The Dangers of Statin Drugs: What You Haven't Been Told About

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The Dangers of Statin Drugs: What You Haven't Been Told About

Cholesterol-Lowering Medication, Part IV

 

http://www.mercola.com/2004/jul/31/statin_drugs.htm

 

<< Previous [ Part I, Part II, Part III, Part IV ]

 

By Sally Fallon and Mary G. Enig, PhD

Originally printed at Weston A. Price

 

PROVE-IT (2004)

 

PROVE-IT (PRavastatin Or AtorVastatin Evaluation and Infection Study),50 led

by researchers at Harvard University Medical School, attracted immense media

attention. " Study of Two Cholesterol Drugs Finds One Halts Heart Disease, "

was the headline in the New York Times.51 In an editorial titled " Extra-Low

Cholesterol, " the paper predicted that:

 

" The findings could certainly presage a significant change in the way heart

disease patients are treated. It should also start a careful evaluation of

whether normally healthy people could benefit from a sharp drug-induced

reduction in their cholesterol levels. " 52

 

The Washington Post was even more effusive, with a headline " Striking

Benefits Found in Ultra-Low Cholesterol. " 53

 

" Heart patients who achieved ultra-low cholesterol levels in one study were

16 percent less likely to get sicker or to die than those who hit what are

usually considered optimal levels. The findings should prompt doctors to

give much higher doses of drugs known as statins to hundreds of thousands of

patients who already have severe heart problems, experts said. In addition,

it will probably encourage physicians to start giving the medications to

millions of healthy people who are not yet on them, and to boost dosages for

some of those already taking them to lower their cholesterol even more, "

they said.

 

The study compared two statin drugs, Lipitor and Pravachol. Although Bristol

Myers-Squibb (BMS), makers of Pravachol, sponsored the study, Lipitor (made

by Pfizer) outperformed its rival Pravachol in lowering LDL. The " striking

benefit " was a 22 percent rate of death or further adverse coronary events

in the Lipitor patients compared to 26 percent in the Pravachol patients.

 

PROVE-IT investigators took 4,162 patients who had been in the hospital

following an MI or unstable angina. Half got Pravachol and half got Lipitor.

Those taking Lipitor had the greatest reduction of LDL-cholesterol -- LDL in

the Pravachol group was 95, in the Lipitor group it was 62 -- a 32 percent

greater reduction in LDL levels and a 16 percent reduction in all-cause

mortality. But that 16 percent was a reduction in relative risk.

 

As pointed out by Red Flags Daily columnist Dr. Malcolm Kendrick, the

absolute reduction in the rate of the death rate of those taking Lipitor

rather than Pravachol, was one percent, a decrease from 3.2 percent to 2.2

percent over two years.54 Or, to put it another way, a 0.5 percent absolute

risk reduction per year--these were the figures that launched the massive

campaign for cholesterol-lowering in people with no risk factors for heart

disease, not even high cholesterol.

 

And the study was seriously flawed with what Kendrick calls " the

two-variables conundrum. "

 

" It is true that those with the greatest LDL lowering were protected against

death. However, ... those who were protected not only had a greater degree

of LDL lowering, they were also on a different drug which is rather

important, yet seems to have been swept aside on a wave of hype. If you

really want to prove that the more you lower the LDL level, the greater the

protection, then you must use the same drug. This achieves the absolutely

critical requirement of any scientific experiment, which is to remove all

possible uncontrolled variables ... As this study presently stands, because

they used different drugs, anyone can make the case that the benefits seen

in the patients on atorvastatin [Lipitor] had nothing to do with greater LDL

lowering; they were purely due to the direct drug effects of atorvastatin. "

 

Kendrick notes that the carefully constructed J-LIT study, published two

years earlier, found no correlation whatsoever between the amount of LDL

lowering and death rate. This study had 10 times as many patients, lasted

almost three times as long and used the same drug at the same dose in all

patients. Not surprisingly, J-LIT attracted virtually no media attention.

 

PROVE-IT did not look at side effects but Dr. Andrew G. Bodnar, senior vice

president for strategy and medical and external affairs at Bristol Meyer

Squibb, makers of the losing statin, indicated that liver enzymes were

elevated in 3.3 percent of the Lipitor group but only in 1.1 percent of the

Pravachol group, noting that when liver enzyme levels rise, patients must be

advised to stop taking the drug or reduce the dose.55 And withdrawal rates

were very high: 33 percent of patients discontinued Pravachol and 30 percent

discontinued Lipitor after two years due to adverse events or other

reasons.56

 

REVERSAL (2004)

 

In a similar study, carried out at the Cleveland Clinic, patients were given

either Lipitor or Pravachol. Those receiving Lipitor achieved much lower

LDL-cholesterol levels and a reversal in " the progression of coronary plaque

aggregation. " 57 Those who took Lipitor had plaque reduced by 0.4 percent

over 18 months, based on intravascular ultrasound (not the more accurate

tool of electron beam tomography); Dr. Eric Topol of the Cleveland Clinic

claimed these decidedly unspectacular results:

 

" Herald a shake-up in the field of cardiovascular prevention ... the

implications of this turning point--that is, of the new era of intensive

statin therapy--are profound. Even today, only a fraction of the patients

who should be treated with a statin are actually receiving such therapy ...

