Fidaxomicin approved by the FDA

[Its Z]

Fidaxomicin, Dificid received approval today.

That's all.

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[Jabberwocky12]

Would you mind giving a little explanation of the benefits of this new medicine? I see that it helps wipe out a particular bacteria without wiping out the normal flora of the intestine resulting in less physiological responses like diarrhea.

Am I missing something here about the importance? It looks like another standard antibiotic to me, but I'm just a pre-pharmer who takes microbiology in the fall

 

[Its Z]

Would you mind giving a little explanation of the benefits of this new medicine? I see that it helps wipe out a particular bacteria without wiping out the normal flora of the intestine resulting in less physiological responses like diarrhea.

Am I missing something here about the importance? It looks like another standard antibiotic to me, but I'm just a pre-pharmer who takes microbiology in the fall

Yes, I mind.

 

[rxlea]

Would you mind giving a little explanation of the benefits of this new medicine? I see that it helps wipe out a particular bacteria without wiping out the normal flora of the intestine resulting in less physiological responses like diarrhea.

Am I missing something here about the importance? It looks like another standard antibiotic to me, but I'm just a pre-pharmer who takes microbiology in the fall

C dif is a nasty bug. Right now they use metronidazole and vanco, the latter of which is increasing in use because of resistance. Since they throw vanco at everything these days, it's no surprise c dif would show some resistance. It will be good to have something else in the armory. We have seen a HUGE increase in C dif in the ICU recently. Not good...

 

[Its Z]

C dif is a nasty bug. Right now they use metronidazole and vanco, the latter of which is increasing in use because of resistance. Since they throw vanco at everything these days, it's no surprise c dif would show some resistance. It will be good to have something else in the armory. We have seen a HUGE increase in C dif in the ICU recently. Not good...

You left out C.Diff being the #1 hospital acquired infection in the US.

Prepharm or not, just throwing out "another standard antibiotic" to a drug without doing any research is not acceptable since this is the first drug approved in 25 years for CDI. Simple google of fidaxomicin would have led to information about C.Diff and its dangers along with limited treatment options.

 

[Jabberwocky12]

You left out C.Diff being the #1 hospital acquired infection in the US.

Prepharm or not, just throwing out "another standard antibiotic" to a drug without doing any research is not acceptable since this is the first drug approved in 25 years for CDI. Simple google of fidaxomicin would have led to information about C.Diff and its dangers along with limited treatment options.

You're right.I googled the brand name only and just got a bunch of marketing things at first that just talked about it targeting the one bacteria mainly but it did mention vanco and metro like lea said. I wiki'd the bacteria involved and the sicknesses the bacteria cause and didn't connect the importance. I'll just take it as a lesson to be a little more thorough.

 

[rxlea]

You left out C.Diff being the #1 hospital acquired infection in the US.

Prepharm or not, just throwing out "another standard antibiotic" to a drug without doing any research is not acceptable since this is the first drug approved in 25 years for CDI. Simple google of fidaxomicin would have led to information about C.Diff and its dangers along with limited treatment options.

Z you're feisty today

 

[Its Z]

You're right.I googled the brand name only and just got a bunch of marketing things at first that just talked about it targeting the one bacteria mainly but it did mention vanco and metro like lea said. I wiki'd the bacteria involved and the sicknesses the bacteria cause and didn't connect the importance. I'll just take it as a lesson to be a little more thorough.

Just F'ing with you...

But I'm glad you looked it up.

 

[Its Z]

Z you're feisty today

You should see me present at P&Ts then..

 

[UES Girl]

You should see me present at P&Ts then..

We still kick ass, with our humble californian ways. UC pride all the way.

 

[Its Z]

We still kick ass, with our humble californian ways. UC pride all the way.

I went to SC !!!! But work with many proud SF grads.. they're all dorky.

 

[KARM12]

Plus CDAD makes the unit smell nasty as it wafts through the halls...seriously one of the worst smells EVER!

 

[rxlea]

Plus CDAD makes the unit smell nasty as it wafts through the halls...seriously one of the worst smells EVER!

True story. I would rather smell a moldy fridge.

 

[Jabberwocky12]

Looking at my micro syllabus for the fall apparently we are going to be talking specifically on a case study for C dif. I feel epic prepared now and am going to wow the class with my newfound knowledge.

I won't be a noob where it counts

 

[rxlea]

Looking at my micro syllabus for the fall apparently we are going to be talking specifically on a case study for C dif. I feel epic prepared now and am going to wow the class with my newfound knowledge.

