The objective of this activity is to address ethical issues involved in ghost writing. After reading the Vioxx Case Stud

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The objective of this activity is to address ethical issues
involved in ghost writing. After reading the Vioxx Case Study
located below. Analyze and discuss the case by answering the
following questions. In addition, you must appropriately cite all
resources used in your response and document in a bibliography
using APA style.
Part 1: Given the criticisms of PR and
publicity tactics such as ghost blogging reviewed in this lesson,
critique the apparent ghost writing involved in this case.
Part 2: What are the ethical
responsibilities of academic authors who appear as the apparent
authors of research studies such as the ones reviewed here?
Part 3: What is the responsibility of
the journals in which these papers appear to ensure accurate
attribution of authorship?
""Case study Ethical issues in
withholding information – lessons from Vioxx
This case focuses on the marketing
(and eventual withdrawal) of Vioxx, a non-steroidal
anti-inflammatory drug (NSAID) in the mid-2000s, the largest
prescription drug withdrawal in US history (Jain et al., 2005).
There is a growing body of literature detailing the circumstances
leading up to the drug’s eventual withdrawal from the market,
examining marketing ethics and also legal aspects of the case. Some
of these papers have been included in the list of further reading
which follows this case study. While the focus of this case is on
pharmaceutical marketing tactics, the issues relating to selective
presentation of information apply to much wider product
categories.
Vioxx (also called rofecoxib) was
introduced by Merck Sharp & Dohme in 1999 as an effective and
safer alternative to other NSAID drugs already on the market. The
primary use was for the treatment of pain in conditions such as
osteoarthritis. In a large-scale trial of Vioxx – Vioxx
Gastrointestinal Outcomes Research study, also known as VIGOR – its
gastro-intestinal safety relative to existing medications was
proven. However, these trials raised concerns about increased risk
of ‘cardiovascular events’ such as heart attacks, strokes, blood
clots and unstable angina (Rotthoff, 2010). Information regarding
the latter aspect of Vioxx was not communicated to prescribing
doctors or their patients (Dieppe et al., 2004).
After a 2001 committee meeting for
the US Food and Drug Administration (FDA) at which the VIGOR study
– and cardiovascular risks – were discussed, Merck instructed its
3000+ sales force to not discuss the FDA meeting or the VIGOR study
itself when talking to medical professionals. A pamphlet which
provided selective information and thus a misleading picture of
effectiveness and risk factors was provided by Merck’s marketing
department for distribution to doctors (Waxman, 2005).
Vioxx was withdrawn from the
market in September 2004 at the FDA’s request. A second trial
confirmed an increased risk of cardiovascular events, particularly
in patients who had been taking the drug for longer than 18 months
(Jain et al., 2005). At the time of its withdrawal, over two
million people were taking the drug and sales were estimated to be
in the vicinity of US$2.5 billion per year. As at 2007, Merck faced
legal claims from nearly 30,000 people who had ‘cardiovascular
events’ while taking Vioxx. While the company announced intentions
to vigorously defend itself, its reputation suffered, as did its
share price (Krumholz et al., 2007).
Documentation subsequently
obtained as part of litigation against Merck indicates that wording
in a report on the study was changed at Merck’s request in order to
obscure risk data. Nearly one million copies of the report were
distributed to health professionals.
An ‘expression of concern’ was
published in The New England Journal of Medicine in 2005 and
reaffirmed in 2006 (Curfman et al., 2005; Curfman et al., 2006),
which included allegations that critical data on cardiovascular
toxicity had been withheld in reports of the VIGOR trial. For
example, an article published in The New England Journal of
Medicine (Bombardier et al., 2000) and one in the Annals of
Internal Medicine (Lisse et al., 2003) compared differences between
Vioxx and a competitor focusing on gastrointestinal tolerance and
effectiveness but minimised or did not discuss cardiovascular risk.
These articles, and articles in other journals, were subsequently
claimed to have been ghostwritten by Merck staff, leading the
journal to subsequently publish a full correction (Krumholz et al.,
2007).
An author of the 2003 study
admitted to a journalist that:
Merck designed the trial, paid for
the trial, ran the trial …. Merck came to me after the study was
completed and said, ‘We want your help to work on the paper. The
initial paper was written at Merck, and was then sent to me for
editing’. (Laine and Mulrow, 2005: 611)
Drugwatch.com, an organisation
that helps people who have been harmed by prescription drugs that
have harmful side effects and medical devices that cause damage,
notes the following:
To resolve the consumer claims
quickly and quietly, Merck set up a $4.85 billion settlement fund
and paid nearly 35,000 complaints. The varied financial settlements
to injured patients allowed for compensation in accord with
injuries. Of the original 59,365 claims, about 25,000 resulted in
no payment. The remaining claimants received a sliding-scale
settlement based on individual injuries. Of the 20,591 heart-attack
claims, which included 2,878 deaths, payments ranged from $18,000
to $1.79 million. For the 12,447 valid stroke claims, including 590
related deaths, settlements ranged from $5,000 to
$820,000.
Civil lawsuits were also
commenced. Drugwatch.com also notes that, in the US:
Although Merck agreed to pay $950
million and plead guilty to a federal misdemeanour related to its
marketing practices, many were outraged by the settlement because
the company still gleaned billions of dollars in Vioxx profits and
was hardly reprimanded for the related deaths. The company did pay
a $321 million criminal fine, $426 million to the federal
government and $202 million to 48 states and the District of
Columbia to settle civil claims that Merck’s illegal marketing
influenced doctors to prescribe a drug they would not have
otherwise prescribed. (Drugwatch.com, 2014)
Subsequently, in late 2004, Pfizer
announced that a clinical study on its NSAID Celebrex revealed an
elevated risk of heart attacks. In 2005, the FDA asked Pfizer to
remove its painkiller Bextra from the market, and called for
stronger warnings on the Celebrex label (Epstein, 2013; Smith,
2005), raising questions about the safety of all drugs in the class
and leading to an FDA directive ‘that all prescription and
over-the–counter NSAIDs include specific information regarding
potential cardiovascular, gastrointestinal and other risks’ (Cotter
and Wooltorton, 2005: 1299).
This case study presents numerous
issues ranging from the process by which approval of new drugs is
given through to what disclosures of safety and risk information
must be provided by marketers – and not just for pharmaceutical
products. It also raises the question of ghost writing – which is
not confirmed to the medical industry: the tobacco industry has
been accused of ghostwriting reports for the International
Advertising Association (Davis, 2008).
Of concern is a recent content
analysis of efficacy descriptions of material from pharmaceutical
websites. This study shows that less than 5% of drugs featured on
the websites studied provided ‘a complete, specific and numerical
description of drug efficacy’ (Davis, 2012: 211), while almost 80%
used vague and general terms, potentially leading to over-estimates
of efficacy.""