From the same reporter at the Edmonton Journal who brought us yesterday’s DCA article comes news of a highly-experienced Canadian pharmacist who has been providing patients with physician-prescribed dichloroacetate. Jodie Sinnema reports that a local pharmacist has been selling DCA to patients but their supplier has stopped providing the pharmacy with the compound after intervention by Health Canada, the Canadian equivalent of the US FDA.
Ron Marcinkoski, a pharmacist at Market Drugs Medical at 97th Street and 102nd Avenue, said he was doing what he could to help cancer patients when University of Alberta professor Dr. Evangelos Michelakis phoned the pharmacy to say DCA, which shrank tumours in rats but hasn’t been tested in humans, could be lethal or cause horrible side-effects.
SInce the pharmacist has been practicing for 26 years, it’s clear that he should understand completely the drug approval process and the basic tenets of off-label drug prescribing – but apparently doesn’t:
Although Marcinkoski stopped filling prescriptions before the phone call from Michelakis — his supplier was no longer willing to sell DCA to the pharmacy after supposedly being contacted by Health Canada — Marcinkoski said he doesn’t believe he was doing anything illegal. Doctors routinely write off-label prescriptions, using a drug to treat a different health complication than it was made for.
But Michelakis, whose research was published in the medical journal Cancer Cell in January, said, “The concept of off-label use (in this circumstance) is confusing and dangerous.”
He asked how a doctor can prescribe a drug off-label when it hasn’t been approved by Health Canada for any medical treatment. It’s solely being tested on humans in clinical trials.
However, Sinnema reports that Canadian physician and pharmacy groups are aware of the issue and have taken the appropriate stance that DCA, no matter how promising it may seem from animal studies, is still an investigational drug:
Kelly Eby, spokeswoman for the College of Physicians and Surgeons of Alberta, said since the drug hasn’t been approved in Canada, physicians shouldn’t be prescribing it.
“If we were aware of physicians in particular, we would be telling them it’s inappropriate and this would have to stop,” Eby said. However, the college has no way to find these doctors and Eby said it’s up to Health Canada to decide if prescribing an unapproved drug is illegal.
Greg Eberhart, registrar for the Alberta College of Pharmacists, strongly urged his members not to fill DCA prescriptions outside clinical trials.
Understandably, the pharmacist states that he was trying to be compassionate toward patients, citing that Michelakis knew of his animal results two years ago. However, that stance is indefensible. Literally thousands of anticancer agents prove useful in animal studies, only to be found less effective and/or more toxic in human clinical trials. My oncology colleague, Orac, recently wrote on how DCA might prove ineffective against human cancers.
One would never want to deny a patient a useful anticancer drug but supplying DCA with today’s evidence constitutes giving patients false hope, not to mention that the drug’s safety has not been assessed in cancer patients. I’m also not sure about Canadian pharmacist malpractice guidelines but any pharmacist supplying DCA to patients might care to consult first with their insurance carrier.
Read the entire article by Jodie Sinnema in today’s Edmonton Journal.