I won't be a noob where it counts

That antibacterial gel doesn't kill it either and when nurses don't wash their hands good enough and go from patient to patient, it spreads.

 

[Jabberwocky12]

That antibacterial gel doesn't kill it either and when nurses don't wash their hands good enough and go from patient to patient, it spreads.

So if the antibacterial gel doesn't kill it, then is it just straight hand washing only? Scrubbing like you are about to go to surgery? If nurses know that then why are they allowed to continue using that gel stuff?

BTW the gel stuff always worried me because a lot of people use it for substituting hand-washing. Isn't it supposed to be most effective after washing hands?

 

[Its Z]

That antibacterial gel doesn't kill it either and when nurses don't wash their hands good enough and go from patient to patient, it spreads.

why

 

[rxlea]

why

Cause it's spore forming

 

[rxlea]

So if the antibacterial gel doesn't kill it, then is it just straight hand washing only? Scrubbing like you are about to go to surgery? If nurses know that then why are they allowed to continue using that gel stuff?

BTW the gel stuff always worried me because a lot of people use it for substituting hand-washing. Isn't it supposed to be most effective after washing hands?

Well the guidelines say ýou can use the gel if your hands aren't visibly soiled. It works for most things but you have to do it right and there are recommendations for how much to use and what not. You don't have to scrub like you're going to surgery but you want to make sure you wash under your fingernails and in between your fingers and for a certain amount of time. Some nurses/doctors/nurse assistants get in a rush and don't do it right.

 

[Its Z]

Cause it's spore forming

Then why you aint said so ??

 

[rxlea]

Then why you aint said so ??

Fine. Next time I will provide a more thorough answer just for you. I didn't realize you wanted a "presentation" besides, I don't want all these pharm people to think I am spouting off as a know it all, cuz I sure am not.

 

[Its Z]

Fine. Next time I will provide a more thorough answer just for you. I didn't realize you wanted a "presentation" besides, I don't want all these pharm people to think I am spouting off as a know it all, cuz I sure am not.

I don't know everything. Far from it. But I pretend to know everything. That's kinda my job.

 

[IndustryPharmD]

I don't know everything. Far from it. But I pretend to know everything. That's kinda my job.

Even I don't pretend to know everything. 😀

 

[Its Z]

Even I don't pretend to know everything. 😀

Its not an easy task to pull off.

 

[joetrisman]

I don't know everything. Far from it. But I pretend to know everything. That's kinda my job.

Wizard of Oz? Bet you've got great benefits 👍

 

[StewardshipDude]

Looking forward to trying it. Vanc is not the option that it once was. Vanc, although the gold standard for treating CDAD, is also one of the main causes of CDAD.

While not first line, we have also had outstanding results treating CDAD with tigecycline.

Of course my guess with this new option is that ID and my own comrades in pharmacy will restrict the hell out of the agent. No wonder we have so few new drugs. Wall Street will just move the capital to another PPI or statin because the return is just not there with ABXs.

 

[Its Z]

Of course my guess with this new option is that ID and my own comrades in pharmacy will restrict the hell out of the agent. No wonder we have so few new drugs. Wall Street will just move the capital to another PPI or statin because the return is just not there with ABXs.

You actually believe "pharmacy restriction" is the reason for having so few new drugs????

You're an idiot.

 

[rxlea]

What do you mean by "outstanding" results? And what are you even talking about? There was an article that came out in march (I think) about tigecycline efficacy and safety that you might be interested in, though. I will post the link later.

 

[gotdrugs]

Meh.

Just do a fecal transplant. Problem solved.

 

[StewardshipDude]

You actually believe "pharmacy restriction" is the reason for having so few new drugs????

You're an idiot.

You are not a good person. You are foul and you are closed minded. You have your fans here, but you are not a pleasant person and it is difficult to imagine you having an individual patients's best interests at heart. The way you treat people here is telling. Kinda like when you see someone who hurts animals for fun or is rude to service staff because they are weak. You just know.

I think there are many reasons why we don't have many new antibiotics, especially ones for ESKAPE pathogens:

Better return on R&D in other areas
Very good generic options entrenched in market

But most important, the lack of incentive to introduce a product. If it meets an un-met medical need, ID and we in pharmacy will put such restrictions on it that it will not be a commercial success for industry. No problem, it's our right to "save it for later". But it's industry's right to shift their R&D focus.

Too many in our role still view things around cost only. Strict enforcement of restrictions, blind adherence to guidelines, and cost containment programs masquerading as stewardship programs.

