Re: Merck, Schering-Plough Defend Efforts for Vytorin, Zetia



New York Probes Vytorin Study
By SARAH RUBENSTEIN
January 26, 2008 4:30 p.m.

New York Attorney General Andrew Cuomo has launched an investigation
into Merck & Co. and Schering-Plough Corp.'s handling of a
controversial study of their cholesterol drug Vytorin.

Mr. Cuomo has served the companies with subpoenas as part of a probe
into whether the companies "deliberately concealed" negative results
from the study, called Enhance, his office said in a news release on
Saturday.

Both companies said they received the subpoenas and will cooperate.
Merck spokesman Chris Garland said the company stands behind the
efficacy and safety of Vytorin and its sister drug, Zetia, and "acted
with integrity and good faith in connection with the clinical trial."
Schering-Plough spokesman Lee Davies said, "We stand behind our
medications and our clinical trials."

One prong of the investigation focuses on the "aggressive marketing"
of the drug to patients and doctors. The other involves the sale of
the companies' stocks to investors before the study's unflattering
results were disclosed, probing whether certain insiders' stock sales
were appropriate and whether the companies' statements to investors
were accurate.

The subpoenas seek, among other things, Vytorin-related documents that
pertain to marketing and advertising and to communications with drug
representatives, investors and analysts, as well as information about
insiders' sales of the companies' stock or exercise of options. Mr.
Cuomo's office says that over the past two years, New York State's
Medicaid Program spent approximately $21 million on Vytorin.

The Enhance clinical trial cast doubt about whether Vytorin is better
than a cheaper generic drug in slowing the progression of
cardiovascular disease, even though Vytorin was more effective in
reducing LDL, the so-called bad cholesterol, which is a major risk
factor for heart attacks.

The trial was completed in April 2006, but the companies didn't
disclose the disappointing results until Jan. 14 of this year. During
that time, combined annual sales of Vytorin and a sister drug, Zetia,
grew to more than $5 billion.

In November, a firestorm erupted after the companies announced they
were changing the trial's primary measure of effectiveness to
"expedite" analysis of data--a move generally considered a violation of
scientific protocol. That triggered complaints from cardiologists and
a congressional inquiry. The companies have since said they went back
to the original primary endpoint.-

Write to Sarah Rubenstein at sarah.rubenstein@xxxxxxx



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