The Australian – Australia’s only national newspaper
Cure worse than the ill
Julie-Anne Davies | March 20, 2008
HOW sad, stressed or downcast does a teenager have to be before they are diagnosed as depressed and prescribed anti-depressants?
Not very if you believe 16-year-old Melbourne schoolgirl Hannah Mulcahy and her mother Nicola. According to the Mulcahys. Hannah became suddenly mentally ill and suicidal after taking the antidepressant Zoloft for just four days in September last year.
She wound up in the adolescent psychiatric ward at the Royal Children’s Hospital. She was given Prozac and the sleeping drug Stilnox and her condition deteriorated further.
It was only after Nicola Mulcahy took her daughter home and threw away the pills that Hannah began to recover.
Now her mother is suing the doctor who originally prescribed the antidepressant because, she says, not once did this doctor or any of the other doctors who treated her daughter ever explain that sometimes the cure can actually be the problem.
The case, believed to be the first of its kind in Australia, begins today in the Victorian Civil and Administrative Appeals Tribunal.
Hannah, a high-achieving student with an ambition to work for the UN, was taken to GP Vanessa Haler at the Peninsular Women’s Health Centre in outer Melbourne last September because she was feeling “stressed out”. Her menstrual cycle was irregular, she was suffering from headaches and had trouble sleeping.
The doctor wrote in a letter to Hannah’s school that in her opinion the teenager had “depressive and anxiety symptoms and some hormonal imbalances”. She prescribed a 25mg dose of the anti-depressant Zoloft. Five days later she told Hannah to double the dose.
“I never got to do that because on the fifth day I flipped out,” says Hannah. Her mother takes up the story because from this moment and for the next six weeks Hannah was very sick.
The night she first “lost it” the police were called and Hannah was taken to the emergency department of the Royal Children’s Hospital by ambulance. She was discharged a few hours later. “The next day she drank 454mg of eucalyptus oil, grabbed a knife and ran up our hallway threatening to kill herself,” Nicola Mulcahy says.
She wrestled her daughter to the ground and rang the ambulance again. Hannah was admitted to Banksia House, the adolescent psychiatric unit at the Royal Children’s Hospital.
Over the next five weeks there were six suicide attempts and many arm-slashing episodes. Today, in Melbourne’s blistering late summer heat, Hannah wears a sports bandage over her left arm because “I can’t bear for people to see what I did”.
Everyone agrees Hannah was mentally ill. Where the doctors at the Royal Children’s Hospital and the Mulcahys part company is what provoked it.
Nicola Mulcahy is convinced her daughter’s illness was caused by the drug Zoloft and then exacerbated by the commonly prescribed anti-depressant Prozac, that the doctors at the RCH gave Hannah after she was admitted.
It has been a difficult few months for Big Pharma, as the world’s drug companies are collectively labelled.
First, Australia’s drug regulator, the Therapeutic Goods Administration, slapped a blackbox warning – the strongest warning applied to medicines in this country – on the sleeping medication Zolpidem, better known as Stilnox.
This is the drug that approximately 250,000 Australians have been taking for a number of years, blissfully unaware until now that it can produce some bizarre and dangerous sleep-related behaviour.
These include sleep walking, sleep cooking and even sleep driving. It was also one of the drugs Hannah Mulcahy was given without her mother’s consent in the RCH, according to her medical file.
Just days after the TGA/Stilnox intervention came the findings from a British-led team of researchers that Prozac and three of its selective serotonin reuptake inhibitor (SSRI) cousins were no more effective than a placebo in treating all but the most severely depressed patients.
Hannah Mulcahy’s case is unusual because her mother is prepared to go to court. But this teenager is not alone in being prescribed anti-depressants.
Of the more than 12 million SSRI antidepressant scripts subsidised by Australia’s Pharmaceutical Benefits Scheme last year, 224,792 were for children and teenagers aged 10 to 19 years.
These are conservative figures. They do not include children under 10 years old who also are being prescribed anti-depressants or, cautions Medicare Australia, the very large number of private prescriptions issued by doctors for anti-depressants that fall below the PBS co-payment threshold – which accounts for most of the SSRI drugs.
“We simply don’t have the numbers to get the big picture of what’s going on out there,” a Medicare Australia spokesman says.
