CDER

[tangent]

the FDA's CDER says docs are poorly educated and wants to keep affordable antibiotics out of citizens hands.

http://www.raps.org/pdf/ac/2001/ Galson_S_CDER_Exec_Brief_Mon_1100.pdf

try that again...

http://www.raps.org/pdf/ac/2001/Galson_S_CDER_Exec_Brief_Mon_1100.pdf

[Reasonable Rascal]

Document not found.

RR

[RESQDOC]

What it says is that doctors are poorly educated about drug product risk management (which is true IMO). (page 9)

What it says is that efforts were made to keep unapproved foreign made Cipro off the market post 9/11. (page 22)Would you care to comment on the confirmed cases of counterfeit Cipro and Doxy pouring in from Mexico post 9/11?

You fail to mention the many positive efforts made regarding drug safety in general and NBC response in particular, not the least of which is a shelf-life extension program not only for military but civilian drug stockpiles. (page 17-25)

Get your facts straight before posting. This forum is for facts, information, and experience. Half truths, out of context extractions, and selective quoting to alter the clear intent of the origional document does not help our pupose here or anywhere for that matter.

The tone of your post reeks of black helicopter fantasies and other sillyness. If you haved an opinion based on FACTS, post it. If you want to offer out of context speculations based on selective quotes, go play on the paranoia boards.

This post demonstrates poor scholarship and questionable integrity in a researcher. If you can't demonstrate better judgement than this it brings your entire body of work on drug stability into question.

I am disappointed to say the least.

[tangent]

I will have to re-read the document. Quite frankly I just scanned it and took exception to a couple of "bulleted" items. At that point writing it off.

I should also note that I have a pre-existing bias against CDER, considering that they have been playing semantic games with me, claiming that cited documents don't exist and passing the buck to irrelevant departments concerning a FOIA request I have had in with them for months trying to get basic information on the SLEP program.

you are correct - it was poor judgment to post that on a "knee jerk" reaction without completely reading the document and getting all the context.

As to counterfeit cipro coming in from Mexico - this is the first I have heard of it. It looked like yet another attempt to clamp down on affordable drugs from offshore/online pharmacies under some pretext - at least that was my take on it. Keeping in mind that our government has a track record of legislating and regulating all sorts of things out of existence, be they products or rights under the pretexts of protecting us from ourselves and the various "wars on..." - drugs, terrorism, crime, etc... If there is bad cipro coming into the country from Mexico, why not make a concerted effort against those companies and those packages instead of trying to stop all online pharmacies outside of the US from selling drugs to US citizens. That's the impression I got from reading that. Maybe the excuse was cipro, but the effect was on all of them and all their products - at least the prescription ones.

As to Dr's being poorly trained in that area of pharmacology, that is news to me. I thought docs were very well trained in this country.

--------------
on re-reading:
Under the section on Risk Management in CDER; Is anything broken - is says simply:

Docs are poorly Educated

NOT

Docs are poorly educated about risk management

The two statements are not identical. Even from context, they are talking about CDER's risk management mission and issues that they think fall under that. Not the same as risk management as it applies to all the following issues.

As to the mail order pharmacies, yes, the trigger that produced those letters was any overseas pharmacy selling cipro, and the intent was to crack down on all Rx drug sales, not just cipro. Note, and this is a VERY IMPORTANT note, that anyone selling cipro was targeted, not just those pharmacies that had sold bad/fake cipro.

[RESQDOC]

The document appears to be adapted from a Powerpoint presentation, perhaps used at a briefing.

The comments on docs appears to me to be limited to inadequate education on that issue, and a talking point to be fleshed out during the presentation.

I sympathize with battles with the CDC & HHS to get info, been there too, but if you have problems with them or your FOI search this is not the place to fight that battle. The is a forum for facts and experience about remote, austere, wilderness, and 3rd world medicine. Keep the politics and opinions elsewhere.

Ditto on comments about FDA policy on overseas drug sales. I share some of your concern about citizen access to medications, as I also have concerns about the safety, use & misuse of medications, resistance issues, and other points related to that issue. None of which is directly relevant to the forum, and will not be discussed here.

This discussion serves to remind ALL OF US of the need to READ something and THINK about it before we post it here, ditto avoiding off the cuff comments and spur of the moment posts, copying bits of posts from other forums without context or quality control, etc. I'm as bad as anyone about this and will try my best to do better in the future. Lets all keep it in mind.