NEWS OF THE W EEK
TRIAL RESULTS ROIL DRUG COMPANIES PHARMACEUTICALS: Merck, Schering-
Plough are under fire for withholding negative clinical trial data
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ERCK & CO. and Schering-Plough are facing harsh criticism from lawmakers who say the companies held back negative clinical trial data so that they could continue to profit from sales of their cholesterol-lowering drugs Vytorin and Zetia. Nearly two years after the end of a clinical trial called Enhance, researchers reported that Vytorin—a combination of simvastatin and Zetia (ezetimibe)—was no better than simvastatin alone in preventing the buildup of arterial plaque. The complete results were presented on March 30 at an American College of Cardiology (ACC) meeting and are published in the New England Journal of Medicine (2008, 358, 1431). At the ACC meeting, a panel of five medical experts recommended that doctors prescribe statin-based drugs first rather than Vytorin or Zetia. Statins limit cholesterol synthesis in the body, whereas ezetimibe prevents the absorption of dietary cholesterol. Both lower levels of LDL (bad) cholesterol, but only statins have been shown to reduce heart attacks and deaths; studies are under way to show whether Zetia can do the same. A day after the results were presented, Sen. Charles E. Grassley (R-Iowa) chastised the companies in writing for not giving doctors the facts earlier so that they could make informed decisions. The lack of information, he added, imposed financial burdens on patients and the government, which had spent hundreds of millions of dollars on Vytorin in the two years since the end of the trial. The Senate Finance Committee, on which Grassley serves, as well as the House Energy & Commerce
Committee and the New York State OH attorney general’s office have been OH investigating whether the companies delayed publication for marketing purposes. A Schering-Plough spokeswoman says, “We are cooperating N F O fully, and we stand behind our products as we have done nothing wrong.” Ezetimibe Among other things Grassley F questioned money that the companies’ joint venture budgeted to O HO promote Vytorin. “I remain troubled that Merck/Schering-Plough failed to O O report any results from the Enhance O trial until January 2008 while tryH ing over the past year or two to get doctors to switch their patients to Vytorin from other, less expensive statin drugs,” he wrote. The joint venture’s combined sales of Vytorin Simvastatin and Zetia were $5.2 billion in 2007 and accounted for 15% of the U.S. cholesterol-lowering drug market. Grassley published disparaging e-mail excerpts from John Kastelein, lead investigator for the Enhance trial, to the joint venture. “This starts smelling like extending the publication for no other [than] political reasons,” Kastelein wrote. To show the comments in context, Schering-Plough has released what it says is the full text of e-mails “concerning an issue that Merck/ Schering-Plough and, we believe, Dr. Kastelein considered long resolved,” the Schering-Plough spokeswoman says. (Go to www.cen-online.org for links to the e-mails and Grassley’s letter.) The companies assert that the study took longer than anticipated to complete due to unexpected challenges in analyzing the data. But once these issues were addressed, they disclosed initial results just two weeks after the study was unblinded in late 2007, the spokeswoman says, and then assisted Kastelein in promptly publishing and presenting the full results.—ANN THAYER
INTELLECTUAL PROPERTY Ohio jury decides in favor of Leadscope’s counterclaims against ACS An Ohio jury concluded on March 27 that the American Chemical Society must pay $19 million in compensatory damages and $7.5 million in punitive damages to Leadscope Inc., a Columbus-based chemical informatics company that the society says infringed on its intellectual property. The society said “it would pursue appropriate posttrial motions” and, if necessary, an appeal of the jury’s decision. “ACS is, of course, disappointed in the result of the trial,” said Michael G. Long, an attorney at Vorys, Sater, Sey-
mour & Pease, the firm that represents ACS. “Nonetheless, ACS continues to be committed to protecting its intellectual property. ACS remains confident in its position.” In 2002, ACS brought suit against Leadscope and three former ACS employees who founded the company: Paul E. Blower Jr., Wayne P. Johnson, and Glenn J. Myatt. All three had worked in ACS’s Chemical Abstracts Service division. In the original suit, ACS alleged that the defendants improperly used ACS’s
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intellectual property to develop, patent, and market Leadscope software products. The Leadscope defendants filed a counterclaim against ACS, charging defamation, tortious interference with business relations, unfair competition, and deceptive trade practices. The jury found in favor of Leadscope on all but the last of the counterclaims. Neither the attorneys for Leadscope nor its CEO, Loftus Lucas, could be reached by C&EN for comment at press time.—WILLIAM SCHULZ
