for Code of Federal Regulations, citing the references in the law to each charge.) Each charge is followed with specific cases of infractions found by the FDA inspectors to the clinic that was conducted from January to March 2013 to examine the conduct of the clinical investigations of the investigational drugs Antineoplastons A10 and AS2, and expanded access use of the investigational drugs Antineoplastons A10 and AS2.
Here is another letter issued also on 12/3/2013:
From our review of the FDA establishment inspection report, the documents submitted with that report, and your April 5, 2013, written response, we conclude that BRI did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects. We wish to emphasize the following:
1. Failure to ensure proper monitoring of the investigations and failure to ensure that the investigations are conducted in accordance with the general investigational plan and protocols contained in the IND [21 CFR 312.50 and 21 CFR 312.56(a)].
2. Failure to obtain from an investigator sufficient financial information to allow the sponsor to submit complete and accurate certification or disclosure statements required under 21 CFR part 54 [21 CFR 312.53(c)(4)].
This is bad for Burzynski and his clinic. Very bad. He was accused of falsifying records! And much, much more. While it is viewed as putting the screws to Stan by his cult following, the bottom line is this treatment has NEVER been shown to be effective but is certainly harmful. He is a quack, no doubt about that. That is enforced by the citations listed by the FDA; this man thinks he is a savior, that he is above the law. He’s not. I do hope this is the end for the Burzynski Clinic and his unfounded, expensive treatments. He’s hurt too many people.
The clinic has 15 days to respond to the charges. He has dropped the ball on that in the past (note the altered records part in the story here). Will Dr. B dig he way out of this hole?
More info to come.
Thanks to Liz Szabo of USA Today. Folk Heroism: Lessons from USA Today’s cancer doctor investigation | Reporting on Health.
Kudos to Bob Blaskiewicz for maintaining this site and for helping to coordinate a push on legislators to investigate the FDA oversight of the clinic.
Thanks to Orac for brilliant, sharp content about the clinic and their cancer quackery. The drip, drip, drip, drip of FDA findings against Stanislaw Burzynski continues – Respectful Insolence.
Tip: Bob Blaskiewicz