Cancer Drug for MS Brings Up More Thoughts on Off Label Prescribing
The other day, to the consternation of some, I discussed my opposition to "off label" prescribing, meaning when a drug is approved for use to treat one malady, it is prescribed for a different one even though the medication was not specifically tested for that circumstance. To me, off label prescribing is a form of human experimentation that should either not be allowed or which should be thoroughly disclosed to the patient at the time of prescribing--with potential civil liability if things go wrong.
That is not to say that when a drug is found to have potential off label uses, it should just be ignored. The proper approach, it seems to me, is to alert the medical community and FDA, and then test it properly for the new use. And that is exactly what has been done with a cancer drug that may be efficacious for treating MS. From the story:
The blockbuster cancer drug Rituxan may help treat multiple sclerosis, according to the results of a small clinical trial that opens up a broad new approach to understanding and possibly treating the disabling disease.Such off label trials would move much faster than the original testing process because so much would already be known about the drug's working and risks. This is the proper way to go.The study encouraged Rituxan's co-developers Genentech Inc. and Biogen-Idec, which hope larger trials will establish the drug as an approved treatment for the disabling neurological disorder. But the trial's more sweeping impact may come from the light it sheds on the mechanisms of the disease.
Labels: Off Label Prescribing
posted by Wesley J. Smith @ 7:58 AM
3 Comments
3 Comments:
I think on this "off label prescription" stance Wesley I have to disagree with you. As long as patients are properly informed and give their consent, I don't think there is anything wrong with it.
Long and arduous regulation processes like the FDA kill people by delaying the availability of drugs as well as preventing the development of other ones because the cost of getting approval is so expensive.
Off label prescribing at least provides a way for drugs that are effective in a broader range of cases to be used in them.
Are there actual cases of off label prescribing being done as part of deliberate human experimentation ? I've never encountered that, although if you have examples I would be interested to hear them.
In my experience it is normally done because the drug is known to be effective in cases in which it is not officially test for use in.
I could be wrong. But at the very least, full informed consent is a must. Particularly since some of these drugs have powerful side effects that might be worth risking for one malady but not another, and which might not work as well for the off label use.
"I could be wrong. But at the very least, full informed consent is a must."
Absolutely consent is a must. I agree with you there.
Ultimately it is a question of trade offs. Two things are certain to be the case.
If you have an FDA with a long complex trial process then you can be sure people will die waiting for drugs that could have saved them but were unavailable because they were tied up in the approval process.
If you have a more lenient review process and off label use etc, then some people will die from bad reactions etc.
Either way people will die, probably not the same people, but people all the same. You have to decide which way to make the trade off.
The real problem is that the people who die in the second case are obvious and noisy and garner head lines while the people who die in the first are quiet and unobtrusive, because they would typically die in ignorance of the drug that could save them.
So the first way is more popular because it looks less problematic, but I suspect if you tried both and compared the results it would be route 1 that killed more people, especially from things that could have been prevented.
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