B.C. health ministry firings caused delay in Accutane-pregnancy study

B.C.'s Minister of Health Terry Lake confirmed Tuesday that the release of a study into birth defects caused by pregnant women taking Accutane was delayed while the province dealt with the firing of eight pharmaceutical researchers. 

The study — commissioned by Health Canada — was published Monday. It concludes that many women continue to become pregnant while taking the acne-fighting drug, even though Accutane is known to cause serious harm to a fetus.

The study, which contained these warnings to women, might have been published sooner, according to the company that conducted the study, but researchers were forced to wait for information from B.C.

Those researchers had to wait because the B.C. government locked down its public health data after its firing of eight pharmaceutical researchers in 2012

Lake said the province only delayed the data by six months; but the study's author says these delays caused the study to be held back for a full year.

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That information couldn't be released until the provincial government concluded its investigation into the firings of the health workers over a medical data breach.

"While we were making those changes we could not provide access to some researchers," said Lake. "We had unsecured, unencrypted data on flash drives and that was against ministry policy.

"We needed to have a bit of a lock down to make sure we secured the information."

He added, "This was not a study that was directly linked to patient outcomes, it was to see if the physicians followed the recommendations.

"B.C. was only one of the provinces being studied. If they had gone ahead without B.C., perhaps the findings would have been the same, I don't know."

Research 'fundamentally damaged'

But the B.C. New Democrats say the province put pregnant woman at risk by delaying the data release.

If the information had been published when it was originally requested — in October 2013 rather than in June 2014 —more Accutane users may have been aware of the potential risks of taking the drug, said NDP MLA Adrian Dix.

"The Ministry of Health knew what the study was about, knew what was the significance was especially for women and decided to do that," Dix said.

"What it means is the health ministry scandal fundamentally damaged health research."

'We really needed the data,' says researcher

Dr. David Henry, lead author of the study that looked into Accutane and pregnancy, has made a direct link between the health research firings, the subsequent lockdown on health data collected in the province and the delay of his study.

He told On The Coast host Stephen Quinn, "The reason we waited for the British Columbia data is we really needed the data."

"British Columbia has a very comprehensive drug coverage program, unlike all the other Canadian provinces, and they collect very, very good data," Henry said.

"Really, the study without the British Columbia data, would not have been nearly as informative."

He says the data, once received, did not show any major variations from other data in the study, which looked at 15 years of Accutane use. But the researchers still had to wait for the data to complete the study.

And even though he eventually received the Accutane data, the process for accessing health data in B.C. is "significantly slower" than in other provinces.

"It means we've had to do other studies without British Columbia data, quite important studies, on incretin drugs that are used in diabetes, some of the anti-coagulant drugs that are used in cardiovascular medicine … because it just takes too long," he said.

Henry says for national drug safety studies, a timeline of three months would be appropriate for getting data from B.C., instead of the now-usual six to nine months.

With files from CBC Radio One's On The Coast