Safety Issues Played a Role in Vioxx's Withdrawal from the US Market

DUBLIN, Ireland--(BUSINESS WIRE)--Jan. 27, 2006--Research and Markets
(http://www.researchandmarkets.com/reports/c31670 ) has announced the
addition of The Vioxx Withdrawal: Changes and Opportunities for the
Industry to their offering.


The safety issues that precipitated the withdrawal of Vioxx from the
U.S. market have had a devastating effect on the market potential of
the selective COX-2 inhibitor class and raised doubts about the safety
of all nonsteroidal anti-inflammatory drugs (NSAIDs). Furthermore, the
Vioxx withdrawal sparked a continuing controversy over the FDAs
regulation of drugs in the United States and the pharmaceutical
industrys promotion of drugs.

This report contrasts the Vioxx withdrawal with other U.S. drug
withdrawals, highlighting the unusual set of circumstances surrounding
the event, and examines its ramifications for the industry. We discuss
potential changes to drug regulation and promotion in the United
States, consider how public opinion shapes the decisions of regulators
and legislators, and propose that the pharmaceutical industry become a
willing and proactive partner in the reforms triggered by this unique
event.

Business Implications

-- The withdrawal of Vioxx from the U.S. market occurred against a
backdrop of public relations disasters for the FDA, public criticism
of rising drug costs, debate over Medicare reform, and increasing
concern about the safety of approved drugs. The withdrawal set in
motion a series of events likely to change the face of drug regulation
and marketing in the United States.

-- Public opinion of the pharmaceutical industry is at an all-time
low. Criticism of the cost and quality of drug marketing has
heightened in the wake of the Vioxx withdrawal because heavy promotion
to doctors and the public is blamed for the vigorous uptake of this
drug. Further, the public in the United States blames the rising cost
of pharmaceuticals, in part, on what it considers excessive marketing.

-- Following a long and public drug safety debate in the United
States, the FDA must rebuild its reputation. The lengthy time that
Vioxx remained on the market while its safety was in question and high
mortality estimates have been most damaging. Public confidence in the
agency has been shaken, and many commentators charge that the FDA's
short approval times undermine safety.

-- The FDA has responded by introducing a series of reforms and
initiatives aimed at strengthening drug safety programs and increasing
the transparency of its operations. A return to slower drug approval
times looks set for the future, together with more stringent
postmarketing surveillance and rapid, effective response to safety
concerns.

-- Pharmaceutical companies need to embrace the coming changes if they
are to be successful in the future. There is no question that the
industry will be held more accountable for its activities, and public
perception may be the key to its success.

Topics Covered

Overview

The Perfect Storm

The Vioxx Withdrawal in Context: A Brief Chronology

Far-Reaching Effects

Outlook

List of Figures and Tables

Figure 1. Share Price History: Comparison of Merck and Pfizer Stocks
with Industry Indexes

Figure 2. Public Survey Results of Consumer Confidence

Figure 3. Mean US pproval Times for NMEs, 1984-2003

Figure 4. FDA Drug Approvals Against Percentage of Drugs Withdrawn,
Based on Year Approval

Figure 5. Public Survey Results of Attitudes to Drug Advertising

Table 1 Drugs Withdrawn for Safety Reasons in the United States,
1980-2005, in Order of Time on the Market

Table 2. Ten Best-Selling Therapeutic Classes by U.S. Sales, 2004

Table 3. Top Ten Drugs by DTC Spend, 2000

Companies Mentioned

-- AstraZeneca

-- Aventis

-- GlaxoSmithKline

-- Merck & Co.

-- Pfizer

-- Schering-Plough

-- Wyeth

For more information visit http://www.researchandmarkets.com/reports/c31670

Source: Decision Resources, Inc.