Saturday, June 11, 2005

How Johnson & Johnson Marketed Propulsid

The NY Times reported on the events leading up to Johnson & Johnson's withdrawal of Propulsid, based on documents made available by related lawsuits. Propulsid was withdrawn from the market after its use was related to serious cardiac rhythm disturbances.
MedRants commented on the story here, saying " we cannot rely on Big Pharma to tell us the truth about efficacy or side-effects. Yet we need the truth." MedRants was then taken to task by a commentator who asserted (here) that doctors continued to prescribe Propulsid despite warnings that were eventually added to its label, and hence "we have no room to complain that we weren’t given the truth."
In this case, as in many others within our dysfunctional health care system, "we have met the enemy and he is us." Doctors have often been far too enthuisiastic about particular treatments, whether pharmaceutical or procedural. I would like to think that most of this time this over-enthusiasm comes from their fervent wishes to make their patients better. Maybe physicians would make more realistic treatment decisions were they to be better educated about evidence-based medicine (EBM). Although doctors also must shoulder some blame for resistance to EBM, there has been little support for its dissemination from the many large organizations, including pharmaceutical manufacturers, managed care organizations, and academic medical centers who have publicly endorsed it.
Nonetheless, there is also reason to complain, in my humble opinion, about how truthful Johnson & Johnson was in its marketing of Propulsid. Johnson & Johnson had failed to prove efficacy of the drug in children, and its label did not include use in children.
However, according to the NY Times, the company paid to distribute 10,000 copies of a pediatric gastroenterology text-book that recommended Propulsid for children; had the text's author address a company seminar meant to train other doctors to talk about the drug; and financed a support group for parents with children with gastrointestinal diseases while that group's focus shifted to gastro-esophageal reflux disease (GERD), and while that group actively promoted Propulsid to treat this common, and usually not very serious condition.
So, the Times' summary seems reasonable: "It is a story that has particular resonance now, as troubled arthritis painkillers - Vioxx, Celebrex, and Bextra - have again focused attention on what critics say is the federal Food and Drug Adminstration's inability to monitor and regulate pharmaceuticals effectively once they are on the market. "

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