- 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.