Letter to the FDA

[xrn]

Dr Eric 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.

[carbuffmom]

WOW, you are awesome! Thanks from the bottom of my heart!

[xrn]

I sincerely hope that this letter will have some effect on the FDA, now that they have closed the door to over-the-counter statins becoming available within the USA, for the third time.

What it represents is an official complaint, despite the fact that I am not a resident of the USA.

thanks for your very kind comment DEB. <3

Jeff

[cjbrooksjc]

Jeff: Would you tell me - did you Email this document or send it physically (Mail, FedEx, etc.). I would be happy, as an American citizen who has had prior (one way) contact with the FDA and the US Congress about this subj., to forward my personal letter of support for your (spot on) fact-based hypotheses. I would like the address you used so my letter will follow the path and find same desk (hopefully) at the FDA.

KUDOS!

Brooks

[xrn]

Hi Brooks. I hope this e-mail finds you in improving health. Because of the festive season the mail service in the UK is now unreliable. (I could not refrain from pointing out that it always is)

I used the FDA website and followed the links for contacting the FDA. I did not specifically use the various drug related links. I have a large list of the workers at the FDA, with telephone numbers and room addresses; no less, and I selected the person I wanted to write to and after composing the letter offline, I cut and pasted it into the tiny box that is provided for writing a comment.

I will happily post you a PDF copy of the list. :))))
The guy, Eric Colman is the deputy director of the Division of Metabolism and Endocrinology Products (DMEP) and he can be found at W O 22/Rm. 3360. The phone number is 301-796-1190 and the phone code tells me that the office must be located in Berwyn, Maryland.

It makes no difference to me Brooks, because an e-mail letter is efficient (include an e-mail address if you want a reply) and I will be calling Dr Colman (at his office) on Monday. If he proves to be out, then his boss, Dr Mary Parks, is the director just two rooms away in 3362 and her phone number is 301-796-2290. You can be sure that one of them can expect a call from the UK on Monday. :)))))

Jeff

[cjbrooksjc]

Jeff: Thanks for asking: some days a diamond...

In reference to the FDA - I prefer a personal piece of correspondence over EMAIL whenever possible and so will use the address you provided with a 'confirmed delivery' request. I don't know what our chances are of making an impact, but to let them know the concern spans at least 6,000 miles AND the Atlantic appeals to me.

Regards,

Brooks

[cjbrooksjc]

Jeff: This ltr., along with a copy of your internet corresp. will go out US Mail tomorrow.



**************************************************************
Dr. Mary Parks
Director, DMEA
WO22 Room 3362
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, Md 20857-0001


Dr. Parks,

I write you in support of the following alert from Mr. Jeff Cable of Bedfordshire, England. Mr. Cable and I are acquainted through Statin-related misfortune. I, due to actual Statin damage; Mr. Cable, due to his background and professional intuition.

Though Mr Cable is not a U.S. citizen, he speaks for me and many other U.S. citizens so painfully affected by the careless proliferation of Statin drugs. I urge you to take this warning seriously and to act diligently to prevent further damage to our citizenry through the unwarranted and reckless dispersal of these medications.

We know Statin drugs are a desperately defended cash cow of the pharmaceutical industry. And it seems THAT, and not the rewards of a well-tested and valid medical solution, is the industry precipitate for continuing Statin drug dispersal unabated. Dr. Parks, it is the professional ethic of the F.D.A on which we depend to prevent such prejudice from injuring American citizens.

I would point out that Mr. Cable and I have become acquainted through an internet forum established by Dr. Wayne Graveline, a former NASA physician and Statin damage sufferer, to address the issue of Statin side effects. Please ask your staff to take the time to review the content of this forum (www.spacedoc.net).

Dr. Parks, I know you are all under a crushing load of responsibility, but we desperately need your professional involvement. Please take this alert seriously and act to prevent further injury.

Respectfully,

John L. Brooks
4408 Bowman Dr.
Colleyville, TX 76034

cc: Dr. Eric Coleman


***************************************************************

Many thanks Jeff,

John

[cjbrooksjc]

It was quickly pointed out to me - I misspelled Dr. Graveline's first name. That has been corrected; thanks Allen.

Brooks

[xrn]

Excellent, John. I have had no success with telephoning Dr Colman despite repeated calls to his office phone number at varying times of the day. Maryland should be EST as far as I can tell and that should have meant that I was ringing at suitable times. Either he is an incredibly busy person without a PA or he is on leave.

I will wait until after January 1st and try again. The full postal address is useful information and I will resend my materials, with a covering letter, on a CD. The only additional information which I can pass on at this point is for the extension telephone number system. If you dial any of the general numbers, you can put the number 6 before the unique 4 figure number for the person you want to speak to and it becomes their internal extension number, thus: 301-796-2290 (for Dr Mary Parks) becomes extension 62290.

that's all folks

Kind regards,
Jeff

[Brian C.]

They are probably still on "academic time" so don't expect any signs of life for at least a couple of weeks

Brian.

[cjbrooksjc]

Yes, Md. is on Eastern time. I actually lived Rockville Md. in another life, and one of my clients was NIMH, as in The Rats of NIMH (which actually stands for Nat'l Inst of Mental Health). Also, Brian is right: Federal employees, like academicians, clear out during the holidays; after the 1st is a good bet.

Brooks