From New York Times

Two widely prescribed cholesterol-lowering drugs, Vytorin and Zetia, may not work and should be used only as a last resort, a panel of four cardiologists told an audience of more than 5,000 people at a major cardiology conference on Sunday.

Instead, physicians and patients should rely more heavily on older cholesterol-lowering drugs called statins, which have proven benefits and can be cheaper, the panel said.

The strongest recommendation we can make on this panel is to go back to statins, said Dr. Harlan M. Krumholz, a cardiologist at Yale. They work.

Statins include drugs like Lipitor and simvastatin, the generic version of Zocor. But other, lesser-known drugs like niacin should also be tried before Vytorin and Zetia, the panel said.

Vytorin and Zetia are among the top-selling drugs in the world, with combined sales of $5 billion last year. About five million people worldwide, including four million Americans, take the medicines, which have been heavily advertised to consumers in the United States.

The New England Journal of Medicine made a similar recommendation about the drugs in an editorial published on Sunday.

Both the panel and the editorial were timed to coincide with the release of full results from a two-year clinical trial that showed that the drugs failed to slow, and might have even sped up, the growth of fatty plaques in the arteries. Growth of those plaques is closely correlated with heart attacks and strokes.

Merck and Schering-Plough, the companies that make Vytorin and Zetia, said on Sunday that they disagreed with the recommendations. Vytorin and Zetia have been proved to lower cholesterol and are valuable treatments for patients, said Dr. Rick Veltri, vice president of the Schering-Plough research institute.

We feel that nothings changed, Dr. Veltri said.

On Monday, shares of Merck fell $6.77 to $37.74 while Schering fell $5.07 to $14.40 at mid-day.

The stakes of the debate are high both medically and financially. The drugs produce about 70 percent of Schering-Ploughs profit, according to analysts.

Prescriptions for the medicines have already dipped by about 15 percent since January, when preliminary results were disclosed from the trial discussed in detail on Sunday. Still, the drugs are very widely used, with about three million prescriptions written each month in the United States alone.

Unlike statins, which block the liver from making cholesterol, Zetia works by blocking the intestine from absorbing cholesterol in food. Vytorin is a single pill that combines Zetia with simvastatin, or Zocor.

LDL cholesterol, the harmful kind, is known as a risk factor for heart disease, and so doctors have generally assumed that lowering LDL cholesterol would reduce the risk of heart attacks and strokes.

But proving that a drug actually cuts those risks requires an expensive, multiyear clinical trial involving 10,000 or more patients. Those studies, called outcomes trials, have been conducted for statins, and they have proved that patients taking those drugs do have a reduced risk of heart disease. No such outcomes trials exist for Vytorin and Zetia.

The Food and Drug Administration initially approved Zetia in 2002 on the basis of trials that lasted no more than 12 weeks and covered only 3,900 patients.

In 2006, four years after Zetia reached the market, Merck and Schering began enrolling patients in their own outcomes study, which compares people taking Vytorin to those taking Zocor alone.

But the companies said Friday that the results of the trial, which had been expected in 2011, would not be available until 2012, and possibly later.

As a result, doctors who prescribe the medicines are doing so without hard evidence that they help patients, said Dr. Steven Nissen, chairman of cardiology at the Cleveland Clinic.

Weve got a drug that has no clinical outcome trials, Dr. Nissen said. I advise my colleagues essentially to use this drug only as a last resort.

Dr. John Kastelein, the Dutch cardiologist who conducted the trial, called Enhance, that was discussed at the conference, said the companies must aggressively explore reasons that the trial failed. For example, they need to examine closely whether Zetia blocks the absorption of nutrients other than cholesterol in the intestine, or whether it has other effects on the lining of blood vessel walls.

We can use a lot better science, he said.

The recommendations released Sunday will probably have an immediate impact on clinical practice, said Dr. Douglas Weaver, the incoming president of the American College of Cardiology, which was host of the conference. Nearly half of the 30,000 cardiologists in the United States attend the conference, and many of those doctors heard the panels recommendations firsthand.

I do think that the drugs have been overutilized in this country, Dr. Weaver said. Heavy marketing has probably contributed to that overuse, he added. But use will decline as more patients and doctors focus on the results of the Enhance trial.

Sometimes you have to tell people multiple times before they get the message, he said

Many have high percentages of body fat, leaving them prone to heart disease, diabetes

From HealthDay

Despite appearances to the contrary, more than half of normal-weight Americans have a high percentage of body fat. And, like their overweight contemporaries, this makes them susceptible to heart disease, diabetes and other metabolic disorders, a new study says.

Men whose body fat is greater than 20 percent and women whose body fat is greater than 30 percent are suffering from “normal weight obesity,” the study authors said, even though their weight may be normal for their size.

“The prevalence of people with a high amount of body fat despite a normal weight is relatively high,” said lead researcher Dr. Francisco Lopez-Jimenez, a cardiologist with the Mayo Clinic in Rochester, Minn. “Many of these people have metabolic abnormalities.”

These findings should alert doctors that body weight isn’t the only way to protect against health problems caused by excess pounds, Lopez-Jimenez said. Even normal-weight people should be advised to exercise and eat a healthful diet to reduce their level of fat, especially belly fat, he added.

The findings were expected to be presented Tuesday at the American College of Cardiology’s annual meeting, in Chicago.

