A Colorado Business Litigation Lawyer Blog posted August 18, 2010 reported on the SmithKline study that clearly showed that Avandia (a diabetes drug) had a significantly higher heart attack and death risk than its competitor drug Actos.
Along comes a new study funded by WellPoint, Inc. that claims to show
that the increased risk of heart problems linked to either drug is exactly
the same at 4%. This latest study reported on subjects whose age averaged
54 years, while the earlier study’s subjects averaged 74.4 years
young (a politically correct word). Some scientific observers commented
that the age difference may have skewed the WellPoint results, since younger
persons would likely be in better overall health than older persons.
One diabetes researcher from Australia suggested that it appears that
both drugs may be risky, since the 4% heart attack and death increase
is “pretty high” given the short study periods.
The FDA is expected to make a decision on whether Avandia should be taken
off the market or perhaps change its warnings to reflect the risks involved.
It is unclear (a word used by journalists when they don’t have the
answer) when the decision will be made. Given the fact that our government
sometimes (almost always) moves at less than a snail’s pace, and
given the fact of the new, conflicting study results, we should not hold
our collective breath.
While we wait, let’s think about the dilemma our prescribing doctors
have until the FDA acts.