Finally, the FDA acts on TheDCASite.com

It sure took the FDA long enough, nearly five months, but it finally acted. It finally shut Jim Tassano down, as this notice on TheDCASite.com states:

Two agents from the FDA visited us on Tuesday,July 17, 2007 and ordered that we stop making and selling DCA. Unfortunately, the site www.buydca.com will be shut down immediately.

It is against US government law to sell substances with the suggestion that they are cancer treatments unless they are approved by the FDA.

DCA can still be obtained from pharmacies with a prescription and from chemical companies.

To keep you informed and abreast of new developments and potential cancer treatments, www.thedcasite.com will continue.

Thank you for all your support.

Jim Tassano & the DCA Team

And, on the discussion boards:

Two agents (Chris and Steve) from the U.S. Food and Drug Administration’s Office of Criminal Investigations, San Francisco, arrived unannounced at about 11:30 am, on July 17, 2007 at our pest control office in Sonora California. They walked in, like men on a mission, I am told, and said “I need to speak to James Tassano”.

I wasn’t at that office. Our manager Eric called and informed me that 2 men from the FDA had come to see me. I was with Ilene, getting ready for a noon appointment. I spoke to Chris and told him I could meet him afterwards. We arranged to meet at 1:30.

Ilene and I drove down to that office, arriving 10 to 15 minutes early. The agents were standing next to their car, waiting. They were dressed in polo shirts and slacks. The four of us went into a conference room.

Chris said “this won’t take long.” He got to the point and said that we were manufacturing DCA as a cancer cure. He said something about the FDA orange book having some regulations that we had violated. 21 CFR 312, and 21 USC 321 and 352. He read a few others that went by faster than I could write.

I explained that we made no claims on the www.buydca.com site, no advertising, made no mention that we were offering DCA to treat cancer. Our site does state that it was the same material used in the University Of Alberta studies, but that was all.

However, they stated what counted was our “intent”. Since DCA is not an FDA-approved cancer drug, if our intent was to sell it as such, despite the lack of claims or statements we were in violation.

Our case had been run by the US Attorney General’s Office which recommended that we be told to not make and sell DCA. We had committed a misdemeanor, but now that we were warned, we could be cited with a felony.

We were told to stop making and selling DCA. No paperwork passed hands, either way.

The meeting was relatively brief. The agents were polite but firm. They had no interest in hearing much of anything, and did not care if it worked. They said we needed to contact the regulatory side of the FDA if we wanted to pursue anything. And that it was very costly to develop a drug. They were good ‘company men’ for the FDA.

All I can say is: What took the FDA so long?

Naturally, it didn’t take long for the conspiracy-mongering to start, particularly the comparisons of the FDA to Nazis, something so predictable and a comparison so mundane that it really wasn’t worth dragging the poor old undead Führer out of his crypt to mock. For example:

They’re full of it.
The gestapo tactics used by these “officials” are a crime.

Matter of fact, I suggest a class action lawsuit under conspiracy.

Not only are they disallowing a substance that is not illegal or harmful to have without a prescription, but they themselves have no substantiated claims that it DOES NOT act as a deterrent or aide in the positive progress against carcinomas.

[…]

You want to know the real Felon? Try the FDA and the large Medical firms around the globe… The ones that put fear into those of us who can only afford less-than-average ways to try and help ourselves.

It’s a money game. If it works, and they see it as a possible profit loss, its pretty much game over for the little guys. Maybe even population control…

3 years from now, you’ll see DCA being mass-marketed by someone like pfizer or some big-wig company making a mint off of it, while you, good sir, wont get a single red cent.

And, of course, the conspiracy-mongering started, particularly the “FDA is a tool of big pharma” sort. For example:

Of course the FDA shut down buyDCA.com – it’s because we’ve been proving that DCA is an effective cancer treatment, and they wouldn’t want Big Pharma to have AAAAANNNNYY competition now would they!!

What an infringement on the rights of the individual!! DCA is not a drug, it is a chemical. How dare they shut down cancer patients’ access to a life saving treatment!!

Talk about stupid. All drugs are chemicals. Anything chemical or mixture of chemicals that has a physiological effect on the human body (or in animals) is a drug, particularly if that effect can be used for therapeutic effect. There was plenty of paranoid conspiracy-mongering elsewhere, too:

DCA must be a hot item (it most work real good on cancer) for the FDA to restrict DCA sales. That is my guess.

No, it didn’t. At least it was not a miracle cure, and there were not even any testimonials that, when critically examined, supported its being a “hot item.” There was plenty more where that came from:

In my opinion, this is a classic example of the FDA overstepping its boundaries of “protecting” people from their own preferred medical treatments, while forcing them to return to “medically accepted,” but in my humble opinion, rather medieval methods of treatments (pick between getting poisoned, burned, or cut…. or combine a mix of each…?)…. And in so doing, the FDA protects the monopoly status of very expensive drugs that offer results that are not better, and sometimes are worse. (Note that a single infusion of Rituxan , for example, a monoclonal antibody made by Genentech, and commonly used against blood-based cancers, costs some US$10,000 each, and patients usually need at least four courses of treatment before getting some relief…. other branded chemotherapy agents are as least as expensive if not more so… and they are rarely curative…..)