For the study, Lopez-Jimenez and his colleagues collected data on 2,127 people who participated in the U.S. government’s Third National Health and Nutrition Examination Survey. Specifically, the researchers looked at risk factors for heart disease, diabetes, and metabolic syndrome, a precursor of diabetes.

The researchers found that 61 percent of the participants had levels of body fat that indicated “normal weight obesity.” In addition, Lopez-Jimenez’s group found changes in blood chemistry that can affect heart and metabolic health, including high cholesterol; high levels of leptin, a hormone found in fat and other tissues that’s involved in appetite regulation; and high rates of metabolic syndrome.

Lopez-Jimenez said the study shows that just because your weight may be normal for your size, it doesn’t mean you aren’t at risk for heart disease and diabetes.

“If you have a normal weight, don’t feel that everything is just OK,” Lopez-Jimenez said. “If you have an excess amount of fat, you might have metabolic abnormalities as well,” he said.

One expert agrees that normal body weight is not synonymous with good health.

“Body weight is a very blunt instrument; it is not a reliable gauge of obesity, or health, at the individual level,” said Dr. David L. Katz, director of the Prevention Research Center at Yale University School of Medicine. “For example, a muscular man may have a very high body weight, yet be perfectly fit and healthy. Many people whose body weight is in the normal range are anything but.”

And some people are vulnerable to weight gain in all the wrong places, such as in and around the vital organs of the abdomen, notably the liver, Katz said.

“Even a small amount of extra fat where it matters most can wreak metabolic havoc, increasing risk for diabetes and heart disease, while leaving you with a body weight that looks perfectly innocent,” Katz said. “Excess body fat in the belly is a menace, whatever your weight. This study should sensitize patients and providers alike to this concern.”

From WebMD.com

A new study shows an antioxidant found in red wine destroys cancer cells from the inside and enhances the effectiveness of radiation and chemotherapy cancer treatments.

Researchers say the antioxidant found in grape skins, known as resveratrol, appears to work by targeting the cancer cell’s energy source from within and crippling it. When combined with radiation, treatment with resveratrol prior to radiation also induced cell death, an important goal of cancer treatment.

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Up to half of cancer deaths could be avoided with lifestyle changes, experts say

From HealthDay

Imagine therapies that could cut cancer deaths in half.

Well, these “breakthrough” treatments are here, according to a recent American Cancer Society report that said as many as 50 percent of cancer deaths could be prevented with lifestyle changes, such as quitting smoking, maintaining a healthy weight, and getting screened for certain malignancies.

“Nearly half of all cancer is related to two things — tobacco and obesity,” said Dr. Jay Brooks, chief of hematology/oncology at Ochsner Health System in Baton Rouge, La. “That’s something I don’t think people truly grasp.”

Dr. Neil Hayes, a medical oncologist specializing in lung and head and neck cancers at the University of North Carolina School of Medicine, concurred. “Most of my patients are smokers, so it’s rare I see someone truly surprised by the diagnosis. But I don’t think they fully think through the risk associated with smoking,” he said.

Evaluating your risk of cancer, and taking steps to modify those risk factors within your control, could save your life.

Smoking is far and away the leading cause of preventable cancer deaths. In the United States, nearly one-third of all cancer deaths — more than 170,000 Americans — each year are related to tobacco use, according to the American Cancer Society (ACS). Yet, almost one in four American adults still uses tobacco. And, about 22 percent of teens are still lighting up.

“Not smoking is the single most important thing you can do to lower your risk of cancer,” Brooks said.

Another important risk factor cited by the cancer society is the increasing girth of the average American. Poor nutrition, lack of exercise, and excess weight are likely at the root of as many as 188,277 cancer deaths annually, according to the ACS.

A recent New England Journal of Medicine study that included more than 900,000 U.S. adults found that the heaviest people had the highest risk of death — 52 percent higher for men and 62 percent for women — compared to people of normal weight.

However, what isn’t yet known, Hayes said, is if proper nutrition can prevent that increased risk. “We have an incomplete understanding of diet’s impact on cancer. But a healthy lifestyle is associated with all kinds of good things,” he said.

The ACS recommends eating at least five servings of fruits and vegetables a day, and getting at least 30 to 60 minutes of moderate to vigorous activity at least five days a week. Walking, biking and skating are examples of moderate activity, while jogging, fast bicycling, weight training, aerobics and swimming are considered vigorous activity.

Hayes said too much alcohol is also associated with some cancers, particularly tumors of the esophagus, pharynx, and mouth. The ACS recommends that women drink no more than one alcoholic beverage a day and men no more than two alcoholic drinks a day.

Then there’s the lifesaving issue of screenings. Some cancer screenings, such as those for skin, breast, cervical and colon cancers, can actually detect precancerous changes that may eventually lead to malignancies.

For instance, with a colonoscopy a doctor can find and remove polyps before they turn into cancer. The ACS report estimated that as many as half of the 55,000 colon cancer deaths that occur each year could be prevented with proper screening.

“Aside from avoiding tobacco and maintaining a healthy body weight, cancer screening is the most important thing people can do to reduce their chances of dying from cancer,” the ACS report stated.

Dr. Perlmutter’s comment:

As many of you know, we have employed fasting in our cancer therapy protocols essentially for the purpose of activating sirtuin genes. Keep this mechanism in mind when reviewing the following report.

From Bloomberg.com: Science