Dear FDA,

This is getting absolutely ridiculous.  For almost 8 months now I have been part of an Expanded Access Program, which has been going on for two full years now, for the clinical study of the drug Aztreonam delivered via a nebulizer.  To explain a little about this study, Aztreonam is an antibiotic which has been approved used successfully (SINCE 1986!!!) via the interveineous route and routinely used in the treatment of Cystic Fibrosis lung exacerbations (i.e. chronic lung infections that eat away at the lung tissue eventually completely diminishing lung function).  Recently doctors/researchers have had the brilliant (and commonsense) idea to deliver antibiotics directly to the infection in the lungs of cystic fibrosis patients.  So far there has been great success with this as Tobi (inhaled tobramyacin) is now widely used as a treatment.  Currently the supporters of those with cystic fibrosis have been trying to get the FDA to approve use of another antibiotic, giving us with CF another powerful weapon against our deadly disease.  Unfortunately the FDA is refusing to approve the drug and asking for more studies to be done.

It is unbelievable and unethical in my view for the FDA to keep dragging their feet on approving this drug to be used via the inhaled route delivering the medication directly to the problem area, the (literally) life-sucking bacteria in the lungs.  If any there were any horrible side affects, you would think, would have already been shown themselves when the drug is introduced DIRECTLY into the BLOODSTREAM via intravenous therapy!  None the less to hear the rumor that you (the FDA) wants to have one MORE phase of this study done head-to-head with Tobi, which is a drug that some cystic fibrosis patients can not tolerate (like myself). Now I agree that Tobi has proven to be very affective as an anti-Pseudomonal (anti-nasty infectious bug) drug… but some of us who suffer from the evil cystic fibrosis can not tolerate Tobi no matter how hard we try.  Some can not inhale Tobi into their damaged and sensitive lungs at all because it is too irritating. Me, I suffer from flu like side affects. Yes, I can “tolerate” Tobi you may say since I can inhale it, but really? How the hell can I be a successful, productive member of society when I have to stay in bed because I feel so achy, nauseous, and down right hellish that the only place comfortable is my bed? (this comes from someone who hates being tied down). Why compare the two when that isn’t an option for some of us.

DO YOU NOT UNDERSTAND THE TIME SENSITIVITY OF CYSTIC FIBROSIS DRUGS?  People are on the road to an earlier death because they can not have access to this drug.  Transplant patients are not allowed on the study even though they may have had CF, and have Pseudo. Their lives hang in the balance.  Death does not wait for FDA approval.  Cystic fibrosis patients need every weapon in their artillery to fight this nasty disease and for the FDA to keep this drug from helping others is just down right disgusting.

I hope you are listening FDA.

Love always,

Salty.

*edited 8/18/2009 – some content removed/edited to save my own ass *