SIDE EFFECTS

Heated account of pharmaceutical giant GlaxoSmithKline’s troubles when the company was discovered concealing evidence that suicidal thoughts occurred as a rare side effect of its popular antidepressant Paxil.

Boston Globe science journalist Bass begins her account with the horrifying saga of a painfully shy teenager whose Paxil prescription prompted sleeplessness, agitation, episodes of self-cutting and a suicide attempt. Introduced in the 1980s and ’90s, new psychoactive drugs like Paxil, Prozac and Zoloft helped many depressed patients, the author emphasizes, but reports of troubling side effects were not welcomed by the manufacturers of these wildly profitable medications. Displaying an unfortunate fondness for invented dialogue and passionate internal monologues by leading characters, Bass introduces her heroes and villains. Dressed in white: an idealistic lawyer in the New York State Attorney General’s office, which filed suit against GlaxoSmithKline in 2004; a struggling hospital official who learned that a powerful researcher was collecting money for nonexistent studies; and a brilliant psychiatrist who found suicidal ideation among patients taking Prozac, only to have his findings dismissed by the FDA. Dressed in black: pharmaceutical company scientists and lawyers, as well as psychiatrists whose income from the companies clearly influenced their prescribing habits and their eagerness to interpret questionable research results as favorable to a drug. Bass has little good to say about the FDA, starved of funds by Congress but encouraged to charge “user fees” to speed up new drug approval. Providing more than half the FDA’s drug-review budget, these fees inevitably distorted the approval process. Rather than go to trial, GlaxoSmithKline settled, agreeing to post descriptions of all studies (not just those with positive results) on the Internet. Other companies agreed to do the same, and leading medical journals unanimously adopted guidelines requiring full disclosure in submitted research papers. Congress declined to provide the FDA more money, yet allowed it to raise user’s fees, thereby perpetuating a corrupt process.

Despite the irritating lapses into docudrama, a substantive examination of an important issue.