A report that should be broadcast far and wide

[Brian C.]

The result of much hard application by our own Jeff Cable (aka 'xrn'), this analysis of responses to his WHO petition makes sober reading:

Self-Reported Patient Anecdotes - Should Clinical Judgement Reflect Them?

*http://files.me.com/jeffcable1/x9fh5b

It is in the process of being promulgated far and wide - and to the highest levels. I am sure you, dear reader, will do your bit ;o)

The WHO petition is still active and can be found here:

*http://www.gopetition.com/online/11757.html

Our heartfelt thanks to Jeff for this powerful document.

Brian.

[xrn]

[quote="Brian C."]The result of much hard application by our own Jeff Cable (aka 'xrn'), this analysis of responses to his WHO petition makes sober reading:

Self-Reported Patient Anecdotes - Should Clinical Judgement Reflect Them?

*http://files.me.com/jeffcable1/x9fh5b

It is in the process of being promulgated far and wide - and to the highest levels. I am sure you, dear reader, will do your bit ;o)

The WHO petition is still active and can be found here:

*http://www.gopetition.com/online/11757.html

Our heartfelt thanks to Jeff for this powerful document.

Brian.[/quote]



Thank you for the plaudit, Brian. Greetings to one and all on spacedoc.

So far, the informal report has gone to every agency charged with a responsibility for drug safety. Where I have not been able to find the responsible body, I hope that the WHO will pick it up. I have notified every major agency both national and international and I am starting to address the medical profession.

Countries contacted via national governmental bodies include the USA, UK, Europe, Canada, Australia, New Zealand, Singapore, Japan and China. I am also in touch with the secretary of state for public health in the UK and the Chief public health officer in Canada. I have contacted several national media outlets in the UK and I am awaiting some fallout from that.

I have been sending the information to agencies that deal exclusively with ALS on voluntary basis and this week I am going to target care of elderly and Neurological conditions and the agencies that may be interested.

The viral spread would be improved by every spacedoc member downloading a copy of the report and handing it to their clinicians and to friends and family who are known to be taking or considering taking a statin.

get your report here: *http://files.me.com/jeffcable1/x9fh5b

copy url to address bar of your browser and remove asterisk to be taken to a page that will download the 230kb file immediately. It is a PDF file so you will need Adobe Acrobat reader to view the file. the URL for obtaining your free copy of the reader is here:

*http://www.adobe.com/products/reader/

That's it for now. Will keep you all updated from time to time.

Jeff (aka xrn)

[xrn]

President Vaclav Klause (a sensible person, not easily swayed by pseudo science as seen in his concerns about the growth of environmentalism without thought)

The Lancet (a prestigious medical journal)

Thats all for now.
Jeff

[xrn]

Some more contacts which have received the report. Journal of the the American Medical Association, New england Journal of Medicine and Journal of Neurology.

That's it for now.

[David Staup]

Jeff,

I'm just curious, what responces have you received and what actions do you expect or hope will be taken ?

good work by the way, we all thank you

David

[xrn]

David,
I am planning (rather than hoping) for some medic or journalist to pick it up and run with it. Less loosely, this next phase is to court the media. I have contacted the BBC TV Newsnight investigative journalism team and relayed this information with my previous attempts to contact the secretary of state of public health in the UK.

My hope is that one of the official pharmcovigilance agencies around the world will undertake a short formal study to replicate my own informal results. It is cheap and rapid and will be very revealing. In some senses I do not care which agency picks it up... all of them are capable of understanding the implications. I also require statin-damaged people to pass the report onwards to their doctors and friends and relatives who may be taking a statin. this will open the debate and keep it alive.

I have also notified the medical profession within some of the largest medical establishments on the planet and in some of the most prestigious medical journals. I have started to notify important journals within the field of neurology and I will do the same for cardiac care and other related fields.

I just don't accept 'no can do' and will do all that I can to shift the weight of opinion. when I started the ePetition, there were quite a few detractors. At this end of the first report, I can see that I was right to persist.

