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.
You’ll recall that while DCA slows the growth of human tumors grown in rats, so do hundreds or thousands of other compounds that never show such effectiveness in humans. The difference with DCA is that is an easily-synthesized small molecule in the public domain that cannot be patented. However, it is illegal to sell it as a cure or treatment for cancer, which is exactly what theDCAsite.com did via buydca.com. (In fact, it is illegal in the US to sell any chemical for disease treatment without systematic safety and efficacy testing, review of the data, and approval by the FDA). Of course, they claimed that it was for veterinary use but then gave dosing directions for a 70 kg animal (the average weight of a human used in most clinical and pharmacokinetics textbooks.).
And, of course, the conspiracy theorists are out in force, claiming essentially that FDA is seizing the cure for cancer. The truth is that we won’t know the utility (or safety) of DCA for human cancer until proper clinical trials are done. The FDA merely stepped in and prevented the sales of an unapproved drug as they are charged to do by Congress to protect the public from “snake oil” type sales approaches of the early 1900s.
As I have said many times before, I truly hope that DCA proves useful in treating cancer. However, we’ll never know the answer to that by testimonials from customers of theDCAsite.com. The University of Alberta group that first published on DCA in experimental cancer models continues to raise funds for a properly controlled and conducted clinical trial.
Until then, the sale of DCA as a self-medicating cancer treatment is irresponsible, misleading, and potentially dangerous.
And that is why the FDA stepped in.