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Pharma set up 1995 Neurontin "study" to sway participating neurologists


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The 772 neurologists who thought they were hired to conduct this "study" actually were selected targets of drug company persuasion. This revealed by Pfizer trial for promotion of off-label prescription of Neurontin. A similar marketing effort was conducted for Merck's Vioxx. Can these be the only two times pharma played researchers for fools?


A Neurontin Study Was Really A Seeding Trial


Ed Silverman, Pharmalot June 27, 1011


A 1995 study that was ostensibly designed to assess the safety, efficacy, tolerability and quality of life among Neurontin patients was actually a thinly disguised seeding trial, according to an article in The Annals of Internal Medicine. The finding is one of the rare instances in which evidence of a seeding trial - an industry term for a study designed for marketing purposes - has been uncovered. The last example involved a study for the Vioxx painkiller that was withdrawn by Merck (see this).


Ostensibly, the Neurontin study was supposed to evaluate titration for the widely prescribed anti-epileptic, which was the focal point of an off-label marketing scheme by Warner-Lambert and its Parke-Davis unit, now owned by Pfizer. In 2004, the drugmaker paid $430 million in criminal fines and civil penalties and pleaded guilty to two felony counts for marketing the pill for unapproved uses.


The authors of [The Annals of Internal Medicine paper] argue that the .... true purpose [of the study] was to encourage [the] 772 neurologists who participated as investigators, to more readily prescribe Neurontin. And the documents they reviewed, which were from Neurontin litigation, indicate Parke-Davis examined the impact that participation had on prescribing and dosing by physicians. For instance, prescribing rose 38 percent after physicians attended a STEPS briefing.


They also found the trial was poorly designed - it was uncontrolled and unblinded .... an official from the FDA’s Division of Medical Marketing, Advertising and Communications was referred to in an internal memo as saying the trial was useful from a marketing perspective, but not needed to acquire info about the highest dose.



The authors maintain the episode underscores that seeding trials undermine informed consent principles, since patients are not aware of true marketing objectives. In this instance, physicians were also unaware, which constitutes an ethical breach, as did free lunches to physicians who recruited a certain number of patients. ....


....of 2,759 patients, ....11 died, 73 suffered severe adverse events and 997 experienced less serious side effects, “suggesting patients were at more than minimal risk,” according to the authors, two of whom are paid consultants to the plaintiffs in the Neurontin litigation; a third is an unpaid consultant (here is a link to the paper in the Annals of Internal Medicine).


One of the authors of the paper notes that Pfizer had marked the STEPS document as confidential and initially refused to make them available....


View the full article

This is not medical advice. Discuss any decisions about your medical care with a knowledgeable medical practitioner.

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