North County Gazette- March 14, 2011
NEW YORK—-The state Attorney General’s office has reached a $3.1 million settlement with the major pharmaceutical company AstraZeneca following allegations that it improperly marketed and promoted the antipsychotic drug Seroquel.
These practices violate consumer protection laws established to protect patients and ensure that health care providers are fully briefed on the medications available, including all known potential benefits and side effects.
It had been alleged that AstraZeneca engaged in deceptive and misleading practices when it marketed Seroquel for unauthorized, or “off-label,” uses and failed to adequately disclose the drug’s serious potential side effects to health care providers, including hyperglycemia and diabetes mellitus.
Seroquel is approved for the treatment of schizophrenia, certain instances of bipolar disorder and depressive episodes associated with bipolar disorder. When it was first introduced to the market in the 1990s, experts thought that it would be less likely to produce Parkinson’s type symptoms and motion disorders such as tardive dyskinesia, and therefore could be used in long-term treatment of schizophrenia. However, while Seroquel may reduce the risk of these symptoms, it also produced dangerous side effects, including hyperglycemia and diabetes.
New York’s investigation demonstrated that AstraZeneca concealed and minimized the risks of these side effects. AstraZeneca also marketed Seroquel for off-label and potentially dangerous uses including pediatric use, for use at high dosage levels, for the treatment of symptoms rather than diagnosed conditions, and to treat dementia and Alzheimer’s Disease in the elderly.
Following the Attorneys General’s investigation, AstraZeneca agreed to change its marketing of Seroquel and to cease promoting off-label uses of the drug, which are not approved by the U.S. Food and Drug Administration (FDA).
The settlement, filed in state court, also contains powerful injunctive terms prohibiting the use of financial incentives to manipulate doctors, deterring off-label marketing and requiring that AstraZeneca disclose scientific evidence of dangerous side effects.
In addition, the settlement requires AstraZeneca to provide accurate, objective and scientifically balanced responses to requests for off-label usage information. AstraZeneca must also have policies in place to ensure that financial incentives are not given to marketing and sales personnel for off-label marketing and that sales personnel do not promote to health care providers who are unlikely to prescribe Seroquel for an FDA-approved use.
*In addition to New York, attorneys general of the following states and the District of Columbia participated in the settlement: Arizona, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, Maryland, Maine, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.