Disputing 'Side Effects'

I am writing to express my disappointment at the inflammatory review of Alison Bass's book, "Side Effects" ("The unhealthy ties that bind FDA to drug firms," July 5). Judging by the statements in the review, "Side Effects" is inaccurate and does not reflect the facts related to paroxetine as we know them and as have been shared publicly.

Among the numerous inaccuracies, GlaxoSmithKline rejects any suggestion that it withheld drug trial information. Results were submitted to regulators in a timely manner, presented publicly, published in scientific journals, and have been made available on the company's website.

We are conscious of the duty we owe to the millions of patients who suffer from depression, and we remain firm in our belief that we acted properly and responsibly in the conduct and communication of our clinical trials program for paroxetine. We believe in transparency of data, irrespective of outcome, to safeguard those patients who use our medicines and vaccines.

Ignoring the body of research supporting the appropriate use of antidepressants has done a disservice to the millions of patients who have battled mental illness. These medicines are effective and remain an important option, in addition to counseling and lifestyle changes, for treatment of major depressive disorder.

John E. Kraus, MD, PhD
Senior Director, Neurosciences Medicines Development Center,
GlaxoSmithKline