Lipitor Executive Summary

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.

All statin medications reduce cholesterol by inhibiting (HMG-CoA) while at the same time reducing the production of over 30,000 biomolecules such as vitamin K, coenzyme Q10, and all steroid hormones by up to 60%.  This effect is biochemically unavoidable.

Pfizer manufactures Lipitor (Atorvastatin) which was approved by the FDA in 1996 on the basis of 4 clinical trials:  ASCOT, CARDS, TNT and IDEAL

• Lipitor@Pfizer is a member of the drug class known as statins.
  • Due to toxicity the maximum allowable dose of Lipitor@Pfizer is 80 mg per day.

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

• 2002 – Rhabdomyolysis and Myopathy
• 2004 – Crestor and Rhabdomyolysis
• 2005 – Existing conditions increase risk of statin-related muscle problems
• 2005 – Statins and memory loss 
  • The 2005 Health Canada statement in the Canadian Adverse Reaction Newsletter suggested a possible association between statins and memory loss. The onset of these 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.
• 2010 – Statins and interstitial lung disease

In 2009 the FDA conducted a 6-week inspection of Pfizer’s New York headquarters where inspectors found system-wide lapses at the world’s largest drug manufacturer 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”.

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 and has been well understood for decades :
  • 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  is used for energy production in cell mitochondria found in every cell in the human body.
  • Low plasma concentrations of Coenzyme Q10 have been associated with other factors contributing to coronary heart diseases.
    

Cognitive Side Effects

• The second most common adverse side effect of statins are cognitive side effects including Confusion, Memory Loss, and Emotional Disorders.
  • Lipitor@Pfizer is lipophilic and passes through the Blood Brain Barrier
  • 25% of 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 is the process by which neurons are produced and occurs within the Hippocampus.
  • Damage to the Hippocampus interferes the brain’s ability to form and retain new memories and results in anterograde amnesia.

In 2006 I had a heart attack and was prescribed 80 mg of Lipitor@Pfizer per day in order to lower my high cholesterol.

Whatever the validity of the lipid hypothesis, there are clear and substantial risks associated with taking Lipitor@Pfizer which I took as prescribed for eight years, and I was not warned.  

No one can afford this standard of healthcare and medical practice. There is no insurance for it.

IMHO : The BC College of Pharmacists and the College of Physicians and Surgeons of British Columbia have a legal duty to address the widespread failure of their members to have knowledge of the adverse side effects of the medications that they prescribe.