WHO-US Adverse Reaction Reports For Statins - When Where What?
The 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
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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
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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
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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 2005
URL of this article:
http://www.newmediaexplorer.org/chris/2004/11/25/whous_adverse_reaction_reports_for_statins_when_where_what.htm
Readers' Comments
I HAVE HEARD THERE ARE OTHER DRUGS FOR CHOLESTRAL LOWERING OTHER THAN THE ONES USUALLY PRESCRIBED SUCH AS LIPITOR. I CANNOT SEEM TO FIND OUT WHAT THEY ARE. DOES ANYONE KNOW?? LIPTOR CAUSED ME MUCH MISERY FOR A LONG TIME.
Response:
See:
Class Action - Statins Increases Heart Disease By 10% In Women
Chris Gupta
Posted by: Sepp on November 26, 2004 10:08 PM
I HAVE HEARD THERE ARE OTHER DRUGS FOR CHOLESTRAL LOWERING OTHER THAN THE ONES USUALLY PRESCRIBED SUCH AS LIPITOR. I CANNOT SEEM TO FIND OUT WHAT THEY ARE. DOES ANYONE KNOW?? LIPTOR CAUSED ME MUCH MISERY FOR A LONG TIME.
Response:
See:
Class Action - Statins Increases Heart Disease By 10% In Women
Chris Gupta
Posted by: Kami on June 30, 2005 10:08 AM
I HAVE HEARD THERE ARE OTHER DRUGS FOR CHOLESTRAL LOWERING OTHER THAN THE ONES USUALLY PRESCRIBED SUCH AS LIPITOR. I CANNOT SEEM TO FIND OUT WHAT THEY ARE. DOES ANYONE KNOW?? LIPTOR CAUSED ME MUCH MISERY FOR A LONG TIME.
Response:
See:
Class Action - Statins Increases Heart Disease By 10% In Women
Chris Gupta
Posted by: tim brown on July 10, 2005 11:56 PM
I have taken almost all statins for high colesteral and have suffered muscle and joint pains from statins. After discontinuing statins, the pains went away, but my colesteral readings increased.
Posted by: Edward Stinson on July 20, 2005 10:44 PM
I HAVE HEARD THERE ARE OTHER DRUGS FOR CHOLESTRAL LOWERING OTHER THAN THE ONES USUALLY PRESCRIBED SUCH AS LIPITOR. I CANNOT SEEM TO FIND OUT WHAT THEY ARE. DOES ANYONE KNOW?? LIPTOR CAUSED ME MUCH MISERY FOR A LONG TIME.
Response:
See:
Class Action - Statins Increases Heart Disease By 10% In Women
Chris Gupta
Posted by: on August 30, 2005 05:36 PM
Read:
How cholesterol-lowering drugs turned a fit and healthy man into a kidney failure patient.
Posted by: Chris Gupta on August 30, 2005 08:50 PM
I HAVE HEARD THERE ARE OTHER DRUGS FOR CHOLESTRAL LOWERING OTHER THAN THE ONES USUALLY PRESCRIBED SUCH AS LIPITOR. I CANNOT SEEM TO FIND OUT WHAT THEY ARE. DOES ANYONE KNOW?? LIPTOR CAUSED ME MUCH MISERY FOR A LONG TIME.
Response:
See:
Class Action - Statins Increases Heart Disease By 10% In Women
Chris Gupta
Posted by: David Fisher on September 28, 2005 08:07 PM
I HAVE HEARD THERE ARE OTHER DRUGS FOR CHOLESTRAL LOWERING OTHER THAN THE ONES USUALLY PRESCRIBED SUCH AS LIPITOR. I CANNOT SEEM TO FIND OUT WHAT THEY ARE. DOES ANYONE KNOW?? LIPTOR CAUSED ME MUCH MISERY FOR A LONG TIME.
Response:
See:
Class Action - Statins Increases Heart Disease By 10% In Women
Chris Gupta
Posted by: Anne Lapeze on December 15, 2005 04:25 PM
I HAVE HEARD THERE ARE OTHER DRUGS FOR CHOLESTRAL LOWERING OTHER THAN THE ONES USUALLY PRESCRIBED SUCH AS LIPITOR. I CANNOT SEEM TO FIND OUT WHAT THEY ARE. DOES ANYONE KNOW?? LIPTOR CAUSED ME MUCH MISERY FOR A LONG TIME.
Response:
See:
Class Action - Statins Increases Heart Disease By 10% In Women
Chris Gupta
Posted by: Judith Benson on March 11, 2006 10:26 PM
At 84 started Zocor 3/1/01. Cardiologist and GP ignored my complaints of burning and calf muscle pain from April to July 26 when I called Merck and told to stop. Permanent damage to date 4/10/06. Have seen nuerologist,rheumatologist,ortho.,gp,cardiologist. Neurontin-ng, Lyica-6 pills-reaction two days in Hosp.What Now?
Posted by: Paul Widebrook on April 8, 2006 12:36 PM
I am just home from the hospital after a severe attack of pancreatitis, which the doctors, albeit reluctantly, say may be related to the Lipitor I took for 2 months this year!!! Is this possible?
Posted by: Ruth Mills on April 22, 2006 12:58 AM
Your articles are great,Thank you.