More than 200 million people worldwide meet the criteria for treatment, but

fewer than 25 million take statins. " 58

 

Not surprisingly, an article in The Wall Street Journal noted " Lipitor

Prescriptions Surge in Wake of Big Study. " 59

 

But as Dr. Ravnskov points out, the investigators looked at change in

atheroma volume, not the change in lumen area, " a more important parameter

because it determines the amount of blood that can be delivered to the

myocardium. Change of atheroma volume cannot be translated to clinical

events because adaptive mechansims try to maintain a normal lumen area

during early atherogenesis. " 60

 

Other Uses

 

With such paltry evidence of benefit, statin drugs hardly merit the

hyperbole heaped upon them. Yet the industry maintains a full court press,

urging their use for greater and greater numbers of people, not only for

cholesterol lowering but also as treatment for other diseases like:

 

Cancer

Multiple sclerosis

Osteoporosis

Stroke

Macular degeneration

Arthritis

Even mental disorders such as memory and learning problems, Alzheimers and

dementia.61

New guidelines published by the American College of Physicians call for

statin use by all people with diabetes older than 55 and for younger

diabetes patients who have any other risk factor for heart disease, such as

high blood pressure or a history of smoking.62 David A. Drachman, professor

of neurology at the University of Massachusetts Medical School calls statins

" Viagra for the brain. " 63 Other medical writers have heralded the polypill,

composed of a statin drug mixed with a blood pressure medication, aspirin

and niacin, as a prevent-all that everyone can take. The industry is also

seeking the right to sell statins over the counter.

 

Can honest assessment find any possible use for these dangerous drugs? Dr.

Peter Langsjoen of Tyler, Texas, suggests that statin drugs are appropriate

only as a treatment for cases of advanced Cholesterol Neurosis, created by

the industry's anti-cholesterol propaganda. If you are concerned about your

cholesterol, a statin drug will relieve you of your worries.

 

Creative Advertising

 

The best advertising for statin drugs is free front-page coverage following

gushy press releases. But not everyone reads the paper or goes in for

regular medical exams, so statin manufacturers pay big money for creative

ways to create new users.

 

For example, a new health awareness group called the Boomer Coalition

supported ABC's Academy Awards telecast in March of 2004 with a 30-second

spot flashing nostalgic images of celebrities lost to cardiovascular

disease--actor James Coburn, baseball star Don Drysdale and comedian Redd

Foxx. While the Boomer Coalition sounds like a grass roots group of health

activists, it is actually a creation of Pfizer, manufacturers of Lipitor.

" We're always looking for creative ways to break through what we've found to

be a lack of awareness and action, " says Michal Fishman, a Pfizer

spokeswoman. " We're always looking for what people really think and what's

going to make people take action, " adding that there is a stigma about

seeking treatment and many people " wrongly assume that if they are

physically fit, they aren't at risk for heart disease. " 64 The Boomer

Coalition Web site allows visitors to " sign up and take responsibility for

your heart health, " by providing a user name, age, e-mail address and blood

pressure and cholesterol level.

 

A television ad in Canada admonished viewers to " Ask your doctor about the

Heart Protection Study from Oxford University. " The ad did not urge viewers

to ask their doctors about EXCEL, ALLHAT, ASCOT, MIRACL or PROSPER, studies

that showed no benefit--and the potential for great harm--from taking statin

drugs.

 

The Costs

 

Statin drugs are very expensive--a course of statins for a year costs

between $900 and $1,400. They constitute the mostly widely sold

pharmaceutical drug, accounting for 6.5 percent of market share and $12.5

billion in revenue for the industry. Your insurance company may pay most of

that cost, but consumers always ultimately pay with higher insurance

premiums. Payment for statin drugs poses a huge burden for Medicare, so much

so that funds may not be available for truly lifesaving medical measures.

 

In the UK, according to the National Health Service, doctors wrote 31

million prescriptions for statins in 2003, up from 1 million in 1995 at a

cost of 7 billion pounds--and that's just in one tiny island.65 In the

United States, statins currently bring in $12.5 billion annually for the

pharmaceutical industry. Sales of Lipitor, the number-one-selling statin,

are projected to hit $10 billion in 2005.

 

Even if statin drugs do provide some benefit, the cost is very high. In the

WOSCOP clinical trial where healthy people with high cholesterol were

treated with statins, the five-year death rate for treated subjects was

reduced by a mere 0.6 percent. As Dr. Ravnskov points out,66 to achieve that

slight reduction about 165 healthy people had to be treated for five years

to extend one life by five years. The cost for that one life comes to $1.2

million dollars. In the most optimistic calculations, the costs to save one

year of life in patients with CHD is estimated at $10,000, and much more for

healthy individuals. " This may not sound unreasonable, " says Dr. Ravnskov.

" Isn't a human life worth $10,000 or more? "

 

" The implication of such reasoning is that to add as many years as possible,

more than half of mankind should take statin drugs every day from an early

age to the end of life. It is easy to calculate that the costs for such

treatment would consume most of any government's health budget. And if money

is spent to give statin treatment to all healthy people, what will remain

for the care of those who really need it? Shouldn't health care be given

primarily to the sick and the crippled? "

 

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