Re: The news gets worse... my letter to the FDA

[Guest guest]

>

> the WSJ has an article that shows that the FDA have refused Merck/s request to

make

statins

> available as OTC (over the counter medicines).

>

> The link allows you to write comments.

> http://blogs.wsj.com/health/2007/12/13/fda-calls-for-research-on-lou-gehrigs-

statin-

> link/

>

> I have written a couple of comments. I have just discovered that I have a

total of 9

people in

> 310, who have developed ALS and 6 of them were taking Lipitor.

>

> Jeff

>

Dr Colman - Deputy Director: Division of Metabolism and Endocrinology

Products

Dear Dr. Colman,

I am prompted to write to you with news of that which, on its face, appears to

be a

significant finding. I have been running a global e-petition, since April 3rd

2007, for the

purpose of collecting sufficient signatures to encourage the World Health

Organisation to

initiate an impartial investigation into the risks that attend the use of statin

therapies.

It has taken some time for the petition to become known about and I have

recently

analysed the first 100 signatures. The analysis can be found at the following

URL,

http://talkingstatins.com/page4/page33/page33.html The global petition can be

found at

the following URL: http://www.gopetition.com/online/11757.html

The petition was neutral about what people ought to write in support of their

signature.

(each signatory can append a 500 word commentary in support of their comments)

After

the analysis of the first 100 useful commentaries, I changed the rubric to

reflect a desire

to see more useful information being appended by the people who had chosen to

write a

comment in support of their signatures.

The resulting analysis had surprised me because many more people were

experiencing

what were obviously disruptive adverse reactions; to the statins they had been

taking. The

most noticeable adverse reaction was that 5% of the respondents had ascribed

their

development of Amyotrophic Lateral Sclerosis (ALS) to the fact that they had

taken statins.

Given the significant insult to several major processes within the mevalonate

metabolic

pathway, that follows the inhibition of cholesterol production with statin

therapies, the

conclusion that statins may be implicated in the development of ALS, among

statin takers,

is not beyond the bounds of reason.

As the number of signatories to the e-petition has started to climb, one

noticeable trend

is that more people are reporting the development of ALS. After 310 signatories

(not all of

whom have commented) the total number of people reporting the development of

ALS,

which they ascribe to statin treatment, now stands at nine cases, of which six

people had

reported that they were taking atorvastatin.

In the same sample of the population, one person had reported developing

rhabdomyolysis and one person had reported what was described as a case of " near

rhabdomyolysis " . The incidence of rhabdomyolysis is thought to be 4 cases in

every

100,000 patients, as can be seen from either of the following links.

http://www.jr2.ox.ac.uk/bandolier/booth/cardiac/statmusc.html

http://jama.ama-assn.org/cgi/content/full/292.21.2585v1

The incidence of ALS in the USA and Europe is thought to be 2 cases in every

100,000 as

can be seen from the following URL.

http://www.neurology.org/cgi/content/full/68/13/E17

It is clear that, for my sample population of 310, I could have expected to see

two cases of

rhabdomyolysis to every one case of ALS. For 310 reports, I would have expected

one

occurrence of each condition. Nine cases of ALS suggests to me that either ALS

is not

being reported frequently, or that its development is on the increase and that

it may be

that statins are fomenting the increase. The incidence of ALS among so very few

statin

takers, would suggest to me that this is a very fruitful area for initiating

future research

efforts.

The widespread use of statins is predicated on the cholesterol/heart hypothesis,

which has

been comprehensively discredited by researchers investigating the links between

heart

disease and cholesterol since the work of the Framingham study and Ancel Keys

had

become instrumental in changing the way we perceive cholesterol and its role in

our

bodies.

Thousands of years of evolution did not equip our bodies with a statin-mediated

regulatory mechanism for bringing down our dangerously high cholesterol counts.

The

literature appears to say, repeatedly, that lower cholesterol values are

associated with

earlier mortality. Regulatory bodies such as the FDA in the USA (and NICE in the

UK) are

apparently unable to include this revolutionary notion within their

deliberations about

statin therapies.

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 your convenience, at your request.

