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Context of '1996-2000: Parke-Davis Launches Marketing Campaign to Promote Off-Label Uses for Neurontin'

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Warner-Lambert launches a new campaign to aggressively promote its epilepsy drug Neurontin. To boost the drug’s sales, the company begins marketing the drug for uses that have not been approved by the FDA. (While it is legal for doctors to write prescriptions for “off-label” uses, drug companies are prohibited from promoting such uses.) The company’s discreet campaign claims the drug can be used to treat pain, headaches, Lou Gehrig’s disease, attention deficit disorder, restless leg syndrome, drug and alcohol withdrawal seizures, bi-polar disorder, and other psychiatric illnesses. [New York Times, 5/15/2002; Associated Press, 8/8/2003] One marketing executive is recorded on tape telling a sales representative, “If we are going to market Neurontin effectively, we have to do it for monotherapy, for epilepsy, also for pain and bipolar and other psychiatric uses.” (Neurontin is only approved for use in conjunction with other drugs—it is not supposed to be used monotherapeutically.) Independent studies later suggest that the drug is not an effective treatment for some of those unapproved uses, and in some cases, Neurontin may even make a patient’s condition worse. Furthermore, patients may suffer if a doctor takes them off an effective medication so they can take Neurontin instead. [New York Times, 5/15/2002] The company’s marketing campaign is so effective that by 2003, 90 percent of the drug’s $2.7 billion in sales is for uses not approved by the FDA. [New York Times, 5/14/2004] In addition to the promotion of off-label use, the Warner-Lambert sale representatives are instructed to press doctors to prescribe the drug at levels higher than the FDA-approved dosage. [New York Times, 5/15/2002]
Marketing tactics -
bullet Paying doctors to write favorably about the drug. In one case the company reportedly pays $303,764 to publish a textbook on epilepsy written by Ilo Leppik, a professor at the University of Minnesota. Leppik later denies that the book was a marketing tool and says the book discussed other drugs beside Neurontin. [New York Times, 3/30/2003; Associated Press, 8/8/2003]
bullet Hiring marketing firms to help write articles favorable of Neurontin. Doctors are paid to claim authorship for the articles, which are vetted by Warner-Lambert before being submitted to a journal for publication. In one case, Warner-Lambert agrees to pay a company $12,000 per article and $1,000 to any doctor agreeing to accept authorship. [New York Times, 5/15/2002]
bullet Rewarding dozens of doctors who write a high-volume of Neurontin prescriptions with consulting or speaking contracts worth tens of thousands of dollars. By 1997, Dr. B. J. Wilder, a former professor of neurology at the University of Florida, receives almost $308,000 for speeches he gives. Six other doctors get paid more than $100,000 each. And Dr. Steven C. Schachter, a neurologist at Beth Israel Deaconess Medical Center, earns $71,477 for speaking on the drug’s off-label uses. [New York Times, 3/30/2003]
bullet Paying doctors $350 a day or more to admit sales representatives into examining rooms to meet with patients, review their medical charts, and recommend treatment. This tactic, known as “shadowing,” involves approximately 75 to 100 doctors in several Northeast states. [New York Times, 5/15/2002]
bullet Instructing sales representatives to pressure doctors to write Neurontin prescriptions for unapproved uses (see April 1996-July 1996).

Entity Tags: Parke-Davis

Timeline Tags: US Health Care

David Franklin later accuses drug company Parke-Davis of instructing its sales representatives to pressure doctors to prescribe the drug Neurontin for off-label uses. This marketing tactic is part of a larger effort aimed at increasing Neurontin prescriptions for uses not approved by the FDA (see 1996-2000). “I was trained to do things and did things that were blatantly illegal,” he says. “I knew my job was to falsely gain physicians’ trust and trade on my graduate degree.… I’d tell them we had physicians across the county, some involved in clinical trials, and others who had hundreds of patients on Neurontin, all getting an extraordinary response rate. We’d make them think everyone was using it but them.… [W]e were taking people who were moderately controlled on another drug and experimenting with Neurontin. We were gambling with people’s lives.” Franklin quits after two executives pressure him to get with the program. When Franklin tells one of them that he’s leaving, the executive warns, “I can’t guarantee what is going to happen to you or your career.” [Boston Globe, 3/12/2003]

Entity Tags: Pfizer, David Franklin, Parke-Davis

Timeline Tags: US Health Care

David Franklin, a former salesman for Warner-Lambert drug company, files a lawsuit alleging that Warner-Lambert is illegally marketing its drug Neurontin for non-approved uses (see 1996-2000 and April 1996-July 1996). Franklin also says that the company’s illegal promotion of the drug is resulting in state Medicaid programs spending millions of dollars on Neurontin for non-approved uses. [New York Times, 5/15/2002]

Entity Tags: David Franklin, Parke-Davis

Timeline Tags: US Health Care

Florida NAACP official Anita Davis begins receiving phone calls from African-American voters in Leon County, which includes the heavily African-American areas in and around Tallahassee, complaining about Highway Patrol roadblocks that are interfering with their attempts to get to their polling places. Davis calls the Highway Patrol office and is told the roadblocks are just routine traffic stops, asking motorists to show their license and insurance identification. However, given Florida’s often-ugly history of racial oppression, Davis wonders about the timing and nature of the roadblocks. “It’s odd for them to be out there on Election Day,” Davis says. “It just doesn’t smell right.” Davis and fellow NAACP officials soon conclude that the Highway Patrol is attempting to interfere with black citizens’ attempts to vote. [Tapper, 3/2001]

Entity Tags: Anita Davis, National Association for the Advancement of Colored People, Florida Highway Patrol, County of Leon (Florida)

Timeline Tags: 2000 Elections, Civil Liberties

Pfizer pleads guilty and agrees to pay $430 million to settle criminal and civil charges that Warner-Lambert, a company it acquired in 2000, marketed its epilepsy drug, Neurontin, for non-approved uses (see 1996-2000, August 1996, and April 1996-July 1996). [New York Times, 5/14/2004]

Entity Tags: Pfizer, US Department of Justice

Timeline Tags: US Health Care

Javal Davis.Javal Davis. [Source: Jana Birchum / Getty Images]During a pre-trial hearing for Sgt. Javal Davis held at a US military tribunal in Mannheim, Germany, Judge Col. James L. Pohl denies a motion by Davis’ attorney to have Rumsfeld testify. Pohl says the defense failed to link the actions of the accused with Rumsfeld’s orders and actions. [CNN, 8/24/2004] Davis will eventually be convicted and sentenced to six months in prison (see May 19, 2004-March 22, 2006).

Entity Tags: Javal Davis, James L. Pohl, Donald Rumsfeld

Timeline Tags: Torture of US Captives

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