merck minimized the true risks of vioxx

- These legal documents
spell out what Merck knew

and when they knew it In clinical trials

during the late nineties,

the company tested whether
their anti-inflammatory drug

Vioxx could prevent
cognitive decline in patients

with Alzheimer's disease.

Life-threatening risks were documented,

but were never reported
to the FDA or the public.

- The company found a threefold
increased risk in mortality

and failed to see a safety
signal by scientific standards.

This is a major safety issue.

- Dr. Bruce Passade

and colleagues at the University

of Washington reviewed
numerous legal documents from

litigation involving Merck and Viox.

In a published report
in 2004, Merck reported

that Vioxx is quote
generally well tolerated

by the elderly patients in our study.

But this internal company
document tells a different story.

It reveals Merck knew about
an increased risk in mortality

associated with Vioxx, and
they knew this in 2001.

- If these findings had been
made public back in 2001,

many fewer people would have taken Viox.

And because it is associated
with an increased risk

of mortality

and of heart attacks, many fewer
people would've been harmed

- In 2002.

Despite knowing the
risk Merck extended one

of the clinical trials

and even re-enrolled
patients during this time,

eight deaths were associated
with the use of Viox.

- Large clinical trials like
these clearly need independent

data and safety monitoring committees

to protect the patients.

- Dr. ADE's review appears
this week in JAMA Journal

of the American Medical Association. The

- Wisdom of allowing companies to control

and analyze the data from their studies

really comes under question
when we have mortality

findings that are concealed.

In this way,

- ADE says, stricter regulations
are necessary not only

to avoid selective reporting of results,

but to help restore public trust.

Jennifer Mitchell, the JAMA report.