[Ephejvll]

Here's a real hoot. I decided to try a new medication for COPD. It's called Arcapta Neohaler. You only have to take it once a day, compared to twice a day with most other similar medications, so I thought that sounded like a plus.

Enclosed with the Neohaler was a medication guide with the statement, "It is not known if LABA medicines such as Arcapta Neohaler, increase the risk of death in people with COPD".

Say what? This is an FDA approved medication. In order to be approved, there had to be clinical trials and yet it is not known if it can increase the risk of death in the very group of patients that it is approved for?

Is this the same FDA that says our own stem cells are drugs and that the entire approval process must take place before it is legal for them to be administered to us?

Is this the FDA that says it really isn't good enough to know that worldwide there are very few reports of death due to autologous stem cell treatment; that it is necessary to have years of very costly clinical trials to prove that our own stem cells will not harm us?

Is this the FDA that is allowing doctors to prescribe medications that may increase the risk of death or have severe side effects, but at the same time does not believe that these same doctors are capable of making decisions as a practice of medicine when it comes to administering our own stem cells as treatment?

I do concede that there are unscrupulous doctors and others out there that are taking advantage of desperately ill people, processing stem cells carelessly and only caring about money, but this is not something that needs to be or even can be fixed by lengthy, expensive clinical trials for autologous stem cell treatment. FDA regulations making our own stem cells drugs will not help with those that are unethical and not acting in a patient's best interests. There will always be snake oil salesmen, bad doctors and patients who do not do their homework, but to hold the rest of us hostage because of this small group, is doing more harm than good. Many are dying while waiting for stem cell treatment that might improve their life. This forum has lost quite a few members because of that situation.

I really am outraged that I can legally obtain a medication (it was fairly expensive too) specifically prescribed for my condition that the manufacturer cannot even tell me if it may or may not increase my risk of death by using it. If the FDA can approve something like that, then they need to step aside and let those of us who wish to have our own stem cells used to treat us, do so.

[erubresen]

Yes, it's the same FDA who instead of protecting us, is protecting Big Pharma.