Merck & Co. Inc. Schering-Plough Corp. joint venture investigated for slow disclosure of negative drug study results
AUSTIN - Texas Attorney General Greg Abbott and 35 other state attorneys general today reached a multi-million dollar agreement with pharmaceutical manufacturers Merck & Co. Inc. Schering-Plough Corp. and a joint venture between the two companies MSP Singapore Company LLC.
Together the three manufacturers agreed to pay $5.4 million to resolve the states investigation which examined the manufacturers delayed release of negative clinical trial results. Texas will receive $300000 for its efforts to investigate this matter.
The manufacturers clinical trial indicated that the cholesterol lowering drug Vytorin which is a combination of the drugs Zetia and simvastatin was no more effective reducing formation of plaque in carotid arteries than the cheap generic alternative simvastatin. Although the study ended in May 2006 complete results were not published until April 2008. In the meantime the companies heavily promoted Vytorin in direct-to-consumer advertisements.
Todays settlement requires the companies to follow several requirements when promoting Vytorin and Zetia including:
• Obtain pre-approval from the U.S. Food and Drug Administration (FDA) for all direct-to-consumer television advertisements;
• Comply with FDA suggestions to modify drug advertising;
• 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 detailed rules prohibiting the deceptive use of clinical trials.
The investigation was led by Oregon Attorney General John R. Kroger and an Executive Committee including the Attorneys General of Arizona California Florida Illinois New Jersey Ohio Pennsylvania South Carolina Texas and the District of Columbia.
The 36 states participating in todays agreement are Arizona Arkansas California Colorado Delaware the District of Columbia Florida Hawaii Idaho Illinois Iowa Kentucky Louisiana Maine Massachusetts Michigan Mississippi Missouri Montana Nebraska New Jersey Nevada New Mexico North Carolina North Dakota Ohio Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Vermont West Virginia Washington and Wisconsin.
Enthuze is receiving a $1.65 million investment to commercialize new research methods for data mining tools and a next generation social networking platform available online and on mobile or wireless devices.
Pronucleotein is receiving a $1 million investment to commercialize a suite of products for rapid onsite food safety testing. The technology uses DNA aptamer sequences in a portable hand-held detection device for fast real-time on-site detection of pathogens such as E. coli and salmonella in food and water.
The ETF is a $200 million initiative created by the Texas Legislature in 2005 at the governors request and reauthorized in 2007 and again this session with $203.5 million for the 2010-2011 biennium. A 17-member advisory committee of high-tech leaders entrepreneurs and research experts reviews potential projects and recommends funding allocations to the governor lieutenant governor and speaker of the House. To date the ETF has allocated more than $99 million in funds to 78 early stage companies.
For more information on the ETF please visit
www.emergingtechfund.com.
