August 23, 2012 Clippings

Clinical drug trials killed over a thousand people last year: Health Minister

Clinical drug trials killed 1144 people in the last two years, the government said today. Earlier we had reported how from 2008-2011 clinical trials caused over 2000 deaths however only 22 received compensation.

Of the 1144 deaths in 2010 and 2011, 1106 died of diseases like cancer, terminal illness, etc. which is known as Serious Adverse Event (SAE) of death, the Health Minister Ghulam Nabi Azad told the Rajya Sabha. ”The number of SAE of deaths in clinical trials reported during the last two years (2010-2011) was 668 and 438 respectively. However, deaths attributed to clinical trials in 2010 and 2011 were 22 and 16 respectively,” Azad said in a written reply in the House.

The Minister also said that the Parliamentary Standing Committee on Health and Family Welfare in its report has made a number of observations on functioning of Central Drugs Standards Control Organisation (CDSCO) and had raised the issue of approval of drugs without clinical trials. The Standing Committee had also pointed out various issues pertaining to the drug industry, particularly the fact that there were very few drug inspectors.

“It (the Parliamentary Committee) has also made some observations on media coverage of conduct of clinical trial on the poor and illiterate people in India and deaths of trial subjects reported during these trials,” Azad added. On safety of people during these trials, Azad said, “There are cases pending in Allahabad High Court and Supreme Court on issues relating to safety and well-being of human subjects enrolled in clinical trials in the country.”

Source: http://health.india.com

23.08.2012

Egg yolks almost as bad as smoking for heart

Eating egg yolks accelerates atherosclerosis, also called coronary artery disease, in a manner similar to smoking cigarettes, say researchers.

Dr. David Spence of Western University, Canada, and his team surveyed more than 1200 patients and found that regular consumption of egg yolks is about two-thirds as bad as smoking when it comes to increased build-up of carotid plaque, a risk factor for stroke and heart attack.

Atherosclerosis is a disorder of the arteries where plaques, aggravated by cholesterol, form on the inner arterial wall. Plaque rupture is the usual cause of most heart attacks and many strokes.

The study looked at data from 1231 men and women, with a mean age of 61.5, who were patients attending vascular prevention clinics at London Health Sciences Centre’s University Hospital.

The researchers found carotid plaque area increased linearly with age after age 40, but increased exponentially with pack-years of smoking and egg yolk-years. In other words, compared to age, both tobacco smoking and egg yolk consumption accelerate atherosclerosis. The study also found those eating three or more yolks a week had significantly more plaque area than those who ate two or fewer yolks per week.

“The mantra ‘eggs can be part of a healthy diet for healthy people’ has confused the issue. It has been known for a long time that a high cholesterol intake increases the risk of cardiovascular events, and egg yolks have a very high cholesterol content. In diabetics, an egg a day increases coronary risk by two to five-fold,” said Dr. Spence, a Professor of Neurology at Western’s Schulich School of Medicine and Dentistry and the Director of its Stroke Prevention and Atherosclerosis Research Centre (SPARC) at the Robarts Research Institute.

“What we have shown is that with aging, plaque builds up gradually in the arteries of Canadians, and egg yolks make it build up faster - about two-thirds as much as smoking. In the long haul, egg yolks are not okay for most Canadians,” he stated.

Dr. Spence added the effect of egg yolk consumption over time on increasing the amount of plaque in the arteries was independent of sex, cholesterol, blood pressure, smoking, body mass index and diabetes.

And while he said more research should be done to take in possible confounders such as exercise and waist circumference, he stresses that regular consumption of egg yolk should be avoided by persons at risk of cardiovascular disease.

The research has been published online in the journal Atherosclerosis.

Source: www.dnaindia.com

23.08.2012

It is a great thing to know the season for speech and the season for silence

Seneca