Statins Don’t Boost Risk Of Lou Gehrig’s Disease
12 CommentsBy Ed Silverman // September 29th, 2008 // 4:30 pm
This is according to an FDA analysis, which began last year and was undertaken after agency officials received a higher-than-expected number of adverse event reports of amyotrophic lateral sclerosis, or ALS, in patients taking statins. Nonetheless, the FDA says further study is warranted.
The review of data from 41 long-term controlled clinical trials showed no increased incidence in those given a statin compared with placebo, and was reported today in Pharmacoepidemiology and Drug Safety. ALS, by the way, is a fatal neurodegenerative condition with an overall annual incidence of 1 to 2 per 100,000 people in the general population. The incidence increases with age.
The FDA’s paper noted that nine of about 64,000 patients treated with a statin and 10 of about 56,000 patients treated with placebo were diagnosed with ALS. From this data, the incidence of ALS in patients treated with statins was 4.2 cases per 100,000 patient-years and the incidence of ALS in patients treated with placebo was 5.0 cases per 100,000 patient-years.
“While the FDA finds the lack of an increase in the incidence of amyotrophic lateral sclerosis in patients treated with statins in clinical trials reassuring, given the extensive use of this class of drugs and the serious nature of ALS, continued study of this issue is warranted,” Mark Avigan, who heads the division of pharmacovigilance at the FDA’s Center for Drug Evaluation and Research, in a statement.
The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use that is being conducted by Lorene Nelson, chief of the division of epidemiology at the Stanford University School of Medicine, and Kaiser Permanente division of research. Results should be available within six to nine months. FDA is examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins, the FDA says.
NR
That’s a very deceptive headline Ed. I know you may not have written it, but I still don’t think you should let it stand. It is not a reflection of the study.
Ed Silverman
Hi NR,
For better or worse, I write all the headlines, which can be an imperfect endeavor, given space constraints. Beyond that, what would you have suggested?
Regards
ed
NR
Statins kill?
Go ahead. Prove me wrong.
LILLI
Statins Do Kill! Our government allows this to continue—protecting Pharmaceuticals.—not the patient
Ed You write the headlines-Do more research when the genral Public’s lives are in danger. It is the same as the bailout—forget about the average American protect the RICH AND CORRUPT.BECUASE OF OUR POLITICAL UNTHETHICAL VALUES AND AMERICAN POLITICS IS BURYING THE TRUTH. EVEN YESTERDAY’S DECISION ON THE BAILOUT PLAN IS CORRUPT! AT THIS TIME THE GENERAL PUBLIC DOES NOT KNOW WHO IS HONEST AND TELLING THE TRUTH. ED I KNOW YOU DO NOT LIKE CAPITAL LETTERS—BUT WHAT IS HAPPENING IN OUR WORLD IS DISGRACEFUL. I AM ANGRY. i HAVE LEGIMATE REASON TO BE ANGRY.
Justice in MI
NR - Can you elucidate your summary of the study?
NR
ED! ED! What a time you picked to take a couple days off.
http://www.forbes.com/business/pharma/2008/09/30/pfizer-drug-agenda-biz-bizhealth-cx_mh_0930pfizermemo.html
The Lord
NR - Ed didn’t pick them.
Nathan
Wow! Thanks for that link NR!! That’s incredible. It actually parallels some rumors I’ve heard for my own corner of the big pharma world. We have to invest our research $$$ in areas where drugs are profitable, approvable, and needed. It seems that Pfizer has identified a few areas that just don’t meet these criteria.
LILLI
From Spacedoctor: One could say much about the sample of the population that I have reported on and one
could also find many reasons to exclude such a sample, based on their own self-reported
and anecdotal evidence, from serious deliberation about the therapeutic value of any
specific group of drugs. Many anecdotal reports about the adverse reactions to statin
therapies are indicative of the highly toxic nature of this class of drugs.
The inhibition of Heme A within the mevalonate metabolic pathway presages the death of
cells that can no longer derive energy from the food that we are eating. The work of
Professor Bruce Ames is instructive: Bruce N. Ames, Ph.D. Professor University of
California, Berkeley, Senior Scientist, Children’s Hospital Oakland Research Institute;
U.S. National Medal of Science; Research in delaying the mitochondrial decay of aging.
I can see that there are many technical considerations as to why statins may not be the
causative agent in cases of ALS or ALS-like symptoms. Equally valid; I can see why there
would be many reasons for a raised index of suspicion when one considers the toxic
effects of statins that give rise to numerous adverse reactions that were not experienced by
the patients before they had started to take statins to lower their cholesterol.
The medical profession appears to be unable to accept that there may be anything wrong
with statin therapies. I commend the following link to you.
*http://www.thincs.org/NEJMcommenttoTNT.htm
My lay mind was suspicious of my findings and, at first, I thought that I must be mistaken.
Accepting for one moment (for the sake of this discussion) that I am not mistaken, I wish
to make a formal request that the FDA makes a determined effort to examine the
possibilities raised by my letter. The FDA ought to insist on the closest scrutiny and
reporting of the aetiology of every case of ALS, especially where one of the common
factors was known to be a statin.
All of the petition material on the global petition website and the analysis from my own
website, can be supplied as PDF files for
NR
Isn’t it uncanny how all the drugs Pfizer will focus on now just happen to treat statin adverse effects.
And what’s happened to the Cholesterol Hypothesis then. Oops? Poof? All better now?
T.Lord. I’m not Jewish. Oy. (Bows, genuflects and apologizes.).
The Lord
That’s OK. Some of my best creatures are not Jewish.
LILLI
What is this aboutbeing Jewish? Jesus was Jewish.