If there were any doubts about the
final score of the government's decade long "landmark study"
aspiring to defeat diabetes by throwing best of drugs - and lots of
them - at it, there's none left. Last month, the remaining two
pieces fell in, and the quick summary is: can't do it.
Of course, we are talking about the ACCORD study, which attempted
to fight diabetes at all three major fronts at once: by lowering
blood glucose, pressure and
cholesterol in diabetes II patients at high risk for heart
attacks and strokes, by subjecting them to
super-high doses of
multiple prescription drugs.
The study started accepting participants back in 2001. By 2008,
when sufficient data accumulated, the intense arm of the study - the
core of the whole experiment - was cancelled due to significantly
higher death rates in treatment groups - particularly the
all-intense (i.e. for blood sugar, cholesterol and pressure
treatment) groups - vs. placebo. This is covered in more details by
HealthKnot ACCORD articles at the
Participants from the cancelled arm - half of the total - were
merged with the standard treatment arm, till study's planned ending.
The final results were published in March 14th New England Journal
The Combination Lipid Therapy arm of the study (Ginsburg
et al), which used combination of
sold as Lipitor and Zocor) and fibrate (fenofibrate TriCor)for the
treatment group, vs. statin alone in the control group, had average
follow-up of 4.7 years per participant. The rate of "primary
outcome" - fatal and non-fatal heart attack or stroke - was nearly
identical in the two groups (annual rate 2.2% vs. 2.4%,
respectively), and so was the "death of all causes" rate (1.5% vs.
Gender-wise, study results indicate that the treatment may have
possible beneficial effect for men, but harmful for women.
In all, the authors conclude that the combined statin/fibrate
therapy for reducing cardiovascular risk in diabetes II patients
does not seem to be a viable alternative for routine use.
The other half of the crippled study had the goal of establishing
if lowering systolic blood pressure with (unspecified) medications
below 120 mm Hg will be beneficial in lowering cardiovascular risk
in diabetes II patients vs. standard therapy, targeting systolic
pressure below 140 mm Hg. The results, for the same outcomes, were
1.87% vs. 2.09%, and 1.19% vs. 1.07% (annual rates) for the overall
death rate with intense vs. standard treatment, respectively.
The conclusion: driving systolic blood pressure below 120 mm Hg
with intense drug treatment did not reduce the rate of heart attacks
and strokes compared to lowering it below 140 mm Hg with the
standard drug treatment.
But it sure has caused more adverse effects. The rate of serious
adverse effects "attributed to antihypertensive treatment" was
more than two and a half
in the intense treatment group.
Unexpected? Not really; where the expectations failed was
treatment benefit. Has it played out as planned, the whole package
would have been wrapped up in the old, proven-to-work cliché of
"benefits outweighing the risk" and sold to the public.
The real question is, why not a single alternative non-drug
treatment for diabetes was included in the study? We can understand
that drug companies don't do it in their studies; why should a
business promote its deadly competition? But why not the government?
What makes medicating diabetes more of a priority to the government
than striking at its very causes and promoting a number of proven,
alternatives, both preventive and therapeutic?
Of course, we all know that the National Cancer Institute,
formally sponsoring the study, is far from being independent of the
pharmaceutical industry and its influence. It is easy for a big game
to find ways to protect and promote its interests. The question is,
who represents the rabbits?
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