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11 April 2008

Does Cholesterol Matter? Only if You're on a Cholesterol-Lowering Drug

The makers of Zetia and Vytorin (which combines Zetia and Zocor) recently announced that their aggressively advertised cholesterol-lowering drugs failed to slow the development of fatty plaque in arteries. In fact, the drugs actually promotes the formation of plaque in arteries, which fuels heart disease and increases the risk of a heart attack. The announcement –- in a news release, not a medical journal –- came after long delays in reporting the findings of their study.

Why the delays? Follow the money. Sales of the two drugs added up to $5 billion in revenues in 2007.

The news release was the first of several fascinating and bizarre reports on Zetia and Vytorin. Even though the drugs don't prevent heart disease, the American Heart Association quickly issued an official news release in defense of the drugs.

If you're confused by that, just follow the money trail again. According to an article in the New York Times, the American Heart Association gets $2 million a year from Merck/Schering-Plough Pharmaceuticals, the pharmaceutical group that markets Vytorin.

The failure of this and other recent cholesterol-lowering drug trials has renewed a long-simmering debate about the role of cholesterol in heart disease. Cholesterol is a symptom -- get that, a symptom -- not a cause of heart disease, and Vytorin and other drugs merely alter a symptom. In fact, cholesterol has long been known as only a weak indicator of heart disease risk (American Journal of Epidemiology, 1977;105:281-9). Half of the people who have heart attacks have normal cholesterol levels.

What then causes heart disease? The answer is a variety of factors, most of which are no-brainers, such as prediabetes and being overweight, which result from excess intake of refined sugars, processed sugar-like carbohydrates, and trans fats. This dietary pattern elevates blood sugar, insulin –- and, yes, cholesterol, see ( . Even the oft-recommended high-carb diet for preventing heart disease raises cholesterol and triglyceride levels. That's because, in most people, elevated cholesterol and triglyceride levels reflect sugar and carb intake, not fats.

If all this isn't strange enough, consider one more recent report. The average cholesterol level of Americans is now lower than it was back in 1960 because of all the cholesterol-lowering drugs that have been prescribed. At the same time, two-thirds of Americans are now overweight –- the number one risk factor for diabetes and heart disease. In effect, Rome is burning while medicine fiddles with cholesterol.

Marketing, Not Research, is Now the Core of the Drug Industry

In 1950, George Merck, president of the company founded by his father and bearing his name, said, "We try never to forget that medicine is for the people. It is not for the profits."

If that was ever true, it is certainly not true now. Drug companies are hugely profitable enterprises, and they spent more on political lobbying than any other industry between 1998 and 2004. The transformation is owed in large measure to blockbuster drugs, meaning any medication that generates more than $1 billion in sales annually.

It might have begun with the selling of Zantac, an anti-ulcer drug that came on the market in 1983. GlaxoSmithKline priced it more expensively than the competitor drug Tagamet, to imply that it was superior. In reality, Zantac was chemically almost identical to Tagamet and no more effective.

But more importantly, the revenues from Zantac were spent not on research and development as was then customary, but on a massive marketing campaign for the drug. GlaxoSmithKline linked the drug to the relief of a common but minor condition, heartburn, then made consumers and doctors worry that the condition was a sign of a more worrisome disease, which the company dubbed Gastro-Esophageal Reflux Disease, or GERD. Soon, millions of Americans were using the expensive drug Zantac instead of the over-the-counter remedies which easily relieve most heartburn.

GlaxoSmithKline's strategy, novel in the 1980’s, has become standard operating procedure in the pharmaceutical industry. Most money goes into marketing, and research falls by the wayside; most “new” drugs are slight alterations of older ones.


* Washington Post April 6, 2008

Vaccine-Autism Question Divides Parents, Scientists

13-year old Michelle Cedillo is at the center of a court case pitting thousands of families of children with autism against the medical establishment. While a number of prestigious medical institutions say there is no link between vaccines and autism, the families believe vaccines caused their children's autism, and have taken their case to court.

Theresa and Mike Cedillo, Michelle's parents, believe the MMR vaccine, which at the time contained a mercury-based preservative, drastically altered the course of their daughter's development. Within days of receiving the injection, Michelle suffered from a high fever, persistent vomiting and problems with her digestion -- and also stopped speaking and no longer responded to her name.

Many doctors, however, argue that the apparent connection between vaccines and autism is nothing more than a sad coincidence. But families who believe vaccines can trigger autism point to the case of 9-year-old Hannah Poling; the U.S. government conceded that vaccines "significantly aggravated" her underlying illness, predisposing her to symptoms of autism.

The court heard testimony in the Cedillo claim in June of 2007. Testimony in other test cases is scheduled for 2008.


* April 2, 2008