The FDA is getting tough.
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.
If Burzynski fails to adequately address the FDA’s concerns, the agency could terminate his clinical trial; disqualify Burzynski from conducting future FDA research; issue a civil fine; or pursue criminal charges, according to FDA regulations. Burzynski has 15 days to respond to the FDA.
That’s from a summary on USA Today, which you might not want to visit because of the annoying autoplay videos they’ll fling at you. You can read the FDA’s official letter instead, which is a solid rebuke. Here are the highlights:
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)].
Each of those is accompanied by a detailed breakdown of all of Burzynski’s failings — it’s a real pleasure to read how this quack is getting ever so firmly and formally raked over the coals. I’m going to go out on a limb here — a very stout, strong limb — and predict that Burzynski is going to be incapable of addressing any of the complaints with anything other than bluster, and that right now he’s making plans to slither his clinic over the border into Mexico.