- 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.