Merck and Schering-Plough appear to have avoided being slapped with any new state oversight requirements as a result of the controversy surrounding a failed study of Vytorin .

The firms agreed to pay $5.4 million to state attorneys general to resolve an investigation of the companies' delay in releasing negative study results of the cholesterol lowering drug.

The sum covers the investigative costs of the 35 states and the District of Columbia that launched the investigation. The agreement did not include any admission of liability by the companies.

"We've said the companies conducted the ENHANCE trial in good faith and that our promotion of Vytorin and Zetia was in compliance with the law," a Merck spokesman said July 15, adding that the size of the settlement reflects this. He noted that the states did not file a lawsuit or make any allegations.

The states, led by the Oregon Department of Justice, looked into the companies' delay in releasing the results of the ENHANCE clinical trial. The study found that Vytorin -- a combination of Zetia (ezetimibe) and simvastatin -- was no more effective in reducing the formation of plaque in carotid arteries than the generically available simvastatin. The study was completed in April 2006 but the findings were not announced until January 2008 ('The Pink Sheet' DAILY, Jan. 14, 2008).

The settlement also requires the companies to obtain pre-approval from FDA for all direct-to-consumer television advertisements and to comply with FDA suggestions to modify the ads. In addition, they must register clinical trials and post their results; prohibit ghost writing of articles; reduce conflicts of interest for Data Safety Monitoring Boards that ensure the safety of participants in clinical trials; and comply with rules prohibiting the deceptive use of clinical trials.

Merck said it is already fulfilling these requirements. The same terms were included in the $58 million agreement Merck reached with state AGs last year to resolve a three-year investigation of marketing and promotion of Vioxx ('The Pink Sheet' DAILY, May 20, 2008).

A spokesman for the Oregon DoJ said these are the standard injunctive terms included in state settlements with pharma companies. State AGs have become more aggressive in pursuing pharma for alleged health care fraud, inking more than 20 settlements with drug companies since 2001 ("The 'Super FDA': State Attorneys General Flex Their Muscle in Pharma Enforcement," The RPM Report, January 2009).

-Brenda Sandburg (b.sandburg@elsevier.com)

Merck, Schering-Plough Dodge Vytorin Enforcement Bullet

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