Arthritis - Company deceived doctors about Vioxx's safety, lawmaker says

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Company deceived doctors about Vioxx's safety, lawmaker says

Roman Bystrianyk

2005-05-12, 11:53 am

http://www.healthsentinel.com/news....ist_item&id=801

Tony Pugh, "Company deceived doctors about Vioxx's safety, lawmaker
says", Kansas City Star, May 6, 2005,
Link:
http://www.kansascity.com/mld/kansa...cs/11574395.htm

After a March 2000 study linked Merck's painkiller Vioxx to heart
problems, Merck instructed its marketing force not to discuss the
findings with physicians, according to company documents released
Thursday by a congressional committee. Instead, Merck's sales staff
provided doctors with different studies that suggested Vioxx was safe.

Those actions, along with a multimillion-dollar ad campaign, helped
make Vioxx a success for Merck. It reached $2 billion in annual sales
faster than any of the company's other drugs, said Rep. Henry Waxman,
D-Calif. But Vioxx may also have been a factor in thousands of heart
attacks and strokes in patients who would have been better served with
another medication, according to medical experts.

A senior Merck marketing official rejected charges that Merck had
misled doctors and said the information provided to them was true and
balanced.

Waxman, the ranking minority member of the House Government Reform
Committee, charged that the 20,000 pages of documents that Merck
submitted to the committee show that Merck's sales force was permitted
to discuss only approved journal articles that "provide solid evidence
as to why doctors should prescribe Merck products."

The committee is investigating actions by Merck and the Food and Drug
Administration prior to Merck's decision to withdraw Vioxx from
pharmacy shelves in September 2004.

Merck faces more than 2,300 personal injury lawsuits and more than 200
class-action lawsuits related to Vioxx. Its profits and market value
have slumped sharply since the drug's withdrawal, and on Thursday,
Merck CEO Raymond Gilmartin stepped down. Richard Clark, a senior Merck
executive, replaced him.

The House committee released hundreds of pages of company documents
detailing how Merck's 3,000-member sales force persuaded doctors and
hospitals to prescribe their products, including the once-popular
arthritis painkiller Vioxx.

The documents also reveal much about how drug sales personnel work with
doctors.

The instructions told marketers how to be good listeners: "nod head,"
"don't interrupt," "take notes," "sound interested" and "use voice
inflection and energy." They also described how the proper handshake
should be "firm, but painless," last "about three seconds," come "with
eye contact" and "start and stop crisply."

At Thursday's hearing on Capitol Hill, Waxman told committee members
that after a study linked Vioxx to heart problems in 2000, Merck's
sales force provided doctors with "inaccurate and misleading"
information that claimed Vioxx was "eight to 11 times safer" than other
anti-inflammatory painkillers.

The information that sales personnel handed out to doctors didn't
include findings of Merck's Vioxx gastrointestinal outcomes research
study, dubbed "VIGOR." That study found that Vioxx users were up to
five times more likely to have heart attacks or strokes than users of
Naproxin, another anti-inflammatory pain reliever.

One memo, dated Feb. 9, 2001, told sales representatives, "Do not
initiate discussions" on VIGOR.

Instead, according to company documents that Merck submitted to the
committee, Merck's sales staff was instructed to give doctors
"cardiovascular cards" - promotional materials that asserted Vioxx was
safe for the heart. The cards cited and summarized findings from
previous clinical trials on Vioxx conducted prior to its FDA approval
in May 1999.

But an FDA official, whom Waxman didn't name, said those studies had no
relevance on the cardiovascular safety of Vioxx. The FDA official,
Waxman said, added that it was "ridiculous and scientifically
inappropriate to use the data in the way Merck did."

Dennis Erb, Merck's vice president for global strategic regulatory
development, disagreed. He said company sales representatives gave
doctors "accurate, balanced and fair" material about Vioxx.

Erb said he believes in the safety of Vioxx and added that Merck is in
discussions with the FDA to allow Vioxx back on the market.

"I feel very positive about the safety profile of Vioxx," Erb said.

Erb denied trying to deceive physicians. He said Merck's sales force
couldn't discuss the VIGOR study with doctors because company policy
allows them to discuss only information that's been approved by the FDA
for the drug's product label.

He maintained that doctors were informed about the VIGOR study through
news accounts and articles in medical journals.

"The cardiovascular results of VIGOR were widely reported and discussed
at the time. We worked diligently with the FDA to review the data and
develop revised prescribing information," Erb testified.

Doctors who wanted more information about the study only had to request
the material from the company, Erb said. About 133,000 did so, he
added.

But even after an FDA advisory committee recommended in April 2001 that
doctors should be advised about the findings of the VIGOR study, Merck
sent a bulletin to its representatives urging them not to "initiate
discussions on the FDA arthritis committee ... or the results of ...
the VIGOR study."

"Instead of informing doctors about the risk of Vioxx," Waxman
continued, "Merck told its reps to continue to rely on the highly
questionable cardiovascular card."

Waxman said the 20,000 pages of documents that Merck submitted to the
committee show that "health risks were viewed as obstacles that the
sales force was instructed to surmount."

To view the Merck sales documents, go to:
http://www.democrats.reform.house.gov/story.asp?ID=848.

sklocke@gmail.com

2005-05-12, 11:54 am

That the downfalls of Vioxx have only just come to light has me quite
puzzled. There have been doubts from the beginning, and I recall as
early as 2001, as a first year Biochemistry student, being told that it
was ineffective and potentially dangerous.