Ments and a Sham Court Verdict

Holiday Reading

Book review Spilling the beans on the pharmaceutical industry

At this point, CMAJ gets a walk-on Side Effects: A Prosecutor, a part in the book. In 2004, CMAJ re- Whistleblower, and a Bestselling vealed a confidential memo in its news Antidepressant on Trial pages that proved the makers of parox- Alison Bass Algonquin Books of Chapel Hill; 2008 etine “knew they were holding back in- 260 pp $24.95 ISBN978 1-56512-553-7 formation and that what they were do- ing was wrong,” as a lawyer in the New Our Daily Meds: How the Pharmaceutical York attorney general’s office put it 1 Companies Transformed Themselves into later. The CMAJ’s news story pro- slick Marketing Machines and Hooked the vided the attorney general’s office with Nation on Prescription Drugs the requisite smoking gun in a case that Melody Petersen turned out to have broad implications. Sarah Crichton Books, Farrar, Straus and In a settlement, Glaxo agreed to post its Giroux; 2008 clinical trial results, jump-starting the 414 pp $26.00 ISBN 978-0-374-22827-9 international movement to register all clinical trials. Writing with a novelist’s touch and he past 4 years have witnessed honing her material for its underside, a wave of books condemning Bass has produced a gripping who- T the pharmaceutical industry for dunit replete with dead bodies, hidden unethical practices, but in 2008, Algonquin Books of Chapel Hill documents, public monies spent on Pharma began to turn the corner, nonexistent studies and even a sham transformed by clinical trial registries, dustry’s bad behaviour in Africa. Here court verdict. bans on ghostwritten papers and the heroine is Rose Firestein, a nearly Our Daily Meds, a treatise on the (south of the border, at least) trans- blind, diabetic woman in her 50s who overuse and misuse of brand-name parency regarding companies’ submis- toiled behind the headlines as an assis- medications, also has corpses, but it’s sions to regulators. The transformation tant attorney general, digging for evi- closer to advocacy journalism than nar- is in many ways a credit to whistle- dence that would prove the company’s rative nonfiction. For Petersen, the blowers and to those who acted on bad behaviour was criminal. Through pharmaceutical companies cause “far their evidence. Two new books from scanning the literature and meeting too much needless harm” through their US journalists — Side Effects by for- with a whistle-blower, she discovered “profiteering,” and she refers so often mer Boston Globe reporter, Alison the hidden studies showing that paroxe- to the “medicine merchants” and “med- Bass and Our Daily Meds by Melody tine doesn’t work against depression in icine marketers” with their “hoards of Petersen, who covered Pharma for the children and adolescents and jumped cash” and “cash-filled coffers” that, at New York Times — expand our under- on them. “I think we can argue that by times, Our Daily Meds becomes an un- standing of this tarnished industry by not fully disclosing all of its research enlightening, one-sided screed. But introducing us to a few of the individ- uals who found themselves battling against it from the inside and chose to Bass has produced a gripping whodunit come forward. Side Effects lays out the compelling drama of how New York’s then- replete with dead bodies, hidden docu- attorney general Elliot Spitzer — be- fore his downfall while state governor ments and a sham court verdict. — charged GlaxoSmithKline with fraud for deceiving doctors about its results, Glaxo is guilty of fraud under what lifts it up, and will stay with you, blockbuster antidepressant, paroxetine the New York statute!” she told a col- are the individual characters she depicts (Paxil). Though the case is compli- league. But the attorney general’s of- and the dramas they’re caught in. Iowa cated, the book draws readers along in fice had never sued a drug company on is Petersen’s home state and she went what could almost be a screenplay for a those grounds and, initially, none of her there to be a fly-on-the-wall as drug North American version of the Con- superiors thought it was possible. company sales reps subtly suggested stant Gardener, the award-winning Firestein had to convince the team and that consumers swallow new pills. At

DOI:10.1503/cmaj.081496 2005 film about the pharmaceutical in- Bass lets us watch her do it. the medical centre in Storm Lake,

Iowa, population 20 000, she lunched few. Petersen gives concrete evidence Franklin taped the voice mails and filed with a group of women who were of this via the story of David Franklin, a suit under the United States false claims being encouraged to worry about sleep- scientist who went to work for Parke act, a unique mechanism that can pro- less nights. One said she thought her Davis in 1996 as a sales rep touting the vide an incentive to whistle-blowers antidepressant was keeping her awake, who discover their employers are rip- but the luncheon speaker, a rep for ping off the government. The company Sanofi-Aventis, makers of the best- eventually paid the government nearly a selling sleeping pill, zolpidem (Am- half-billion dollars and, as the whistle- bien), wasn’t discussing drug side ef- blower in the case, Franklin’s share was fects; she was describing insomnia, a nearly $30 million. Petersen, angry that condition she said could result in for- none of those behind the gabapentin getfulness, moodiness, heart disease, scheme were sanctioned, argues for a obesity, “psychotic issues” and car reform plan that would throw a few crashes. “I don’t mean to scare you,” pharma executives in jail, but leaves the rep told the assembled women, but readers wondering about Franklin. How of course, she did. Her job, it seems, did he fare when he faced his former su- was to leave the women, half of whom periors in court? Why was he the only were seniors, terrified of insomnia and employee who was driven to complain besieging their doctors for zolpidem, publicly about the company’s practices? described in kits left in the lunchroom And, most important, why did he blow as the country’s “#1 prescribed sleep the whistle instead of just walking aid.” What the women weren’t told is away? that for many patients, especially the The value of both these books is that elderly, the risks of sleeping pills out- they underscore how crucial such a de- weigh their benefits. Zolpidem’s side cision can be. The change that’s com-

effects — daytime sleepiness, amnesia, Farrar, Straus and Giroux ing to Pharma has been brought about and dizziness — can lead to falls and by the converging efforts of several fractures and it has such high potential benefits of the antiseizure medication, Rose Firesteins and David Franklins, for addiction that its label warns doc- gabapentin (Neurontin) and found him- watching, listening and spilling the tors not to prescribe it for more than 10 self morally repulsed by his job. A beans. days. group of Parke Davis executives calling Our Daily Meds demonstrates that themselves the New Product Committee Miriam Shuchman MD many of the deaths and injuries that re- instructed Franklin and his fellow reps Psychiatrist sult from prescription drugs aren’t acci- to promote gabapentin for conditions Toronto, Ont. dents; they’re the direct result of a mul- where there’s minimal evidence that it titiered system of inducements that drug works, then told them to be careful to companies hurl at doctors, consumers, communicate solely through the corpo- REFERENCE 1. Kondro W, Sibbald, B. Drug company experts ad- magazine publishers, hospitals, pharma- rate voice mail program since anything vised staff to withhold data about SSRI use in chil- cies, and elected officials, to name a in writing could be audited. Instead, dren. CMAJ 2004;170:783

Holiday Reading Acknowledgements Our call for submissions to the Holiday Reading section — a literary deviation from our usual Holiday Review — drew an unprecedented number of submissions, resulting in some extremely difficult judging decisions. Thank you to our esteemed panel of reading enthusiasts: Erin Driscoll, Jesse Craig, Kate Schissler, Kelly Clarke, Patricia Lightfoot and Wayne Kondro. Thanks also to our designer Carole Lalonde. And a very special thank you to everyone who submitted a manuscript. Wishing you many hours of enjoyable reading over the holidays, Barbara Sibbald Deputy Editor, News and Humanities