AP: Lawmakers v. Vytorin Snake Oil Salesmen

The credibility of the pharma industry is at stake - well actually it is out the window with this one. It would be in the industry best interest and ours (the consumers) if the wrongdoers are sent to prison. If heads do not roll, the industry will suffer even more.

Credibilty gone. Congressional investigation. Why would people believe the pharma snake-oil salesmen now about any "study"?

Congress Investigating Vytorin Ads
WASHINGTON -
Congress is investigating advertising for the cholesterol-busting drug Vytorin following a study that suggested the pill may have no advantage over a generic cholesterol medicine, according to letters released Wednesday.

In letters dated Wednesday and addressed to Schering-Plough Corp. and Merck & Co., which jointly sell Vytorin, and the U.S. Food and Drug Administration, Reps. John Dingell and Bart Stupak, Michigan Democrats, raised questions about the ads for the medicine.

In the letter to the companies, the congressmen wrote that the House of Representatives' Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations are probing the "withholding of clinical trial data that may significantly affect the medical management of hypercholesterolemia, as well as the use of misleading statement in direct-to-consumer advertisements for prescription medicines."

Vytorin is in the news this week after the results of a long-awaited study, called Enhance, indicated the drug may be no better than a generic statin at slowing the progression of heart disease.

In the FDA letter, the lawmakers write that they are "concerned that the study's results may have been available to Schering-Plough and Merck officials, and yet the massive advertisement campaign for Vytorin was allowed to continue." They ask for agency records related to the Vytorin ads.

The congressmen also asked the companies for records related to the ads as well materials related to Enhance study leader John Kastelein, a cardiologist in the Netherlands. They also seek information about the press release this Monday that disclosed the Enhance results, almost two years after the last patient completed the study.

In 2005, the companies spent $155 million on Vytorin ads, a budget exceeded that year only by Sepracor Inc.'s Lunesta campaign and AstraZeneca PLC's Nexium ads, according to an article in the New England Journal of Medicine.

The companies have defended their handling of the Enhance study.