book-jacket-side-effects

“Side Effects reads like a John Grisham thriller, but it teaches you everything you need to know about how some drug companies have used their marketing and legal muscle to lie about science.”
The Carlat Psychiatry Blog

Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial tells the true story of a groundbreaking court case and the personal drama that surrounded the making and unmasking of a bestselling drug. It chronicles the lives of two women – a prosecutor and a whistleblower – who exposed the pattern of deception in the research and marketing of Paxil, an antidepressant prescribed to millions of children and adults.

First, a courageous administrator uncovers evidence that researchers at the prestigious Ivy League university where she works may have misrepresented data in a key study of Paxil. What’s more, the researchers may have minimized the suicide risks in adolescents taking the drug.

Next, a gutsy lawyer in the New York State Attorney General’s office discovers that GlaxoSmithKline, Paxil’s manufacturer, suppressed findings that their drug was no more effective than a sugar pill in children and adolescents, and she and her colleagues file an unprecedented lawsuit against the drug company for misleading physicians and patients – in essence, for committing consumer fraud.

With meticulous research, Alison Bass lays bare the unhealthy ties between the medical establishment, big pharma and the FDA – conflicts of interest that place vulnerable children and adults at risk. GlaxoSmithKline, as it turns out, was not the only drug maker to deceive the American public about the safety and effectiveness of their products. Medical researchers and their corporate sponsors knew as far back as the ’90s that Paxil and other antidepressants, known as selective serotonin release inhibitors (SSRIs), were dangerous and no more effective in treating depression among children than a sugar pill. But they did not publish these negative findings – a glaring omission that the nation’s premier public health agency did nothing to prevent.

Side Effects captures the anything-goes decade of drug development, as drugs like Prozac, Paxil and Zoloft became blockbuster drugs and pharmaceutical companies went to sometimes shocking lengths to reap profits. The same pattern of duplicity was repeated with other best-selling drugs like Vioxx and Zetia. But as a result of the lawsuit brought by the New York State attorney general’s office, it is now more difficult for pharmaceutical companies to deceive consumers about the safety and effectiveness of new drugs, and there are greater safeguards on the sale and testing of medications.

Side Effects is the story of how a prosecutor and a whistleblower took on the powerful pharmaceutical industry – and won.

Why this story is so important:

  • Paxil was the best-selling antidepressant in the world in 2002, with sales of $3.3 billion worldwide.
  • Pediatric prescriptions for Paxil soared in the U.S. even though there was no hard evidence the drug performed any better than sugar pills in treating depression in children and adolescents.
  • The authors of an influential Paxil trial in adolescents misrepresented data in order to minimize the suicide-related risks of the antidepressant, allowing GSK to mislead physicians and consumers about the safety and efficacy of Paxil.
  • The New York Attorney General’s case was the very first lawsuit filed against the pharmaceutical industry for consumer fraud and paved the way for other states to rein in the excesses of pharmaceutical companies.
  • The settlement against GSK created an environment in which other drugs, including Vioxx, whose safety had not been properly disclosed, were pulled from the market; it also called for the public posting of all drug studies and additional black box warnings on certain medications, something that the pharmaceutical industry had fought against for years.

Reviews

“Alison Bass’s excellent book Side Effects [is] about how good intentions to effectively treat depressed patients can be subverted by an increasingly market-driven pharmaceutical industry…Thanks to the persistence of the individuals described so eloquently by Alison Bass in Side Effects, much more light is illuminating the dark side of drug development.”
-Nature Medicine Full Review

“Alison Bass has written the powerful story of a leading medication, its manufacturer, and a favored psychiatrist, whose driving force was profit not treatment.”
-The American Journal of Psychiatry Full Review

Bass’s “narrative bristles with data without fraying into tedium… Side Effects is long-form journalism at its best.”
-The Washington Post Full Review

“Concepts such as conflict of interest and transparency could make for dense reading. In Side effects, Alison Bass shows that this needn’t be the case. Here, she knits together the stories of the people behind a path breaking campaign for transparency in the drug trial business…Readers will be struck by the sheer guts of the fighters, given the odds that they face.”
-Indian Journal of Medical Ethics Full Review

“The suppression of unfavorable research is the subject of Alison Bass’s engrossing book, Side Effects. This is the story of how the British drug giant GlaxoSmithKline buried evidence that its top-selling antidepressant, Paxil, was ineffective and possibly harmful to children and adolescents.”
-The New York Review of Books Full Review

Side Effects lays out the compelling drama of how New York’s then-attorney general Elliot Spitzer — before his downfall while state governor — charged GlaxoSmithKline with fraud for deceiving doctors about its blockbuster antidepressant, paroxetine (Paxil). Writing with a novelist’s touch and honing her material for its underside, Bass has produced a gripping whodunit replete with dead bodies, hidden documents, public monies spent on nonexistent studies and even a sham court verdict.”
-The Canadian Medical Association Journal Full Review

“In her new book Alison Bass obeys the most important rule of investigative journalism: She follows the money wherever it leads. In “Side Effects,” her examination of mammoth pharmaceutical companies and their pursuit of profits at any cost, she exposes the dark web of researchers, doctors, and regulators feeding at the Big Pharma trough and undermining public health in the process…Meanwhile, it took the New York attorney general’s office to compel GlaxoSmithKline to publicly disclose Paxil’s link to suicidal thoughts. Bass provides a dramatic account of this lawsuit, following state attorney Rose Firestein as she digs up evidence of Glaxo’s deceptive conduct.”
-The Boston Globe

