Tuesday, January 15, 2008

Cholesterol Drug Zetia Has No Benefit in Trial, Makers Say

I'm not sure why this is news, except that millions of people have been taking this drug on the misguided premise that it can reduce cholesterol, and therefore, heart attack risk.

Zetia, which is also in Vytorin (mixed with Zocor), supposedly could stop dietary cholesterol from becoming serum cholesterol. The only problem with this theory is that scientists have known for more than 50 years that dietary cholesterol has little impact on serum cholesterol.

As far back as 1956, a literature review showed little or no association between the cholesterol we take in as food, and the levels of cholesterol in our blood:

1. Two cross sectional surveys in Minnesota on young men and 4 on older men showed no relationship between dietary cholesterol and the total serum cholesterol concentration over most of the ordinary intake range characteristic of American diets.

2. Two surveys on the Island of Sardinia failed to show any difference in the serum cholesterol concentrations of men of the same age, physical activity, relative body weight and general dietary pattern but differing markedly in cholesterol intake.

3. Careful study during 4 years of 33 men whose diets were consistently very low in cholesterol showed that their serum values did not differ from 35 men of the same age and economic status whose diets were very high in cholesterol.

4. Comparisons made of 23 men before and after they had voluntarily doubled their cholesterol intakes and of 41 men who halved theirs failed to show any response in the serum cholesterol level in 4 to 12 months while the rest of the diet was more or less constant.

5. A detailed study of the complete dietary intakes of 119 Minnesota businessmen failed to show any significant increase of serum cholesterol with increasing dietary cholesterol intake.

6. In 4 completely controlled experiments on men the addition to or removal from the diet of 500 to 600 mg of cholesterol daily had no effect on the serum cholesterol fall produced by a rice-fruit diet or on the rise in changing from a rice-fruit diet to an ordinary American diet.

7. In a completely controlled experiment on 5 physically healthy men the change from a rice-fruit diet containing 500 mg of cholesterol daily to the same diet devoid of cholesterol had no effect on the serum level.

8. In a similar experiment with 13 men receiving 66 gm of fat daily there was no significant effect in changing from a cholesterol intake of 374 mg/day to one of 1369 mg/day. In another 12 men the reverse change was likewise without effect on the blood serum.

9. It is concluded that in adult men the serum cholesterol level is essentially independent of the cholesterol intake over the whole range of natural human diets. It is probable that infants, children and women are similar.

Another more recent article came to the same conclusion:

Nonetheless, numerous studies have shown that dietary cholesterol can increase serum LDL-cholesterol, but the size of this effect is highly variable between individuals and, according to over 30 years of prospective epidemiology, has no clinically significant impact on CHD risk.

It boggles my mind that this far into the game some drug company decided to take such a proven to be wrong approach to reducing the risk of heart disease -- and that the FDA approved the drug in the first place.

Medicine has done a lot of good, but companies like Merck and Schering-Plough, who manufactured the drug and the then held back the evidence that it didn't work for the more than two years, give medicine a bad name.

1 comment:

Anonymous said...

Amitofo! And amen my brother. This NEEDS to be news!