[Guest guest]

Jeff, thanks for this!!! See how you like my comment....you just have to understand that public companies will burn the furniture to make their numbers. Look at the risky loan debacle - people giving out BS loans just to keep their jobs another quarter.... KipJeff Cable <jeff@...> wrote: >> the WSJ has an article that shows that

the FDA have refused Merck/s request to make statins > available as OTC (over the counter medicines). > > The link allows you to write comments. > http://blogs.wsj.com/health/2007/12/13/fda-calls-for-research-on-lou-gehrigs-statin-> link/> > I have written a couple of comments. I have just discovered that I have a total of 9 people in > 310, who have developed ALS and 6 of them were taking Lipitor. > > Jeff>Dr Colman - Deputy Director: Division of Metabolism and Endocrinology ProductsDear Dr. Colman,I am prompted to write to you with news of that which, on its face, appears to be a significant finding. I have been running a global e-petition, since April 3rd 2007, for the purpose of collecting sufficient signatures to encourage the World

Health Organisation to initiate an impartial investigation into the risks that attend the use of statin therapies.It has taken some time for the petition to become known about and I have recently analysed the first 100 signatures. The analysis can be found at the following URL, http://talkingstatins.com/page4/page33/page33.html The global petition can be found at the following URL: http://www.gopetition.com/online/11757.htmlThe petition was neutral about what people ought to write in support of their signature. (each signatory can append a 500 word commentary in support of their comments) After the analysis of the first 100 useful commentaries, I changed the rubric to reflect a desire to see more useful information being appended by the people who had chosen to write a comment in

support of their signatures.The resulting analysis had surprised me because many more people were experiencing what were obviously disruptive adverse reactions; to the statins they had been taking. The most noticeable adverse reaction was that 5% of the respondents had ascribed their development of Amyotrophic Lateral Sclerosis (ALS) to the fact that they had taken statins. Given the significant insult to several major processes within the mevalonate metabolic pathway, that follows the inhibition of cholesterol production with statin therapies, the conclusion that statins may be implicated in the development of ALS, among statin takers, is not beyond the bounds of reason.As the number of signatories to the e-petition has started to climb, one noticeable trend is that more people are reporting the development of ALS. After 310 signatories (not all of whom have commented) the total number of people reporting the development

of ALS, which they ascribe to statin treatment, now stands at nine cases, of which six people had reported that they were taking atorvastatin.In the same sample of the population, one person had reported developing rhabdomyolysis and one person had reported what was described as a case of "near rhabdomyolysis". The incidence of rhabdomyolysis is thought to be 4 cases in every 100,000 patients, as can be seen from either of the following links. http://www.jr2.ox.ac.uk/bandolier/booth/cardiac/statmusc.htmlhttp://jama.ama-assn.org/cgi/content/full/292.21.2585v1The incidence of ALS in the USA and Europe is thought to be 2 cases in every 100,000 as can be seen from the following URL. http://www.neurology.org/cgi/content/full/68/13/E17 It is clear that, for my sample population of 310, I could have expected to see two cases of rhabdomyolysis to every one case of ALS. For 310 reports, I would have expected one occurrence of each condition. Nine cases of ALS suggests to me that either ALS is not being reported frequently, or that its development is on the increase and that it may be that statins are fomenting the increase. The incidence of ALS among so very few statin takers, would suggest to me that this is a very fruitful area for initiating future research efforts.The widespread use of statins is predicated on the cholesterol/heart hypothesis, which has been comprehensively discredited by researchers investigating the links between heart disease and cholesterol since the work of the Framingham study and Ancel Keys had

become instrumental in changing the way we perceive cholesterol and its role in our bodies. Thousands of years of evolution did not equip our bodies with a statin-mediated regulatory mechanism for bringing down our dangerously high cholesterol counts. The literature appears to say, repeatedly, that lower cholesterol values are associated with earlier mortality. Regulatory bodies such as the FDA in the USA (and NICE in the UK) are apparently unable to include this revolutionary notion within their deliberations about statin therapies.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.htmMy 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 your convenience, at your request.True affluence is not needing anything- Snyder

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