Jump to content
IndiaDivine.org

The Dangers of Statin Drugs: Part 4

Rate this topic


Guest guest

Recommended Posts

Guest guest

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

 

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

Told About Cholesterol-Lowering Medication, 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? "

 

References

Link to comment
Share on other sites

Join the conversation

You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.

Guest
Reply to this topic...

×   Pasted as rich text.   Paste as plain text instead

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

Loading...
×
×
  • Create New...