In a sign that authorities are taking the alleged withholding of negative study results seriously, New York Attorney General Andrew Cuomo has subpoenaed Merck & Co and Schering-Plough Corp for documents and information to see whether the companies hid the results of a study on their cholesterol drug Vytorin.
The move, announced on Saturday, came one day after US regulators said they would review the study, called Enhance, which showed Vytorin worked no better than a generic in preventing the build-up of arterial plaque.
The US Food and Drug Administration said it was not advising doctors to stop prescribing Vytorin, but shares of the two companies fell on Friday as news of the review unnerved investors.
The two stocks have fallen more than 20 percent since the results of the study were released on January 14, triggering a debate over Vytorin's value.
Cuomo said the investigation would review the marketing of Vytorin and also the sale of the companies' stocks to investors before the study's negative results were disclosed.
Will be held accountable
"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 in a statement on Saturday.
"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."
Vytorin combines the widely used generic Zocor with a newer cholesterol-fighting pill called Zetia (Ezetimibe). The Enhance study examined Vytorin against Zocor alone in patients with a rare genetic predisposition to dangerously high cholesterol levels.
Vytorin failed to halt the clogging of neck arteries better than Zocor alone, but did a better job of reducing "bad" LDL cholesterol.
We did nothing wrong
"We are aware of the subpoena and will cooperate with the attorney general's office. The company stands behind our products as we have done nothing wrong," said Schering-Plough spokeswoman Rosemarie Yancosek.
Those sentiments were echoed by Merck.
"We've received the subpoenas and will cooperate fully. Merck stands behind the safety and efficacy profiles of both Zetia and Vytorin," Merck spokesman Chris Garland wrote in an e-mail. "We acted with integrity and good faith in connection with the clinical trial."
Merck and Schering-Plough sell Vytorin and Zetia in a joint venture, and the products have combined annual sales of about $5 billion. – (Reuters Health)
Cholesterol drug Zetia useless