Is off label use woo?

[Dancing David]

There is the flip side to off-label use. Drug reps for awhile were touting and promoting off label indications for some of their products. However, this turned out to be disaterous for one drug (can't remember the one, and which company was guilty: I think astra zenica)
There is the flip side to off-label use. Drug reps for awhile were touting and promoting off label indications for some of their products. However, if an off label indication results in unacceptable incidences of health effects that wouldn't be approved by FDA, this can be disasterous for the drug manufacturer. (I think this actually happend for a drug, but I can't remember which one).

Anyway, drug reps are barred from promoting ANY use that is specifically approved by the FDA. However, the Dr. is still free to read literature and use medications as best he/she sees fit. This just means that the Dr. bears full responsibility if there is a terrible or unexpected side effect.



related link: http://www.insidecounsel.com/issues/insidecounsel/3_circuit/

I have heard many a drug rep say the following

"There are a lot of doctors that find this to be effective. I can't say that it is but i will tell you they say it is. Almost a miracle."

 

[fuelair]

What drugs are prescribed for things they have not been studied for? Isn't this illegal?

Not studied for is not exactly correct, usually people who have a condition the drug is for also have others. If they begin noticing that the drug prescribed seems to be hurting or helping another condition, doctors (particularly specialists) who treat a number of the people with that condition set will be reporting it to appropriate agencies. That establishes a basis for starting tests for the fully approved use (or no further use, as appropriate) AND some doctors - particularly with patients most in need of possible relief- will begin prescribing it for the off-lablel use (for example, Accompli [rimonobant] is an excellent and safe drug for diet purposes but it also -off label use - is excellent for reducing cravings for nicotine).

 

[ponderingturtle]

Part of what got me thinking on this is that really Chelation to treat say autism is an off label use.

 

[blutoski]

I was not aware that there could be real studies demonstrating effectiveness, and have it considered off label.

But the point does stand to an extent, what about when a medication is used for something it has not been tested for, because of reports of effectiveness at treating such a condition? Is this really evidence based medicine, as it has all the problems with bias that a naturopath would have.

Basically I am having problems resolving these issues with the general claims about evidence based medicine, when there are drugs prescribed based on anecdote. Now I understand more that off label encompasses more than this though.

I was confused by it at first, too. Here's where I discovered I was missing a piece of the puzzle: the manufacturer gets to decide what he wants the product to be approved for. He doesn't get to decide what researchers show works.

Some drugs treat multiple illnesses, proven by research they may or may not have funded. Nevertheless, a manufacturer may only choose to seek approval for one benefit per drug.

There are two reasons for this:

1. the manufacturer may already have drugs for the other illnesses, and they don't want to cannibalize their sales

2. the manufacturer may want to extend their patent-control of the drug by getting it approved for the first illness, then x years down the line, get it approved for the next illness, and so on.

Dancing David had a good example with atypicals used as mood stablizers. Why give the psychotic with depression a second drug for the mood disorder? It would seem to be unnecessarily increasing the side effects without significant increase in benefit.


When a doctor writes a scrip for an off-label, he should be doing so based on scientific research (as opposed to the manufacturer's marketing dpt). That's one reason it's legal in most jurisdictions: patients appear to be better served by the scientific literature than by the patent/licencing legalities.

In some cases, off-label use is explicitly approved by medical colleges, and can be considered a standard of care.

Where off-label prescription is inappropriate is when the MD has made a bad judgement call, and the scientific literature does not in fact support the solution prescribed. This is usually identified as an MD who flaunts the policy or standard of care papers, published by his college.

 

[blutoski]

Part of what got me thinking on this is that really Chelation to treat say autism is an off label use.

Yes, that's a good example.

It's not a bad idea strictly because it's off-label: it's a bad idea because the research on the subject was either absent (in the past) or (now) contrary to its effectiveness.

There is a difference between prescribing off-label for a condition that has good literature behind it

versus

prescribing off-lavel for a condition that the drug has either never been tested against (in which case, this is a medical experiment) or for a condition that the drug is known to be ineffective against (in which case this is blatant malpractice).

 

[ponderingturtle]

Yes, that's a good example.

It's not a bad idea strictly because it's off-label: it's a bad idea because the research on the subject was either absent (in the past) or (now) contrary to its effectiveness.

There is a difference between prescribing off-label for a condition that has good literature behind it

versus

prescribing off-lavel for a condition that the drug has either never been tested against (in which case, this is a medical experiment) or for a condition that the drug is known to be ineffective against (in which case this is blatant malpractice).

But before this thread I did not quite understand how something can be proven effective but still be an off label use.

 

[DRBUZZ0]

But before this thread I did not quite understand how something can be proven effective but still be an off label use.

I can think of one example which my doctor prescribed a drug for. I was given a prescription for an anti-allergy drug because I had skin hives. The drug was relatively new and was labeled for use for nasal and respiratory allergies and was not actually indicated for skin allergies.

However, the doctor indicated that she had had very good experience with it in treating skin allergies and that it lasted all day, was non-drowsy etc. In this case, the drug in question was really a general-purpose allergy suppressant which worked on the immune system's reaction.

At the time, the drug had not been entirely evaluated and given the blessing by the FDA to be labeled as a treatment for skin allergies. However, that doesn't mean it didn't work. It was logical to think it would work for other allergies and experience and initial studies indicated it would.

In this case, the evidence could be called semi-anecdotal, but the burden of proof would be a lot less based only on the fact that you would expect it to work on such conditions, based only on the nature of the drug.

Furthermore, it was not treating a life threatening condition, and the drug was very safe to begin with. Worst case senerio would probably be that it would just not be all that effective.

 

[SYLVESTER1592]

What's "woo", and what's not?...

I don’t think of label use is necessarily woo. There are medical experiments to
see if the indications for use can be changed or expanded, but also a lot of “side-effects”of a drug can sometimes be a desired effect in other conditions. A famous example of that is sildenafil, but other examples are available. Usually the examples are for medical conditions that are less frequent and are harder to test for. Sometimes for medical conditions in which there is sufficient evidence of the principle and effects, but not enough profit for the pharmaceutical companies to test it in a specific small group (such as pediatric drugs, but also less common conditions). Also the scientific evidence provided in one country leads to the use of medication for a certain condition, but when the approval for that use is still pending approval by the FDA, it is not included on the label. Medicine is still an academic study and requires understanding of the principles involved, interpreting scientific data and assessment of the individual patient, therefore some doctors may have a different opinion about treatment even when the diagnosis is identical.

Since medical knowledge is ever increasing and even some accepted practices have not yet been properly investigated, some experimental drugs will always be out there and some drugs will always be used for another indication then the one it was designed for. However, there always has to be some evidence of principle, based and building on previously acquired knowledge and significant, convincing proof of clinical effect before it is used outside of a controlled experiment. This is the most obvious difference with true drugs of “woo”, which supply no significant clinical evidence and are not based or build on previously established knowledge of the mechanisms and principles of treatment and disease. This is only my opinion, but I think it’s also the general consensus among clinicians…

Sincerily,
SYL