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Medical Forum / General / General / January 2005

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99 per cent fail label comprehension

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Zee - 12 Jan 2005 23:59 GMT
"For example, in briefing materials released Wednesday, the FDA noted
that a label comprehension study showed that 99 percent of patients who
said they thought they could use Mevacor right away actually had at
least one risk factor that meant they shouldn't use the drug.

The medical consumer center's Levin said Mevacor's proposed switch
mirrors the gradually evolving perception of statins as "silver bullet"
preventatives against heart disease for healthy people, rather than
simply a cholesterol-lowering therapy for those who already have heart
disease

If it's cleared for OTC use, Mevacor "will be aggressively marketed as
a preventative, but that promotion might take people's minds off other
things they should be doing to stay healthy," he said, such as eating a
healthy diet and exercising.

Sidney Wolfe, head of the Health Research Group for the consumer group
Public Citizen, also said he had reservations about lipid-lowering
drugs going OTC.

There's insufficient evidence, he said, that statins actually reduce
cholesterol levels in healthy people, or in those who have never had a
heart attack, stroke or angina and who have either one or no risk
factors. stroke or angina and who have either one or no risk factors."
http://tinyurl.com/4q9v3
Steve Marcus - 13 Jan 2005 10:05 GMT
> "For example, in briefing materials released Wednesday, the FDA noted
> that a label comprehension study showed that 99 percent of patients who
[quoted text clipped - 21 lines]
> factors. stroke or angina and who have either one or no risk factors."
> http://tinyurl.com/4q9v3

If the cited article quotes him directly, then it is clear that Sidney Wolfe
has zero credibility.  Statins are chemicals, not viruses; they aren't
alive.  They don't know whether a person taking a statin drug is "healthy",
or "sick", and the mechanism by which the statin would operate to reduce
total cholesterol would be the same in either.  Certainly a person who has a
very low total cholesterol and a healthy ratio of HDL to LDL that is
achieved through diet/exercise/genetics might not significantly benefit from
a statin drug, but that's not the same as saying that in two people, each
having 200 TC and a poor HDL/LDL ratio, the statin will work to reduce TC
and improve the HDL/LDL ratio in the one that has coronary artery disease
and two risk factors but not in the other who has no CAD and one risk
factor.

The issue of whether the healthy person in the example above should take a
statin as a prophylactic is a different matter entirely.

Steve
Signature

The above posting is neither a legal opinion nor legal advice,
because we do not have an attorney-client relationship, and
should not be construed as either.  This posting does not
represent the opinion of my employer, but is merely my personal
view.  To reply, delete _spamout_ and replace with the numeral 3

Zee - 13 Jan 2005 18:50 GMT
> > "For example, in briefing materials released Wednesday, the FDA noted
> > that a label comprehension study showed that 99 percent of patients who
[quoted text clipped - 33 lines]
> and improve the HDL/LDL ratio in the one that has coronary artery disease
> and two risk factors but not in the other who has no CAD and one risk

> factor.
>
[quoted text clipped - 8 lines]
> represent the opinion of my employer, but is merely my personal
> view.  To reply, delete _spamout_ and replace with the numeral 3
The fault is probably with the reporter and not Wolfe.

Zee
Steve Marcus - 14 Jan 2005 14:16 GMT
>> > "For example, in briefing materials released Wednesday, the FDA
> noted
[quoted text clipped - 70 lines]
>
> Zee

I have a question for you Zee, and the purpose is nothing other than to
point you in a direction of "self-improvement."

Why is it that if someone makes a reply to a given post of yours which tends
to demonstrate that the info in your post may not, for example, have been
entirely accurate, your response is to bury your reply in such a way as to
camoflauge that you even replied, or to attack the other poster?

Wouldn't you (that is, your credibility) have been better served by posting
your reply "The fault is probably with the reporter and not Wolfe." so that
it was easily visible, rather than in such a way that one has to search
carefully to even detect that you did reply?  Wouldn't you (and your
credibility) have been better served by agreeing with my post, and then
stating that you hope (or even doubt) that Wolfe was not quoted directly, or
that the reporter garbled the matter in some other way?

Steve
Signature

The above posting is neither a legal opinion nor legal advice,
because we do not have an attorney-client relationship, and
should not be construed as either.  This posting does not
represent the opinion of my employer, but is merely my personal
view.  To reply, delete _spamout_ and replace with the numeral 3

Zee - 14 Jan 2005 16:30 GMT
http://tinyurl.com/5nrzx

> >> > "For example, in briefing materials released Wednesday, the FDA
> > noted
[quoted text clipped - 94 lines]
> represent the opinion of my employer, but is merely my personal
> view.  To reply, delete _spamout_ and replace with the numeral 3
MrPepper11 - 14 Jan 2005 21:36 GMT
FDA Panel Nixes OTC Cholesterol Drug Sales
Associated Press

BETHESDA, Md. Jan 14, 2005 - Federal health advisers recommended
against over-the-counter sales of a cholesterol drug, saying that
patients need medical guidance in treating a condition that has no
symptoms and requires drugs for life to stay healthy.

The panel advising the Food and Drug Administration also voiced concern
that women who are pregnant, and may not know it, will wind up taking
Mevacor and possibly damage the developing fetus.

