Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial by Alison Bass

From the Publisher

As the mental health reporter for the Boston Globe, Alison Bass's front-page reporting on conflicts of interest in medical research stunned readers, and her series on sexual misconduct among psychiatrists earned her a Pulitzer Prize nomination. Now she turns her investigative skills to a landmark case that exposed increased suicide rates among adolescents taking popular antidepressants such as Paxil, Prozac, and Zoloft.

In Side Effects we meet a courageous Ivy League university employee who risked her job to expose suspicious practices at her lab, a feisty assistant attorney general who spearheaded an unprecedented lawsuit against a pharmaceutical giant, plus the medical researchers who were being paid by the drug companies whose products they were testing. And Bass introduces us to the vulnerable children and adults placed at risk because of greed, corruption, and negligence.

Though pediatric prescriptions of Paxil—at the time one of the world's bestselling antidepressants—were soaring, there was no hard proof that the drug performed any better than sugar pills in children and adolescents. Bass reveals how data from drug trials and the suicide risk the drug posed were withheld, allowing GlaxoSmithKline, the maker of Paxil, to mislead physicians and consumers about the safety and efficacy of the drug.

When the New York State attorney general's office brought its lawsuit against GlaxoSmithKline for consumer fraud, it launched a tidal wave of protest. As a result of this case, drug companies agreed to publish negative results from their research studies. A congressional investigation into industry practices finally prompted the FDA to mandate strictwarnings for all antidepressants.

In the tradition of A Civil Action, Side Effects goes behind the scenes of the headline-making case that forced the government to start protecting its citizens. It lays bare the unhealthy state of our country's pharmaceutical industry.

The Washington Post - Susan P. Williams

Bass evokes sympathy for many players in this story. Her narrative bristles with data without fraying into tedium. And she underlines the gravity of hiding patients' injuries. Side Effects is long-form journalism at its best.

Publishers Weekly

This densely researched report adds to the growing literature on Big Pharma's efforts to sell blockbuster drugs and with its two crusading heroes seems ready for Hollywood. Expanding on her reporting for the Boston Globe, Bass focuses on psychiatrist Martin Teicher, who as early as 1988 noticed that the antidepressant Prozac seemed paradoxically to cause suicidal thoughts in his patients, and the nearly blind Rose Firestein, a lawyer in the New York State attorney general's office who was investigating the inappropriate marketing and use of Paxil for unapproved purposes. Drug companies insisted there was "no scientific evidence whatsoever" linking GlaxoSmithKline's Paxil, Ely Lilly's Prozac and other serotonin-increasing antidepressants to suicidal thoughts and behavior, and Bass describes the dogged battle to show that company researchers had deliberately suppressed the results of trials with negative outcomes. Bass also follows the story of Tonya Brooks, an unhappy teenager who attempted suicide while taking Paxil. Although the story sometimes gets lost in the details of then attorney general Eliot Spitzer's 2004 suit against GlaxoSmithKline (eventually settled for $2.5 million), this story of determined do-gooders is inspiring. (June)

Kirkus Reviews

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 theapproval 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. Agent: James Levine/Levine Greenberg Literary Agency

Product Details

• ISBN: 1565125533
  
• ISBN-13: 9781565125537
• Format: Hardcover, 260pp
• Publisher: Algonquin Books of Chapel Hill
• Pub. Date: June 2008
• Sales Rank: 123,384

• Table of Contents

Table of Contents