Friday, October 04, 2013

Mylan Pharmaceuticals: Ill-Informed Consent

Are Mylan Pharmaceuticals Being Truthful on the 2013 Fluox Patient Information Leaflet?

Mylan Pharmaceuticals are, it appears, keeping the causal role of Fluox and suicide away from New Zealand Healthcare professionals and, more importantly, the consumers of New Zealand.

Here's how they are doing it.

Mylan's Fluox Patient Information Leaflet.

Updated Feb 2013

What they say about Fluox and suicide.

Although a causal role for fluoxetine in inducing such events has not been established, some analyses from pooled studies of antidepressants in psychiatric disorders found an increased risk for suicidal ideation and/or suicidal behaviours in paediatric and young adult (<25 years of age) patients compared to placebo

Notice the underlined, "Although a causal role for fluoxetine in inducing such events has not been established"

Notice the date the patient information leaflet was updated, "Updated Feb 2013"

Now, lets look at Mylan's causality assessment of 17 year old Takapuna teen Toran Henry who died by suicide whilst medicated with Mylan's Fluox.

It's worthy to note the dates.

I'll point out Mylan's glaring errors as I go along.

The spontaneous report was received by Mylan on 23 November 2010.

Fig 1

The report lists the patient, Toran Henry as being 19 years of age. [Fig 1]

Toran was 17 at the time of his death.

In Fig 2 we see how Mylan's report states that Toran was prescribed Fluox because he had a diagnosis of depression.

This is not true. Toran's diagnosis was deferred. At no point was he diagnosed with depression. Pharmaceutical companies will often blame the 'illness' as a factor of suicide. Even listing Toran as having an illness they deemed the Fluox induced his suicide [probably]. Why did they list Toran as being depressed? His medical records, which I have had access to, do not claim any psychiatric disorder.

Fig 2

Fig 3 shows the causality assessment result. Bottom lines reads, "Company assessment of causality PROBABLE"

Fig 3

As I said previously, the adverse reaction was received by Mylan on the 23 November 2010.

Interestingly, the date when the assessment of Toran's death was sent to the Centre for Adverse Reactions Monitoring [CARM] was 6 December 2010. The signatory of the letter is that of Judith Ling, Mylan's Regulatory Affairs Officer.[Fig 4]

Fig 4

So here we have Mylan, in late 2010, saying the suicide was probably caused by their product Fluox yet the updated February 2013 patient information leaflet has this to say about Fluox use and suicide, "Although a causal role for fluoxetine in inducing such events has not been established."

The term "causal role" is pretty vague and is, just like the chemical imbalance myth, a theory.

Are Mylan having their cake and eating it here?

On one hand they are, through a causality assessment made in 2010, suggesting that Fluox was the probable causation of induced suicide yet some three years later they are suggesting that no causal role for fluoxetine in inducing suicide has been established.

It's one thing to tell a mother that Fluox was the probable cause of her son's induced suicide but, it appears, this is not important enough to tell healthcare professionals or the New Zealand public. Why?

Could it be suggested that Mylan Pharmaceuticals are lying on their updated patient information leaflet or are they just basing this statement on a group of philosophical theories that aim to characterize the relationship between cause and effect using the tools of probability theory?

So, which is true?

Is Mylan's causality assessment of Toran Henry suggesting that Fluox induced his suicide? Well, according to Mylan, 'probably'.

Is Mylan's updated patient information leaflet suggesting that there is no causal link between Fluox and suicide? Yes they are, there is no 'probably' about it.

Let's look at the statement again:

"Although a causal role for fluoxetine in inducing such events has not been established."

This is a lie given that they have already admitted a causal role on the causality assessment of Toran Henry, right?

If Mylan are purposely lying one could argue that they are knowingly endangering the lives of the New Zealand public. They are, it could be argued, not letting doctors or consumers know about the causal link between their product and its propensity to induce suicide.

There really is no other way to dress this up. Mylan are telling doctors and the New Zealand public that no causal role for Fluox inducing suicide has been established.

Although a causality of 'probable' is not quite being established as definite it is, nonetheless, a causal role.

Why are Mylan telling us different on the patient information leaflet?

If Mylan are telling a blatant lie here then maybe they should change their name to Lylan. If they are not telling a lie then I'd like to throw out the following question.

Exactly what is Mylan's Modus operandi?

If New Zealand had the culture of the United States then I'm almost certain that their current patient information leaflet would open doors to class action lawsuits. If I was an attorney I'd view this patient information leaflet as a gift horse and it would be just bad manners to look into its mouth.

Who knows, maybe some law firm in New Zealand will take up the gauntlet and run with it.


Despite bringing it to the attention of Mylan that Toran was 17, a pediatric patient, when he died, Toran's mom, Maria Bradshaw, has still not received an amended version of Toran's causality assessment. She asked for this back in April 2013 and has since re-requested the information. Mylan have not even had the decency to acknowledge either of her requests . [Back stories here and here]

I, myself, have wrote to World Team Tennis who, earlier this year, struck a sponsorship deal with Mylan. They, just like Mylan, never even acknowledged receipt of my email to them. [Back story]

I've always thought tennis was for rich kids anyway.

Bob Fiddaman