**The original title of this post has been changed due to some late developments. It was to be entitled, "Mylan Leave Grief-Stricken Mother in Limbo" - But as you will see, events over the past few days have took a startling u-turn... I hope.
When Maria Bradshaw's son, Toran, killed himself, part of his mother died too. I should know, I see it on a daily basis. The distant stare, the tears, the anguish - none of which will ever subside.
Here we have a 17 year old boy let down by the mental health system here in New Zealand, prescribed Fluox, the generic form of Prozac, without actually being diagnosed with a 'mental illness'.
Told by a psychiatric registrar [trainee psychiatrist] to cease taking Fluox at the weekends so he could enjoy up to six bottles of beer then restart his medication again come Monday was, to put it mildly, a faux pas considering alcohol is banned in minors. **Toran's medical records show that the trainee psychiatrist had made a note that he had told Toran he could drink up to six beers.
His suicide, whilst under the care of Waitemata District Health Board was never reported to CARM (Center for Adverse Reactions Monitoring) - it was Toran's mother that painstakingly filled out the adverse reaction report - just as well as CARM found that the probable cause of death was due to the Fluox he had ingested [Fig 1] - Fluox has been known to cause suicidal thoughts and completion in those taking it, particularly adolescents. I've previously wrote about the way adverse reactions are sent to CARM here.
|Fig 1 - Click on image to enlarge|
Above is the CARM assessment sent to Toran's mother. You will note key points highlighted, by me, in yellow. Top right assessed the reason for use, in other words why was Toran prescribed Fluox? There was no reason given because Toran was never diagnosed with a 'mental disorder'. You'll also note 'Outcome' "Died, drug may be contributory". Finally, 'Reactions' and the relationship to the drug he was taking is marked as "probable".
To be defined as 'probable', according to the standardised case causality assessment used by the World Health Organization, [WHO] is explained below. [Fig 2]
|Fig 2 - Click on image to enlarge|
|Fig 3 - Click on image to enlarge|
One could argue that CARM's assessment could have been 'certain' but, perversely, to prove this Toran would have had to have died twice to return a cause of death by Fluox as 'certain'. Even CARM, as good as a job they are doing, have some flaws in their assessment process.
If all of the above wasn't enough, the inquest into Toran's death resulted in the extremely rare occurrence of the Coroner making 'adverse findings' against Waitemata District Health Board but the Coroner Dr Murray Jaimeson, who had not seen the CARM assessment, made a final recommendation that “children should take their medication as prescribed.” A strange finding given Toran was taking his medication as prescribed, as his toxicology tests showed. A less than satisfactory result for Maria Bradshaw considering the inquest, in which she faced 7 teams of lawyers arguing that the treatment Toran received had nothing to do with his death, meant she lost her house, car and job.
The CARM assessment clearly shows that based on probability Toran's medication, manufactured by Mylan and prescribed by a trainee psychiatrist, caused his death
Is there a lawyer in the house?
Ironically, there is...or at least there was.
|Dr Luigi Palombi|
Toward the later part of July this year Maria Bradshaw received a phone call from a Dr Luigi Palombi, he told her he was the lawyer representing Mylan New Zealand, the manufacturers of Fluox. Maria had previously asked Mylan New Zealand for documents relating to the death of her son, namely the report they had filed to CARM and any other documents pertaining to her son and their drug. Astonishingly, Mylan New Zealand told Maria Bradshaw that she needed a court judgement to prove that she was the legal representative of Toran, a judgement that costs in the region of $900.
Palombi, who holds degrees in law and economics from the University of Adelaide, Australia, was, initially sympathetic and apologised on behalf of Mylan New Zealand. He also informed her that the documents she requested would be sent to her and also agreed to travel to Auckland to meet with her in September. Bradshaw told me, "When I told him I would like to discuss the fact that Mylan's products do not have any warnings on them and do not contain patient information leaflets he expressed shock that this was the case."
It's October now, spring is kicking in here in New Zealand but neither Mylan or Dr Luigi Palombi have delivered.
I wrote to Palombi to ask him the following:
Can you, for the record, confirm that a conversation took place between yourself and Miss Bradshaw on the telephone. Could you also confirm that you;
a; apologised on behalf of Mylan.
b; made assurances that Miss Bradshaw would not need a court order for Mylan to release documents to her.
c; arranged to meet Miss Bradshaw in Auckland this September.
What followed was a series of bizarre emails from Palombi. Repeatedly he avoided any of the questions I had put to him, repeatedly he told me, "On August 3, 2012 I ceased being an employee of Mylan."
At the end of our correspondence I informed Palombi that I would be using our emails in this blog post of mine. Palombi deemed it "inappropriate" for me to use our correspondence, this after, once again, telling me that he ceased working for Mylan on August 3rd.
Something very odd is going on here.
A lawyer representing a pharmaceutical company telephones a grieving mother in late July, apologises for the way that same pharmaceutical company have treated her, agrees to meet with the same grieving mother then days later no longer works for the pharmaceutical company?
Palombi, at the very least, should have informed Maria Bradshaw when he left Mylan. Okay, he wasn't duty bound and had no legal requirement to do so but surely common decency on a humanitarian level should have prevailed here.
By making initial contact with Maria Bradshaw Palombi showed that he had the ability to show empathy toward the emptiness and sorrow another human being was feeling, kudos to him for that. His departure from Mylan should not have meant that he completely disassociate himself from the promises he made to her, at the very least he could have made the effort to contact Maria Bradshaw to explain reasons why no such meeting between him and her could take place and the records that were promised to her were not being released by Mylan.
Maria Bradshaw will continue to seek what Mylan hold, their reluctance to release would suggest that they are withholding information because it may damage them in some way.
As for Palombi's short term representing them on a legal level, the plot thickens. Shortly after his phone conversation with Maria Bradshaw, Palombi flew from Australia to the United States to meet with executives at Mylan's HQ.
It's unknown whether Palombi was fired, resigned or... just wasn't needed anymore. Either way Maria Bradshaw's quest for the truth remains in limbo and Mylan continue to request that she prove that she is Toran's legal representative by paying $900 for a signature from a Judge, this despite Maria Bradshaw holding Toran's blood samples, closing his bank accounts and arranging his funeral and that both the New Zealand government and judiciary have always accepted that as the mother of a minor child, Maria is undoubtedly his legal representative."To pay money for evidence that I am Toran's legal representative would mean a precedent would be set and I don't wish for any other person to have to go through that", Bradshaw told me.
Mylan executives should be utterly ashamed of themselves for treating a human being this way. Palombi has now apparently washed his hands of the matter. His last email to me reads:
Dear Mr Fiddaman,The Mylan US website boasts the following:
It is inappropriate for you to draw any inference of any kind from my responses to you.
I am unable to be of any further assistance since I no longer work for Mylan.
We understand that "it's not about us" – it's about helping others – and we believe there's no situation we can't handle. We would do whatever it takes, work 'round the clock, cross any river and spare no effort – all to meet someone’s need.
I'd suggest that it is very much about Mylan and not about helping others and that the only river Mylan's top paid executives dare to even tread is the great Egyptian one called Denial.
Hold the front page.
Yesterday CEO of Mylan NZ, Lloyd Price, contacted Maria Bradshaw and told her that he had spoken with Luigi Palombi and denied that Mylan had ever asked for Maria to prove herself to be Toran's legal guardian.
In my next post I'll be showing the emails that dispute the claims of Mylan's CEO.