MHRA response to my adverse reaction report and my response

[xrn]

Hello All,
Below is a copy of the MHRA response (UK drug safety body) to my statin adverse reaction report and my response to that reply. The commentary from the MHRA is worth reading very carefully. I have no wish to overwhelm people with a huge amount of technical literature. I do wish people to be accurately informed. For people who find it difficult to read a lot of technical argument, it can be summarised as follows:

My report is spontaneous and incapable of providing incidence data so it would appear to be discounted as worthless (in the strictly scientific sense) but it also appears to prevent the MHRA from listening to any patient derived information. I have responded with my view of this conduct and I have added a new paper reference that shows that statins reduce the function of the heart muscle. I guess that we now wont see a reply until after the new year holiday but I will keep people informed.

I wish you all a happy Christmas and a peaceful new year.


Dear Mr Cable,
Thank you for your three emails and informal report on the subject of statins and a possible association with neurodegenerative disorders. I will answer all of these emails (one of which was addressed to Claire Tilstone) in this single response.

The Medicines and Healthcare products Regulatory Agency (MHRA) together with independent expert advice from the Commission on Human Medicines (CHM) is responsible for ensuring that the overall balance of benefits and risks of medicines is positive at the time of licensing and remains so thereafter. The safety of all medicines including statins is actively monitored by the MHRA on an ongoing basis.

Cardiovascular disease is a significant problem in the UK and the British Heart Foundation (2008) has estimated that it is the cause of more than one in three deaths - nearly 198,000 a year. Statins have been shown to reduce the risk of cardiovascular events and save lives for certain patient groups. This has been demonstrated in a number of large trials of long duration, carried out in a diverse set of patients.

However, no medicine that is effective can also be completely free from side-effects. The decision to prescribe a statin is a joint one that should involve both the patient and his/her GP, and include a consideration of both the benefits and risks of the medicine as well as the personal medical history of the patient. Prescribing practice policy on a national basis is determined by the National Institute for Health and Clinical Excellence (NICE) who produce guidelines for prescribers.

The MHRA uses many methods to monitor the safety of all medicines, including spontaneous adverse drug reaction reports (via the Yellow Card Scheme, to which anyone – doctors, coroners, nurses, pharmacists, patients, can report), as well as randomised clinical trials, observational studies and sources from the literature.

A possible association between statins and amyotrophic lateral sclerosis (ALS) has been considered relatively recently by the MHRA. This potential signal was highlighted by a report by Edwards et al (Drug Safety 2007; 30 (6): 515-525) which used Vigibase (the spontaneous reporting database of the WHO programme for International Drug Monitoring) and found a disproportionately high reporting rate for ALS/ALS-like syndrome in association with statins.

Because of the recognised limitations of spontaneous reporting, the Food and Drug Administration (FDA) has since published an analysis of 41 placebo controlled clinical trials ranging from 6 months to 5 years in duration. This analysis found no suggestion of a link between statin treatment and ALS. It is published in Pharmacoepidemiology and Drug Safety (2008; 17(11): 1068-1076) by Colman et al.

The MHRA have more recently carried out a study of statins and ALS using the General Practice Research Database (GPRD). This study also found no evidence for a link between ALS and statins; instead it found that whilst the number of prescriptions for statins has increased dramatically between 1995 and 2007, the prevalence and incidence of ALS appears to have declined. These results were discussed by the Pharmacovigilance Expert Advisory Group, an independent expert group of the CHM, who concluded that the data did not support an association.

Your report clearly highlights many of the limitations of spontaneous data. In particular the following points need consideration: a temporal relationship for a suspected reaction does not prove causality; the patient group in question (statin users) is likely to have a higher background incidence of these types of disorders; the sample obtained will be influenced by many factors for example media attention that affect the rate of reporting, and the sample will be biased in the case of e.g. a petition such as that described in your report: not only will the people who fill in such a survey be unrepresentative of the population as a whole but also the petition is actively recruiting patients who have suffered an adverse event. For these reasons and several more, notably the lack of an accurate denominator, it is not possible to generate any form of incidence rate from these data. This is why studies such as that conducted in the GPRD, as described above, are so important.

We recognise that the clinical application of statins is a developing field and prescribing guidelines are changing to reflect the latest evidence. This means that a significant amount of new information is becoming available as more people start taking statins. However, please be assured that the MHRA, together with CHM, will continue to review any important new evidence and will, if necessary, take further regulatory action to minimise any risk to patients.
I hope that this information is helpful.

Vigilance and Risk Management of Medicines (VRMM)


My own response to this MHRA letter follows:


Thank you for your response to my e-mail messages concerning the self-reported adverse effects of HMG-CoA reductase inhibitors.

I am pleased to learn that MHRA and CHM will continue to review any important new evidence that may precipitate the need for regulatory action. I accept your point about spontaneous reporting but I did deal with that specific issue when describing the limitations of self-reported phenomena in my report. If the patients do not describe what they are experiencing how is anyone else to know precisely what the patients are feeling and experiencing? I agree that the background incidence of neurological conditions is likely to be higher in people who take statins (the question why is precisely the issue with which I am concerned) which was one of my prime reasons for writing an informal report detailing these self-reported adverse events.

The undeniable result of HMG-CoA reductase inhibition of cholesterol synthesis within the mevalonate metabolic pathway is that several other vital processes, which are unrelated to the production of cholesterol, are also affected. I have not found any satisfactory explanation or rationale in the literature that specifically requires the adjunctive inhibition of Coenzyme Q10, prenylated proteins, dolichols and heme A. Total cholesterol level is not altered by dietary intake but the notion still enjoys wide acceptance, to the point where we have minor celebrities appearing on television regaling us with tales of 'success' in lowering our numbers while imploring us all to cut our cholesterol by eating less of it. Why must the nation endure such nonsense? Low cholesterol levels are a robust predictor of early mortality and the literature supports that proposition.

