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Context of 'April 1996-July 1996: Parke-David Sales Reps Instructed to Market 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

Fearing increased public concern over the safety of Vioxx, Merck sends its sales representatives a bulletin instructing them in all capital letters: “Do not initiate discussions on the FDA Arthritis Advisory Committee… or the results of the… VIGOR study.” The previous day, an FDA panel (see February 8, 2001) reviewed the results of the VIGOR study and said physicians need to be informed that Vioxx appears to cause “an excess of cardiovascular events in comparison to naproxen.” The Merck bulletin provides a list of responses that its representatives are authorized to use in addressing physicians’ concerns. It emphasizes that these are the only responses they are allowed to use. If doctors ask about Vioxx’s effects on the heart, sales persons should say, “Because the study is not in the label, I cannot discuss the study with you.” However, as a report by Henry A. Waxman notes, drug company representatives are permitted by FDA regulations to discuss safety concerns even when those concerns are not on the label. The sales persons are also advised to tell physicians to submit their questions in writing to Merck’s medical services department. Merck says reps can also show the physicians the Cardiovascular Card, a pamphlet consisting of data that appears to show that Vioxx is safe (see April 28, 2000). The bulletin indicates that sales reps are not supposed to leave the pamphlet with the doctor. [Merck, 2/9/2001 pdf file; Office of Representative Henry A. Waxman, 5/5/2005, pp. 22 pdf file]

Entity Tags: Merck

Timeline Tags: US Health Care

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

A survey of 483 physicians by GfK Market Measures finds that one-third feel drug company sales representatives are “too aggressive or pushy.” Roughly an equal percentage says that many reps are “not knowledgeable.” One general practitioner tells GfK, “It’s silly that a highly trained sales force does not know what their product is used for and they have to ask me.” According to the survey, drug companies Pfizer and Merck are considered by doctors to have the most effective marketing teams. Abbott Laboratories’ sales force is rated as the least effective. [CNN, 9/14/2005]

Entity Tags: GfK Market Measures, Merck, Abbott Laboratories, Pfizer

Timeline Tags: US Health Care

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