No, it’s a case of the FDA finally getting off of its duff and enforcing the law.

All of this lead Heather Nordstrom (whom we’ve also met before) to make the most hilariously disingenuous statement I’ve heard in a very long time:

They came to their conclusion somehow by reading the sites and thinking that our intent was to sell for the treatment of cancer. Tha was enough “evidence” for them. Apparently we cannot sell it for the treatment of animal’s cancer either.

Of course, months ago, I provided copious evidence from the DCA Site itself that the whole “Pet-DCA” thing was nothing more than a ruse to try to provide plausible deniability in case the FDA came calling and lots of quotes from the DCA Site itself that showed that the intent was clearly to sell DCA to treat humans. Then there was all the discussion about the use of DCA on the DCA Site forums, facilitated by Jim Tassano and Heather Nordstrom. Come on, Heather, just how stupid do you think people are? Even if the FDA were as clueless as you think it is, you and Jim made it exceedingly obvious that you intended to sell this stuff to humans to treat human cancer. Jim even said so himself in at least one interview, oh-so-piously assuring the interviewer that it would be wrong not to be upfront about what he is doing. Now that you’re busted, you’re not only whining, but you’re lying about your original intent. Clearly Heather has nothing but contempt for anyone who supports evidence-based medicine and might read this.

Most frighteningly, one commenter suggested buying DCA from Sigma Chemical Company. This is not a good idea at all, given that this is not pharmaceutical grade DCA. Very likely, it won’t be completely neutralized to pH 7.0 in solution, and you don’t know what other impurities it might have in it.

I certainly hope that DCA turns out to be a highly effective cancer treatment. Unfortunately, most of the testimonials on the DCA Site were, when critically examined, negative, nothing more than wishful thinking, while the ones that seem as though DCA was effective were probably a classic case of attributing the “cure” to DCA when taking all sorts of other conventional anticancer therapy and alternative supplements, although it’s certainly possible that DCA was synergistic with conventional therapy in this case.

I also hope that you and I played some small role in bringing this about when I urged you all a few months ago to file complaints with the FDA about The DCA Site. The denizens of the site are correct about one thing, though. Even though Tassano’s operation has been shut down, it’s virtually certain that someone somewhere (presumably in a country with more lax drug regulations) will set up shop again and start selling the stuff. The best way to help cancer patients is not to try homebrew chemotherapy drugs on them without medical supervision. (And make no mistake, DCA is chemotherapy.) Rather, it is to make sure through well-designed randomized clinical trials that the drugs we propose to give them are actually effective against their cancer before subjecting them to their potential toxicities.

My only regret is that Jim Tassano got away with just a warning. He should have been hit with a big fine at least or even given a jail sentence. On the other hand, doing so would have created a martyr to the cause; so maybe it’s better this way.

All Orac posts on DCA:

  1. In which my words will be misinterpreted as “proof” that I am a “pharma shill”
  2. Will donations fund dichloroacetate (DCA) clinical trials?
  3. Too fast to label others as “conspiracy-mongers”?
  4. Dichloroacetate: One more time…
  5. Laying the cluestick on DaveScot over dichloroacetate (DCA) and cancer
  6. A couple of more cluesticks on dichloroacetate (DCA) and cancer
  7. Where to buy dichloroacetate (DCA)? Dichloroacetate suppliers, even?
  8. An uninformative “experiment” on dichloroacetate
  9. Slumming around The DCA Site (TheDCASite.com), appalled at what I’m finding
  10. Slumming around The DCA Site (TheDCASite.com), the finale (for now)
  11. It’s nice to be noticed
  12. The deadly deviousness of the cancer cell, or how dichloroacetate (DCA) might fail
  13. The dichloroacetate (DCA) self-medication phenomenon hits the mainstream media
  14. Dichloroacetate (DCA) and cancer: Magical thinking versus Tumor Biology 101
  15. Checking in with The DCA Site
  16. Dichloroacetate and The DCA Site: A low bar for “success”
  17. Dichloroacetate (DCA): A scientist’s worst nightmare?
  18. Dichloroacetate and The DCA Site: A low bar for “success” (part 2)
  19. “Clinical research” on dichloroacetate by TheDCASite.com: A travesty of science
  20. A family practitioner and epidemiologist are prescribing dichloracetate (DCA) in Canada
  21. An “arrogant medico” makes one last comment on dichloroacetate (DCA)

Posts by fellow ScienceBlogger Abel Pharmboy:

  1. The dichloroacetate (DCA) cancer kerfuffle
  2. Where to buy dichloroacetate…
  3. Local look at dichloroacetate (DCA) hysteria
  4. Edmonton pharmacist asked to stop selling dichloroacetate (DCA)
  5. Four days, four dichloroacetate (DCA) newspaper articles
  6. Perversion of good science
  7. CBC’s ‘The Current’ on dichloroacetate (DCA)