WHO-US Adverse Reaction Reports For Statins - When Where What?
CategoriesThe number of people who have reported problems in the comments of just one post: "Bad News About Statin Drugs" let alone others, only gives a smattering of the extent of the problem. For only one side effect this month's JAMA says:
"Conclusions Rhabdomyolysis risk was similar and low for monotherapy with atorvastatin, pravastatin, and simvastatin; combined statin-fibrate use increased risk, especially in older patients with diabetes mellitus. Cerivastatin combined with fibrate conferred a risk of approximately 1 in 10 (or 10%) treated patients per year."
Imagine the extent of the real problem, if the job of Adverse Reaction Reporting (ADS) was done honesty....
Chris Gupta
--------------------------------------------------------------------------------------------Chris
Stand by for a major expose on 60 Min, if all goes well, and every one is still alive.
Hope it is not like the hatchet job they did with the vaccine issue! CG
-----------------------------------------Dear all,
Rule number one, red wine is good for you - but not necessarily for your e-mails.As the Vioxx scandal makes clear the adverse event reporting system works jolly well if the manufacturer of the drug lists all the adverse reactions possible. However, if you want to pick up a new adverse reaction e.g. killing the patient, or, in the case of Statins, causing global memory loss, forget it. If it's not listed as a possible adverse event, no doctor will record it. A more perfect self-fulfilling system designed to miss major problems with a drug could hardly be imagined.
Malcolm
---------------------------------------Dear All
As you would recall, Duane visited Sydney and gave his expose on Satins and cognitive impairment. As pointed out by some rather angry and confused person (my guess - possibly a drug company rep) during Duane's presentation, Australian PI for all Statins includes a warning about potential for cognitive impairment, and since very recently the same is true for the US PIs. But, as you would expect some ridiculous estimate of it eventuating is probably quoted and the statement is probably buried. (I had no time to check it).
However, one particular thing Duane has asserted during his presentation was rather worrying if not amazing.
Apparently, and I have no reason not to belive a NASA scientist (after all they did land on the moon - ooops) - FDA, when in the possession of an ADR for a Statins, rather than compiling it into an electronic database (as is done over here, in Oz), creates a file which is placed on the shelf for storage. Now - that is a very serious allegation, should it be the case.
As Duane has communicated to us during breakfast - a certain prominent internationally syndicated TV program is very interested in the modus operandi of FDA in that particular area!!!, and in the carnage Statins have been causing over the years.
But, even I could not just let it go, so I asked my associates at work from our ADR section.
They suggested that such a scenario as proposed by Duane is very unlikely, and that to their knowledge - FDA has an electronic database which is regularly maintained, but not by the FDA staff (as is the case in Oz), but rather by outside
contractors!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Clearly, these contract firms must first be sent these ADRs, possibly after they gathered dust on the FDA shelves for an unknown period. So far so good! or should it be baaaaaad!
To make it even more interesting, the received reports (unlike in Oz) are not scrutinized during the entry into the FDA database, and are NOOOOOOOT reviewed by the advisory expert committee on the regular basis (as is the case in Oz).
Now that is some system for picking up sh.....!!!
Now considering the above - it is therefore quite conceivable that ADRs to
Statins are not being processed by FDA.
Why would I propose that?
Well - let me point your attention to the attachments. (not provided with this email)
An intrigued soul living a short stroll down the corridor from my office, did a little scant search of the WHO ADR database, apparently the most comprehensive one there is, compiling data from most "good" countries.
As you can see, although I am unsure about the validity of results, world-wide, only 158 cases of amnesia induced by Simvastatin and 154 cases by Atorvastatin were reported to WHO. No wonder some would claim Statins do not cause cognitive impairment!!!!
But even more stunningly, the latter was implicated in only 2 (two) cases of cognitive deterioration in the almighty US of A.
That is unreeeeeeeeal maaaaaaaaaan !
God bless America and FDA!
Malcolm, - would you join me for a bottle of red!
Cheers!
Anon
PS
According to an estimate presented by Duane at his presentation, about 150,000 patients out of 20 mil taking Statins in the US must experience some form of cognitive impairment!!!! Now, how do you hide that group of people????
The best way is not to ask! After all they will eventually forget to complain!
Another glass........
Perhaps our friends in Sweden could ask the mob at Upsala Uni, which runs WHO ADR database, to do a proper search for all Statins-related ADRs.
It should be some story!
Cheers!What is the point - lets drink from the bottle.....Na zdrowie!
posted by Chris Gupta on Thursday November 25 2004
updated on Saturday September 24 2005URL of this article:
http://www.newmediaexplorer.org/chris/2004/11/25/whous_adverse_reaction_reports_for_statins_when_where_what.htm
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