The most frequently prescribed drugs to lower cholesterol are in the class known as statins. These include atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), simvastatin (Zocor) and rosuvastatin (Crestor); statins are also found in the combination drugs Advicor and Vytorin. Children are increasingly being targeted as statin consumers, aided by The American Heart Association’s new screening guidelines.

Perhaps the most important observation to come out of the latest American Heart Association’s childhood cholesterol guidelines is what it did not say about the use of statin drugs in children. First and foremost is the evidence just reported in the New England Journal of Medicine by Edison and Muenke. They report on babies born with severe malformations from being exposed to statins in the first trimester. This report more than any other serves to rip apart the recommendations from the Heart Association before the ink has dried on the paper.

Statins are associated with a high rate of birth defects
Edison and Muenke reviewed FDA’s MedWatch repository for first trimester exposure to statins from the period 1987 to 2001, and found that 20 of the 52 babies born in this time period had serious congenital anomalies, including severe central nervous system defects and malformed limbs. Nearly half of the exposed babies had these severe anomalies. Of course women of child-bearing age had been warned to prevent pregnancy, but pregnancies happen. Even though the numbers of cases are thankfully small, the ratio of abnormal to normal speaks of extraordinarily potent mutagenic effects from statin use. Remember thalidomide? This is in the same ballpark!

Now the American Heart Association guidelines talk about screening children for cholesterol, which leads directly to the use of statins to keep their cholesterol down to below 190 (or below 160 if other risk factors co-exist). These children, physiologically, are basically the same as these fetuses, just a little older. They are about to be exposed to powerful reductase inhibitors, known as statins. This introduces the second major item that the American Heart Association failed to mention – how little physicians and pharmacists (and drug companies) really know about the mechanism of action of the statin class of drugs. I can assure you that if the people who promulgate these guidelines had the slightest awareness of how many side effects there really are, and if they actually knew what reductase inhibition really means, they would be far more conservative in their thinking.

After six years of research on statin mechanisms, the figures for congenital anomalies just released do not surprise me. Historically, statins were designed to function on one level – that of decreasing the synthesis of cholesterol through reductase inhibition of the mevalonate metabolic pathway. I’ll bet not one physician in a hundred understands the consequences of this. Most of it was not even taught when we were medical students. If it had been taught, the light of awareness would have dimmed considerably by the time of graduation and progressively extinguished over the next few years, for it is not a subject dealt with frequently by clinicians.

Statins are associated with amnesia
I am talking here of the impact of cholesterol synthesis inhibitions on the brain’s glial cells – sole source of our vital synaptic cholesterol, without which memory falters. In 2003, Wagstaff reported in Pharmacotherapy “60 cases of statin related amnesia”, gleaned from FDA’s MedWatch repository of adverse drug reactions. For years I had been told that my own two episodes of amnesia, coming on shortly after a statin was started, were pure coincidence, because “statins don’t do that”. For years transient global amnesia reports had been sitting on FDA shelves gathering dust while statin users in all walks of life were getting these strange amnesia reactions and occasional permanent loss of short-term memory. Now we have collected many hundreds of cases of severe memory impairment from the use of statins.

One wonders at the FDA’s delay in reporting these serious reactions. I suspect the FDA was awaiting guidance from the pharmaceutical industry on how best to handle this potentially explosive situation. At that time, statin drugs were even allowed for commercial airline pilots, little suspecting the association of statin drugs with the abrupt onset of completely unheralded amnesia. This is MedWatch, our government’s protective umbrella, supposedly shielding us from adverse post-marketing drug events, but actually completely subservient to the drug companies.

Continuing with  the effects of statin drugs in our bodies, I am talking of the inevitable girding of the mevalonate tree by statins so that our CoQ10 and dolichols must be depleted along with our cholesterol. The U.S. public is just beginning to realize statin’s effect on CoQ10 and the need for supplementation when taking statins (as Canada’s government has insisted on for the past 15 years).