Blogging Since 2006

Blogging Since 2006
WHEN INJUSTICE BECOMES LAW, RESISTANCE BECOMES DUTY

Thursday, May 02, 2013

Patient Information or Litigation Disclaimer?




I was browsing through some SSRi patient information leaflets [PILs] earlier and have come to the conclusion that the manufacturers warnings about this, that and the other are merely coded messages to the consumer.

Years ago, when SSRi's first hit the market, there were few warnings of side-effects. Sure, back then we had dizziness, nausea, sweating etc but that's standard for most, if not all, prescription medicines.

Today, after US litigation, patient reporting and, it has to be said, internet activism, the PILs take on a completely different look. They [the manufacturer] are telling us we can't sue because we were told.

It's almost as if pharmaceutical compliance departments had a eureka moment and turned really bad news into something that could be productive in the future. "Hey if we stick broad but vague warning labels on our drugs then we cover ourselves from future litigation... quick, get the number for that medical ghostwriting team we used back in 1998"

Let's take a look at Seroxat for example. [NHS Information]




Motion to dismiss

1. Some people who take Seroxat may find that it intensifies depression and suicidal feelings in the early stages of treatment. 
Very vague statement but one that would certainly be used by GlaxoSmithKline attorneys if they were ever faced with a lawsuit. "There is no case for your client as my client clearly stated in the patient information leaflet that Seroxat wasn't for everyone."

2. "If you are taking Seroxat, or you care for someone who is taking Seroxat, you need to look out for changes in behaviour that could be linked to self-harm or suicide.
"If you notice any of these changes or are worried about how Seroxat is affecting you or someone you care for, you should contact your prescriber, a mental health professional or NHS Direct as soon as possible."

Again, Glaxo attorneys could have a field day, "Your honour, we have reason to believe that the deceased did not contact their prescriber, yet my client clearly stated in the patient information leaflet for them to do so if they were feeling suicidal, therefore we argue that there is no merit in this case" 


 3. Seroxat is not suitable for everyone and some people should never use it.

"Your honour, if the deceased had killed themselves by touching an electrical fence despite there being a warning not to do so would my learned friends still be representing him in court?" 


4. Over time it is possible that Seroxat can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Seroxat has become unsuitable, it is important that the prescriber is contacted immediately.

"Your honour, the plaintiff may have become, over time, unsuitable for our client's product, he may also have had an adverse reaction to my client's product. At no time, leading up to his attempted suicide, did he contact his prescriber despite the fact that my client had advised this in the patient information leaflet."


5. You should only take this medicine during pregnancy if your doctor thinks that you need it
"Your honour, whilst my client has every sympathy for the birth defects the child in this case was born with, it was not my client's fault. My client never prescribed Seroxat to this young mother, it was her doctor."

6. If you take this medicine during the late stages of pregnancy your baby may have some problems after birth

"Your honour, how many warnings did this mother need, was she illiterate, could she not read? My client refutes any responsibly with regard to the plaintiff's son being born with septal heart defects. In fact, my client believes that it should be the plaintiff who should be facing prosecution for acting irresponsibly."

 7. This medicine may decrease fertility in men.

"Your honour, he was warned."


8. Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife.

"Your honour, my client blames the plaintiff and both the doctor and midwife, they should have read the patient information leaflet."


Judge's summation - Sadly, it is with great regret that I am granting GlaxoSmithKline motion to dismiss on the grounds that they covered all bases for any future litigation by applying warnings to their patient information leaflet. I am, however, recommending that in future Glaxo elaborate on the warnings. My recommendations are underlined:


1. Some people, particularly those who are poor metabolizers, who take Seroxat may find that it intensifies depression and suicidal feelings in the early stages of treatment. GlaxoSmithKline nor your prescriber cannot tell you if you are a poor metabolizer so, in essence, by administering Seroxat you are playing solo Russian roulette.

2. If you are taking Seroxat, or you care for someone who is taking Seroxat, you need to look out for changes in behaviour that could be linked to self-harm or suicide. Changes such as an increase in depression, anxiety, an inability to sit still, a lack of empathy toward others, excruciating electric-like zaps in your head, horrific nightmares where the subject matter is death, homicide, suicide. Outbursts of anger, for no apparent reason, aimed at those you love. If you notice any of these changes or are worried about how Seroxat is affecting you or someone you care for, you should contact your prescriber, a mental health professional or NHS Direct as soon as possible. NHS Direct et al should then telephone a 24 hour hotline, manned by an independent body who have no financial ties to GlaxoSmithKline, and request a safe withdrawal protocol. The patient should be hospitalized, at GlaxoSmithKline's expense, and monitored at regular intervals. Any item of clothing that could be used as an instrument for suicide must also be removed. GlaxoSmithKline's CEO, Sir Andrew Witty, should be contacted, no matter what time of day or night it is. Sir Witty may then realise that bad things didn't just happen to patients under JP Garnier's watch, they are still happening and are not part of "an era". Sir Witty can sit with the patient while he/she experiences thoughts of self-harm and/or suicide. Because of the logistics and vast number of people who suffer these kind of adverse reactions to Seroxat it is recommended that Sir Witty handpicks a team of GlaxoSmithKline executives to be on emergency call to tend to the needs of Seroxat induced suicide victims.


3. Seroxat is not suitable for everyone and some people should never use it. Some people cannot excrete Seroxat from their system quicker than others. This means that they build up toxic levels of the drug, in fact these people are overdosing on Seroxat without actually knowing it. This simple fact should be made crystal clear in future patient information leaflets. Sir Witty and his handpicked team of executives should disseminate this information to the public by word of mouth. Alternatively  a full page advertisement can be used in popular mainstream newspapers to warn this vulnerable patient population. "Toxic levels of Seroxat may lead to self harm and suicidal thoughts" should also be added to the patient information leaflet.


