The president of the private drug-compounding company at the centre of a diluted chemotherapy inquiry says Health Canada and regulators in Ontario and New Brunswick declined requests over a year ago to provide oversight for her company.
Marita Zaffiro, testifying before a Queen's Park committee tasked with uncovering why more than 1,200 cancer patients in both provinces were given lower-strength chemotherapy treatments, said her company first approached federal and provincial regulators shortly after winning a contract to provide the drugs to hospitals in the fall of 2011.
"Before we began to service the contract, we went both to the Ontario College of Pharmacists and Health Canada to inquire about the appropriate regulatory approval," Ms. Zaffiro said, adding later that the company also sought regulation in New Brunswick. "Both the College of Pharmacists and Health Canada declined to regulate [Marchese Health Solutions]."
Regulation has emerged as a major theme in the inquiry, as it has come to light that companies like Marchese operate in a jurisdictional grey area because they are neither drug manufacturers nor pharmacies, both of which are regulated.
During her testimony, a calm but at times emotional Ms. Zaffiro expressed doubt that regulation would have prevented diluted chemotherapy cocktails from reaching patients.
She chalked up the breakdown to a "communication issue" at hospitals, reiterating remarks she made in a written statement issued weeks ago that Marchese mixed the chemotherapy to specifications in its contract with Medbuy, a go-between firm that orchestrates bulk drug purchases for health-care providers, and that the drugs were improperly administered at hospitals.
"Hospitals were using our product in a way we had no idea," Ms. Zaffiro said.
Earlier in the day, executives from London Health Sciences Centre, where 691 patients received the treatments, testified that tests performed after questions arose about the chemotherapy showed the concentration of a main ingredient, cyclophosphamide, was 11 per cent below what was expected.
They also said they would have never procured drugs from Marchese had they known that it was not overseen by any regulatory body.
"I believe that would be a showstopper for me," said Neil Johnson, the hospital's vice president for cancer care.
Lori DeCou, spokeswoman for the Ontario College of Pharmacists, acknowledged that Marchese approached the college over a year ago, but said the college suggested the company contact Health Canada because its bulk drug mixing was "not patient specific and therefore not consistent with an accredited pharmacy."
Health Canada spokesman William Wells, responding to a request for comment by e-mail, said the agency advised Marchese about what activities would require it to apply for regulation and that, to date, no application had been made.
Mr. Wells did not specify those activities, but Health Canada has made clear that Marchese would already be in compliance with new stopgap regulations imposed this month.