3 ms·

How does this act relate to drugs targeted to specific genetic markers? I think we're moving into an era when we need to consider that everybody is different,

How does this act relate to drugs targeted to specific genetic markers? I think we're moving into an era when we need to consider that everybody is different, and a lot of cancers are different. This isn't like curing a bacteria, where (mostly) one-size fits all. I wonder: is it possible to bring a drug to market that is ineffective and sometimes fatal to most people without a genetic marker, but is safe and will cure cancer for those with the marker?

jcranmer 8y ago
I believe so, but you do have to make sure your drug application clearly labels when it is safe to use.
chimeracoder 8y ago
> I wonder: is it possible to bring a drug to market that is ineffective and sometimes fatal to most people without a genetic marker We already do this. A large class of both antipsychotics and antidepressants require certain genes in order to metabolize properly and have the intended effect, instead of just giving a bunch of side effects with no benefit. These genes are not universal and not evenly distributed; people of certain ethnic backgrounds are dramatically less likely to have the requisite genes, which means that most antipsychotics and antidepressants literally don't work on them.
- perl4ever 8y ago
  Do you have a citation for this?
mjewkes 8y ago
Yes - if you prove that it is safer than other options for the indicated population, the FDA will approve it with a label indicating it only for that population. Indications can be as specific as "indicated for tumors with specific mutations"[1] or indicated "prostate cancer when all other options have failed"[2] [1]https://en.wikipedia.org/wiki/Pembrolizumab https://en.wikipedia.org/wiki/Pembrolizumab [2]https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm613543.htm https://www.fda.gov/drugs/informationondrugs/approveddrugs/u...

3 ms·

How does this act relate to drugs targeted to specific genetic markers? I think we're moving into an era when we need to consider that everybody is different,

by drewg123 8y ago

jcranmer 8y ago
I believe so, but you do have to make sure your drug application clearly labels when it is safe to use.
chimeracoder 8y ago
> I wonder: is it possible to bring a drug to market that is ineffective and sometimes fatal to most people without a genetic marker We already do this. A large class of both antipsychotics and antidepressants require certain genes in order to metabolize properly and have the intended effect, instead of just giving a bunch of side effects with no benefit. These genes are not universal and not evenly distributed; people of certain ethnic backgrounds are dramatically less likely to have the requisite genes, which means that most antipsychotics and antidepressants literally don't work on them.
- perl4ever 8y ago
  Do you have a citation for this?
mjewkes 8y ago
Yes - if you prove that it is safer than other options for the indicated population, the FDA will approve it with a label indicating it only for that population. Indications can be as specific as "indicated for tumors with specific mutations"[1] or indicated "prostate cancer when all other options have failed"[2] [1]https://en.wikipedia.org/wiki/Pembrolizumab https://en.wikipedia.org/wiki/Pembrolizumab [2]https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm613543.htm https://www.fda.gov/drugs/informationondrugs/approveddrugs/u...