Direct to Consumer Advertising (or DTCA) is an unmitigated disaster. The United States is the last nation in the world to allow this (New Zealand tried it, and is now going to ban it again after drug expenditures increased exponentially).

Basically, DTCA is what allows drugmakers to make those ads you see on the TV all the damn time that encourage everybody to take their drugs, whether they need them or not. It has been a disaster, with spending on prescription drugs increasing exponentially in this country every year since it was legalized during the Clin-ton administration. Without these advertisements, drugs might actually be prescribed based on need. No one would take that worthless scam drug Nexium (it's just omeprazole, which is over the counter, but Nexium is 8x more expensive) without DTCA. Disease mongering, as exposed by PLoS, wouldn't be nearly as big a problem, and we probably wouldn't be getting bankrupted trying to pay for old folks' drugs via medicare. If drug companies are spending more on advertising than they do on R&D (which they are), then we've got a problem.

Now the NYT reports on the Institute of Medicine's study on failures at the FDA and they come to the same conclusion. They don't outright say that DTCA should be banned, but they are advocating stricter limits on advertising of prescription drugs as well as some other excellent common-sense suggestions.

The report's conclusions are often damning. It describes the Food and Drug Administration as rife with internal squabbles and hobbled by underfinancing, poor management and outdated regulations.

"Every organization has its share of dysfunctions, unhappy staff members and internal disputes," the report said. But panel members said that they were deeply concerned about the agency’s "organizational health" and its ability to ensure the safety of the nation’s drug supply.

The report made these recommendations, most of which would require Congressional authorization:

1. Newly approved drugs should display a black triangle on their labels for two years to warn consumers that their safety is more uncertain than that of older drugs.
   
   
2. Drug advertisements should be restricted during this initial period.
   
   
3. The F.D.A. should be given the authority to issue fines, injunctions and withdrawals when drug makers fail - as they often do - to complete required safety studies.
   
   
4. The F.D.A. should thoroughly review the safety of drugs at least once every five years.
   
   
5. The F.D.A. commissioner should be appointed to a six-year term.
   
   
6. Drug makers should be required to post publicly the results of nearly all human drug trials.

The sad thing is that, consistent with Give Up teachings, it took a disaster to bring people around to the necessary reforms. Namely, Vioxx and the other Cox-2 specific inhibitors which have never been shown to be better pain relievers than classic NSAIDs, and have never been shown to be of great benefit in preventing ulcers! I remember in medical school being taught the basis of the theory, that a Cox-2 specific inhibitor should be more gentle on the lining of the stomach, but the clinical trials have never demonstrated that this effect is as strong as one would expect. The marketing, however, pushed these drugs into the mainstream, despite damage to the stomach being a relatively rare event (<5%) and the specific inhibitors showing, at best, a modest improvement in avoiding this side effect of NSAIDs.