Neurontin, manufactured by Pfizer subsidiary Parke-Davis, is a medication originally developed for the treatment of epilepsy. It was approved by the FDA in 1994, and in 2002 an indication was added for the treatment of neuropathic pain. Neurontin has also been used in treating bipolar disorder, a use not approved by the FDA.
Over the past decade, off-label prescribing has become a serious problem. Upon the approval of a drug, the FDA also approves the labeling for the drug which details the manner in which the medication is to be used. It is against the law for a pharmaceutical company to promote a drug for uses outside of the approved labeling. Pfizer has come under heavy criticism for its off-label marketing of Neurontin. In 2004, Warner-Lambert pled guilty to felony charges and paid more than $430 million to resolve the charges regarding the off-label marketing of Neurontin.
Pfizer is currently involved in litigation regarding Neurontin in federal court in Massachusetts. Documents released in October suggest that Pfizer manipulated the publication of scientific studies to boost sales by altering or declining to release the conclusions of studies that found no beneficial effect from the drug for off-label conditions. Experts concluded that Pfizer delayed the publication of studies that found no evidence Neurontin worked for other disorders, spun negative data to place it in a more positive light, and bundled negative findings with positive studies to neutralize the results. Dr. Kay Dickersin, one of the experts who reviewed the documents, concluded that the documents reveal a publication strategy meant to convince physicians of the drug’s effectiveness and misrepresent or suppress negative findings.
Pfizer denies any wrongdoing and issued a statement denying that it manipulated the data. Pfizer contends that off-label promotion began before acquiring Parke-Davis through its acquisition of Warner-Lambert in 2000. Neurontin has been one of Pfizer’s best selling drugs and was one of the 50 most prescribed drugs in the United States in 2003. Despite generic competition, it remains a strong seller. Sales have been about $12 billion since 2000. According to some estimates, off-label prescriptions account for approximately 90% of Neurontin sales.
Source: New York Times
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