Stanley Feld M.D.,FACP,MACE
The New York Times did it again. Once again we are experiencing media hyperbole. The first sentence tells it all.
Bingo. For years teaching physicians have worked hard trying to convince practicing physicians the virtues of statin therapy to lower the incidence of coronary artery disease by lowering LDL cholesterol (bad cholesterol).
Finally, it took hold. Practicing physicians tried for years to convince their patients to take statins to decrease the risk of heart attacks.
Over the years evidence mounted proving that normal total cholesterol value should be lower than 200 mgs% from a previous normal of 240 mg%. The normal LDL cholesterol should be lowered to 100 mgs% from 150% mgs%.
This was not a pharmaceutical industry’s conspiracy. It was arrived at with actual statistically significant clinical data.
The New York Times goes on to say;
“This past week, the Food and Drug Administration raised questions about the side effects of these drugs and developed new labels for these medications that will now warn of the risk of diabetes and memory loss. The announcement said the risk was “small” and should not materially affect the use of these medications.”
As soon as the first sentence was read it immediately put the safety of statins in question. There was no discussion of the flawed data used to reach this conclusion.
I predict the warning that resulted from flawed data will result in the unwarranted decrease in physicians prescribing statins and patients refusing to take statins.
“ The data are somewhat ambiguous for memory loss. But the magnitude of the problem for diabetes becomes much more apparent with careful examination of the data from large clinical trials.”
I believe the data is shabby for both increasing the incidence of diabetes and the decrease in cognitive function.
I also believe the scientists at the FDA also believe the data is shabby.
"1. However, because statins are so widely used, there is a heightened awareness by the public when we make any safety-related labeling changes to this class of drugs."
"These changes do not in any way alter the risk-benefit calculus for this class of drugs. We continue to believe that the benefits of statins far outweigh their risks, but we do want clinicians and patients to be aware of their side effects so that they can be used in the most safe and effective manner possible."
The media has emphasized the safety label change warning patients of the possibility of getting diabetes as a result of taking statins. The fact is there are so many flaws in the studies sited that initiated the label change that the changes are unwarranted.
The FDA goes on to state,
“ We are not recommending that patients be discontinued from their statin therapy based on a small increase in blood sugar levels.”
“Rather, elevations in blood sugar levels should be treated with dietary and lifestyle management and/or adjustment or initiation of antidiabetic therapies. We do not consider this a reason to not continue or not initiate statins, particularly in the diabetic population where patients are at increased risk for major adverse cardiovascular events and statin therapy has been shown to reduce that risk.”
This disclaimer had not been emphasized in the traditional media. The Women’s Health Initiative (WHI) another flawed study did not have one statistically significant leg to the study. Yet it’s handling in the traditional media changed the course of women’s health forever. Evidence from the WHI was used as study material. The statement below assumes the conclusion of harmful effects of statins is real.
“Despite the higher hazard ratios observed in the WHI study, we do not have strong evidence suggesting that there is a gender effect for the development of this adverse effect.”
The FDA looked at the effect of statins on neurocognitive function.
“We looked at those study results; there was no difference in neurocognitive functioning observed between patients exposed to statin therapy vs those unexposed, including in executive function (attention and speed) and memory, both immediate and delayed.”
There is no evidence here.
"There were trials conducted with statins to see if they could improve cognitive functioning in patients with mild to moderate Alzheimer disease. We reviewed the results of one such study, which showed neither evidence of benefit nor harm in cognitive functioning associated with statin therapy.”
My fear is the misleading warnings being publicized in the press will change the course of therapy for patients at risk for coronary artery disease.
The science used to arrive at these warnings is shabby. It is important to understand the defects in the evidence so that society does not do to statins what it did to hormone replacement therapy for women's health.
The opinions expressed in the blog “Repairing The Healthcare System” is, mine and mine alone
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