4. Over time it is possible that Seroxat can become unsuitable for some people, particularly those who are poor metabolizers, or they may become unsuitable for it, particularly those who are poor metabolizers, If at any time it appears that Seroxat has become unsuitable, it is important that the prescriber is contacted immediately. The Prescriber should then contact GlaxoSmithKline to file an adverse reaction report. In turn GlaxoSmithKline should investigate the adverse reaction and report back to the prescriber with a causality assessment. This will then help the prescriber decide, in future consultations with patients, if Seroxat is the drug for them.

5. You should only take this medicine during pregnancy if your doctor thinks that you need it - This whole sentence needs drastic change. A doctor does not have access to the rat pup studies that GlaxoSmithKline has and kept from the public. Expectant mothers should be made aware of the Sloot study whereby Seroxat and other SSRi's were exposed to rat fetuses. Out of all the SSRi's used in this study only one came out as a clear teratogen - Seroxat. Another example of a teratogen, in case consumers are not aware of the word, is the anti-nausea and sedative drug, Thalidomide.

6. If you take this medicine during the late stages of pregnancy your baby may have some problems after birth. The sort of 'problems' are:


Persistent Pulmonary Hypertension of the Newborn (PPHN) – 6 times increased risk
Anencephaly (fatal neural tube defect) – 2.5 times increased risk
Clubfoot – 5 times increased risk
Craniosynostosis (craniofacial defect) – 2.5 times increased risk
Omphalocele (abdominal wall defect) – nearly tripled risk
Gastroschisis (abdominal wall defect) – 30 percent increased risk
Pulmonary Atresia – 3 times increased risk
Spina Bifida – 60 percent increased risk
Diaphragmatic Hernia – 80 percent increased risk
Anal and Esophagal Atresia – 30 percent increased risk
Heart Defects – nearly doubled risk
Septal Defects, including Atrial and Ventricular (also known as “hole in the heart” defects)
Hypoplastic Left/Right Heart Syndromes
Malformed or blocked heart valves that will not close
Transposition of the Great Arteries
Tetralogy of Fallot
Mitral Valve
Heart murmur

Like packets of cigarettes I make the recommendation that GlaxoSmithKline add a photograph to the packaging of Seroxat. An example is below.


Spina Bifida – 60 percent increased risk when taking Seroxat [1]


7. This medicine may decrease fertility in men. Given recommendation 6 this may not be such a bad thing, particularly if the female partner is also digesting Seroxat. Sir Witty and his team of handpicked executives may wish to visit any male patient who has decreased fertility as a result of taking Seroxat and, if requested, help to fill out some adoption forms for the wannabe father. GlaxoSmithKline shall foot the bill for the whole adoption procedure, including lawyers fees and expenses for the child up to the age of 19.

8. Before you have your baby you should discuss breast-feeding with your doctor or midwife as Seroxat can find a way into your baby when he/she breast feeds. This can cause serious implications for the newborn child and may result in Seroxat overdose, addiction, agitation and in some instances death. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. They will also offer you the court transcripts from the Kilker Vs GlaxoSmithKline birth defect trial where GlaxoSmithKline were found guilty for manufacturing a drug [Seroxat] that caused Lyam Kilker to be born with heart defects. This will  help expectant mothers to make a fully informed decision and may deter them from breast feeding given that Seroxat can harm a baby whilst it is still in the womb so chances are the baby can be harmed if ingesting breast milk that is still in the mother's system. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife and with the knowledge that your doctor or midwife actually know what they are talking about.


I make these recommendations with the knowledge that healthcare professionals and GlaxoSmithKline have the right to ignore them as do global medicine regulators and coroners. In fact, the word 'recommendation' means nothing. It just makes people like me seem as if I really care when in actual fact I'm just recommending what I think should be done but I know that the likelihood of any recommendations made simply means that nothing has to be adhered to. I'm a Judge and I have to be seen to be doing something. I use war as an example. World leaders got together to fight the might of Hitler. At some point it was only recommended that they intervene. They didn't have to but because they did they stopped Hitler, some would suggest that those recommendations to intervene should have been carried out earlier, maybe more lives would have been saved. Thing is, those recommendations were listened to, they were put into place and we are a better world for it.

I would urge for GlaxoSmithKline's CEO and handpicked executives to search their consciences but past litigation [in the US] has shown that these individuals blame everyone and everything but their product.

I would like to recommend that Seroxat is removed from the shelves but know I would face tough opposition from those who have been duped into believing that the benefits of this particular antidepressant outweigh the risks. The risks, all of them, should be printed out in clear laypersons terms, again, I can only recommend this. I do know that, after reviewing all the court documents in cases such as Seroxat induced suicide, Seroxat birth defects, Seroxat withdrawal/addiction, that I will never allow any family member of mine to take this drug. That's my privilege as I am a Judge.

Glaxo's motion to dismiss - Granted.

Rt Hon Judge I.M Pointless


**Footnote**

Later that year the Rt Hon Judge I.M Pointless granted the same motions to Eli Lilly, Wyeth, Pfizer, Forest Labs, Lundbeck and other SSRi manufacturers, including those manufacturers that make generic versions of SSRi medication. 

He also made similar recommendations.


[1] Birth Defects Cased By Seroxat [Birth Defect Resource]




Bob Fiddaman




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