Medical Forum / General / General / January 2005
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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