Hi lady_express_44,

regarding case # vs. ISR...your overall impression is correct.

But just in case you want more detail...think of it this way.

1. Imagine that you take a drug and suffer a HEART ATTACK and are HOSPITALIZED on March 1, 2008.

2. Because of this, you might file an INITIAL adverse event report to the FDA that says something along the lines of "I took Drug X and I had a heart attack and was hospitalized on March 1, 2008."

3. This INITIAL report gets both a Case # **and** an ISR.

4. NOW imagine that 2 days later you died of that heart attack.

5. your spouse or MD or attorney might submit a FOLLOWUP report saying, "and by the way...we had the initial outcome as HOSPITALIZATION, but there's a new outcome of DEATH as well."

6. This FOLLOWUP report (and any other followup reports) gets the same Case #, but it gets a separate ISR #.

So...this is my long-winded way of saying Case # ties together 1 or more reports for the same patient. Each report gets a separate ISR.

Hope that makes sense!

Is the case# like an individualized "personnel" number for each client/patient, so that ANY time you get a report on a 'person', you source their previously assigned case#?
YES!

But when we look at the ISR'#s assigned to an individual case#, sometimes it "appears" that the exact same thing can be reported several times, sometimes on the same event date, but not necessarily. Does that just mean that the same event was reported that many times (from various sources?), or that these are seperate events?

This is a good question, but the answer is not clear as there do not appear to be standardized methods for reporting adverse reactions. I **think** (emphasis on think) that most often, the adverse reactions that are repeated are actually duplications, but that is not necessarily always the case.

It shows two similar "ISR #'s" under that case# (person), but in different "Quarters" (one in Q1, and one in Q2), and with only one "Event date" documented .... How would we know if that is the same "event" remitted from two sources, or two seperate events that occurred?
Again, the answer isn't clear. In *some* cases, you can probably use common sense to figure out what's going on (e.g., if esophogeal cancer is listed in 2 separate ISRs from the same case, it's likely to simply be a duplication), but this isn't always the case.


Also, where is the legend for the outcomes, like "DE" or "OT"?
DE = Death
OT = Other (i.e. not death, hospitalization, congenital anomaly or "required intervention")
If you click on the column heading labeled "Outcomes", it will pop up a small window that gives you the legend.

Hope that helps.


Best,

-tba

Thanks again, tba.

It's too bad there isn't an additional field that ultimately clarifies if events (ISR's) tie together . . . but I suppose that would take a lot of analysis and administration.

Your clarification is appreciated.

Cherie

Hi Cherie and others,

Hi all,

I thought many of you might be interested in an extension that I've built to the FDAble web-site.

Specifically, it's a WIKI that will hopefully be of use in examining pharma- and drug-related info.

Right now, the only relevant drug listed is tysabri...**

Anyway, if you go to the main FDAble site, the bottom of the page will link to the wiki and then you can simply search for Tysabri to see the relevant info.

I've just begun to consolidate a fair amount of Ty info that is scattered across the web.
**

Thanks for your time.

Best

-tba

Thanks, tba! I'll have a look at that.

Since you are updating Tysabri in particular, I wonder if you plan to be merging the Natalizumab and Tysabri data into one drug file? I understand that there may be several brand names for various drugs, sometimes made by different manufacturers, etc., but in the case of Tysabri/Natalizumab it is ONE drug, made by ONE manufacturer, so why not merge the data?

Do you work for the FDA, tba? If so, I have another question . . .

There are several drugs on the market that have the potential to cause serious risks (like Tysabri, Compath, etc.). In the FDA database, there are several "reports" of patients who "apparently" may have had i.e. PML, yet many of those cases have never been reported in the media/confirmed publically. I have "assumed" this means there was confirmation that that was NOT the cause then . . .

So . . . are all of the reported cases of "potential" PML cases reported on this site ultimately autopsied/100% screened out for PML? Is that the reason that those cases reported to the FDA were ultimately not "confirmed"?

Also, in the case of Tysabri, is there another formalized reporting method other than this site? I appreciate that this site takes "voluntary" reports, ie. it's up to the doctor/patient/family members to report (or not), but it's my understanding that the Tysabri Risk Plan established a seperate reporting method for adverse events . . . Or is this it?

