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Paxil: Ethical Concerns

By June 26, 2010July 9th, 2019Uncategorized

There have been a number of issues raised about the safety of the popular antidepressant Paxil. It has been linked to increased suicide risk in young children it is prescribed to, as well as a number of birth defects. A definitive causal relationship may not have been demonstrated, but warning flags have been going up consistently since its approval by the FDA.

Part of the skepticism that surrounds Paxil and related antidepressants is the huge amount of good press the producers — in this case Glaxo Smith Kline (GSK) — give themselves, while downplaying their negative effects. The object isn’t necessarily even to force GSK to close down, or to take Paxil entirely out of the market, but to rather demand honesty in advertising and a much more stringent set of guidelines as to who and who cannot be prescribed the medicine.

When GSK is busily promoting the drug, however, information can be difficult to sift through.

For example, consider the growing concerns about Study 329, an investigation GSK did into its antidepressant. The spin put on the article basically suggested that the results were positive and favorable. However, ongoing investigations have raised doubts about the accuracy of these claims.

Reports from 1998 indicate, for example, that GSK was aware the actual results of the study were negative, rather than positive. Attempts to investigate and call these matters into question were met with hostility. Furthermore, there is evidence that the entire article was ghostwritten. Ghostwriting (the method of hiring a professional writer to write the actual documents) is a valid practice in many cases, but one wonders why the research team didn’t have anyone qualified to write up and publish their works.

GSK eventually had to admit that they had overstated the positive effects of its big name medication. In many ways, this story highlights the core difficulty of dealing with such companies. They can massage data and have in-house teams perform dubious evaluations, while investigations from outside are difficult and take expert hands.