 In filing a joint complaint and settlement Thursday, Madigan and the other
attorneys general alleged that GlaxoSmithKline engaged in unfair and deceptive
marketing practices when it misrepresented the safety of Avandia and the effects
it would have on a patient's cholesterol levels and cardiovascular health.
Madigan and the other attorneys general alleged the company promoted Avandia
using false and misleading representations on the safety of the drug for
diabetic patients. The attorneys general also alleged GlaxoSmithKline lacked
scientific evidence to back up its claim that Avandia would lower a patient's
cholesterol and falsely promoted the drug's cardiovascular benefits, when
Avandia may instead increase a patient's cardiovascular risks.
"Our investigation demonstrated that GlaxoSmithKline had little regard for
the facts or for the health and safety of the patients it targeted with its
misleading marketing," Madigan said.
As part of the settlement, GlaxoSmithKline will
reform how it markets and promotes diabetes drugs. The company is prohibited
from:
-
Making false, misleading or
deceptive claims about diabetes drugs.
-
Making safety claims not
supported by substantial evidence or substantial clinical experience.
-
Presenting favorable
information on drugs that have been proven invalid.
-
Promoting drugs before they
have received approval from the U.S. Food and Drug Administration.
-
Misusing statistics or otherwise misrepresenting
the nature, applicability or significance of clinical trials.
[to top of second column] |
Under the settlement, for a period of at least eight years,
GlaxoSmithKline must post summaries of all company-sponsored
observational studies and company-sponsored clinical trials of
diabetes products. GlaxoSmithKline must also follow requirements
under federal law on registering and posting such clinical trials
and must comply with uniform requirements of the International
Committee of Medical Journal Editors for manuscripts submitted to
biomedical journals.
The investigation was led by Madigan and the Oregon attorney
general's office. Also participating in the settlement are attorneys
general in Alabama, Alaska, Arizona, Arkansas, California, Colorado,
Connecticut, Delaware, the District of Columbia, Florida, Hawaii,
Idaho, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan,
Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, North
Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island,
South Dakota, Tennessee, Texas, Vermont, Washington and Wisconsin.
[Text from file received from the office
of
Illinois Attorney General Lisa
Madigan]
 |
