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U.S. bureau looking into unapproved cancer drug

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http://www.canada.com/nationalpost/news ... 8d&k=68890

FDA will not confirm if it is investigating buydca.com site

Jodie Sinnema, CanWest News Service

Published: Tuesday, March 20, 2007

EDMONTON - The fraud division of the U.S. Food and Drug Administration is looking into concerns that an American entrepreneur and chemist are selling an unapproved compound to people fighting cancer.

The FDA wouldn't say if there is an actual investigation into the buydca.com Web site, but in general, if the agency learns about something unsafe or illegal, it moves swiftly to take action and protect the public.

Last week, the University of Alberta researcher who discovered dichloroacetate or DCA shrank tumours in rats warned people they could die if they took DCA.

Even though the owners of buydca.com are marketing the compound as an experimental treatment for pets with terminal cancer -- and clearly specify the DCA powder is "not for use by humans" -- the FDA spokesperson said that doesn't mean the Web site creators can skirt regulations.

As a basic rule, anything sold as drug products for use in humans requires FDA approval.

Neither the FDA nor Health Canada has approved DCA for use in humans, though the University of Alberta's Dr. Evangelos Michelakis hopes to begin clinical trials in cancer patients this spring.

Health Canada spokesman Alastair Sinclair said his department isn't investigating the use of DCA by hundreds of desperate cancer patients, self-medicating after buying the compound from the States or getting local doctors to write off-label prescriptions (using a drug made for one health problem to combat another).

Mr. Sinclair said Health Canada only looks into drugs if a company approaches the department to seek market approval.

David Gorski, a cancer surgeon of eight years and surgery professor in New Jersey, said the DCA controversy is a case pitting the needs of the many against the needs of individuals, and safety against speed.

"If it's not tested properly, we would never truly know if it would work," said Mr. Gorski, noting individual testimonials about effective treatment doesn't serve the public nor prove anything.

Jim Tassano, the man selling DCA through his Web site, said his motives are honest and pure. He said he's contacted the FDA to work with them and said in one or two months, he suspects people will come forward with X-rays, showing their tumours have shrunk.

So far, his biggest result is a 175-pound Rottweiler whose tumours began weeping within five days of treatment. No new tumours have formed, Mr. Tassano said.

"In a way, I see that as the first actual person," Mr. Tassano said. "No one can claim tumour shrinkage yet. It's too early ? [but] it's a question of a person's right to life."

Dr. Michelakis and researchers discovered that a simple molecule, used for decades to treat children with rare metabolic diseases, commits "immortal" cancer cells to a natural death. The researchers found DCA causes regression in several cancers, including lung, breast and brain tumours.

DCA, a non-toxic compound comprised of "a couple of oxygens, a couple of chlorides and a couple of carbons," appears to repair the damage that cancer cells cause to mitochondria -- the energy- producing units in cells.

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