TRENTON
-- Attorney General Anne Milgram announced
today that New Jersey has entered into a multi-state
settlement with Merck & Co. Inc, Schering-Plough
Corporation, and a joint venture of the two
companies, MSP Singapore Company, LLC, resolving
an investigation into a lengthy delay by the
companies in issuing negative results from
a clinical trial of their cholesterol-lowering
drug Vytorin.
The
clinical trial was called Ezetimibe and Simvastatin
in Hypercholesterolemia Enhances Atherosclerosis
Regression, or ENHANCE.
Under
terms of the settlement, Merck & Co.,
Schering-Plough and MSP Singapore have agreed
to pay the participating states $5.4 million
to cover costs related to the investigation.
New Jersey, as part of the multi-state group’s
investigatory Executive Committee, will receive
$200,000.
Among
other things, the settlement requires Merck
and the other entities to obtain pre-approval
from the federal Food and Drug Administration
(FDA) for all direct-to-consumer advertisements,
and to comply with detailed rules concerning
the use of information from clinical trials.
Under the settlement, there is no admission
of wrongdoing on the part of any of the three
companies.
“This
is an important settlement for New Jersey
consumers. Consumers have a right to accurate
information about the medications that are
advertised and placed on the market and, potentially,
prescribed by their physicians. This is particularly
true when we’re talking about medications
as vital as cholesterol-lowering drugs,”
said Attorney General Milgram.
In the ENHANCE study, Vytorin -- a combination
of the drug Zetia and
simvastatin -- was no more effective in reducing
formation of plaque in carotid arteries than
simvastatin alone. Simvastatin is an inexpensive,
generically available cholesterol lowering
drug. Although the ENHANCE study ended in
May 2006, a partial reporting of negative
results did not occur until January 2008.
Complete results were not published until
the following April.
Prior to the release of the negative study
results, Vytorin had been heavily promoted
in direct-to-consumer advertising.
Among the injunctive terms that now apply
to Vytorin and Zetia are requirements to:
-
Obtain pre-approval from the FDA for all
direct-to-consumer advertisements;
-
Comply with FDA suggestions to modify drug
advertising;
-
Register clinical trials and post their
results;
-
Prohibit the “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
multi-state investigation was led by Oregon.
New Jersey was part of an investigatory Executive
Committee that also included Attorneys General
from Arizona, California, Florida, Illinois,
Ohio, Pennsylvania, South Carolina, Texas
and the District of Columbia.
Other states participating in today's agreement
include: Arkansas, Colorado, Delaware, Hawaii,
Idaho, Iowa, Kentucky, Louisiana, Maine, Massachusetts,
Michigan, Mississippi, Missouri, Montana,
Nebraska, Nevada, New Mexico, North Carolina,
North Dakota, South Dakota, Tennessee, Vermont,
West Virginia, Washington, and Wisconsin.
Deputy
Attorneys General Cathleen O’Donnell
and Alina Wells, assigned to the Consumer
Fraud Prosecution Section within the Division
of Law, represented the state in this investigation.
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