Critical research required for a national study on birth defects caused by pregnant women taking an acne medication was delayed by at least one year because of the B.C. government's botched firing of a group of pharmaceutical researchers, the study's lead author says.
The warnings, contained in a medical report published Monday, would have been issued earlier, but researchers had to wait for the B.C. government to conclude an internal inquiry into its firing of eight workers over a breach of medical data.
David Henry of the Canadian Network for Observational Drug Effect Studies said in an interview the study was sidelined by the B.C. health firings. The study found that one or two children are born in Canada every year with preventable birth defects as a result of isotretinoin treatment – a drug also known by the brand name Accutane – because some women of child-bearing age are not being properly warned about the dangers of the drug.
"We want to change practices, we want to make doctors and pharmacists and patients more aware. During that year, unquestionably there were women becoming pregnant while on the drug," Dr. Henry said in an interview. "We would have liked to have got the warning out earlier."
Researchers examined health data for female patients between 12 and 48 who were prescribed isotretinoin from 1996 to 2011 in B.C., Saskatchewan, Manitoba and Ontario.
The B.C. government suspended the transfer of medical records related to the Accutane project in September, 2012, when it fired a group of health researchers, some of whom had been contributing to the study.
Last December, the province settled a wrongful-dismissal lawsuit with two of the health researchers who were swept up in the mass firing – the final settlement that cleared the way for an independent investigation that could explain why the government overreacted to a data breach. The other workers were either rehired or received settlements, except junior researcher Roderick MacIsaac, who killed himself after being interrogated by government officials and fired just two days before the end of his student co-op term.
The investigation by the provincial ombudsperson, Jay Chalke, is not expected to be complete until the fall.
New Democratic Party MLA Adrian Dix, who has championed the cause of the workers over the past three years, raised the impact of the firings on the Accutane study on Monday, the day the results were published in the Canadian Medical Association Journal.
By blocking access to the researchers and data, he told the legislature, the government put patients' health at risk.
"We know the consequences of this for women in British Columbia, in Canada, were serious," Mr. Dix said.
"The government damaged the completion of this important report with their incompetence in the health firings matter. … This was one of the consequences of the health researchers' scandal that is less understood – the damage done to the capacity of the Ministry of Health's ability to do research, and to the people who benefit from that health research."
Health Minister Terry Lake defended the government's actions, saying ministry officials were responding to a serious concern of a breach of confidential medical information.
"There were 20 information-sharing agreements, with the researchers and a number of organizations, that had to be suspended while an investigation was conducted … We did what we needed to do to ensure the privacy and confidentiality of medical health information in the province of British Columbia," he said. "That resulted in some access delays; there's no question."
Dr. Henry said the study could not be completed without the B.C. researchers and their access to patient data which, he stressed, was anonymous.
"Obviously we were frustrated because we needed the British Columbia data. The study itself was to do with the safety of babies, whether they are being affected by a drug … The data was so good, so complete in British Columbia, we couldn't do it without them."
B.C. health officials said Monday the report confirms that doctors and pharmacists should be discussing the risks of pregnancy with patients taking Accutane, whenever the drug is prescribed.