Dr. Fitness and the Fat Guy

After sitting on the results of a study that could cause a negative impact on stock prices, Merck and Schering-Plough Pharmaceuticals, finally released data for the ENHANCE trial, testing the effect of Vytorin (ezetimibe and simvastatin combined) against an older drug, now available in generic form, Zocor (simvastatin alone). Unfortunately, the data showed that the combination drug Vytorin, which is quite expensive, was no better at reducing artery clogging than the older and cheaper statin.

720 patients with heterozygous familial hypercholesterolemia (inherited high cholesterol from one of their biological parents) participated in the ENHANCE study. Over the two years of the study, there was no significant difference in the ability of the two drugs to slow the growth of plaque in carotid arteries supplying blood to the brain.

The American College of Cardiology said patients should not stop taking the drug on the basis of these results, the situation is not urgent, and they should talk to their doctor about any concerns they have. More research is needed before firm conclusions can be made about the risks and benefits of statin alone versus statin plus ezetimibe, said the ACC. The American College of Cardiology said in a press release that “major clinical decisions not be made on the basis of the ENHANCE study alone”.

What I find interesting is the fact that the two year drug study ended in April 2006. January 16, 2008 we receive the results? In the words of John McEnroe “You cannot be serious!!!!!” According to a report by Reuters news agency, Congress is planning to investigate how the two companies handled the release of the study’s results, calling the delay a “suspiciously long time”.

Drugmaker Merck & Co. produces about half of the nation’s annual supply of 14 million doses of Hib vaccine. Merck recalled the lots after this week identifying a sterility problem in a Pennsylvania factory. It said sample vials from the recalled lots, tested before shipment, were not contaminated but the company could not assure sterility of the entire lots.

The Fat Guy had a great blog entry today about the flu vaccine and no sooner as I finished reading it that I came across this article about the Hib vaccine.  The recall is more than likely going to magnify the debate over childhood vaccines, their safety and whether too many are required. Some parents are distrustful, like myself and suspect some vaccines of being linked to autism. The mechanism is far from being identified but I believe it to be a genetic trigger of some sort when introduced to some children.

This week, New Jersey, my favorite state, took a controversial step backward in my opinion by becoming the first state to require flu shots for preschoolers after a health advisory board backed new vaccine requirements over opposition from some worried parents.