I went off Lipitor after
reading an article that it can cause Alchiemers disease
also my wife got me on to B6 & B12 + Folic acid after my
stroke, also chelation therapy(EDTA), I recovered my speech and use of my limbs within three treatments. I strongly recommend to avoid bypass operations as well.Cholesterol is a falacy we need it otherwise we have heart problems
Posted by: George Mackay on May 18, 2006 10:23 AM
Kris
Here is what happened to my husband after 5 years on Zocor, now he has heart problems, a block valve( stint in place since Nov2005)
30% blockage of kidney. Not to mention memory loss. He took this as part of a Veterans Study I believe. He was on Tamulosin for (5 years) Prostrate problems and can no longer get this because it is to expencive, But they put him on Doxozosin,or on Treoziosin but he is allergic to the first one and the second one is closeley related( hospitalized for a week, with this reaction). What the heck is our goverment doing to us? I feel that the people in power, have split the country down the middle, the rich and the poor. The kings and the mice to use for experamentation. Thanks for a wonderful and informative sight. Suzanne C
Posted by: Suzanne C on May 22, 2006 04:45 AM
been on simvastatin for 3 yrs...cant remember grand kids names.....cannot spell...cannot follow conversations...shoulder joints ache... wife just recently went on lovastatin....now she having congnative problems...cannot grasp situations.....knew something wrong....now i know...telling doc going off statins...
Posted by: richard on June 9, 2006 12:42 AM
i have been taking statins for about 3 years and have complained about mussel pain all along, dr. dismissed this complaint,why i dont konw she was more worried about the numbers 230 was the last i think but my upper arms ache like i lifted weights. i am seriously thinking about going off them to feel pain free.also when walking or standing for any lenght time calfs burn... i really think its the mevacor
Posted by: danna on September 10, 2006 05:38 PM
I HAVE HEARD THERE ARE OTHER DRUGS FOR CHOLESTRAL LOWERING OTHER THAN THE ONES USUALLY PRESCRIBED SUCH AS LIPITOR. I CANNOT SEEM TO FIND OUT WHAT THEY ARE. DOES ANYONE KNOW?? LIPTOR CAUSED ME MUCH MISERY FOR A LONG TIME.
Response:
See:
Class Action - Statins Increases Heart Disease By 10% In Women
Chris Gupta
Posted by: Glenn on August 23, 2007 04:41 PM
I HAVE HEARD THERE ARE OTHER DRUGS FOR CHOLESTRAL LOWERING OTHER THAN THE ONES USUALLY PRESCRIBED SUCH AS LIPITOR. I CANNOT SEEM TO FIND OUT WHAT THEY ARE. DOES ANYONE KNOW?? LIPTOR CAUSED ME MUCH MISERY FOR A LONG TIME.
Response:
See:
Class Action - Statins Increases Heart Disease By 10% In Women
Chris Gupta
Posted by: Jean Gronmeyer on September 5, 2007 04:20 PM
I HAVE HEARD THERE ARE OTHER DRUGS FOR CHOLESTRAL LOWERING OTHER THAN THE ONES USUALLY PRESCRIBED SUCH AS LIPITOR. I CANNOT SEEM TO FIND OUT WHAT THEY ARE. DOES ANYONE KNOW?? LIPTOR CAUSED ME MUCH MISERY FOR A LONG TIME.
Response:
See:
Class Action - Statins Increases Heart Disease By 10% In Women
Chris Gupta
Posted by: Neil Ridlingafer on September 10, 2007 12:19 AM
I HAVE HEARD THERE ARE OTHER DRUGS FOR CHOLESTRAL LOWERING OTHER THAN THE ONES USUALLY PRESCRIBED SUCH AS LIPITOR. I CANNOT SEEM TO FIND OUT WHAT THEY ARE. DOES ANYONE KNOW?? LIPTOR CAUSED ME MUCH MISERY FOR A LONG TIME.
Response:
See:
Class Action - Statins Increases Heart Disease By 10% In Women
Chris Gupta
Posted by: Erik on November 15, 2007 10:23 AM
I HAVE HEARD THERE ARE OTHER DRUGS FOR CHOLESTRAL LOWERING OTHER THAN THE ONES USUALLY PRESCRIBED SUCH AS LIPITOR. I CANNOT SEEM TO FIND OUT WHAT THEY ARE. DOES ANYONE KNOW?? LIPTOR CAUSED ME MUCH MISERY FOR A LONG TIME.
Response:
See:
Class Action - Statins Increases Heart Disease By 10% In Women
Chris Gupta
Posted by: CAROLYN GLASS on November 16, 2007 09:44 AM
took Crestor ,5mg, 12 days. Stopped because of painful upper thighs and overwhelming fatigue. Dr. said nothing, changed me to Lipitor, 10mg. Took only TWO pills. A wave of weakness overcame me, couldn't balance after sitting, mind a complete fog. Dr. didn't want to see me....said nothing. Finally symptoms continued to worsen, even tho I had discontinue the lipitor. Dr. saw me, ran several blood and urnine tests. Said my enzymes were too high in my muscles and told me not to take Statin drugs. She has since not given me any information on what to do or not to do to improve. Told me it would go away as the medince leaves my system.............it has been a month, feel better, but get very tired if I do too much? Should I take the Q10 supplement or try to talk to my Dr. again? Isn't this suppose to be reported to the FDA?
Posted by: Vonda on January 27, 2009 09:43 AM
Statins have crippled me with severe muscle pain and weakness...doctor dismissed my complaints. Another doctor married to doctor who also tried statins had the same problems. The natural remedy for this problem is: red yeast rice by Natures Plus; omega 3 fish oil; ultra CoQ 10 by Qunol. Go to www.consumerlabs.com for information on the effecacy of any health food brand as they are not always what they say they are. ConsumerLabs does independent testing on all product so you can have the facts.
As far as the pain in the muscles goes, I have been off everything for a year now and am even worse now having to take pain pills to get through the day and night; at least with the pills I can do some physical work. My life has been changed forever thanks to the "statin drugs".
Response:
I can never understand why women are put on cholestrol lowering drugs. High cholestrol in women has never been linked with heart disease! CG
Posted by: Barbara Wallace on September 16, 2011 07:50 PM
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