Merck & Co and Schering-Plough have agreed to pay $5.4 million to settle litigation with a number of US states over the way the firms handled controversial study data and promoted the cholesterol treatments Vytorin and Zetia.

The drugmakers said they have reached a civil settlement with 35 states and the District of Columbia who investigated whether they violated state consumer protection laws in connection with the ENHANCE clinical trial or by their marketing of Vytorin (ezetimibe/simvastatin) and Zetia (ezetimibe). Merck and S-P noted that the settlement "does not require the companies to make any other payment, and does not require or include any admission of misconduct or liability."

As part of the deal, the companies said they had “agreed to continue to comply” with the Food, Drug and Cosmetic Act, the US Food and Drug Administration Amendments Act, and other laws “requiring the truthful and non-misleading marketing of pharmaceutical products”. They also made “other voluntary assurances of compliance” related to the promotion of Vytorin and Zetia.

The settlement also requires Merck and S-P to receive FDA approval before broadcasting any television advertisements for the drugs, and to meet certain criteria when providing data about clinical studies in media outlets. It also includes restrictions on the ghostwriting of medical articles.

Bruce Kuhlik, Merck’s general counsel, said the agreement is “consistent with our belief that the companies conducted the ENHANCE trial in good faith” and that their promotion of the two drugs “was in compliance with the law". S-P lawyer Thomas Sabatino added that “resolving these inquiries for an amount equal to the states' investigative costs is in the interests of all stakeholders".

It had been claimed that Merck and S-P delayed the release of unfavourable results for Vytorin and Zetia from the ENHANCE trial, completed in May 2006 but only published in January 2008. Other legal cases are still pending.