The first official recognition that changing brands of epilepsy drugs may have been a factor in at least one of six deaths has come to light as a Chief Coroner's inquest into the brand switch opens today.
A neurologist's report to the Coroner says changing brands of the anti-seizure drug lamotrigine could not be ruled out as a factor in the death of 31-year-old Auckland man Andre Maddock in December last year.
But how much of a role the brand switch played in the deaths of Maddock and five other people with epilepsy looks set to be hotly contested at the inquest, with initial reports to the coroner showing it was unlikely to have been a major factor in several of the other deaths.
Maddock's death left his partner Nadia Jooste on her own with their young son Lucas and with a huge hole in their lives.
"It's been okay, on some days. But then on the days when Lucas really needs that role model, that father figure, it hits me a little bit more. And then that brings that whole emotion of how unfair the death of a loved one is," Jooste said.
More than 10,000 people with epilepsy were forced to switch brands of lamotrigine from the Lamictal and Arrow brands, that 90 percent of them were on, to a generic form of the drug called Logem.
Drug buying agency Pharmac aimed to save $30 million over five years, freeing up money to spend on other drugs, but made the lamotrigine switch against the advice of MedSafe, which said switching brands posed a safety risk.
"I am angry because it's like a choice that was taken away from everyone that got switched. It was like someone wanted to save money so they gave a cheaper, generic drug," Jooste said.
A report by neurologist Elizabeth Walker said the brand switch could not be excluded as a factor in Maddock's death.
But she said the most likely cause was an increase in the dosage of the drug, which coincided with the brand change.
RNZ has seen neurologist's reports on two of the other five deaths and both say the brand change was unlikely to have been a factor.
The inquest will focus on the safety risks of changing between brands of epilepsy medicine, rather than suggestions that any one of the drugs is inferior.
Documents that have been prepared for the inquest included a report from Otago University Associate Professor Natalie Medlicott, an academic pharmacist, who said there was a risk of reduced control of epilepsy when patients switched brands of lamotrigine.
This was because lamotrigine was a drug with what was known as a narrow therapeutic range - meaning that small differences in the dose could have significant impacts.
A submission prepared by Medsafe for the Chief Coroner's inquest made a similar point, outlining why the medicines safety watchdog opposed Pharmac's brand switch.
It said while most generic medicines could freely be substituted, a small group of medicines should be prescribed by brand because they had a narrow therapeutic window and some anti-epileptics fell into this category.
"There are a few patients who experience a clinically-difference in the amount of active ingredient reaching the blood," the Medsafe submission said.
"For anti-epileptic medicines a change in the blood level of the active ingredient can result in significant adverse events for the patient."
Cynthia Sharpe, a pediatric neurologist, provided a sworn statement saying she had serious concerns that the brand switch could have played a role in the deaths.
Patient advocate Arabella Gubay, whose daughter has epilepsy, said that the number of reported adverse side effects increased 30-fold after the brand switch and the number of deaths doubled.
"The coroner holds a decade of data showing that in this group of patients with epilepsy taking lamotrigine, there were an average of three deaths a year for roughly the 10 years before the switch. Post switch we are aware of at least seven deaths in the first year."
Pharmac said the Logem brand of lamotrigine was widely used around the world, was entirely safe and stressed that if people were using the drug today they should not stop taking it.
But despite the controversy, RNZ can reveal that Pharmac considered another brand switch of epilepsy drugs in August this year.
"The fact that Pharmac were putting epilepsy drugs on the table for further switches is an outrage and it shows that the Ministry of Health urgently needs to step in and implement the international brand switching guidelines and insist that pharmac follow them," Gubay said.
Pharmac quietly shelved the proposal after opposition from Epilepsy New Zealand.
"We said we weren't happy that those epilepsy drugs were included and Pharmac removed them, so we were very pleased with that," Epilepsy New Zealand chief executive Ross Smith said.
Nadia Jooste said she was pleased to at least get her day in court, as she faced a second Christmas without Andre.
Like the other relatives, she didn't yet know what role, if any, the brand switch played in her partner's death, but she felt the patients were not able to make an informed choice.
"If they're going to change the drug, you make sure that they sign on the dotted line that they understand the side effects," she says. "It's just giving someone the choice. The choice was taken away from these loved ones that have passed away."
The inquest opens this morning in the Auckland District Court.