Kamis, 26 Juni 2008

History of Prozac fight gives hope to underdogs (AP)

"Side Effects: A Bestselling Drug on Trial" (Algonquin Books. 240 pages. $24.95), by Alison Bass: It's hard not to cheer for the little guy in "Side Effects," the true story of underdogs who stand up to powerful drug companies and their questionable ethics.

It's also a story that needs to be told -- one that explains the potential defects of a drug-approval process that's far too susceptible to political influence and lobbying clout.

But author Alison Bass tries a little too hard to tell the story. The chain of events is compelling enough on its own that it doesn't need the literary flourishes that Bass adds throughout.

She tells the tale of the drug makers who sell Prozac, Paxil and other pills to treat the symptoms of depression. While doctors welcome the new weapons for their mental-health patients, mounting evidence begins to suggest a litany of ominous side effects.

The drugs seem to help most people. But some patients, mainly children and adolescents, see their symptoms deteriorate -- they become hostile, aggressive, even suicidal.

One doctor investigates but finds no mention of such severe side effects in the medical literature or the companies' own drug warnings. He initiates his own mini-studies, gaining fame among his peers and eventually earning an invitation to a federal conference where the evidence is discussed.

But the doctor, Marty Teicher, is shocked when his concerns are ignored at the conference. Prozac maker Eli Lilly and the U.S. Food and Drug Administration combine to dominate the event, and a compliant media does little more than repeat Lilly's marketing message afterward.

Meanwhile, more smoking guns are uncovered.

One employee of Brown University in Rhode Island knows her boss receives hefty consulting fees from drug companies. One day she discovers documents that question the accuracy of clinical trials her boss oversees for those companies. She leaves her company after publicizing those documents, and eventually becomes a pariah at her next job.

The hero is Rose Firestein, a feisty lawyer who worked under Eliot Spitzer when he was still New York's attorney general. She takes on GlaxoSmithKline, successfully showing how the maker of Paxil promoted only its positive research and systematically suppressed all unfavorable data.

Her arduous legal efforts prompt widespread industry changes, an inspiring victory for David over the deep-pocketed pharma Goliath.

On its own, Bass' book is interesting, mainly as a can-do tale that teaches that quixotic battles need not be futile. Stand with integrity, the message preaches, and you can win even against daunting odds. But the message gets diluted by frequent digressions. Bass provides in-depth character profiles of the protagonists, sharing excessive details of Firestein's failing eyesight and Teicher's marital issues.

Doubtless she wants her characters to have more than one dimension, and some background information explains why the characters are the way they are. But it doesn't take long for the detours to become more distracting than illuminating.

It's almost as though the author is including that content to make it easier to turn the book into a movie.

Even so, "Side Effects" is an interesting account of the drug-approval process and its shortcomings. It's also a tale of rare victory for the little guy that will leave readers cheering.

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