Thanks again,

Cherie

I have always been warned that Wiki is unreliable for obtaining "facts" about ANY subject, although I have not found this to be the case at all. I love Wiki, personally . . . mostly because it is normally written in layman's terms, but also because it is constantly being verified & updated by MANY sources.

I'm curious if this means that the FDA (US government agency) generally considers this a reliable source of information?

Cherie

I would seriously doubt it. The FDA does serious research on adverse events reported in the AERS before they do anything. Their decisions are based on science and data (lots of it).

it is merged...I was actually just being imprecise by saying "tysabri", when what I actually meant was "tysabri OR natalizumab"

short answer: no. Long answer: no. never. I work in biotechnology.

you are correct in thinking they are "POTENTIAL" cases. Since anyone can file an AE report, the reports themselves span a wide range of 'quality of verification'. I believe the makers of Ty have explicitly stated that while AERS shows a # of suspected PML cases with Ty, there are only a small # that have been confirmed independently.


There may be a separate reporting system (in the U.S.) specifically designed for Ty...I think you are referring to the Touch(tm) risk minimization system. However, anything that goes into Touch should ultimately also makes its way into AERS as well.


I think skepticism is a good rule for any bit of information...and your comfort level may vary depending on the specific source and the specific information.
So far, I am the only person who has added to the wiki and my information has come exclusively from government data...so it's a matter of trusting me...and the US government.
the way that I look at Wikis in general is that they should be a "jumping off point" for additional study. But they *can* be rather informative.

I have no way to say whether the FDA or other agencies consider WIKIs reliable sources of information.
However, I should say that I began making the FDAble last month and someone asked me why I just didn't add information to Wikipedia's entry on Tysabri.
There are a number of reasons for making a different wiki.
0. the idea behind the FDAble WIKI is to aggregate pharma data that is distributed across governmental agencies (e.g. FDA, CDC, clinical trials, USPTO, etc.)
1. wikipedia's goal is to give a narrative about different topics and is generally suited for the layperson. The FDAble wiki is more "data-centric" (less narrative) and more specialized in the type of information dispensed.
2. wikipedia frowns on articles that use many links that lead "outside" of wikipedia (I've tried). FDAble wiki is trying to do the opposite (provide many links that lead outside of the wiki).
3. wikipedia makes it difficult (if not impossible) to add graphical data (e.g. timelines and dynamic maps). FDAble wiki is trying to graphically show the duration of clinical trials and other data.
4. I'll stop there, but there are a few more germane reasons.

Thank you for the feedback!

p.s. I read the other day about a woman with MS who is planning to climb Everest!
pretty impressive considering that you can't get me to climb a chair in my kitchen without a handful of tranquilizers.

Best,

-tba

Cool!

So why is it that when I type in "natalizumab" a seperate database comes up :

http://www.fdable.com/search/aers/ad...y/2fcb1d403a66

Also, do you know why reports for Avonex, Betaseron, etc. all pop up in the database when I request only Tysabri?

http://www.fdable.com/search/aers/ad...y/9eb4fec4b9b6

So, curiousity got the cat . . . why are you responsible for updating the FDAble AERS then? Moonlighting?

So are all cases of PML that are reported through AE SENT for independant confirmation then?

It would seem to me that people reporting PML cases shouldn't be doing so willy nilly. They must have some convincing evidence to venture such a "guess". . .

You might remember when the Crohn's patient died from what was reported as some other condition, and eventually his cause of death was re-evaluated. Not sure how they did this , but they determined in the end that it was PML. That was before the days when they "looked" for PML, of course, but clearly the dx isn't cut and dry even now.

Do you have any idea what happens when a AE reported PML case is "suspected"? Are all of these cases flagged and sent for independant analysis, or ?

That reminds me, TOUCH is only in the US and about 1/3 (I think) of the patients currently on Tysabri are from outside the US.

Is the AE system only for US reporting too, or does it include all countries?

Yes, I guess it would the the "risk minimization system", but I've not been able to find anything that describes the established procedures for reporting through that system.


Yeah, I just thought it was interesting to see a government site hook up to Wiki, but that's cool.

Do you have MS too?

You've been a big help, thanks!

Cherie

The criteria for diagnoses of PML is clear

- Symptoms suggestive of PML
- MRI findings consistent with PML
- JC viral DNA in the CSF

All suspected cases of PML are worked up by BiogenIdec to confirm/rule out PML.