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Book Review

     Summer 2009



      Side Effects
     By Alison Bass
       Algonquin Books, Chapel Hill, NC, pp. 236, 2008

      Criticizing the pharmaceutical industry (aka "big pharma") has recently become something of a cottage
      industry for journalists, prominent physicians and politicians. And of course they mostly are correct in
      their indictments: too much money spent on advertising, both direct to the public on TV and in
      publications and to doctors via medical journals or company reps (now mostly young attractive women);
      promoting favorable results from clinical studies of their products while hiding or deemphasizing negative
     data, both pre and post FDA approval; paying large "consulting fees" (?bribes) to opinion making
      physicians and scientists to promote their drugs for approved and "off-label" use; arranging "ghost-
      written drug studies presumably authored by respected physicians but in reality company written; a
      sort of "pay to play" arrangement in which the companies finance the FDA that is charged with
      evaluating the effectiveness and safety of their drugs. The list goes on and on and we have not even
      mentioned the enormous sums spent on lobbying Congress and influencing politicians to preserve
      their stranglehold on the status quo.

      This book is by a former Boston Globe mental health reporter and focuses on the successful promotion
      of the newer anti-depressive drugs, the so-called SSRI inhibitors (Prozac, Zoloft, Paxil and several
      others), by several drug companies that either hid or denied important side-effects, mainly suicide by
      those taking the drugs. Ms. Bass offers a compelling story, told in a journalistic narrative that keeps
      the reader turning the pages and able to follow the important players in what is a complex series of
      events. Skipping forward and back in time, she follows the thoughts and actions and inter-actions of
      three main characters: a whistle-blowing hospital administrator, a courageous attorney working in
      the New York attorney general's office, and a brilliant but beleaguered psychiatrist and researcher
      caught up in the legal battles. There are plenty of villains: Dr. Martin Keller, a psychiatrist at Brown
      University who conducted many of the Paxil trials, drug company executives and their lawyers and
      many politicians who ignored the problems in the industry, presumably due to campaign contributions.

      The main part of the story involves a lawsuit filed by the New York Attorney General (then Eliot Spitzer)
      against GlaxoSmithKline, the makers of the SSRI anti-depressive Paxil. The crux of their innovative
      legal argument was based on the lack of publication of several company clinical trials that had
      negative results (Paxil was no better than a placebo or older non-SSRI drug in treating depression in
      children and teenagers) and the fuzzy interpretation of a single study that purported to show positive
      results but side effects (suicidal ideation among others) of the Paxil group were intentionally glossed
      over and endpoints of the study were changed in midstream.. This of course was the only study that
      supported the use of this drug in the company's advertising to psychiatrists and physicians generally.

      The lead attorney for the attorney general's office, Rose Firestein, a sight-impaired "attack dog" came
      up with the novel idea that the company's hiding of negative results violated the consumer protection
      statute in New York state because physicians were not informed of the negative results and harmful
      side effects of the drug, thus impairing their ability to decide whether or not to prescribe the drug.
      This lack of complete information thus resulted in potential harm to the patient and constituted
      fraud on the part of the company. The defendants fought for a while, trying to remove the case
      to federal court and implying the so-called FDA pre-emption precluded any state regulation of drug
      prescribing (later rejected by the Supreme Court in Wyeth v. Levine) but they ultimately settled for a
      small (for them) fine and the promise to be more forthcoming with negative study results and
      deleterious side effects. Part of the agreement included mandatory pre-registration of clinical trials
      on a special website outlining the major endpoints to be investigated and more details of the
      planned drug trial.

      Ms. Bass finishes off her book with a look at the current situation. The pharmaceutical industry
      still wields enormous power and influence but some of it is beginning to erode. The plaintiffs' bar
      and finally the FDA are beginning to chip away at some of their clout. The Vioxx recall by Merck
      (three years too late according to some critics) and the black box warnings for all anti-depressives
      and other drugs such as the diabetic pill Avandia or the antipsychotic Zyprexia have alerted the public
      (and Congress) to the dangers of a poorly regulated drug industry, especially for drugs already on
      the market. Some of this is due to underfunding of the FDA and especially the law that that
      allows the drug companies to fund the FDA's evaluation of their products in order to expedite approval
      for release to the public. Medical journal editors have helped by refusing to publish clinical
      trial results that have not been pre-registered but this does not preclude manipulation of data or
      failure to perform appropriate statistical analysis of the study.

      A short, well-written account of a major problem in the public's health, made fascinating by the
      stories of individuals caught up in the battle.

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