Healthy Skepticism Library item: 14840

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Shuchman M.
Book Review: Spilling the beans on the pharmaceutical industry
CMAJ 2008 Dec 2; 179:(12):1309
http://www.cmaj.ca/cgi/content/full/179/12/1309

Full text:

Side Effects: A Prosecutor, a Whistleblower, and a Bestselling
Antidepressant on Trial Alison Bass; Algonquin Books of Chapel Hill;
2008; 260 pp $24.95 ISBN978 1-56512-553-7

Our Daily Meds: How the Pharmaceutical Companies Transformed
Themselves into slick Marketing Machines and Hooked the Nation on
Prescription Drugs Melody Petersen; Sarah Crichton Books, Farrar,
Straus and Giroux; 2008; 414 pp $26.00 ISBN 978-0-374-22827-9

The past 4 years have witnessed a wave of books condemning the
pharmaceutical industry for unethical practices, but in 2008, Pharma
began to turn the corner, transformed by clinical trial registries,
bans on ghostwritten papers and (south of the border, at least)
transparency regarding companies’ submissions to regulators. The
transformation is in many ways a credit to whistle-blowers and to
those who acted on their evidence. Two new books from US journalists – Side Effects by former Boston Globe reporter, Alison Bass and Our
Daily Meds by Melody Petersen, who covered Pharma for the New York
Times – expand our understanding of this tarnished industry by
introducing us to a few of the individuals who found themselves
battling against it from the inside and chose to come forward.

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). Though the
case is complicated, the book draws readers along in what could almost
be a screenplay for a North American version of the Constant Gardener,
the award-winning 2005 film about the pharmaceutical industry’s bad
behaviour in Africa. Here the heroine is Rose Firestein, a nearly
blind, diabetic woman in her 50s who toiled behind the headlines as an
assistant attorney general, digging for evidence that would prove the
company’s bad behaviour was criminal. Through scanning the literature
and meeting with a whistle-blower, she discovered the hidden studies
showing that paroxetine doesn’t work against depression in children
and adolescents and jumped on them. “I think we can argue that by not
fully disclosing all of its research results, Glaxo is guilty of fraud
under the New York statute!” she told a colleague. But the attorney
general’s office had never sued a drug company on those grounds and,
initially, none of her superiors thought it was possible. Firestein
had to convince the team and Bass lets us watch her do it.

At this point, CMAJ gets a walk-on part in the book. In 2004, CMAJ
revealed a confidential memo in its news pages that proved the makers
of paroxetine “knew they were holding back information and that what
they were doing was wrong,” as a lawyer in the New York attorney
general’s office put it later.1 The CMAJ’s news story provided the
attorney general’s office with the requisite smoking gun in a case
that turned out to have broad implications. In a settlement, Glaxo
agreed to post its clinical trial results, jump-starting the
international movement to register all clinical trials.

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.

Our Daily Meds, a treatise on the overuse and misuse of brand-name
medications, also has corpses, but it’s closer to advocacy journalism
than narrative nonfiction. For Petersen, the pharmaceutical companies
cause “far too much needless harm” through their “profiteering,” and
she refers so often to the “medicine merchants” and “medicine
marketers” with their “hoards of cash” and “cash-filled coffers” that,
at times, Our Daily Meds becomes an unenlightening, one-sided screed.
But what lifts it up, and will stay with you, are the individual
characters she depicts and the dramas they’re caught in. Iowa is
Petersen’s home state and she went there to be a fly-on-the-wall as
drug company sales reps subtly suggested that consumers swallow new
pills. At the medical centre in Storm Lake, Iowa, population 20 000,
she lunched with a group of women who were being encouraged to worry
about sleepless nights. One said she thought her antidepressant was
keeping her awake, but the luncheon speaker, a rep for Sanofi-Aventis,
makers of the best-selling sleeping pill, zolpidem (Ambien), wasn’t
discussing drug side effects; she was describing insomnia, a condition
she said could result in forgetfulness, moodiness, heart disease,
obesity, “psychotic issues” and car crashes. “I don’t mean to scare
you,” the rep told the assembled women, but of course, she did. Her
job, it seems, was to leave the women, half of whom were seniors,
terrified of insomnia and besieging their doctors for zolpidem,
described in kits left in the lunchroom as the country’s “#1
prescribed sleep aid.” What the women weren’t told is that for many
patients, especially the elderly, the risks of sleeping pills outweigh
their benefits. Zolpidem’s side effects – daytime sleepiness, amnesia,
and dizziness – can lead to falls and fractures and it has such high
potential for addiction that its label warns doctors not to prescribe
it for more than 10 days.

Our Daily Meds demonstrates that many of the deaths and injuries that
result from prescription drugs aren’t accidents; they’re the direct
result of a multitiered system of inducements that drug companies hurl
at doctors, consumers, magazine publishers, hospitals, pharmacies, and
elected officials, to name a few. Petersen gives concrete evidence of
this via the story of David Franklin, a scientist who went to work for
Parke Davis in 1996 as a sales rep touting the benefits of the
antiseizure medication, gabapentin (Neurontin) and found himself
morally repulsed by his job. A group of Parke Davis executives calling
themselves the New Product Committee instructed Franklin and his
fellow reps to promote gabapentin for conditions where there’s minimal
evidence that it works, then told them to be careful to communicate
solely through the corporate voice mail program since anything in
writing could be audited. Instead, Franklin taped the voice mails and
filed suit under the United States false claims act, a unique
mechanism that can provide an incentive to whistle-blowers who
discover their employers are ripping off the government. The company
eventually paid the government nearly a half-billion dollars and, as
the whistle-blower in the case, Franklin’s share was nearly $30
million. Petersen, angry that none of those behind the gabapentin
scheme were sanctioned, argues for a reform plan that would throw a
few pharma executives in jail, but leaves readers wondering about
Franklin. How did he fare when he faced his former superiors in court?
Why was he the only employee who was driven to complain publicly about
the company’s practices? And, most important, why did he blow the
whistle instead of just walking away?

The value of both these books is that they underscore how crucial such
a decision can be. The change that’s coming to Pharma has been brought
about by the converging efforts of several Rose Firesteins and David
Franklins, watching, listening and spilling the beans.

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