“Alison Bass, a former medicine, science, and technology reporter at The Boston Globe, has put on trial in her book far more than just a bestselling antidepressant — she has used the case of Paxil to expose the unsavory and self-serving relationships among members of the pharmaceutical industry, psychiatrists, and members of the FDA. And she does it in a book that has the brio of a crime thriller… Bass’s riveting and well-researched account of these disturbing ties should be widely read by members of the medical profession, many of whom continue to believe, despite all evidence to the contrary, that they are immune to the influence of drug companies.”
-New England Journal of Medicine Full review

“Side Effects, by investigative journalist Alison Bass, grapples with the controversy over drugs used to treat depression, with a focus on Paxil, Prozac and Zoloft… Bass’ book humanizes the controversy in a way that makes the statistical arguments come alive. Because of her research and storytelling skills, a book exists that is both a public-policy primer and a compelling account of how seeming miracle cures are sometimes death sentences.”
-USA Today Full review

“I finally got a chance over this past weekend to sit down and read Side Effects, the new book by former Boston Globe reporter Alison Bass. I read the book cover to cover, which surprised me, because I was expecting that this would be an information-heavy repetition of the same territory covered by other recent books, such as Claude Barber’s Comfortably Numb or Marcia Angell’s The Truth about Drug Companies. But Side Effects is different and more riveting, because it tells the story of several individuals, peering into details of their professional and personal lives as the events unfold. It reads like a John Grisham thriller, but it teaches you everything you need to know about how some drug companies have used their marketing and legal muscle to lie about science.”
-The Carlat Psychiatry Blog Full Review

“You’ll never swallow another pill, watch another earnest TV doctor discuss side effects or decipher another magazine ad the same way after reading Side Effects…This is a tale of David and Goliath, made all the more powerful because prescription drugs affect each one of us and we’re no longer sure we can trust the government and Big Pharma to do right by us.”
-The Grand Rapids Press

Side Effects is a tour de force that rivals any suspense novel. A meticulous reporter and skilled writer, Alison Bass builds her story from face-to-face interviews with key players and detailed reviews of testimonial transcripts, industry communications, news articles, medical publications, and previously unreleased material. In the best muckraking tradition she reveals how some executives in the giant pharmaceutical industry and their associations with a few corrupt medical professionals can dupe the public in ways that produce tragic outcomes. .”
-Metapsychology Online Reviews Full Review

“Bass executes such a revealing expose on the shadowy world of medical research and the pharmaceutical industry that it proves important stories, like timeless truths, need repeating. Side Effects tells a shocking story about the pharmaceutical giant GlaxoSmithKline and the landmark lawsuit against its blockbuster drug Paxil, once the world’s bestselling antidepressant. Bass, a Pulitzer Prize nominee for investigative journalism, constructs a connect-the-dots legal drama written in a news reporter’s style of precise prose.”
-Pop Matters
Full Review

“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…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.”
-Associated Press

“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…A substantive examination of an important issue.”
-Kirkus

“A richly detailed account of the disgraceful self-serving ties between drug companies and the psychiatric profession, as told through stories about the heroes, villains and victims in this drama. An engrossing read and a valuable contribution to public understanding of the need for reform.”
-Dr. Arnold S. Relman, Professor Emeritus of Medicine and of Social Medicine, Harvard Medical School and former editor, New England Journal of Medicine.

“Side Effects is a serious indictment of the pharmaceutical industry, clinical researchers, and government regulators, told in captivating prose. It makes you worry about the authenticity of the evidence that doctors use from day to day.”
-Dr. Jerome Kassirer, Distinguished Professor at Tufts University School of Medicine, former editor of New England Journal of Medicine, and author of On the Take: How Medicine’s Complicity with Big Business can Endanger your Health

 

Excerpts

Side Effects Prologue
Chapter One

Documents

Brown memo, January 1, 1995
Brown memo, October 30, 1995
Brown memo, November 11, 1995
GSK Report on Patient 65
GSK Report on Patient 70

 

Winner of the NASW Science in Society Award

An excerpt from the NASW announcement: “In Side Effects, Alison Bass, an investigative journalist who has covered medicine, science, and technology for The Boston Globe and other publications, tells the story of how pharmaceutical giant GlaxoSmithKline systematically misled physicians and consumers about the safety and efficacy of Paxil, a popular antidepressant.” It’s a very complicated issue, and the author conveyed this like a mystery story,” said one of the judges, noting that, “Her investigations led to changes in policy in many areas of public health, not only nationally but internationally.”– NASW News

Side Effects introduces us to a fabulous cast of characters: a feisty district attorney in the mold of Erin Brockevitch who takes on big pharma and wins; a courageous whistleblower whose own child suffers from mental illness; a controversial medical researcher being paid by the drug companies whose products he’s testing; and of course the victims – those whose suffering was intensified by greed, negligence, and deception within the medical establishment.

Side Effects captures the anything – goes decade of drug development, as drugs like Prozac, Paxil and Vioxx became blockbuster drugs and pharmaceutical companies went to sometimes shocking lengths to reap profits. In telling the dramatic saga of the New York AG’s lawsuit against one drug company, this book lays bare the longstanding complicity between medical researchers and the pharmaceutical industry – a collusion that places vulnerable children and adults at risk every single day.

With meticulous research, Alison Bass lays out the insidious connections between pharmaceutical giant GlaxoSmithKline (the maker of Paxil), a top Ivy League research institution, and the government agency designed to protect the public.