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Icarus

Lipitor Executive Summary

This isn’t about me. This isn’t about statins. This is about avoidable medical errors that kill and disable.

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. 

  • Lipitor (Atorvastatin)  is a member of the drug class known as statins.
  • 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.  
  • Due to toxicity the maximum allowable dose of Atorvastatin is 80 mg per day.
  • 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 the most successful and commonly prescribed medication in the world earning over $125 billion for the Pfizer corporation over the last 14 years
  • Pfizer has a fiduciary duty to its stockholders.
  • Pfizer stocks are primarily held by institutional and mutual funds.
  • Pfizer has no legal duty to provide the best solution to its customers.
  • Pfizer controls regulatory bodies, influential practitioners, medical universities, ongoing physician training and customer information via stock participation, grants, funded research, mass marketing, direct marketing, kickbacks and benefits to physicians.
  • Corporate data used to secure regulatory approval is not available to the public.

This is referred to as regulatory capture

2006 Ad Spending: $1.006 billion

2007 Ad Spending: $1.253 billion

Pfizer’s net profit margin from 2006 to 2017 was
41.29%

This isn’t about me. This isn’t about statins. This is about avoidable medical errors that kill and disable. This is about quackery, gaslighting, liability shields and enabling administrative bodies.

Icarus Flyby – School of Hard Knocks

Healthcare in Canada: 11.6% GDP

$264 billion by the numbers – October 2019
HEALTH CANADA HAS ISSUED MULTIPLE ADR ADVISORIES RELATED TO STATINS:
  • Canada:  January 2002:  Rhabdomyolysis and Myopathy
  • Canada:  November 2004:  Crestor and Rhabdomyolysis
  • Canada: July 2005: Existing  conditions increase risk of statin-related muscle problems 
  • Canada: October 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.
  • FDA: 2008: Jarvik Campaign
    • The FDA forced Pfizer to end $280 million the “Dr. Jarvik Campaign” because of disinformation.  
      • Dr. Jarvik was not a medical doctor
      • Lipitor does not reduce the risk of heart attack by 36%
      • Lipitor is not 1% better than a placebo.
        • Nothing mattered.  
          • Pfizer kept manufacturing pills, 
          • Doctors kept handing them out
  • FDA: July 2009:  System-wide lapses
    • 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 drugmaker 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.
  • Canada: Statins and interstitial lung disease (October 2010).
  • FDA: February 2012: cognitive side effects
    • 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.

  • In 1989 Merck was issued a 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

The second most common adverse side effect of statins are cognitive side effects including Confusion, Memory Loss, and Emotional Disorders.

25% of total cholesterol in the body, is in the brain. Lipitor@Pfizer is lipophilic and passes through the Blood Brain Barrier.

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 within the Hippocampus. Damage to the Hippocampus interferes with the brain’s ability to form and retain new memories and results in anterograde amnesia.

In 2017 an accredited BC psychiatrist refused to report an adverse effect, because he could not “prove it”.

Icarus Flyby
Medical Trial run-ins screen out patients who experience intolerance and adverse reactions to the medication.
Treating to New Targets Study (TNT)

Intensive lipid lowering with atorvastatin in patients with stable coronary disease funded by Pfizer, the TNT medical trial reported in 2005 studied 10,000 patients with stable Coronary Heart Disease (CHD) for 5 years. Patients were prescribed either 10 or 80 mg of Lipitor@Pfizer

  • 131 patients with myalgia (muscle pain) or abnormal liver tests were dropped during run in
  • A major cardiovascular event occurred in 548 (10.9 percent) of patients receiving 10 mg of atorvastatin
  • A major cardiovascular event occurred in 434 (8.7 percent) of patients receiving 80 mg of atorvastatin
  • 982 patients with stable CDC experienced a major cardiovascular event while taking Lipitor@Pfizer
  • There was no reduction in overall mortality between the two groups.
  • Patients prescribed 80 mg of Lipitor@Pfizer experienced a significant rate of adverse events compared to patients prescribed 10 mg.

There is NO reduction in mortality (Death) in CHD patients who are prescribed Lipitor@Pfizer.

10% of the participants suffered a major cardiovascular event

Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN (SATURN Trial)

Evaluated CRESTOR rosuvastatin 40 mg daily versus LIPITOR atorvastatin 80 mg daily in patients with coronary disease over 18 months.

  • 1578 Patients entered the Trial
  • 193 Patients dropped during Run-In
  • 1385 Patients began the trial
  • 1039 Patients were treated for 104 weeks
  • 346 Patients left during the trial
  • 103 quit by preference of the patient
  • 101 had their first major cardiovascular event
  • 4 were dead

34% of the patients that entered the trial did not finish

The JUPITER trial (Justification for the Use of Statins in Primary Prevention:

An Intervention Trial Evaluating Rosuvastatin trial) was a clinical trial aimed at evaluating whether statins reduce heart attacks and strokes in people with normal cholesterol levels. The JUPITER study studied people with cholesterol levels less than 130 mg/dL and no significant cardiovascular risk, but with elevated (hs-CRP) C-reactive protein (hs-CRP). The study demonstrated that …

cholesterol level
appeared to have no relationship with cardiovascular disease risk

People with low levels of cholesterol die from heart attacks all the time, even when they are taking the maximum allowable dose of 80 mg of Lipitor@Pfizer.

In 2005 Pfizer launched the The Maximum-Dose Lipitor® Campaign

By Jay S. Cohen, MD 2007
The campaign began in earnest in 2005, after a study of maximum-dose Lipitor® for reducing heart attacks was published in the New England Journal of Medicine.  The study, known as the Treating New Targets (TNT) study, was funded by Pfizer, and it received glowing coverage from newspapers and news programs that described maximum-dose Lipitor® as if it was a medical breakthrough. Unfortunately, it was not. Yet the coverage made a strong impression, and so began the campaign to persuade doctors to medicate ever more patients with the most powerful, expensive dose of Lipitor® available.

As doctors prescribe more maximum-dose Lipitor® than ever, serious questions remain about maximum-dose Lipitor®. Is it effective? Is it worth the high cost? Is it safe? Statins are important drugs. Some people require strong statin treatment. Yet the great majority of people with elevated cholesterol do not need high doses of strong statins. The risk of side effects is greater with stronger doses than with milder ones.

There is no scientific basis for using more medication than needed for any medical condition, and this applies particularly to the use of statin drugs. Treatment should be individualized. Safety should be emphasized.

Over medication should be avoided. Side effects should be prevented. These are fundamental principles of medical science. The indiscriminate, widespread, “shotgun” use of maximum-dose Lipitor® violates all of them.


What happened to me was not a medical error

Adverse Effects from medications are the leading medical error