Congressional Hearing Focuses on Merck's Marketing for
COX-2 Drug VioxxMain Category: Arthritis
News Article Date: 07 May 2005 - 0:00am (PST) | email
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Merck sales associates were given
detailed instructions not to mention certain potential
cardiovascular risks when promoting the company's COX-2
inhibitor Vioxx to doctors, according to an analysis of 20,000
pages of internal documents by congressional investigators for
the... House
Committee on Government Reform delivered at a hearing
Thursday, the Washington Post reports (Kaufman,
Washington Post, 5/6). Merck in September 2004
voluntarily withdrew Vioxx from the market, citing
cardiovascular safety risks.
Vioxx Marketing History In March 2000, a
Merck-funded study called VIGOR showed increased heart attack
risks associated with Vioxx (Cohen, Newark Star-Ledger, 5/6). The study
showed a fivefold increase in heart attacks among those who
took Vioxx compared with those who took the painkiller
naproxen. Merck said that the findings possibly were a result
of a protective effect on the heart that naproxen provided,
not an increased risk associated with Vioxx (Appleby, USA Today, 5/6). According to company
documents included in the congressional investigation, Merck
in April 2000 developed a "Cardiovascular Card" for use in
sales representatives' presentations to physicians. According
to the committee, Merck's 3,000 sales representatives were
instructed to refer doctors who raised questions about
cardiovascular risks to the card, which indicated that Vioxx
was eight to 11 times safer than other similar painkillers.
Information on the card was taken from several studies
submitted to FDA and omitted any reference to the VIGOR
study. An FDA advisory committee in 2001 voted that physicians
should be informed of the VIGOR study findings. According to
the committee, Merck subsequently sent a memo to sales
representative that stated, "Do not initiate discussions of
the FDA arthritis committee ... or the results of the ...
VIGOR study." Further, representatives were specifically
directed to respond to doctors' questions about the study by
saying, "I cannot discuss the study with you" (Newark
Star-Ledger, 5/6). Additional cardiovascular risks of
Vioxx were cited in an August 2001 study in the Journal of
the American Medical Association (USA Today, 5/6).
Label Change, Sales Instructions After
"extensive negotiations" with FDA, Merck in April 2002 agreed
to a label change for Vioxx that included risks found in the
VIGOR study. The label also included a statement that the
significance of the findings was "unknown." According to the
committee, Merck told sales representatives "to emphasize the
uncertainty of the VIGOR study to counter physicians'
concerns," the Star-Ledger reports (Newark
Star-Ledger, 5/6). Sales representatives were told to
encourage doctors to submit any questions in writing to
Merck's medical services department. The company received
123,000 inquiries from physicians, according to Dennis Erb,
Merck's vice president for regulatory issues (Alonso-Zaldivar,
Los Angeles Times, 5/6).
Sales Techniques According to the Post,
Merck documents unearthed in the investigation indicate that
sales representatives were given detailed instructions about
how to approach physicians when selling Vioxx. "They were
trained how to smile, speak and position themselves most
effectively when talking with doctors," the Post
reports (Washington Post, 5/6). Representatives also
were instructed how to use "verbal and nonverbal" cues to gain
a physician's trust. Training materials indicated that
representatives should shake a doctor's hand for no longer
than three seconds. Merck officials also informed
representatives about "different personality types of doctors
and recommended [sales] techniques for each type," the
Star-Ledger reports (Newark Star-Ledger, 5/6).
The training included motivational courses in which
representatives were "taught not to take no for an answer."
The courses compared milestones in sales of Merck drugs to
points in the lives of Martin Luther King and Helen Keller.
Campaigns were titled "Project Offense" and "Project
XXcelleration." In documents, doctors' concerns about risks
were termed "obstacles." The company also used "sophisticated
databases" to track the prescribing patterns of individual
doctors and set targets for sales, according to the Los
Angeles Times (Los Angeles Times, 5/6).
Representatives were given $2,000 bonuses for meeting sales
goals (AP/New York Times, 5/6). According to
the Los Angeles Times, Merck's marketing campaign was
"astoundingly successful," with the "overwhelming majority" of
prescriptions dispensed after concerns about heart risks had
surfaced. Vioxx achieved sales of $2 billion annually "faster
than any previous Merck drug," the Los Angeles Times
reports (Los Angeles Times, 5/6).
Committee Report The committee report states,
"When concerns about Vioxx's safety arose, Merck appeared to
use this highly trained force to present a misleading picture
to physicians about the drug's cardiovascular risks." The
report also said that Merck instructed its sales force to
"emphasize outdated and misleading data that indicated Vioxx
was safer than alternatives" (Newark Star-Ledger, 5/6).
Committee ranking member Henry Waxman (D-Calif.) at the
hearing said, "This sales force is given extraordinary
training so that it can capitalize on virtually every
interaction with doctors. Yet when it comes to the one thing
doctors most need to know about Vioxx -- its health risks --
Merck's answer seems to be disinformation and censorship"
(Washington Post, 5/6). He asked, "Why did doctors
write so many Vioxx prescriptions even as evidence of harm
mounted?" He added that the company's "goal was sales, not
education" (AP/New York Times, 5/6). Rep. Gil Gutknecht
(R-Minn.) called Merck's omission of potential risks in its
presentations "confusing and, in some respects, embarrassing."
