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Monday 17 December 2012

NZ Boy's Death Linked to Anti-depressant - Courtesy of Website

Mylan Pharmaceuticals Admit their Drug is the Probable Cause of My Son’s Suicide

December 16, 2012

A couple of days ago, after two years of fighting, I received Mylan Pharmaceuticals assessment of the causal link between their drug Fluox and my son’s suicide. Their conclusion is identical to that of the New Zealand drug regulator Medsafe, that the SSRI antidepressant Fluoxetine is the probable cause of Toran’s death. The rating of ‘probable’ includes an assessment that Toran’s suicide was ‘unlikely to be attributed to disease or other drugs.’
I recieved two documents from Mylan. The first was a record of the adverse reaction report I made to them. It is full of errors. Critically, my son is recorded as having been 19 years old. In fact he never got to be 19, or even 18. He was 17 when he died. He was a pediatric prescription drug user, not an adult as Mylan has recorded.
The second major error is that the person who received the information I reported, recorded that Toran had been diagnosed with depression. Toran did not ever have a diagnosis of depression or any other mental disorder. At the time of his death, his medical records showed ‘diagnosis deferred.’
There are lots of other errors – the dates on which his dose was titrated, the date on which he took three times the prescribed dose and ended up in the emergency room having self harmed, the levels of glucose in his blood prior to starting Fluoxetine, while on the drug and after withdrawal.
The most shocking thing about the form though, is that despite my providing my contact phone numbers, despite my offering to provide Torans medical file and the transcripts of his inquest (in which his clinicians, teachers and others gave evidence on his adverse reactions to the drug), the recorder has finished the report by ticking the box ‘unassessible’ under the heading ‘Causality of Reaction (In the Opinion of the Reporter) which provides the options ‘possible’, ‘unlikely’, ‘unassessible’ and ‘not related’. The definition of unassessable is a report suggesting an adverse reaction which cannot be judged because information is insufficient or contradictory, and which cannot be supplemented or verified.
This makes me unspeakably angry. It takes no small emotional toll to call a drug company and recount the events leading to your child’s suicide. For my report to be dismissed so easily is insulting to me and to Toran.
Perhaps the Regulatory Affairs Team Leader mistook the word causal for the word casual.
This report was sent to Mylan’s UK office for assessment where despite the errors, notably the incorrect record of Toran having depression, the assessment was that the drug was the probable cause of his death.
The Mylan NZ report is here Mylan NZ Causality Assessment
The Mylan UK report is here Mylan UK Causality Assessment
I have written to Mylan correcting the errors in their reports and asking for an amended report to be sent to me along with an explanation of the ‘unassessible’ rating in the face of my clear offers to provide any information necessary for the assessment.
So, approaching the fifth anniversary of Toran’s death I have the following:
  • Statements from both the NZ government and Mylan Pharmaceuticals that the antidepressant Fluox is the probable cause of my child’s suicide. .
  • Denial from the Health Board where Toran was treated that he suffered any adverse reactions to Fluox
  • Admissions on oath from the prescribing psychiatric registrar and his colleague that he did not read my child’s medical file, did not check whether he had any general medical conditions or whether he was taking other prescription drugs, told him to stop and start the drug weekly, told him to drink alcohol with the drug, conducted his psych assessment in a busy public cafe,  refused to discuss treatment alternatives with me, did not advise me of potential adverse reactions and was “somewhat authoritarian and aggressive” with both Toran and I telling me to “stop reading research and trust his professional judgement” when I asked about the links between the drug and suicidality.
  • A legal environment in which the government has refused the requests of the regulator for power to require warnings on drugs or patient information leaflets to be provided with drugs
  • A Prime Minister who has refused to conduct an inquiry into why NZ has the highest rate of youth suicide in the OECD
  • A Coroner whose recommendation following Toran’s inquest was that “children should take their medication as prescribed.”
  • A police force who admit the psychiatric registrar’s actions appear to meet the ingredients of the offence of manslaughter but won’t lay charges on the grounds that ‘juries never convict doctors.’
  • A law which prevents me filing a complaint about the psychiatrist to his professional body, the Medical Council of New Zealand.
  • A Health Commissioner charged with investigating complaints of breaches of patient rights to a reasonable standard of care and fully informed consent, who has refused to investigate my complaint about Toran’s treatment.
  • A regulator who has received a causality assessment determining that Fluox was the probable cause of a child’s death but taken no action, just filed the information.
And a lawyer who is a specialist in medical negligence and is preparing a case under the New Zealand Bill of Rights that Toran’s right to life has not been upheld by the NZ government, the doctors it employs and by Mylan Pharmaceuticals.
On 20 March 2008, the medical professionals and government officials who my taxes employed and who I trusted to provide good quality healthcare to my child, squished him like a bug underfoot – and then kept on walking. While my friends give their children carefully chosen gifts under the Christmas tree in a few days time, I will stand in front of the lillies that we had at his funeral (still not ready to do a Christmas tree) and promise him that those responsible will be held accountable for his death.
The New Zealand government, Waitemata District Health Board and Mylan Pharmaceuticals should not underestimate the fury and tenacity of a mother whose child has been ripped from her arms.

Table 1

Naranjo ADR probability scale—items and score
Question Yes No Don’t know
Are there previous conclusion reports on this reaction? +1 0 0
Did the adverse event appear after the suspect drug was administered? +2 –1 0
Did the AR improve when the drug was discontinued or a specific antagonist was administered? +1 0 0
Did the AR reappear when drug was re-administered? +2 –1 0
Are there alternate causes [other than the drug] that could solely have caused the reaction? –1 +2 0
Did the reaction reappear when a placebo was given? –1 +1 0
Was the drug detected in the blood [or other fluids] in a concentration known to be toxic? +1 0 0
Was the reaction more severe when the dose was increased or less severe when the dose was decreased? +1 0 0
Did the patient have a similar reaction to the same or similar drugs in any previous exposure? +1 0 0
Was the adverse event confirmed by objective evidence? +1 0 0
Scoring for Naranjo algorithm: >9 = definite ADR; 5–8 = probable ADR; 1–4 = possible ADR; 0 = doubtful ADR.

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