being skeptic

[madarka]

hi everyone!
i was wondering how can i trust drugs approved by FDA if lasik surgery was approved by FDA despite horrible risks and possible permanent devastating complications.literally lasik is a pure lottery-u win or u lose!it is a huge business,a gold mine everything but a safe medical procedure.i am desperately waiting for some medical breakthrough for dry eye,but will it be approved by FDA in a same way as LASIK?


devastated lasik victom

[Rebecca Petris]

hi everyone!
i was wondering how can i trust drugs approved by FDA if lasik surgery was approved by FDA despite horrible risks and possible permanent devastating complications.literally lasik is a pure lottery-u win or u lose!it is a huge business,a gold mine everything but a safe medical procedure.i am desperately waiting for some medical breakthrough for dry eye,but will it be approved by FDA in a same way as LASIK?

Madarka,

I'm certainly not the right person to attempt a defense the FDA's drug approval process, however, I'll share my 2 cents anyway.

LASIK is a lot, lot different from drug approvals. It is a surgery and as such it is not regulated by the FDA at all. The devices (the excimer lasers) are approved by the FDA for a specific purpose. But the FDA does not get involved in any aspect of the PRACTICE of lasik - things like patient screening, informed consent, post-operative care and so on. So, although I personally have real issues with the basis of approval for many lasers, and even bigger issues with the total failure of the post-market surveillance process, I think many of the key problems with LASIK in practice are unrelated to the FDA. They're related to the way doctors are screening and communicating with patients.

As regards dry eye drugs... there are many interesting ones in development. I think that it's actually considerably harder to get a dry eye drug approved than drugs in many other categories. Restasis was turned down twice before it was approved, and the same thing has been happening with Inspire's drug. So it's not like they are breezing through the FDA.

[sazy123]

I think that it's actually considerably harder to get a dry eye drug approved than drugs in many other categories. Restasis was turned down twice before it was approved, and the same thing has been happening with Inspire's drug. So it's not like they are breezing through the FDA.

Why do you think this is rebecca? its strange that its harder for dry eye than other conditions.

[Rebecca Petris]

Why do you think this is rebecca?

Part of it is that the FDA requires proof of significant improvement "signs" (eg clinical test scores) and "symptoms" (eg patient-reported symptoms). Dry eye signs and symptoms are notoriously difficult to correlate, that is, someone with low test scores may feel OK and someone with great test scores may feel awful. - With many other health conditions the measurements of progress are more straightforward and easier to establish.

I think another factor is simply the complexity and variety of dry eye diseases, which make most drugs suitable only for a certain percentage of patients.