A Shot In The Kidney
2 CommentsBy Ed Silverman // March 20th, 2007 // 10:49 am
When is an FDA warning not really a warning? When an industry-funded doctors’ group says so.
The Renal Physicians Association is urging its members to be cautious about an FDA warning issued last week that anemia treatments made by Amgen and Johnson & Johnson’s Ortho Biotech unit could increase the risk of death, blood clots, strokes and heart attacks in patients with chronic kidney failure, when given in high doses.
The non-profit, which receives funding from Amgen, J&J and other drugmakers, released a statement calling the advisory potentially “misleading” and says that some of FDA recommendations ‘only partly’ apply to chronic patients. The group is encouraging doctors to make treatment decisions on a case-by-case basis, because the warnings could cause ‘considerable confusion among kidney patients and the kidney community.’
Hmm….What else might cause considerable confusion? Maybe a lack of clarity on just who the organization represents - doctors or corporate patrons. So here’s a cautionary statement for the Renal Physicians Association - next time a press release is issued, disclose all that patronage. And please don’t be so quick to pooh-pooh bad news for your patrons. It isn’t very professional.
The FDA statement.
The letter from the Renal Physicans Association.
The group’s web site.
Hat tip to the Center for Science in the Public Interest[tags]Amgen, Aranesp, Epogen, Johnson & Johnson, Ortho Biotech, Procrit[/tags]
Melody
Ed,
Isn’t this another CYA case. If a doctor should admit that he has prescribed a medication that subsequently proves harmful, or at least the formerly-recommended dosage may be harmful, doesn’t he open himself up for litigation? Unfortunately, I believe this is happening much more often than is reported, e.g. genetically engineered insulin. CYA seems to be the operative mandate for both pharma and (many) physicians. And yet there is astonishment that Americans view both with ever-increasing cynicism? Hmmmmm?
ed
Well, since I’m not an attorney, I don’t know that I have a definitive answer. But I would imagine the FDA statement carries more weight than the RPA, since the organization is nothing more than a professional society to which membership isn’t required.
On the other hand, you raise a good point, because the group’s missive could always be introduced as evidence in the sort of scenario you suggest. On that basis, perhaps, the RPA statement may serve that sort of purpose.
ed