The Cholesterol Con -- Where Were the Doctors?

[Guest guest]

In case you haven't figured it out already, pHARMa is lying to you about

everything..............

this sentence makes no sense " It's true that these drugs can help some

people -- but not nearly as many as we have been told. Moreover, and this

is the kicker, we don't have any clear evidence that they work by lowering

cholesterol. "

Can help some people. I suggest they help no one as the purpose for their

use is based on a lie

for more on this, also see my webpage

http://www.wellwithin1.com/cholesterol.htm

Sheri

http://www.alternet.org/healthwellness/77916/

The Cholesterol Con -- Where Were the Doctors?

By Maggie Mahar, Health Beat

Posted on February 29, 2008, Printed on February 29, 2008

http://www.alternet.org/story/77916/

After the stock market bubble burst, the New York Times asked: " Where were

the analysts? Why didn't they warn us? "

To be perfectly honest, this was a somewhat disingenuous question. As

experienced financial journalists understood all too well, the analysts

plugging the high-flying issues of the 1990s were employed by Wall Street

firms raking in billions as investors bet their nest eggs on one hot stock

after another. It really wasn't in their employers' interest for analysts

to tell us that their products were wildly overpriced. When a small

investor wades into the financial world, there are two words he needs to

keep in mind: caveat emptor.

But physicians, I firmly believe, are different from the folks employed by

Merrill Lynch. (I don't mean to knock people who work at ML. I am simply

saying that they have a very different job description.) When consulting

with your doctor, you should not have to be wary. You are not a customer;

you are a patient. And your physician is a professional who has pledged to

put your interests ahead of his or her own.

This brings me to the question I ask in my headline: During the many years

of the Cholesterol Con, where were the doctors? When everyone from the

makers of Mazola Corn Oil to the Popes of Cardiology assured us that

virtually anyone could ward off heart disease by lowering their

cholesterol, why didn't more of our doctors raise an eyebrow and warn us:

" Actually, that's not what the research shows " ?

No doubt, you've heard about the recent Business Week cover story, " Do

Cholesterol Drugs Do Any Good? " , which blew the lid off the theory that

" statins " -- drugs like Lipitor, Crestor, Mevacor, Zocor and Pravachol --

can cut the odds that you will die of a heart attack by slowing the

production of cholesterol in your body and increasing the liver's ability

to remove LDL, or " bad cholesterol, " from your blood.

It's true that these drugs can help some people -- but not nearly as many

as we have been told. Moreover, and this is the kicker, we don't have any

clear evidence that they work by lowering cholesterol.

Although medical research suggests that statins can definitely benefit one

group -- men under 70 who already have had a heart attack -- researchers

are no longer convinced that the drugs stave off a second attack by

lowering the patient's cholesterol. The drugs do lower cholesterol, but

that is not what helps the patient.

In other words, researchers are questioning the bedrock assumption that

high levels of " bad cholesterol " cause heart disease. " Higher LDL levels do

help set the stage for heart disease by contributing to the buildup of

plaque in arteries. But something else has to happen before people get

heart disease, " Dr. M. Krauss, director of atherosclerosis research

at the Oakland Research Institute, told Business Week. " When you look at

patients with heart disease, their cholesterol levels are not that [much]

higher than those without heart disease, " he added. " Compare countries, for

example. Spaniards have LDL levels similar to Americans', but less than

half the rate of heart disease. The Swiss have even higher cholesterol

levels, but their rates of heart disease are also lower. Australian

aborigines have low cholesterol but high rates of heart disease. "

" Current evidence supports ignoring LDL cholesterol altogether, " Dr. Rodney

A. Hayward, professor of internal medicine at the University of Michigan,

told Business Week's reporter.

In recent years, researchers have begun to suspect that statins help

patients, not by lowering cholesterol levels, but by reducing inflammation.

If this theory is right, " this seems likely to shunt cholesterol reduction

into a small corner of the overall picture of heart disease, " the Guardian

reported four years ago.

And if the key to statins is that they reduce inflammation, it's worth

keeping in mind that this is what other effective heart treatments like

aspirin and the omega-3 fatty acids found in fish oils, garlic and vitamin

E do -- at a much lower cost and with far fewer side effects.

But hold onto your hats, I still haven't gotten to what is most shocking

about the cholesterol story. What raises my blood pressure is the knowledge

that Business Week's scoop isn't really " new " news. " With all due respect

to Business Week, which showed real courage in putting the story on its

cover, and to its author, Carey, who did a superb job of explaining

the medical research, the truth is that medical researchers have been

questioning for many years the theory that widespread use of statins to

lower cholesterol will save lives.

You can find the research questioning the benefits of statins in medical

journals like Lancet (2001) and BMJ (2006), as well as in reports from

medical conferences ( " Tales From the Other Drug Wars, " 1999).

Occasionally, doubts popped up in the mainstream press and then disappeared.