Jon Jureidini, head of the Department of Psychological Medicine at Adelaide’s Women’s and Children’s Hospital, says when you consider that none of these medicines have been approved by Australia’s drug regulator, the Therapeutic Goods Administration, for use in the treatment of depression in children or adolescents, then that adds up to a lot of guesswork.
Gordon Parker, executive director of Sydney’s Black Dog Institute, says diagnosing the type of depression in children can be an imprecise and complex science but it is critical if we are to avoid unnecessary and potentially dangerous drug prescribing.
“I am a horses for courses man myself and I believe that biological depression which may warrant drug intervention is extremely rare in children.”
Parker has prescribed SSRIs to only one child in the past 10 years, yet says he is not part of the “negative bandwagon”.
He does prescribe the drugs to adults and sometimes to teenage patients over 16. “But I always tell them that if they become agitated or anxious in any way to stop the drug dead.”
Parker says the present media focus is overly weighted to reporting negative issues related to SSRIs.
This is as much to do with the initial “oversell” by the drug industry in the 1990s. The miracle cure stories and the tell-all books by celebrities extolling the transforming nature of SSRIs followed soon after. But the hoopla began to wane in 2004 following the results of an extensive analysis of clinical trial data by the US Food and Drug Administration which indicated children taking these antidepressants had about a 4 per cent chance of developing suicidal thoughts or behaviour, compared with only a 2 per cent chance in children taking a placebo.
In 2005 the TGA in Australia forced drug manufacturers to include a warning in their product information stating that SSRIs could increase the risk of suicidal thoughts and behaviour in children.
In the past few years there has been a slight drop off in rates of prescription to children, but Medicare warns to treat this apparent decline with caution. Jureidini argues there are undoubtedly plenty of doctors, notably GPs, who scribble off a script but who are not particularly rigorous in monitoring their patients’ progress down the track.
At Nicola Mulcahy’s instigation, the hospital conducted an internal investigation into Hannah’s treatment. That review, obtained by The Australian, includes an admission by the hospital that it needed to update the drug information provided to parents and patients because it does not include the most serious side-effects – suicidal ideation and self harm – that the TGA in 2005 insisted drug companies include in their product information. The hospital insists Hannah’s mental illness was not a reaction to anti-depressants and as such had not initially reported it as an adverse drug reaction to ADRAC.
Later the hospital says it did notify ADRAC that Hannah had suffered high blood pressure because of the anti-depressants.
Peter Birleson, the RCH’s director of mental health services, mounted a strenuous defence of Prozac in his internal review of Hannah’s case. “Because fluoxetine (Prozac) is used to treat depression and suicidal behaviour, there has been controversy about whether it really does increase suicidal thinking or behaviour, or whether any associated suicidal thinking is caused by the depression,” Birleson wrote in his report. “There has been debate between psychiatrists but the majority of psychiatrists consider that there is an increasing evidence that fluoxetine works.”
The Citizens Commission on Human Rights, a lobby group opposed to anti-depressant therapy, has been tracking the adverse reaction reports for these drugs.
“The reports read like a horror story,” says Shelley Wilkins, executive director of the CCHR. “Too often parents are not told about the side-effects. Parents have a right to know and if they were told anti-depressants can cause suicidal behaviour, heart problems, convulsions or even death, there would not be one child on anti-depressants in Australia.”
Medicare figures shows that since 1990, when Prozac first appeared on pharmacy shelves, there has been nearly 10,000 reports of suspected adverse reactions to SSRIs received by the Australian Adverse Drug Reactions Advisory Committee.
Of those, 449 relate to children aged up to 19 years. The most frequently reported reactions in children and teenagers include nausea, headache, agitation and suicide attempts. There were two reports of suicide.
Nicola Mulcahy believes she’s fighting a lone crusade in trying to force the medical establishment to rethink how they communicate with parents of mentally sick kids.
But last week in the US, New Jersey legislators passed a law which requires informed consent from a child’s parent before a doctor can write a prescription for any psychotropic drug that carries a black box warning. It comes after a year-long fight by two mothers who have argued that informed consent is the only way to make sure information is passed from doctors to patients.
Their particular concern is that side-effects, such as suicidal behaviour and thoughts that are linked to antidepressants can be misconstrued as part of the illness.