Journalist Merrill Goozner, on his blog, calls “attention to some of the complexities that underscore why the FDA’s draft 'Guidance for Industry for Labeling for Outcome Claims for Drugs to Treat Hypertension,' which will be discussed (this) week by the Cardiovascular and Renal Drugs Advisory Committee, is such a curious document. It isn’t so much that it is wrong. It’s what it leaves out and, more importantly, what it puts in that makes one wonder if the agency has sold its soul to the drug industry. …
The medical literature is filled with industry-funded studies that measure the antihypertensive effects of specific agents on patients that have other problems like kidney disease or peripheral arterial disease. These trials, which are sometimes referred to as ‘seeding trials,’ are a way to highlight one drug within this crowded field by getting articles about it published in specialty journals. If the FDA allows these trials to be included on labels, it allows drug detailers to mention that ‘benefit’ to physicians. In essence, it puts the FDA imprimatur on some of the most abusive sales tactics in today’s pharmaceutical marketplace.
Some might argue this is only guidance. Companies don’t have to follow it. Physicians and patients don’t read labels anyway. All true.
But the savvy marketing arms of the major drug companies know what’s at stake. Combine a failure to distinguish between drugs with the right to put the misleading claims of seeding trials on labels and what you’ve given them is a blank check to suggest their pricey patented drugs are superior to generic diuretics, even though the government guidelines say just the opposite. The net effect of this Guidance could be a huge setback for public health and the public purse.�
Posted by schwitz at April 24, 2006 06:54 AM | TrackBack