Five years ago, veteran healthcare blogger Holt pointed to an BMJ

article suggesting that statins might be no better than aspirin. That same

year, Holt raised pointed questions regarding the risk of taking statins,

including possible memory loss. "

Nevertheless, the very next year, the National Cholesterol Education

Program at the U.S. National Heart, Lung and Blood Institute issued new

recommendations that drastically lowered the threshold for statin therapy.

According to its 2004 report, people at a moderately high risk of

developing heart disease (with LDL cholesterol levels between 100 and 129

mg/dL) should be offered statins -- even if they have no previous history

of heart disease. Statin therapy also should be recommended to very

high-risk patients, the panel said, even if their LDL levels are as low as

70. NCEP declared that the recommendations applied to both men and women,

regardless of age.

The bottom line: NCEP was urging millions of Americans to go on statins.

Not everyone agreed, recalls Merrill Goozner, editor of " GoozNews, " a

top-drawer investigative healthcare blog. In 2004, a few months after the

new guidelines came out, a coalition of more than 30 academic physicians

and researchers, inspired by Dr. Abramson (author of Overdosed

America: The Broken Promises of American Medicine), decided to write a

letter to the National Heart Lung and Blood Institute (NHLBI).

Goozner, who does research at the Center for Science in the Public

Interest, organized the group. The letter " outlined all the evidence, which

was there in published clinical trials for anyone who cared to look, "

Goozner recalls, and concluded that while statins " may lower cholesterol in

people at low risk and even many subgroups at moderate risk of a heart

attack ... there was no evidence that the drugs actually saved lives. "

How could this be, if statins lower the risk of heart attack, at least for

some people? Preventing a heart attack does not necessarily mean that a

life is saved. In many statin studies that show lower heart attack risk,

the same number of patients end up dying, whether they are taking statins

or not. " You may have helped the heart, but you haven't helped the

patient, " says Dr. Beatrice Golomb, an associate professor of medicine at

the University of California, San Diego, and co-author of a 2004 editorial

in the Journal of the American College of Cardiology questioning the data

on statins. " You still have to look at the impact on the patient overall. "

" The letter we sent to the NHLBI also called for an independent panel to

review the evidence, " Goozner notes, " since the NLHBI panel that made the

recommendations had been dominated by physicians with ties to statin

manufacturers. " Indeed, the National Institutes of Health later admitted

that eight of the nine experts on the panel had received financing from one

or more of the companies that make statins. (None of the panelists had

publicly disclosed their ties to manufacturers when they made their

recommendations.)

Just how much " financing " were the panelists receiving? According to the

Los Angeles Times, from 2001 to 2003 Dr. Brewer, a leader at the

National Institutes of Health, and " part of the team that gave the nation

new cholesterol guidelines in 2004, " had accepted " about $114,000 in

consulting fees from four companies making or developing the

cholesterol-lowering drugs. "

But " this is relative peanuts compared to Dr P. Trey Sunderland III, a

senior psychiatric researcher at the NIH, who took $508,500 in fees from

Pfizer, Inc. whilst collaborating with them and endorsing their drug

[Lipitor], " says Dr. Malcolm Kendrick, who is a member of The International

Network of Cholesterol Skeptics (THINCS) -- a growing group of scientists,

physicians, other academicians and science writers from various countries.

Dr. Abramson, who is a clinical instructor at Harvard Medical School,

charges that the study that accompanied the updated 2004 guidelines

" knowingly misrepresented the results of the clinical trials that they

supposedly relied upon to formulate their recommendations. The problem is

that the experts claimed to rely on scientific evidence, but they act as if

empowered to ignore the evidence when it is not consistent with their

beliefs. "

This is a serious allegation. Keep in mind that statins are the most

popular drugs in the history of human medicine. Worldwide sales totaled $33

billion in 2007. More than 18 million American now take them.

Nevertheless, " medical research suggests that only about 40 percent to 50

percent of that number are likely to benefit, " says Abramson. " The other 8

or 9 million are exposed to the risks that come with taking statins --

which can include severe muscle pain, memory loss, sexual dysfunction --

and one study shows increased risk of cancer in the elderly -- but there

are no studies to show that the drugs will protect these patients against

fatal heart attacks. "

Abramson can cite many studies to support his claims. But first, he

stresses that statins can help some people.

" Statins show a clear benefit for one group, " he says: " People under 65 who

have already had a heart attack or have diabetes. But even in these very

high risk people, about 22 have to be treated for five years for one to

benefit. "

What about middle-aged people who are not diabetic and have not had a heart

attack? A 2006 study published in the ls of Internal Medicine that

focused on seven trials involving nearly 43,000 middle-aged adults

concluded that statin use did not cut their chances of dying from heart

disease.

Is there any benefit for this group? " If they are high risk, statins can be

beneficial to people under 65 who haven't had a heart attack, but 50 such

men have to be treated for five years for one to benefit. " says Abramson.

