I'll start this evening with an excerpt from the Wall Street Journal. I haven't a link, since it's a pay site. Suffice to say that it's the best newspaper in the world, and I highly recommend a subscription to anyone.
Amid recent worries that some impotence drugs could be associated with vision loss in rare cases, there were predictable suggestions that this information be added to the pills' instructions....But the directions, also called package inserts or labels, have become so bloated and poorly organized that
they often obscure the facts that would be most useful....A government
proposal to make the labels more useful has been in the works since 2000,
long before the recent controversies over safety problems with
antidepressants and arthritis drugs. ''We are working on a final rule now
and don't have a time frame at this point for its completion,'' an agency
The notorious package insert. Long, tedious, meaningless? This article is important, because it clearly describes who the insert is written for - lawyers. It's a giant CYA, with contradictory messages. If the company neglects to put something in the label that they have data for, it's a warning defect, in legalese. But regardless of what they put in, they always preface the list of nasty effects with "regardless causality." So, we've warned you, but we're not saying if we think our drug did it. What a ridiculous method of trying communicate important information to physicians.
Frist vs the WLF?
Bill Frist has gone on record urging drug companies to refrain from DTC in the first two years of a drug's life in the market.
Frist warned that the flurry of consumer advertising that often accompanies
launches of new drugs can lead to inappropriate prescribing and unnecessary
health care spending. He said he is asking the Government Accountability Office
(GAO) to review the Food and Drug Administration's oversight of prescription
drug ads, the drug industry's drug ad spending, and its effect on drug
utilization and health care spending.
This is slightly astonishing, and quite welcome. The last Senator we heard discussing the dangers of DTC was Kennedy. Frist also questioned DTC's role in overprescribing, with deleterious health consequences. Clearly, Frist has wandered off the reservation here, as the article continues to give an opposing viewpoint from PHARMA. Again, no link here, as this was taken from an article from the Bureau of National Affairs, and you need an expensive subscription. DTC is absolutely huge in the first few months of a drug's lifecycle, because everyone is looking at the sales curve for the launch period. The sharpest uptick is always in the first year, and if you don't get the utilization you want during that period, you might never.
But wait, Bill - your Republican anti-trial lawyer free speech buddies probably don't agree with you! According the Washington Times, and the Washington Legal Foundation's own website, DDMAC is already violating the law when it comes to regulating the "free speech" of drug advertising. I admit that DDMAC can be somewhat capricious with these DTC matters. I've got a good story about that, for another time. But the WLF clearly wants to pave the way for drug companies to say whatever they want about their drugs, without any interference, as a matter of right under the First Amendment. I've said it before - my copy of the Constitution and Bill of Rights keeps talking about people, and doesn't contain the word "corporation" or "company" in it. In fact, there's only one reference to "property" at all, and it's the government's property. Where's a strict constructionist when you need one?