Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Wednesday, August 06, 2008

More on the PMS paxil nonsense!

Placebo-Controlled Trial Comparing Intermittent and Continuous Paroxetine in Premenstrual Dysphoric Disorder



Key points of the 'Clinical Research'

  • Serotonin reuptake inhibitors (SRIs) do not have to be administered continuously to be effective for premenstrual dysphoric disorder (PMDD), but can be given during luteal phases only.

  • The study indicates that the response rate when treating PMDD with SRIs is high, and that irritability is a key target symptom. Symptoms such as irritability, affect lability, and mood swings appear to be more inclined to respond rapidly to SRIs, enabling intermittent treatment, than are, for example, the somatic symptoms.

The 'study' was headed by Mikael Landén of the Department of Clinical Neuroscience, Section of Psychiatry St Göran, Karolinska Institutet, SE 112 81 Stockholm, Sweden.

Want to know who had a vested interest in this 'clinical research'?

This study was supported by grants from Novo Nordisk Sweden and GlaxoSmithKline. We thank study nurses Benita Gezelius and Carin Carlquist forskillful assistance. Dr Brian Hunter at Glaxo SmithKline gave valuable input on the study protocol. Niklas Morton and Gunnar Ekroth provided valuable statistical advice."



Paroxetine is manufactured by GlaxoSmithKline.

Do we really need to say anymore?

...And what about the premenstrual syndrome paper?

Written by Kimberly Ann Yonkers, P M Shaughn O’Brien and Elias Eriksson.


"Serotonin reuptake inhibitors (SRIs)Many clinical trials evaluating the efficacy of an SRI for the management ofPMS/PMDD have shown benefit, the response rate usually being 60-90% foractive treatment versus 30-40% for placebo.110 SRIs that have been shown effective are the serotonergic tricyclic antidepressant clomipramine, theselective SRIs citalopram, escitalopram, fluoxetine, paroxetine,andsertraline, and the serotonin and noradrenaline reuptake inhibitorvenlafaxine (table). SRIs reduce both mood symptoms and somatic complaints,and they also improve quality of life and social functioning. Many believethat SRIs should be regarded as first-line treatment in PMS patients withsevere mood symptoms.



Kimberly Ann Yonkers, P M Shaughn O’Brien and Elias Eriksson Conflict of Interest Statement appears in very small text on the paper.

I'll enlarge it for you all. [KAY is Kimberly Ann Yonkers], the other two authors were P M Shaughn O’Brien and Elias Eriksson or PMSO'B and EE



"Between 2004 and 2006, KAY provided a consultation to Wyeth and Berlex; received honoraria from Wyeth and Berlex that was less than $10 000 annually; received grants from Berlex, Wyeth, and medication to support asmall study from GlaxoSmithKline and from Pfizer; grants from the National Institutes of Health, the National Association for Research in Schizophrenia and Affective Disorders, and the Federal Health Resources Services Administration; received an honorarium in 2007 for a lecture from Berlex; and receives continued grants from Wyeth (ongoing since 2006) and from the National Institutes of Health and the National Association for Research in Schizophrenia and Affective Disorders. Between 2004 and 2007.



PMSO'B provided consultations to Bayer Schering and TAP Pharmaceuticals; received research grants from Bayer Schering, Wyeth, GlaxoSmithKline, Beecham, and Lilly; received honoraria from Bayer Schering totally less than £5000; and received grants from the British Heart Foundation and North Staffordshire Medical Institute.



EE has received research grants from Lundbeck and Bristol Myers Squibb, and has provided consultations to Schering, Lundbeck, and Lilly."



Dunno bout you... but something just does not sit right with me.





Fid



Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

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