MK-0524A, as the new drug is called, is the subject of a study based in Oxford University in England. Merck submitted the drug to the FDA for approval, but it was rejected last April. The FDA wanted results from the study known as THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) before it made another ruling.

The study already involves 20,000 people from the UK, Scandinavia, and China who are taking the experimental drug. The problem for Merck, however, is the timeline. The study began in 2006 and is set to end in January of 2013. Sufficient data wouldn’t be available until 2010.

To speed the study along, Merck will increase the number of participants in THRIVE to 25,000. Merck hopes that having more trial participants will amount to obtaining results several months earlier.

In a statement issued by Oxford University, Professor Jane Armitage, one of the principal investigators of MK-0524A sounded hopeful about the study’s expansion, saying that “In terms of numbers, bigger is very much better.”

“This enhancement will give us a more powerful tool with which to assess this intervention for the benefit of heart patients everywhere. The study is scheduled to end in 2013, but with these additional patients, we hope that it will be able to report sooner,” she said.

Merck expected the new drug to stimulate its share of the cholesterol market, which suffered a serious blow when Vytorin was revealed to be first a dud and then a danger. Researcher claim that by speeding up the THRIVE trial, they will be able to help people with vascular disease sooner. For Merck, it’s likely to be a matter of replacing lost profits and establishing a pipeline that’s more appetizing to investors.

SOURCE: Vytorin Recall › Merck speeds trial of new cholesterol drug

The University of Washington’s Thomas Fleming is one respected statistician and adviser to the FDA who cautions against dismissing Vytorin’s link to cancer as merely an anomaly. Leading researchers involved with the SEAS study, which uncovered a Vytorin-cancer link, maintain that the results were a fluke.

In an editorial published in The New England Journal of Medicine, Fleming says that at this point in time, it’s too early to dismiss the Vytorin-cancer link. He suggests that the drug may have more adverse side effects than actual benefits. “ … There are numerous recent cases in which it has been established or strongly suggested that [side] effects of such [drugs] have adversely altered their risk–benefit profile.”

Scientists quick to dismiss Vytorin’s apparent link to cancer support their case by pointing to two larger ongoing studies that appear to diminish the drug’s risks. According to Fleming, however, “There are clinically important increases in the risk of cancer-related death that are not ruled out by this data.” He also argues that prematurely releasing results from the other tests jeopardizes their conclusions.

Vytorin sales soared to the tune of $5 billion in 2007, but dropped by a third after reports of negative tests began to surface. Considering such profits, altering and masking potentially harmful clinical trial data might seem like a good profit-preserving strategy, but it makes you wonder what it’s like to work in the Public Relations department at Merck and Schering-Plough.

SOURCE: Vytorin Recall › scientist cautions against dismissing Vytorin-cancer link