I am now awaiting my dialogue with the current secretary of state for public health. In any event, public health ministers elsewhere will precipitate the debate, even if the UK one does not. Feedback which has been passed to me from clinicians whom I respect a great deal has been very positive.

I want to see a formal report that collects the same information as I did and reveals the extent of statin adverse reactions, type and damage resulting. I want to find out if 60% of people dod not comply with treatment and whether it was adverse reactions that caused them to cease treatment.

I want a repository of statin side-effects knowledge to be used for training doctors in the effects that are likely. I want to see CoQ10 made into an NHS prescription preparation so that many people who cannot afford to treat themselves in order to aid there recovery will be able to get better to some extent.

I intend to bring the whole wrongheaded cholesterol heart disease hypothesis into the public arena where it can be debated sanely. People have the right to be treated with decency and I will settle for nothing less.

Jeff (aka xrn)

[xrn]

The centre for drug evaluation and research at the FDA has responded to my report.It is a standard response but it is being passed further into the machinery of the FDA so I am hopeful. My last attempt to alert the FDA was met with no response so this looks to be more promising. A quick look at the online reporting system requires patient identifiers for each patient so I am going to try and enter a set of numbers and write one comprehensive adverse event report with a URL to my report. That is it for now.


Kind regards,
Jeff

my letter:
Dear CDER,

This report concerns the apparent safety of statin medications. Attached
are two files. One file is the patient's personal accounts, which
provide the information presented in the report. The other file is the
informal report.

My concern is that the the number of serious neurodegenerative diseases
such as amyotrophic lateral sclerosis has an incidence rate of 1:200,000
and in 351 reports there have been 18 occurrences of ALS and a further
11 cases of Parkinson's and Alzheimer's diseases along with one of each
case of progressive supra-nuclear palsy, multiple system atrophy and
chronic inflammatory demyelinating neuropathy, which every patient has
ascribed to statin therapy. One healthy patient had apparently developed
ALS within 6 weeks of commencing statin therapy. Of course there are
many other cases of neurological perturbation and this warrants a proper
investigation by the competent authority.

CDER response:
Thank you for your message to the Division of Drug Information at the
Center for Drug Evaluation and Research (CDER), one of the five centers
within the Food and Drug Administration (FDA).

We do appreciate your diligence in this matter and sending this
information to us. I will forward you comments to the attention of the
appropriate review division.

Meanwhile, we would like to alert you to the FDA's official mechanism (
MedWatch) for reporting adverse effects associated with an approved
drug. The MedWatch program is a voluntary system of reporting to FDA
adverse effects and product problems and we view this reporting system
as a source for signaling trends in these areas. Should a trend emerge,
the FDA will work with the sponsor of the product to address the
problem. Actions may include changes in the labeling information or
product packaging, enhanced warnings in the labeling, or communications
to health care professionals. In the most serious cases or where other
attempted solutions have not been effective, the sponsor may decide to
remove the drug from the market or the drug may be recalled from the
market. As such, we encourage you to submit a MedWatch report .You can
complete the form and submit online ( remember to print a copy for
yourself before submitting) or you can download the forms, complete them
manually and mail them to the address on the form. Forms can be accessed
from our website:

*https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm


Best regards,
Drug Information BLS
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

[xrn]

Good morning to all.

My report has now been accepted for publication.

The revised copy can be viewed at the following URL:

*files.me.com/jeffcable1/1h0utg

Kind regards,
Jeff

[xrn]

The report was published by the Journal of Independent Medical Research.

Please direct the attention of your medical practitioner to the following URL:

*http://www.joimr.org/JOIMR_Vol7_No1_Dec2009.pdf

The document will now always be referred to by the following reference.

Cable J: Adverse Events of Statins - An Informal Internet-based Study. JOIMR 2009;7(1):1

Kind regards,
Jeff (aka xrn)