Terra Sigillata

Orac has the complete story but the FDA has finally shut down sales of dichloroacetate by theDCAsite.com and buydca.com run by Jim Tassano and Heather Nordstrom.

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.

Comments

#1 Robert Smith
July 21, 2007

Yes, and in the years the dca trials have been NOT done, because no drug company will touch a compound whose patent has ran out, 500,000 more Americans a year DIE. In a free country, people are supposed to be able to fight to live. The FDA takes away that right, because the FDA is nothing more than the drug companies proxies. They have a revolving door between drug companies and the FDA and its always spinning. Your advocacy for the status quo is the refuge of a coward.
#2 S.o.G.
July 22, 2007

Robert, do you really want to live in a world where anyone can sell remedies and make any claims for them thy want without being held to any standards for the validity of those claims?
#3 Craig Hunt
July 22, 2007

I wrote to the FDA with this comment:

“I bought DCA from buyDCA.com and had it tested by a chemist. He found that it was more impure than the industrial grade DCA I bought from a major US supplier.”

I had also shared this information with buydca.com as well.
#4 David Boothman
November 10, 2007

I was amused by S.o.G’s comment. I thought I was already living in that world or have I been mislead by false news about Chinese products. It seems few people know that that many vitamins and drugs and food ingredients are now available only from China sources. Even food manufactures often don’t know the source of their ingredients. China has similar safety and quality systems to ours but the difference is in China they get trumped by the old communist management structure which is corrupt. The pet food scandal in which the FDA showed just how powerless and ineffective it is, was even unable to get visas to go to China to investigate. The result was thousands of dead and permanently injured pets. The cause was white flour to which is added the eqivalent of ground up counter laminate and pool chemical in order to make the mixture behave like high protein wheat gluten when tested. This has been routine for years in China and contiues today. Its also a factor in the the food fed to farmed fish. So if you eat farm raised fish does it matter?
#5 Kathleen
February 1, 2008

I understand the FDA also has the ability to fast track drugs that appear to hold promise. Why has this not been fast tracked with results as promising as the Canandian research indicates it might be? I fully understand that the drug may have some side effects….I propose to you that GBM’s and other cancers have fairly serious side effects as well, almost always leading to death. Even if a patient experienced kidney problems, one can live without one or even two kidneys. One cannot live without a brain. Failure by the FDA to fast track trials or studies that might save human life sounds to me like a failure to serve those who need serving the most, without delay.
#6 Abel Pharmboy
February 2, 2008

Hi Kathleen, that’s a very interesting point. FDA can fast-track drugs regardless of patent position but the drug has to have a corporate or govt sponsor. However, I do know that NCI will support the development of promising drugs that are unpatentable. I’ll check into whether any at NCI is taking a look at DCA – good question.
#7 houswife-turned-caregiver/researcher
February 10, 2008

Please hurry it up, Abel. Standard cancer therapies are not working and sugeries are now exhausted for a 39 year old man previously healthy (never a cold, rarely a fever).
You cannot imagine what it is like to tirelessly research alternative and complementary medicine as well as clinicial trials day in and day out. An aggressive fast-growing rare cancer is outrunning doctors’ and my efforts.
#8 owlafaye
September 4, 2008

I live in the US…where can I purchase DCA?

owlafaye@yahoo.com
#9 Ashley Winsor
November 27, 2008

DCA is in clinical trials in edmonton as we speak. they began in september or october of this year. an update on the university website for donations for thier research says that “We are very encouraged by these early results, and are now preparing to initiate additional clinical trials, in Edmonton and in collaboration with other Universities in around the world.”

there is also a clinic in Toronto, Ontario that is reporting a 60-70% sucess rate in shrinking the various tumors they’ve tested it on in humans. but alas they are gettign a slap on the wrist b/c it’s not an official trial and they are not oncologists. damn them for trying a drug that is working but not approved yet.

This research is totally dependent on donations b/c this drug is not patentable. please donate to their research they really do need it. here’s the website for the U of A for their research http://www.depmed.ualberta.ca/dca/
#10 James Howell
February 3, 2009

My son, Gabriel Michael Howell (2 1/2 years old), is given but a few more months to live from cancerious tumors…where can I find/get this drug?

jhowell211@yahoo.com
#11 am
March 5, 2009

DCA dichloric acetic acid is essentially vinegar. go to the supermarket and buy some for a dollar!
#12 Eddie
August 4, 2009

What kind of vinegar?
#13 David Payne
September 14, 2009

when my ECA cancer markers dropped in stage 4 colon cancer after chemo and maintaining a 4.2 range I decided to try DCA. 2 weeks later ECA was down to 2.1. Since last cancer treamtment nueropathy was bad I quit for a month. No change in neropathy so I am resuming at a reduced rate of 1/4 teaspoon 3 times a week. Since my diagnosis was incurable after surgery for the grapefruit size colon tumor which had mastisized in liver, heat and lung attachment and lymph nodes what do I have to lose. I feel great right now. If a onclolgist reads this and is interested with working with me on the Dca approach email me, as my cancer center is dropping my insurance provider the fist of the yr.
#14 David Payne
September 14, 2009

PS. Jim Tassano has been a great help and I did not buy DCA from him as the illustrious FDA had already shut his sales down.
#15 Michael Twombly
September 16, 2009

David, I too am suffering Stage 4 colon cancer with over 100 tumors in my lungs. I am about to begin a clinical trial at Dana-Farber in Boston but I have little faith in it. I’m running out of time and am determined to try DCA even as I do the clinical trial. I would greatly appreciate any advice you may have regarding sources, dosage, etc.