Never enough safety

Today's issue of the New England Journal of Medicine includes a call to step FDA control of direct-to-consumer pharmaceutical advertising up from regulations to a moratorium, as Yahoo! News reports.

Said study author Julie Donohue, "For the majority of heavily advertised drugs, direct-to-consumer advertising starts within about a year of FDA approval and typically well before the safety profile has been established," expressing concerns that consumers should not be exposed to promotional information in the absence of enough safety information.

But what is "enough" safety information? The FDA already requires years' worth of clinical trial data before it will approve a drug for sale, and that includes the collection of safety data, sometimes from thousands of patients. Vioxx, a frequently-denigrated example cited by the study authors, did not reveal any increased risk of cardiovascular events until years after it was approved -- that is, years after even more years of safety data had already been collected. (Incidentally, some clinical investigators now believe that the increase in cardiovascular problems may not have been attributable to Vioxx, but rather to other risk factors, such as obesity, that had nothing to do with the drug. If that's the case, the persecution of Merck has been truly unconscionable.)

Drug companies are not omniscient. The scientists who develop a therapeutic compound cannot be expected to know what its effects will be, decades into the future. So why is it right to muzzle the makers of potentially lifesaving drugs, trampling on their rights to free speech, until every last watchdog group is sure there is no risk? Why can't pharmaceutical companies be allowed to advertise their products freely, knowing that if they are in fact claiming a product is safe when the data has proven otherwise, they can be prosecuted for fraud? And why are consumers treated as too stupid to be told anything about what they are buying?

The fact is, it's the right of drugmakers to advertise their products using whatever non-fraudulent language they choose, and it's the right of consumers to buy those products if they like, without the control of a nanny state seeking to prevent "overuse" of drugs.

And I'll simply note without comment: The New England Journal of Medicine hardly seems to be complaining about ads for doctors. I wonder why?