Re: Lawsuit questions need for Lipitor


Susan wrote:
> x-no-archive: yes
>
> http://www.newsday.com/news/health/ny-hschol094462431oct09,0,695754,print.story
>
> Susan

Thanks for this Susan. The excellent Roni Rabin has been working on
this issue for some time. Here's her first:

'We've been bamboozled' about cholesterol risks
Roni Rabin
Newsday.com
July 6, 2004
{archived on Healthy Skepticism}
http://healthyskepticism.org/publications/nonmedline/2004/0706.htm

If you're a woman like me who worries about your blood cholesterol
level, there's something you should know.

Buried in the back pages of a leading medical journal recently was a
study that raised serious questions about whether cholesterol-lowering
drugs are useful for women who are otherwise healthy.

The study didn't get a lot of media attention. But its results were
surprising - especially considering how many millions of women are
taking drugs known as statins to lower their cholesterol. Women like
me, who've had it drummed into us that heart disease is the leading
cause of death we face. And who've been told repeatedly cholesterol is
a major risk factor.

The paper, published in the Journal of the American Medical
Association, examined the results of 13 carefully selected clinical
trials and teased out the effects on women. It wasn't easy: At least 80
percent of the participants were men.

The researchers found that for women who are taking statins as a
preventative measure - they've never had cardiovascular disease but may
be at risk - it wasn't clear the pills bestowed any benefit. That's
because so few women in this group have heart attacks to begin with.

For women who have cardiovascular disease, the drugs reduced the risk
of another heart incident - but did not reduce overall deaths.

"The risk for total mortality was not lower in women treated with
lipid-lowering drugs, regardless of whether they had prior
cardiovascular disease or not," Dr. Judith M.E. Walsh and Dr. Michael
Pignone wrote.

Last year, scientists at the University of British Columbia's
Therapeutics Initiative came to a similar conclusion about the use of
statins in men who didn't have prior heart disease. Sure, they had
fewer heart attacks - but they still died at the same rate. "What we're
hypothesizing is that there was some other harm" associated with the
medication, said Dr. Jim Wright, the clinical pharmacologist who did
the study, funded entirely by a grant from British Columbia's health
department. "That really should concern people."

"Before we prescribe this to millions of people who are basically
healthy, we should be proving that the overall benefits outweigh the
harms," he said. "And we don't think that's the case."

Health consumer advocates, such as Maryann Napoli of the Center for
Medical Consumers, have expressed concerns about statins, which have
been linked to muscle problems, including a rare condition that can be
fatal. The FDA banned Baycol in 2001; last week, Public Citizen's
Health Research Group called for banning Crestor.

The drugs do reduce blood cholesterol levels. But the relationship
between high cholesterol and heart disease is not so simple, especially
for women. The landmark Framingham heart study found that in the vast
majority of people, there was no difference in blood cholesterol levels
between those who developed heart disease and those who did not. The
only strong association between heart disease and elevated cholesterol
was found in young and middle-aged men - not women - and it receded
with age.

Still, the American Heart Association recommends aggressive treatment
to lower cholesterol in women, especially if other risk factors are
present, according to Dr. Nieca Goldberg, chief of the Women's Heart
Program at Lenox Hill Hospital in New York and a spokeswoman for the
AHA.

And when doctors talk about heart disease risks for women, they mention
high cholesterol in the same breath as high blood pressure, diabetes,
obesity, smoking and family history.

Wright, the Canadian researcher, suggests a distinction should be made.
"The weakest risk factor is cholesterol," he said. "The correlation is
extremely weak and even becomes negative as you get older." He said the
message about cholesterol has been distorted.

"We've been bamboozled," he said.

Dr. Beatrice Golomb, an assistant professor of medicine at the
University of California at San Diego who has done research on
cholesterol and statins, says no study has ever demonstrated that
statins extend life for women. "The people who benefit are middle-aged
men who are at high risk or have heart disease ..." she said. "The
mortality benefits don't extend to the elderly or to women."

Yes, heart disease is the leading cause of death in women - but only
when women 75 and older are included in the figures. Take those women
out and the picture changes.

Younger women know that, intuitively. It's misleading to scold them for
worrying too much about cancer and not enough about heart disease. For
women ages 35-74, cancer is the No. 1 threat, killing almost twice as
many women as heart disease, according to national statistics.

So if your doctor recommends a statin, ask about the side effects. Find
out if you have other risk factors for heart disease that justify the
medication. Male or female, "assume any new symptom you develop after
starting any new drug is caused by the drug," says Dr. Sidney Wolfe, of
Public Citizen. Report muscle aches, pain, tenderness or weakness, and
cognitive changes, and the sooner the better, Wolfe says.

And make sure to tell the doctor what drugs you take.


~~~~~~~~~~~~~~~
A petition to the National Institutes of Health in 2004 regarding the
present cholesterol guidelines (which include the recommendations for
women and elderly):


The press release on the petition:
http://cspinet.org/integrity/press/200409231.html

The petition in pdf, with signatories listed:
http://cspinet.org/new/pdf/finalnihltr.pdf

--snip--

But in a letter to the heads of the National Institutes of Health, the
National Heart, Lung, and Blood Institute and the NCEP, the physicians
and scientists urge an independent review of the scientific studies
behind the new recommendations. "There is strong evidence to suggest
that an objective, independent re-evaluation of the scientific evidence
from the five new studies of statin therapy would lead to different
conclusions than those presented by the current NCEP," the scientists
wrote.

"The studies cited do not demonstrate that statins benefit women of
any age or men over 70 who do not already have heart disease," said
John Abramson, a clinical instructor in primary care at the Harvard
Medical School. "Furthermore, we are concerned about the findings
from one of the five cited studies showing that statin therapy
significantly increases the risk of cancer in the elderly."

--snip--

* None of the new studies provided significant evidence that women
without heart disease benefitted from statins at the new levels;

* The one study that looked at elderly patients over 70 did not
show a significant reduction in heart disease deaths, but it did show a
statistically significant increase in cancer deaths. The authors of the
NCEP report dismissed the finding by combining the cancer data with
data from other studies that included much younger patients;

* Three of the four studies of diabetics showed no significant
benefit from increased statin use. In making its recommendations for
diabetics, the new report made no effort to compare the results of
these statin studies to the far greater reductions in heart disease
that could be achieved through changing diabetics' lifestyles.

The scientists in their letter to NIH pointed out the great benefits of
lifestyle changes on health-something that only received passing
reference in the NCEP report. According to CSPI, media coverage of the
report largely ignored the lifestyle and diet recommendations or placed
them near the ends of their stories."

--snip--

.

Relevant Pages

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  • Re: The Cholesterol Con - Where Were the Doctors?
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    (soc.retirement)
  • Re: Danger of trans fats is a myth?
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  • Re: Bad LDL cholesterol may benefit elderly
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    (sci.med.cardiology)
  • Statins versus Vitamin D (long but interesting hypothesis)
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