Putting GlaxoSmithKline to the test over paroxetineBMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f6754 (Published 12 November 2013) Cite this as: BMJ 2013;347:f6754
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Over 70% of paroxetine studies registered at ClinicalTrials.gov (completion date before January 1st, 2011) remain unpublished. This problem is not unique to paroxetine because other blockbuster antidepressants (e.g., fluoxetine and sertraline) have not published over half of their studies.(1) More unpublished paroxetine studies can be identified analyzing data of other registers (e.g., Eudra CT, ISRCTN, Chi-CTR, among others) downloaded from WHO ICTRP.(2)
Concerns expressed by other authors, regarding the efficacy and safety of antidepressant drugs in humans, are legitimate and well-founded.(3,4) The evidence in peer-review medical journals supporting the efficacy and safety of antidepressants in humans have been cherry-picked.
1. Ramirez, Jorge H (2014): Database of human studies evaluating antidepressant drugs. figshare. http://dx.doi.org/10.6084/m9.figshare.1168926
2. Ramirez, Jorge H (2014): Paroxetine: analysis of unpublished human studies (observational studies and clinical trials). figshare. http://dx.doi.org/10.6084/m9.figshare.1103284
3. Website of CEP: the Council for Evidence-based Psychiatry. URL: http://cepuk.org (accessed: December 11, 2014).
4. Ioannidis JPA. Ranking antidepressants. Lancet 2009;373:1759–60; author reply 1761–2. doi:10.1016/S0140-6736(09)60974-0
Competing interests: I endorse the principles of AllTrials and The BMJ Open Data Campaign.
Below is the exchange of letters between Jon Jureidini and GlaxoSmithKline since November 15, 2013, which continues the earlier discussion and in which Jureidini signals concerns about whose responsibility it is to alert trial participants to harm they may have experienced in the course of the clinical trials.
Competing interests: As declared in the article (BMJ 2013;347:f6754).
Sir: When it comes to exemplars of medical ethics no one expects pharmaceutical companies to be at the front of the list. Nonetheless the recent behaviour of GlaxoSmith Kline (1), or that of AstraZeneca (2), are unacceptable.
Where several compounds are not significantly better at treating a disorder might physicians consider other factors when they discuss choice with patients.
Discussing non-clinical aspects may be a worthwhile and valid aspect of exercising choice. Just as consumers choose green products, and the BMA campaigns on human rights aspects of the conditions of workforces in the production of surgical instruments, so might patients decide that a company behaving in the right way is worth believing in; and rewarding by choosing its product.
If Doctors are believed to be unduly influenced by accepting education from pharmaceutical companies, imagine how 'Pharma' will respond to changing choice from their customers, and a deteriorating bottom line.
1 Pitting GlaxoSmithKlone to the test over Paroxetine. P Doshi. BMJ 2013;347:f6754
2 US Lawyers investigate trial that secured drug licence. D Cohen. BMJ 2013: 347: f6727
Competing interests: No competing interests