Off Label Prescribing and FDA Approval

According to an article in the New York Times, many doctors don’t even know when they are off label prescribing.

Yes, alright. Let’s back up a little bit. What is off label prescribing? Off label drug use takes place when a drug is used to treat an illness the Federal Food and Drug Administration hasn’t approved it for use in treating.

The average physician in the survey identified the F.D.A. approval status correctly for only about half the drugs on a list provided by the researchers, according to a study in Pharmacoepidemiology and Drug Safety.

Confusion was greatest with psychiatric drugs, the survey of some 600 doctors found. Nearly one in five who prescribed Seroquel (quetiapine) in the previous year thought it was approved for patients with dementia and agitation, even though it was never approved for this use and even carried a “black box” warning that it was dangerous for elderly patients with dementia. And one in three doctors who used lorazepam (often marketed as Ativan) to treat chronic anxiety thought it had been approved for this use; in fact, the F.D.A. warning advises against using it for this purpose.

The study’s senior author, Dr. G. Caleb Alexander, assistant professor of medicine at the University of Chicago, said a concern was that off-label uses often did not have the same level of scientific scrutiny as F.D.A.-approved uses.

I’ve been complaining about the F.D.A. approving drugs for use that it shouldn’t be approving, and here’s a study that says most doctors don’t even know what those drugs are for treating that have been approved by the F.D.A.

Using Seroquel, an antipsychotic, on elderly patients suffering from dementia is not something I would recommend. Antipsychotic drugs have been known to shorten the span of life elderly patients given them have. Despite the fact that some facilities typically prescribe such drugs to elderly patients, and thus shorten what time they have left, I’d say it is definitely not a good idea to do so.

With regard to Ativan, you might as well give your patient a couple of bottles of beers, or a couple of glasses of wine. These drugs have an effect on people similar to that you get from alchoholic beverages. As alchohol is not likely to have lessening effect on any dementia an elderly person might be suffering from, perhaps this is not the best course of action to take.

Doctors don’t know what they’re doing. Okay, granted. By contrast the Federal Food and Drug Administration knows what it’s doing. It’s increasing drug company profits, and promoting the quackery and power of the psychiatric profession. That it may be harming a whole bunch of people along the way is seen as a relative small price to pay for this boost in prestige that goes to the privileged. That this price may be rising can be ignored as long as it’s a health price other’s pay while doctors and drug companies profit economically.

What else do we get out of this development? Well, for one thing, we get those horrible direct to consumer advertisements. The F.D.A.’s approval for uses that would otherwise be off label brings these in. You may not have snake oil salesmen and women on your television set, but you might as well have them as you have advertisements for antidepressants that work no better than sugar pills. On top of this, we have advertisements for powerful and dangerous antipsychotic drugs such as Seroquel and Abilify on our computer screens and television sets. They have been approved by the F.D.A. for other uses than those for which they were intended, and thus you can see what the problem is.

Are these drugs actually so much better for treating conditions other than those for which they were intended to be used, and there is some question as to whether they were even effective then, than drugs developed for that purpose? They are absolutely not any better for treating such conditions than another drug might be. Drug companies are raking in trillions of dollars, and the F.D.A. cares more about filling those company coffers, having financial ties to such companies, than it does about the health of the people these companies are, in many cases, ruining.

Maybe now you can begin to get some sort of idea as to why I would be an activist taking on this agency and those drug companies it serves, and why I would invite you to join me in doing the same. It’s an uphill journey, the one toward health and humanity, but it’s one that I would say is well worth the taking.