The vote was 20-3.
Zee - 15 Jan 2005 00:09 GMT
> FDA Panel Nixes OTC Cholesterol Drug Sales
> Associated Press
[quoted text clipped - 9 lines]
>
> The vote was 20-3.

It was the right decision: Zee

We Are Sleep-Walking Into What Could Become A Major Medical Disaster
Because Statin Drugs Will Soon Be Sold Over-The-Counter

By Dr. Malcolm Kendrick

1. Holoprosencephaly (defective septum separating lateral cerebral
ventricles, with cerebral dysfunction), atrial septal defect, aortic
hypoplasia, death at one month of age.

2. Aqueductal stenosis with hydrocephalus, concurrent limb
deficiency

3. Cerivothoracic-to-lumbar neural-tube defect, myelocele,
duplication of spinal cord, cerbellar hernation with hydrocephalus;
apparent agenesis of palate

4. Spina bifida, right-arm abnormality

5. Left leg: femur 16% shorter than right side; foot: aplasia of
metatarsals and phalanges 3,4 and 5; additional VACTERL (vertebral,
anal, cardiac, tracheal, esophageal, renal and limb defects): left
renal dysplasia, reversed laterality of aorta, disorganized lumbosacral
vertebra, single umbilical artery; additional findings: clitoral
hypertrophy, vaginal and uterine agenesis.

It always amazes me that some things seem to strike terror into the
hearts of mankind whilst other, much more dangerous things, are
accepted with a shrug of the shoulders. As my son has taken to saying
'Yeh, whatever.'

Around the world, for example, car crashes wipe out thousands of people
each and every day, yet few people worry about getting into a car. On
the other hand, one plane comes down; killing a couple of hundred, and
it hits the front page of the newspapers around the world. And we are
all nervous about getting into planes - especially the landing bit.

The things that frighten us, it seems, bear absolutely no relationship
to the level of risk that they represent.

Looking at a medical example of irrational fear, the world still reels
in terror at the word "thalidomide." However, it turns out that
this drug provides huge benefits in the treatment of myeloma - who
would ever have thought? Yet, it is almost impossible to prescribe
thalidomide to many who need it, due to extremely strict controls on
its use. Which is completely mad, because it only has one major side
effect, which is to cause birth abnormalities in pregnant women.

So, why is it so difficult to prescribe it to a seventy-year-old man?
Because it is thalidomide, and thalidomide is scary.

On the other hand, in the UK we are going to allow statins to be made
available over the counter and - hey, guess what? If you are a woman,
and you get pregnant whilst on statins there is a massive risk of
severe, horrible birth defects. Worse defects than were ever caused by
thalidomide.

At least thalidomide didn't affect the brain, causing 'defective
septum separating lateral cerebral ventricles', or 'duplication of
the spinal cord.' Duplication of the spinal cord!

We are sleep-walking into what could be a major medical disaster. Most
people, and most doctors, are unaware - or don't seem to care -
that statins should never ever be taken by a women of child-bearing
age. The risk, it would seem, is greater than that posed by
thalidomide, and no-one seems to be the least bit bothered. 'Yeh,
whatever.'

Yet, when statins go OTC it is absolutely certain that women of
childbearing age will take them, knowing nothing of this risk. It is
equally certain that a number of these women will become pregnant, and
many of these pregnancies will result in horribly deformed children.

How can this possibly be allowed to happen? I can only suppose that it
is because everyone believes statins to be utterly safe and cuddly.
'Statins, why they can't do any harm. They are safer than aspirin
aren't they?'

* Left arm: aplasia of radius and thumb, shortened ulna; additional
VACTERL (vertebral, anal, cardiac, tracheal, esophageal, renal and limb
defects): left arthrogryposis, thoracic scoliosis, fusion of ribs on
left, butterfly vertebra in thoracic and lumbar region, esophageal
stricture, anal atresia, renal dysplasia; additional findings:
hemihypertrophy of entire left side, craniofacial anomalies (including
asymmetric ears, ptosis of eyelids, high arched palate), torticollis.

I am quite certain that many of you won't know what some of these
defects actually are; neither do I. Arthrogryposis..... isn't that
the fabled winged beast in Harry Potter?

But these defects shouldn't exactly come as a surprise. Cholesterol
is essential for the development of neural tissue, so we should expect
to find that if the mother is taking a drug that inhibits cholesterol
synthesis at a time when the fetus is developing - horrible
developmental abnormalities will occur. Such as failure of the brain to
develop in the right way, or duplication of the spinal cord.

For more complete details of the birth defects caused by statins
consider reading the New England Journal of Medicine, April 8, 2004:
pages 1579 - 1582. It's a letter by Robin J Edison and Maximilian
Muenke.
listener - 15 Jan 2005 02:23 GMT
"MrPepper11" <MrPepper11@go.com> wrote in news:1105738610.792851.269590
@f14g2000cwb.googlegroups.com:

> FDA Panel Nixes OTC Cholesterol Drug Sales
> Associated Press
[quoted text clipped - 9 lines]
>
> The vote was 20-3.

It was the right decision: L.

[snip all the worthless bullshit...]

L.
Zee - 15 Jan 2005 02:40 GMT
> "MrPepper11" <MrPepper11@go.com> wrote in news:1105738610.792851.269590
> @f14g2000cwb.googlegroups.com:
[quoted text clipped - 18 lines]
>
> L.

So I did ok until I quoted Kendrick are you saying?

Zee
 
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