Jeez - these memos must be oozing with material for the NYTimes to write
yet another piece on the subject:
Thanks to furiousseasons.com for the coverage:
BTW - even w/out access to the memos, there is plenty of nitpicking to
do with Lilly's response to these -
"Patient safety is our first priority at Lilly. We take seriously and
thoroughly examine all adverse event reports received through
post-marketing surveillance (also known as spontaneous adverse event
reporting), from both health care professionals and consumers. We follow
up on reports diligently and intensely -- as we did in this case.
Although these reports are not publicly available, they are shared
routinely with regulatory authorities. It is widely accepted that these
reports do not address causality but they are important and can help
guide further evaluation into potential safety signals. However, they
cannot be interpreted in isolation from clinical trial data."
Really Lilly? Are you sure you aren't distorting this data before
passing it on to doctors and regulators?
Something in these memos suggested you might:
or perhaps it was just "funny" statistics that us laypeople would never
More significantly, Lilly now seems to be changing their tune:
"Zyprexa is not approved for the treatment of patients with dementia-
related psychosis. Elderly patients with dementia-related psychosis
treated with atypical antipsychotic drugs are at an increased risk of
death compared with those patients taking a placebo. In addition,
compared to elderly patients with dementia-related psychosis taking a
placebo, there was a significantly higher incidence of cerebrovascular
adverse events in elderly patients with dementia-related psychosis
treated with Zyprexa."
Oh? How does this statement contrast with the "Viva Zyprexa" campaign?
Maybe the public, as well as the FDA would like to compare the press
release to the internal marketing communications.
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