" The other 49 will not be helped. The problem is that we can't know who is

going to be the 50th man, " he adds. And all 50 will be exposed to the side

effects.

Older adults have little to gain. The drugs don't help people over 70 even

if they have elevated cholesterol levels, according to a report in the

Journal of American Cardiology.

Finally, " there is no evidence of any benefit for women who don't already

have heart disease or diabetes, " says Abramson. According to a 2004 article

published in the Journal of the American Medical Association which reviewed

all trials in which women with high cholesterol had been randomly assigned

to take a cholesterol-lowering drug or a placebo, there was no evidence

that statins prolonged women's lives or cut their chances of dying from

heart disease.

An editorial published in the Journal of the American College of Cardiology

came to the same conclusion -- though there does seem to be a risk that

women on statins develop memory loss so severe that their relatives may

begin shopping for a nursing home.

Memory loss that can mimic alzheimers is the second most common side affect

for people taking statins, right after muscle pain, according to

researchers at the University of California, San Diego. For a number of

years, they have been running a randomized controlled trial examining the

effects of statins on thinking, mood, behavior, and quality of life.

Separately, the UCSD researchers have been collecting anecdotal experiences

of patients, good and bad, on statins.

" We have some compelling cases, " Dr. Beatrice Golomb, the study's lead

researcher, told the Wall Street Journal. " In one of them, a San Diego

woman, Jane Brunzie, was so forgetful that her daughter was investigating

alzheimers care for her and refused to let her baby-sit for her 9-year-old

granddaughter. Then the mother stopped taking a statin. 'Literally, within

eight days, I was back to normal -- it was that dramatic,' said Mrs.

Brunzie, 69 years old. "

According to the Journal, " doctors put her on different statins three more

times. 'They'd say, " Here, try these samples. " Doctors don't want to give

up on it,' she said.' Within a few days of starting another one, I'd start

losing my words again,' added Mrs. Brunzie, who has gone back to

volunteering at the local elementary school she loves and is trying to

bring her cholesterol down with dietary changes instead. "

Returning to Goozner's story, did the letter his group wrote to the NHLBI

in 2004, spark public discussion about the new cholesterol guidelines? No.

" We released the letter to the press, but the mainstream of the national

press ignored us, " Goozner recalls.

In 2008, Goozner is happy to see the statin controversy hit Business Week's

cover -- though he can't help but wonder, " Where were these guys three

years ago? Now, call me a cynic, but why does my perverted mind think to

itself as I watch this coverage: Yeah, now we hear, just when the world's

best-selling drug [Lipitor] is about to go off patent. "

I suspect Goozer is right. It would have been much harder to publish this

story a few years ago.

But there also was a trigger that probably helped spur the Business Week

investigation. Last month, Merck-Schering/Plough released a long-awaited

study revealing that Vytorin, an expensive combination of two drugs

designed to lower cholesterol, brought no added benefits for patients

suffering from heart disease.

The two cholesterol-lowering drugs were Zocor, which is a statin, and,

Zetia, which is not. When combined, the two drugs did drive cholesterol

levels much lower. But the clinical trial offered no evidence that the two

cholesterol-busters were more effective in reducing heart attacks than

Zocor alone. This raises an obvious question: is cutting cholesterol levels

really the key to avoiding heart attacks?

The results of the study helped buttress the strong suspicion that insofar

as statins like Zocor do help anyone with heart disease, the beneficial

effect has little to do with lowering cholesterol levels.

Meanwhile, Zocor is now available in a generic form that can be purchased

for less than $6 for a 30-day supply. By contrast, the new combination,

selling under the brand name Vytorin, was fetching more than $100 for a

three-day supply. In 2006, the drug brought in $1.5 billion with sales

climbing 25 percent in the first half of 2007 to over $2 billion, according

to IMS Health.

Naturally, Merck and Schering/Plough, who were marketing Vytorin in a joint

venture, were shy about reporting the results of the clinical trials. It

was only when they were threatened with a congressional investigation that

they made the results public on Jan. 15 -- more than a year and a half

after the clinical trials were completed.

The day after the drug makers released the news, the American Heart

Association rushed to their defense, declaring that the study was too

limited to draw conclusions about Vytorin's ability to reduce heart attacks

or deaths compared to Zocor alone. The AHA advised patients not to abruptly

stop taking Vytorin without consulting with the doctors who had prescribed it.

The New York Times, to its credit, was quick to respond, noting that " what

the [American Heart Association] did not note in its statement ... was that

the group receives nearly $2 million a year from Merck/Schering-Plough

Pharmaceuticals, the joint venture that markets Vytorin.

This article is part one in a two-part series.

Maggie Mahar is a fellow at the Century Foundation and the author of

Money-Driven Medicine: The Real Reason Health Care Costs So Much

(Harper/ 2006).

© 2008 Health Beat All rights reserved.

View this story online at: http://www.alternet.org/story/77916/

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