New York Attorney General Andrew Cuomo announced yesterday he would subpoena Merck and Schering-Plough Corp for information and documents to investigate if the companies hid research on the heavily advertised cholesterol drug Vytorin. The two companies are partners on the drug.
The study, Enhance, was released on January 14th and showed that Vytorin (a combination of the drugs Zetia and Zocor) does not work any better than Zocor alone in reducing fatty plaque in arteries. The investigation will examine the marketing of Vytorin and the sale of the companies’ stocks to investors before the results were disclosed.
“We will investigate and, when appropriate, hold accountable drug companies for engaging in irresponsible and deceptive conduct and any deceitful marketing of prescription drugs,” Cuomo said.
“Drug companies are on notice that concealing critical information about life-saving prescription drugs, profiting at the expense of patients’ health, and wasting taxpayer dollars, is simply unacceptable.”
Although researchers finalized their conclusions in April 2006, the companies didn’t make results public until two weeks ago. The companies blamed the complexity of the data as the reason for delay. They certainly enjoyed one last hoorah–the drug reaped in $5 billion in sales last year.
The closer you look at this controversy, the messier it gets. Members of Congress want to know why the companies sat on these results for almost two years. State Medicaid agencies, assuming improved results with Vytorin, paid millions for the drug during this time, and could have saved money buying equally effective, older medicines. New York alone paid a whopping $21 million just for this drug.
The companies also changed the “primary endpoint” of the trial (the result being measured to see if a treatment worked) after it was completed. This has left some doctors skeptical. ”This sounds highly unusual to me,” said Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington. ”You need to live with your primary endpoint.”
Hopefully lawmakers will stay true to their word and fully investigate what’s happened here. In the meantime, we’re all waiting for the day when this kind of news will shock us.