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BLOG: February 2008
Diabetes 2 study
Someone please tell doctors to take it easy with diabetes drugs - and all prescription drugs, period!? If there is one single good thing about recent disaster of the diabetes II study, expected with great confidence to glorify the efficiency of drugs, it is that it should have reminded all those involved in the business of treating diseases with drugs of these two simple facts:
● all drugs are potentially
These two facts spell out loud: be very careful when using drugs, more so considering that the exact mechanism of action for most of them is - as medical reference books plainly state - "not known". The fact is, neither those making drugs, nor those prescribing them, know where is that critical line between a benefit, and the adverse effect for any given individual. But should those designing the study have known better? Very much so! Let's take a closer look.
The 2001-2009 Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, funded by the U.S. National Heart, Blood and Lung Institute, so far had treated 10,251 individuals with diabetes 2, age 40 to 85, with high risk of heart attack or stroke, for an average of four years per participant. The participants were randomly assigned to one of two groups: either standard high-blood-glucose treatment, or "intense" treatment, receiving significantly higher dose of both blood glucose lowering drug - metformin (Glucophage), rosiglitazone (Avandia), or pioglitazone (Actos) - plus insulin.
In addition, participants from both standard and intense blood glucose treatment were assigned to one of two additional treatment trials included in the study, either for lowering blood-pressure, or blood cholesterol. These two were also split in standard and intense treatment groups; the hypertension trial branch was using variety of hypertension drugs, with the dosage being the main difference between standard and intense treatments, while the cholesterol trial branch used statins alone in the standard treatment group vs. statins combined with fibrates for intense treatment.
In all, there were 8 groups: intense and standard glycemic control groups, each branching out in its own intense and standard control blood pressure and cholesterol groups.
ACCORD study treatment groups; the major intense glycemic treatment arm has been discontinued due to significantly higher death rate in the treatment group
The groups were of similar size, except that study's cholesterol arm was somewhat larger than its blood pressure arm (5518 vs. 4733 participants).
The goal of the intensive treatments was to bring elevated blood glucose, pressure and cholesterol all the way down to their normal range in healthy individuals, as opposed to standard treatments, generally aiming at a partial reduction.
But things did not go as planned. By the beginning of 2008,
there was 27% more deaths in the intense glycemic control,
than in the standard treatment group: 257 vs. 203, respectively. As a result, the intense glycemic control arm of the study has been discontinued, with its portion of participants merged with the standard glycemic control group, till the planned end of the study in June 2009.
While some doctors are surprised, even "stunned" by this outcome, others are not. Plainly put, regardless of what one wanted to believe or advocate,
there was no solid evidence that pushing blood glucose, blood pressure or cholesterol down to their normal range with high doses of medications does lower cardiovascular risk in diabetes two.
At best, it was wishful thinking based on the shallow, many times over proven false assumption that a power to control the "numbers" - nominal glucose and cholesterol levels, or blood pressure - necessarily translates into controlling a disease. Not only that it plainly ignores complexity of body function, it oversees the obvious: these disturbances in body function have their actual causes, and the only safe way of treating them is to find out what those causes are and have them addressed.
Also, as Dr. McDougall points out, such deviations from normal are always to some degree
compensatory response of the body.
Elevated blood glucose is an attempt to compensate for the loss of insulin sensitivity; elevated blood pressure is an attempt to secure the needed volume of blood flow to body organs and tissues, and elevated cholesterol to repair damage to cell membranes, including those of the inner blood vessel lining, inflicted by free radicals, trans-fatty acids, toxins and other inflammatory agents overwhelming the body.
What is to expect if body's correction action is suppressed, without addressing its cause? Nothing good: respectively, insufficient supply of the cell fuel - glucose, insufficient blood supply, and shortage of a substance as important for proper body function as cholesterol. It may give you better, or even good "numbers", but
your longer-term health prospects are bleak.
Is it too much to ask medical professionals to think of these, and other, facts? There was no reliable evidence that an all-out drug attack on diabetes two in patients with high risk of cardiovascular complications will result in positive outcome.
What was to expect, though, is
more of adverse side effects of drugs, including deaths.
The following is only a part of what has been known about the effects of medications used in the ACCORD study before it was commenced, and why the tragic outcome is not surprise for some doctors. It is far from complete, but should illustrate well how deviant - and plain dangerous - the partnership of drug companies and the "official medicine" has become.
Continues: Diabetes drugs: side effects