The ACA is going to change that as our masters in the C-Suite are incented not on volume and cost but on quality and continuity of care. 10 years from now we will have stewardship programs based upon antibiotic heterogeneity, the Tarragona strategy and the employment of patient based care. We will wish we had more diverse bullets to load. We won't based upon our actions now.

 

[gotdrugs]

You are not a good person. You are foul and you are closed minded. You have your fans here, but you are not a pleasant person and it is difficult to imagine you having an individual patients's best interests at heart. The way you treat people here is telling. Kinda like when you see someone who hurts animals for fun or is rude to service staff because they are weak. You just know.

I think there are many reasons why we don't have many new antibiotics, especially ones for ESKAPE pathogens:

Better return on R&D in other areas
Very good generic options entrenched in market

But most important, the lack of incentive to introduce a product. If it meets an un-met medical need, ID and we in pharmacy will put such restrictions on it that it will not be a commercial success for industry. No problem, it's our right to "save it for later". But it's industry's right to shift their R&D focus.

Too many in our role still view things around cost only. Strict enforcement of restrictions, blind adherence to guidelines, and cost containment programs masquerading as stewardship programs.

The ACA is going to change that as our masters in the C-Suite are incented not on volume and cost but on quality and continuity of care. 10 years from now we will have stewardship programs based upon antibiotic heterogeneity, the Tarragona strategy and the employment of patient based care. We will wish we had more diverse bullets to load. We won't based upon our actions now.

You two obviously have history, but as an outsider, that first paragraph reads as "hi pot, it's kettle........you're black"

Just sayin'

The other side to the restrict abx is that otherwise you will have dapto being used for pneumonia (which I have seen in an unrestricted world) and linezolid being used for a Coag Neg Staph contamination (which I have seen in an unrestrictive world.) Those are just two blatantly obvious examples on why restrictions can have some merit.

 

[owlegrad]

Just a friendly reminder to please keep it civil guys. Thanks!

 

[KARM12]

You are not a good person. You are foul and you are closed minded. You have your fans here, but you are not a pleasant person and it is difficult to imagine you having an individual patients's best interests at heart. The way you treat people here is telling. Kinda like when you see someone who hurts animals for fun or is rude to service staff because they are weak. You just know.

I think there are many reasons why we don't have many new antibiotics, especially ones for ESKAPE pathogens:

Better return on R&D in other areas
Very good generic options entrenched in market

But most important, the lack of incentive to introduce a product. If it meets an un-met medical need, ID and we in pharmacy will put such restrictions on it that it will not be a commercial success for industry. No problem, it's our right to "save it for later". But it's industry's right to shift their R&D focus.

Too many in our role still view things around cost only. Strict enforcement of restrictions, blind adherence to guidelines, and cost containment programs masquerading as stewardship programs.

The ACA is going to change that as our masters in the C-Suite are incented not on volume and cost but on quality and continuity of care. 10 years from now we will have stewardship programs based upon antibiotic heterogeneity, the Tarragona strategy and the employment of patient based care. We will wish we had more diverse bullets to load. We won't based upon our actions now.

How are you an ID pharmacist? Do you really think pharmacy restrictions are the reason for lack of R&D in ID? Abx have shorter durations of use...I can give a me-too statin to a pt for 30yrs, but they may only need 14d of expensive new abx.

 

[nikkai]

Though I don't agree with much of what is posted on the US's "go-to" ID resource, I recommend reading some of the exec summaries posted in their 10x20 website:

https://idsociety.org/10x20.htm

The practice of restriction is just one tiny facet in the uncut lump of coal clogging the ingenuity needed for new antimicrobials. I'm sure both Z and Stewardship Dude/Guy actually agree on many points and I can only presume stewardshipdude (need shorter name) was only anticipating an immediate action and just made a comment in passing.

On the other hand, if he is claiming a larger impact of restriction on R&D, then yes, keep reading/studying.

I think the section in Bad Bugs, No Drugs, entitled "Medical Need versus Market Realities" sums it up.

@RXlea - Increased use of the more expensive drug ain't necessarily due to increased resistance. It's pretty freaking rare to get resistance cdiff, and then even if you do, most places don't test for it. Why do people go to vanc over flagyl without an evidence-based reason? Why do people gravitate towards brand over generic? Many many reasons.

 

[Its Z]

You are not a good person. You are foul and you are closed minded. You have your fans here, but you are not a pleasant person and it is difficult to imagine you having an individual patients's best interests at heart. The way you treat people here is telling. Kinda like when you see someone who hurts animals for fun or is rude to service staff because they are weak. You just know.

Right...like you know how I operate by just reading what I type on SDN.

Quit your whining and grow a pair.