He added that no one "wants to take responsibility for putting
out information that an outside observer might call ...
disingenuous."
FDA Testimony FDA officials at the hearing
testified that they were unaware of the details of Merck's
marketing campaign, the Los Angeles Times reports
(Los Angeles Times, 5/6). Steven Galson, director of
FDA's Center
for Drug Evaluation and Research, said that Merck is
legally obligated only to provide information that was
approved in drug labeling (Newark Star-Ledger, 5/6).
Galson said that that the promotional materials used by Merck
sales representatives were "accurate based on the label, which
was the standard we use" (Rovner, Congress Daily, 5/5).
However, Galson added that is "important that the company
convey truthful information that is up to date." He also said
that Merck appears not to have given doctors "the entire
picture" (Newark Star-Ledger, 5/6). Galson acknowledged
that the agency may have taken too long to remove Vioxx from
the market (CQ HealthBeat, 5/6). However, he said FDA
is taking steps to improve awareness of drug risks (New
York Times, 5/6). "The most important lesson ... is that
the American public, practitioners and patients want to get
clear and accurate information ... in their own health care
decisions," Galson said. Addressing Galson, Gutknecht said,
"It seems to me there's a disconnect here. You're saying your
policies are legal, but are they ethical? Isn't this the
scandal?" (Washington Post, 5/6). Gutknecht also said,
"Both the FDA and the pharmaceutical company sort of missed
the mark" (Tansey, San Francisco Chronicle, 5/6).
Merck Response Erb said at the hearing, "We
believe Merck acted appropriately and responsibly to
extensively study Vioxx after it was approved for marketing to
gain more clinical information about the medicine." He added
that the company "promptly disclosed the results of those
studies to the FDA, physicians, the scientific community and
the media" (Los Angeles Times, 5/6). When asked by
Committee Chair Tom Davis (R-Va.) whether a "wide awake"
physician would have been aware of the drug's risks, Erb said,
"That is correct" (AP/New York Times, 5/6). Erb added,
"We believed wholeheartedly in the safety of Vioxx and that
Vioxx was an important treatment option. My own father was a
regular user of Vioxx" (Freking, AP/Las Vegas Sun, 5/6).
Implications According to the San Francisco
Chronicle, the committee's findings "could bolster moves
by Congress to beef up the FDA's powers" (San Francisco
Chronicle, 5/6). Davis said, "As the committee conducted
its investigation, it became apparent that the relationship
between the Office of New Drugs and the Office of Drug Safety has its challenges."
He said that the challenges include "a lack of communication
between the offices, as well as communication up the chain of
command" (CongressDaily, 5/5). The committee report
could also "prove a bonanza to plaintiffs in civil suits"
against Merck alleging that Vioxx caused severe side effects
or death, the Chronicle reports (San Francisco
Chronicle, 5/6).
Vioxx Return? Erb said that Merck is in
"preliminary discussions," with FDA to determine whether to
apply for approval to resume marketing Vioxx in the United
States. An FDA advisory committee in February "narrowly" voted
to recommend that Vioxx could be allowed back
into the U.S. market under certain conditions, the
AP/Times reports (AP/New York Times, 5/6).
Gilmartin Resigns In related news, Merck board
members on Thursday named Richard Clark as new CEO after
former company CEO and Chair Raymond Gilmartin resigned 10
months before his scheduled retirement, the Wall Street
Journal reports. However, in an "unusual agreement," the
chair position will remain open for one to two years and a
three-member executive committee will advise Clark, according
to the Journal (Martinez/Lublin, Wall Street
Journal, 5/6). Clark, who joined Merck in 1972 as a
quality control inspector, has held positions in production,
new product planning and strategic planning (Johnson/Agovino,
AP/Atlanta Journal Constitution, 5/6). In 1997, Clark
became chief operating officer of the pharmacy benefit manager
Medco Health Solutions, which Merck spun off
in 2003. Clark became CEO and chair of Medco in 2002 and
returned to Merck in 2003 after the spin off. Lawrence
Bossidy, a former CEO of Honeywell International, will lead the
executive committee and likely will become a "key player in
deciding strategy" for Merck. The other executive committee
members will include former Princeton
University President William Bowen, who will advise Clark
on litigation and corporate governance, and Harvard
University professor of medicine Samuel Thier, who will
advise Clark on health care policy (Wall Street
Journal, 5/6). Bossidy also will serve as acting Merck
chair at board meetings. Gilmartin, who will remain with Merck
as a special adviser to the executive committee until 2006,
said that he decided to resign voluntarily (Berenson, New York Times, 5/6). Bossidy said
that the executive committee will "work closely" with Clark
for as long as two years and "provide support and continuity"
(Bloomberg/Los Angeles Times, 5/6).
Clark said, "I can guarantee you that I would not take this
job if I didn't have full responsibility as the CEO of the
company" (McCoy/Appleby, USA Today, 5/6). According to the
Journal, Merck board members had some concerns about
whether to name an internal candidate as the new CEO but
concluded that external candidates were not "head and
shoulders above someone who demonstrated repeatedly that he
can get results" (Wall Street Journal, 5/6).
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