Lipitor Executive Summary

Lipitor is a member of the drug class known as statins. The lipid hypothesis is a medical theory postulating a link between blood cholesterol levels and the development, occurrence and prevention of heart disease and cardiovascular events. As a result, physicians prescribe statin medications to reduce blood cholesterol levels, pharmacists dispense the statin medications and every three months blood is taken and lab work is performed. Statin medications work! Statin medications reduce the level of cholesterol in the blood.

All statin medications reduce cholesterol by inhibiting (HMG-CoA)

Pfizer manufactures Lipitor (Atorvastatin) which was approved by the FDA in 1996 on the basis of 4 clinical trials: ASCOT, CARDS, TNT and IDEAL According to Pfizer Lipitor (Atorvastatin) can lower cholesterol by up to 60%.

Due to toxicity the maximum allowable dose of Lipitor is 80 mg per day.

Lipitor also reduces the production of over 30,000 biomolecules such as vitamin K, coenzyme Q10, heme and all steroid hormones!

This effect is biochemically unavoidable.

mevalonate metabolic pathway.jpg

Common Adverse Side Effects

Myopathy

The most common adverse side effect of all statins is muscle pain referred to as Statin Induced Myopathy and Exercise Intolerance. Myopathy is a disease of the muscle in which the muscle fibers do not function properly.

In 1989 Merck was issued patent (4,933,165) combining a statin and Coenzyme Q10 that was described as a pharmaceutical composition and method of counteracting HMG-CoA reductase inhibitor-associated myopathy.

Coenzyme Q10 (CoQ10) is an essential compound found in virtually every cell in the human body. CoQ10 is essential for energy production in cell mitochondria.

Low plasma concentrations of coenzyme Q10 (CoQ10) have been associated with other factors contributing to coronary heart diseases.

Cognitive Side Effects

A Lawyer, a Pharmacist and a Doctor carrying a duck all go into a bar.

The bartender says what will you have? The Lawyer, says “give me a beer.” The Pharmacist says “Me too!” the Doctor, kisses the duck, the duck quacks and says “Make that three!” The bartender, gives the Lawyer a beer, gives the Pharmacist a beer and then turns to the Doctor and says “I can’t remember the rest of the Joke.”

The second most common adverse side effect of statins are cognitive side effects including Confusion, Memory Loss, and Emotional Disorders . Lipitor (Atorvastatin) is lipophilic and passes through the Blood Brain Barrier (BBB). 25% of total cholesterol in the body, is in the brain. Most of the cholesterol within the brain is used to create myelin sheaths that surround the axons of nerve cells (neurons). Within the brain, the Hippocampus is known to be associated with memory, emotions and motivation. Neurogenesis the process by which neurons are produced : occurs within the Hippocampus. Damage to the Hippocampus interferes the brain’s ability to form and retain new memories and results in anterograde amnesia; commonly referred to as “brain fog”.

Neurons that fire together, wire together! Discordant, out of phase neurons fail to pass on critical signals. The the prefrontal cortex is impacted resulting in complex cognitive behavior changes in personality, decision making and moderating behavior.

“When you lose your memory, you lose everything.”

Lipitor (Atorvastatin)s lowers Cholesterol, Tau Proteins, Dolichol and COQ10 by up to 60%

Cholesterol deficiency results in hopelessness, confusion, agitation, difficulty making decisions and changes in mood. Tau Proteins stabilize microtubules. Tau Protein deficiency induces parkinsonism with dementia. Dolichol deficiency results in Hypotonia, low muscle tone, and ichthyosis, thin skin. COQ10 deficiency causes brain dysfunction, muscle weakness and the failure of other body systems. Selenoprotein deficiency accelerates prostate carcinogenesis


SINCE 2000 HEALTH CANADA HAS ISSUED FIVE ADR ADVISORIES RELATED TO STATINS:

January 2002 - Rhabdomyolysis and Myopathy
November 2004 - Crestor and Rhabdomyolysis
July 2005 - Existing conditions increase risk of statin-related myopathy
October 2005 - Statins and memory loss
October 2010 Statins and interstitial lung disease

In the 2005 Health Canada statement in the Canadian Adverse Reaction Newsletter suggested a association between statins and memory loss. The onset of the adverse events described in the case reports varied, but most occurred within 1 year of statin initiation. Most of the cases reported an improvement in cognitive symptoms once the statin was stopped or the dose reduced.

In July 2009 the FDA conducted a 6-week inspection of Pfizer’s New York headquarters where agency inspectors found system-wide lapses at the world’s largest drug maker and in a 12-page warning letter to Pfizer Chief Executive Jeffrey Kindler, the FDA cited numerous examples of failing to report a growing number of serious side effects involving the company’s top selling cholesterol medication Lipitor@Pfizer dating back as far as 2004.

On February 28, 2012, the US FDA revised statin labels, warning of the potential for “generally non-serious and reversible cognitive side effects (memory loss, confusion, etc.) and reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels”.

John Argast