The US Food and Drug Administration (FDA) has given approval to the drug company, Abbott, for the marketing of Simcor, a combination of Niaspan (extended release niacin) and simvastatin for cholesterol lowering. With the statin / niacin pill, Advicor, already on the market, did we really have a need for another one, almost identical?
All statins work by the same mechanisms: 1) reductase inhibition of the vital mevalonate pathway for the inhibition of cholesterol synthesis and 2) inhibition of nuclear factor kappa B, the inflammatory factor mediating platelet activation, lymphocyte adhesion, macrophage attraction and smooth muscle migration, key elements of the atherosclerotic process. Whatever good statins do in blood vessel disease is dependant upon this process.
Memory impairment associated with statin use has been highlighted by media stories recently including one in which a male doctor claimed, "statins make women stupid" as if males were immune. I have been preaching the cognitive effects of statins for seven years now (Lipitor, Thief of Memory) and if the male doctor had paid the slightest attention to my words, he would know that gender is not a factor.
Simply put, our memory is completely dependent upon abundant stores of cholesterol produced by our brain's glial cells and statins impair this process. There is little doubt about it.
In defense of doctors I must say that this information was not available to the medical community until Pfrieger's report in Science in 2001. Although I did not expect doctors to fully appreciate this at the time, I did expect the FDA and the drug companies to respond. After all, research scientists had just discovered the process by which all statin users become susceptible to amnesia and cognitive dysfunction.
Millions of people already were on statins in the year 2001 and one would expect that the FDA or the drug companies, on their own, would have brought this warning to the attention of the medical community, so that doctors would become responsive rather than dismissive of patient complaints of forgetfulness and amnesia. I have a large number of reports from people about physician lack of awareness of cognitive side effects of statins. Doctors have long been accustomed to look to the FDA for direction. In this very serious case, the FDA failed them. No guidance came out following Pfrieger's report.
Returning again to Simcor and Advicor, why was it felt desirable to add niacin, even in its long-acting form? The Vytorin / Zetia scandal has shown to the world the seeming irrelevance of cholesterol to the atherosclerotic process (something that many research scientists have been saying for years) so why bother to attach niacin to Zocor or Lipitor?
Every doctor knows that the only gain from niacin is a reduction of cholesterol similar to Zetia but only if the patient can tolerate the often disagreeable side effects.
Duane Graveline MD MPH
Former USAF Flight Surgeon
Former NASA Astronaut
Retired Family Doctor