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.
I can’t raise more than one cheer for the FDA here, because of how long it’s taken them to act. ISTR he’s been bilking desperate patients in this way since the mid-90s.
The most interesting finding was how Stan responded to a request for records into how a child died–by sending an apparently altered version of a record that the FDA already said. At the end of the warning letter to Stan, the FDA said:
“The records BRI submitted to FDA on (b)(6), were not in the files that you provided regarding Patient 022387 during the inspection. However, during the inspection, you provided other Case Report Forms for this patient, with the same titles and for the same visit date as noted above, but containing information that differed from that which BRI submitted to FDA.”
Submitting altered records to regulators, I imagine, is a colossal no-no.
If your readers want to help end this, PZ, they should go to thehoustoncancerquack.com, where we are trying to educate Congress about the dealings between the Burzynski and the FDA and why so many sick children had to be subjected to an awful treatment and their parents drained of funds and time before the FDA did anything meaningful.
Even though I’m happy that it’s happening in a sort of “better late than never” sort of a way, I remain disturbed, like Moggie, that it’s taken so long:
http://scienceblogs.com/insolence/2013/12/12/the-drip-drip-drip-drip-of-fda-findings-against-stanislaw-burzynski-continues/
In a way, it’s somewhat understandable, though. The last time the FDA went after Burzynski in a big way, back in the mid-1990s, not only did Burzynski get off but Rep. Joe Barton (R-TX), the then-chair of the House Committee on Oversight, spent two years regularly dragging the FDA’s then-Commissioner David Kessler in front of his committee to castigate him for “persecuting” Burzynski. Meanwhile, Burzynski patients held media events with cancer patients claiming that they would die if Burzynski were sent to prison and his clinic shut down. (He was being prosecuted for insurance fraud at the time.)
To be clear, I can’t blame the patients and their families. They had been convinced that Burzynski was the only person on the entire planet who could save them and their loved ones. However, Burzynski cynically used them as “human shields” against the FDA and federal prosecutors. He’s doing the same thing today.
Personally, I think that it’s taken the FDA 15 years to finally get fed up enough to the point where its disgust at how Burzynski has flouted the law finally overtook its fear of political repercussions in going after him. Indeed, I’m pleasantly surprised that neither Barton nor any other of Burzynski’s political supporters seems to be doing anything about this, at least not publicly, likely because Burzynski’s reputation has become too toxic even for Barton. In any case, what this case, more than anything else, shows is not how “fascistic” and overbearing the FDA is, but how constrained it is by law and its budget (which, let’s not forget, is a constant target of anti-regulation conservatives, almost as much as the EPA budget). The Burzynski saga is a strong argument for beefing up the FDA and giving it the resources to do its job.
From the OP:
Yes, sites with autoplay videos or pop-up ads are bad and should be avoided.
…what?
It’s hardly the FDA who’s to be blamed here. Congress consistently hamstrings them whenever they try to shut down quacks.
Burzynski has been a parasite on Houston’s reputation as a top worldwide city for cancer treatment for the last twenty years. I will be glad to see him move to Nuevo Laredo or Matamoros.
Actually, FDA issued *two* warning letters – one to Burzynski and one to his clinic. I posted links to both on Thunderdome last Wednesday, as soon as FDA posted them on their website.
What USA Today does not adequately explain is how serious these warning letters are. If Burzinsky does not respond adequately, the next step can be legal action up to and including a raid by the US Marshals and criminal prosecution.
As ORAC mentioned above, Burzinsky has been protected by Congress. The death of the young patient and the failure to report adverse events has finally given the FDA what it needs to go after him. Expect things to get really ugly now.
Francisco Bacopa #6
Well. That was a shitty thing to say.
Criminal prosecution, I’m afraid, is highly unlikely. I’d love to be wrong, but the FDA rarely undertakes criminal prosecution. The most we can likely hope for is that it revokes his IND for antineoplastons and shuts down all his clinical trials forever.
I would, however, love to be wrong about this.
actually, he started this “treatment” regime back in 1977. Yeah… it has been wayyyy too long.
i wonder how much money has traded hands in this scheme during all that time.