Sham Neurontin Study was Designed to Boost Prescriptions

Despite increased attention focused on pharmaceutical industry conflicts of interest over everything from excessive perks and inappropriate marketing tactics, fishy marketing programs continue to be unearthed.

The MinnPost reports that, based on an article just published in the Archives of Internal Medicine, significant 1995 research of Neurontin (gabapentin) was never meant to look into the drug’s safety and efficacy. The trial, despite how Parke-Davis spun it at the time, was actually a so-called “seeding trial” that was meant to prompt more doctors to prescribe the anti-seizure medication.

According to MinnPost, Parke-Davis—which is, today, a subsidiary of Pfizer—enlisted 772 neurologists into its Phase IV clinical trial STEPS. STEPS—“Study of Neurontin: Titrate to Effect, Profile of Safety”—was to, allegedly, determine appropriate <"http://www.yourlawyer.com/topics/overview/neurontin">Neurontin dosing, or so Parke-Davis told the doctors and the IRBs (institutional review boards).

The authors of the Archives of Internal Medicine report point out, however, that the clinical trial was not well designed, for instance, they said, the trial was uncontrolled and unblinded, said MinnPost. And, while the study design raised some concern—for instance, with a Johns Hopkins University IRB—the study was allowed to proceed unfettered, noted the MinnPost. Despite the flaws, Parke-Davis was unconcerned, which, said the MinnPost, was obvious based on the drug maker’s internal documents which point to how Parke-Davis was more worried about how the drug influenced physicians and their prescribing habits versus how Neurontin worked on patients.

The MinnPost reports that every step of the Parke-Davis’ trial was about how the drug maker could increase sales and recruit patients. “Company representatives were encouraged to ask site investigators to institute ‘Shadow Days,’ during which patients with epilepsy would make up the bulk of the clinic day’s schedule, permitting representatives to be present and encourage patient enrollment while simultaneously promoting gabapentin,” said the article’s authors, quoted MinnPost. “The company also suggested offering promotional rewards to achieve enrollment goals. For example, company sales representatives rewarded some investigators for achieving specific recruitment milestones; physicians were given a free lunch after recruiting 3 patients and a free dinner after 7 patients,” the report added.

Parke-Davis’ program was an immediate success. After the group attended just a preliminary meeting about STEPS, Neurontin prescriptions increased by 38 percent and individual dosing by about 10 percent, noted MinnPost. But, patients were not advised that doctors were receiving recruitment rewards, which has some wondering if patients actually received true informed consent.

Meanwhile, in 2004, Pfizer paid a massive $430 million in criminal fines and penalties for how it illegally marketed gabapentin for nonFDA-approved uses, including for migraines and pain.

This all highlights what we’ve long been stressing, that the financial relationships between the drug and medical device industries and the health care industry have led to enormous controversy and beg questions concerning conflicts of interest, patient safety, and drug and device efficacy. Critics maintain that relationships rife with such conflicts of interest could unduly influence everything from research findings to prescribing practices.

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