Sunday, March 15, 2015

Why are Doctors Withholding the Truth about $tatins from Patients?

In the ASCOT trial 1.9% of high risk patients on 10 mg Lipitor daily had coronary events compared to 3% on placebo during the 3.3 years of the study.  Look below where I enlarged and underlined that information from the patient package insert produced by the manufacturer of the drug- Pfizer.  Note that it's in parentheses.  That's an ABSOLUTE reduction of 1.1% of coronary events.
Big Pharma and my profession, especially cardiologists sell this as a 36% risk reduction.  That's what's called RELATIVE risk reduction.  They tend to omit mention of the 1.1% number that would be of more interest to patients involved in shared decision making in a mutually respectful relationship with a trusted physician.

How does this omission sit with the principles of medical ethics:  Patient autonomy? Beneficence? Nonmaleficence?  Justice?

Respect for Persons/Autonomy: Acknowledge a person’s right to make choices, to hold views, and to take actions based on personal values and beliefs.

Nonmaleficence (do no harm): Obligation not to inflict harm intentionally; In medical ethics, the physician’s guiding maxim is “First, do no harm.”

Beneficence (do good): Provide benefits to persons and contribute to their welfare. Refers to an action done for the benefit of others.

Justice:  Treat others equitably, distribute benefits/burdens fairly.

Why is our profession allowing the general public, including most patients to believe the 36% reduction with Lipitor instead of the 1.1% reduction?  Could there be a financial issue somewhere?
Just BILLIONS of dollars of profits for the pharmaceutical industry.

I heard another presentation to Family Physicians in Dayton on Saturday that had a big slide noting the 36% reduction.  When will this stop?

How did statins become a religious issue with physicians?  Why won't our profession just tell the patients the facts in a way they would expect us to share it?  Why don't we let the patient make the decision about what levels of risk they are willing to take with diseases or medications?  When did we conclude that WE are the ones who PUT the patient on a statin (Lipitor has been number one in worldwide sales) instead of the patient OPTING to take a statin ( or other actions) as part of their chosen risk reduction strategy?

How did we decide that no other strategy to treat cholesterol other than statins is reasonable?

We need to tell the truth about statins and other strategies to lower cardiac event risks to patients.

We need a reminder of the principles of medical ethics.  May God help us.

"Prevention Of Cardiovascular Disease

In the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), the effect of LIPITOR on fatal and non-fatal coronary heart disease was assessed in 10,305 hypertensive patients 40–80 years of age (mean of 63 years), without a previous myocardial infarction and with TC levels ≤ 251 mg/dL (6.5 mmol/L). Additionally, all patients had at least 3 of the following cardiovascular risk factors: male gender (81.1%), age > 55 years (84.5%), smoking (33.2%), diabetes (24.3%), history of CHD in a first-degree relative (26%), TC:HDL > 6 (14.3%), peripheral vascular disease (5.1%), left ventricular hypertrophy (14.4%), prior cerebrovascular event (9.8%), specific ECG abnormality (14.3%), proteinuria/albuminuria (62.4%). In this double-blind, placebo-controlled study, patients were treated with anti-hypertensive therapy (Goal BP < 140/90 mm Hg for non-diabetic patients; < 130/80 mm Hg for diabetic patients) and allocated to either LIPITOR 10 mg daily (n=5168) or placebo (n=5137), using a covariate adaptive method which took into account the distribution of nine baseline characteristics of patients already enrolled and minimized the imbalance of those characteristics across the groups. Patients were followed for a median duration of 3.3 years.
The effect of 10 mg/day of LIPITOR on lipid levels was similar to that seen in previous clinical trials.
LIPITOR significantly reduced the rate of coronary events [either fatal coronary heart disease (46 events in the placebo group vs. 40 events in the LIPITOR group) or non-fatal MI (108 events in the placebo group vs. 60 events in the LIPITOR group)] with a relative risk reduction of 36% [(based on incidences of 1.9% for LIPITOR vs. 3.0% for placebo), p=0.0005 (see Figure 1)]. The risk reduction was consistent regardless of age, smoking status, obesity, or presence of renal dysfunction. The effect of LIPITOR was seen regardless of baseline LDL levels. Due to the small number of events, results for women were inconclusive.
Figure 1: Effect of LIPITOR 10 mg/day on Cumulative Incidence of Non-Fatal Myocardial Infarction or Coronary Heart Disease Death (in ASCOT-LLA)
Effect of LIPITOR 10 mg/day on Cumulative Incidence of Non-Fatal Myocardial Infarction or Coronary Heart Disease Death - Illustration

LIPITOR also significantly decreased the relative risk for revascularization procedures by 42%. Although the reduction of fatal and non-fatal strokes did not reach a pre-defined significance level (p=0.01), a favorable trend was observed with a 26% relative risk reduction (incidences of 1.7% for LIPITOR and 2.3% for placebo). There was no significant difference between the treatment groups for death due to cardiovascular causes (p=0.51) or noncardiovascular causes (p=0.17).
In the Collaborative Atorvastatin Diabetes Study (CARDS), the effect of LIPITOR on cardiovascular disease (CVD) endpoints was assessed in 2838 subjects (94% white, 68% male), ages 40–75 with type 2 diabetes based on WHO criteria, without prior history of cardiovascular disease and with LDL ≤ 160 mg/dL and TG ≤ 600 mg/dL. In addition to diabetes, subjects had 1 or more of the following risk factors: current smoking (23%), hypertension (80%), retinopathy (30%), or microalbuminuria (9%) or macroalbuminuria (3%). No subjects on hemodialysis were enrolled in the study. In this multicenter, placebo-controlled, double-blind clinical trial, subjects were randomly allocated to either LIPITOR 10 mg daily (1429) or placebo (1411) in a 1:1 ratio and were followed for a median duration of 3.9 years. The primary endpoint was the occurrence of any of the major cardiovascular events: myocardial infarction, acute CHD death, unstable angina, coronary revascularization, or stroke. The primary analysis was the time to first occurrence of the primary endpoint."

What do you think?

p.s. Dr. M., you lose our bet.  1.1% is less than the 3% to 6% you quoted privately to me.

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