Increasing Government Oversight Of IRBs Could Help Prevent Seeding Trials
I thought I read the final chapter in the tale of Pfizer’s shady marketing practices for Neurontin years ago. Sadly, there’s at least one more chapter to go.
Recall that in 2008, leaked documents from a US District Court revealed that Pfizer had covered-up the results of a clinical trial which showed the drug didn’t work for chronic nerve pain, even as it promoted off-label use of the anti-seizure drug for that purpose. The next year, it was revealed that Parke-Davis (now a subsidiary of Pfizer) took advantage of lax disclosure policies by certain medical journals to publish 13 articles promoting off-label use of Neurontin that were ghostwritten and funded by the company without disclosing such arrangements.
Now, it has come to light that Parke Davis’ marketing department sponsored a Seeding Trial of Neurontin back in the day—that is, a trial portrayed deceptively as a patient study but whose real aim was to encourage prescribers to use the drug.
The trial was STEPS, the ‘Study of Neurontin: Titrate to Effect, Profile of Safety’ trial. More than 772 physician ‘investigators’ and 2800 patients participated in STEPS.
The stated objective of STEPS was to study the safety, efficacy and tolerability of Neurontin. However, after reviewing documents compiled for a pair of lawsuits against Pfizer and its subsidiaries, Joseph Ross and colleagues concluded that the actual objective was to increase prescribing rates by ‘investigators’ in the study. Neither the ‘investigators’ nor their patients were informed about the real purpose of STEPS.
The trial worked, from Parke-Davis’ point of view. Read more »
*This blog post was originally published at Pizaazz*
You are sick with something-or-other and your doctor writes you a prescription for a medication. She briefly tells you what it’s for and how to take it. You go to the pharmacy, pick up the medication, go home and follow the instructions, right? I mean, how hard could it be?
Some drugs have to be taken at specific times or under specific conditions, posing little challenge when you are taking only one. But it can be devilishly difficult to coordinate the green pill half an hour before breakfast, the yellow ones on an empty stomach four times a day and the orange one with a snack between meals. It’s complicated; we don’t understand. We’re busy; we forget. We’re sick; it’s confusing.