Yes, cardiovascular disease in the UK is a significant problem, I have not found (from my reading of any of the major studies) that statins are saving lives in any significant numbers. The pharmaceutical study sponsors control the findings data and polish it to show their therapeutic agents in a good light. Drug companies discuss relative risk rather than absolute risk and the study exclusion criteria usually excludes subjects who are likely to smudge the perfection which is claimed for the statin therapies.

The fundamental fallacy of Ancel Keys's Seven Countries Study (excluding all of the countries which did not support the hypothesis) when combined with the less than stellar results from Framingham, could have been expected to halt the madness that is our annually falling cholesterol level targets. The UK permits the selling of statins as OTC medicines and it is clear that pharmacists may not be the best people from whom to seek accurate advice especially if they were to reflect the failure of substantial numbers of clinicians to acknowledge or understand statin-mediated adverse reactions. Why is there a reliance on chemical interventions to reduce cholesterol? Cholesterol is vital to life and it is essential to healthy neurological function. Cholesterol has not yet been shown to be the primary cause of cardiovascular disease.

There does not appear to be any science which supports the notion that female mortality rates benefit from statin therapy within either the primary or secondary treatment arenas. There are a few cases where men are shown to derive some small benefit within a very narrow age range. When I was considering the NICE guidelines following on from the technical appraisals, I was surprised to see that the manufacturers of statins were included in the discussions about national prescribing policy, which appears to be a long way short of an arm's-length arrangement. The chair of the Cholesterol UK Charity was calling for statins to be put in the water supply!

Any blanket treatment that is prescribed for all of the population (probably against their will and without their knowledge as would be case if statins were tipped into the water supply) is the very antithesis of medical practice and tantamount to healthcare by fiat. I must have missed the meeting where it was agreed that medicating people for life was going to be the substitute for a gentle, healthy lifestyle with the appropriate and minimal medical intervention, based upon informed consent, when required.

Yes, my informal report of the spontaneous reporting of adverse reactions was completely unregulated, nevertheless, it does not alter the take-home message. People who take statin therapy are quite likely to fail to comply with their prescribed treatment because of the severity of the adverse reactions they experience. The adverse reactions are likely to be severe because of the mode of action of statins, despite the persistent failure of the pharmaceutical industry to recognise the frequency and the severity of the effects that the reporting patients have attributed to statin therapies. My suggestion for further research would be easy to initiate rapidly and it would give a true picture of the extent of statin-damaged patients. One could also hope that statins would reduce mortality from cardiovascular disease but that is a forlorn hope given that statins will damage every patient, if they survive long enough to take them as was intended.

At no point did I tell the informants what they must write nor were they coached in how to describe the effects they were experiencing. They were free to write whatever they wished and that is what is absolutely compelling abut their accounts. The failure of a substantial number of clinicians to attribute adverse reactions to statin therapies suggests that there is widespread disbelief among clinicians that statins can cause any harm. When a satisfactory explanation is forthcoming as to the fate of the organism, after the inhibition of several vital processes which are unrelated to cholesterol production, then and only then will the picture be anything like complete.

I have absolutely nothing to gain from informing the MHRA pharmacovigilance section about my concerns. I don't sell anything and I no longer work for the NHS. Neither am I looking for fame or fortune. Despite these facts, I am finding it very difficult to understand why it is so hard to engage with the bodies and institutions that are charged with overseeing the health and safety of the public. When Merck patented Lovastatin, they also patented the addition of Coenzyme Q10 in an effort to ameliorate or prevent statin induced myopathy. Why, almost 20 years after that event, is there no adjunctive prescribing of coenzyme Q10?

I am not clinician and I have no research pedigree, neither am I an academic. I do feel that your dismissal of my report, ostensibly because it was spontaneous reporting, is a little hasty. If the editor of the Journal of Independent Medical Research, Professor Trevor Williams, could find some value in my informal report then I am reasonably sure that some value exists. My fear is this: If the MHRA reacts in manner that fails to recognise the potential harm that statins will inevitably cause, then a tableau vivant that is redolent of the thalidomide disaster will ensue and many more people will be damaged needlessly. I am merely the messenger and it is only the message which is crucial, not the person who had delivered the information.

This abstract was copied directly from PubMed and it represents a prime example of the literature not supporting the widespread and indiscriminate use of statin therapies. Any thoughtful person will want to know why statins, which are prescribed to reduce the risk to the cardiovascular system, actually decrease myocardial function. This sort of anomaly abounds in the literature and I can supply you with hundreds of examples that provoke similar questions. When lay people can find so much scientific evidence that cautions against the use of statins, without the open access to the literature that you enjoy, it is right to ask the questions that are begged by such evidence.

Clin Cardiol. 2009 Dec 21;32(12):684-689. [Epub ahead of print]
Statin Therapy Decreases Myocardial Function as Evaluated Via Strain Imaging.
Rubinstein J, Aloka F, Abela GS.
Cardiology Division, Department of Medicine, Michigan State University, East Lansing, Michigan.

OBJECTIVES: The purpose of this study was to evaluate the effects of statin therapy on myocardial function as measured with echocardiography with tissue Doppler imaging (TDI) and strain imaging (SI) independent of its lipid-lowering effect.

BACKGROUND: Statin use is known to improve outcomes in the primary and secondary prevention of ischemic heart disease, but their use is also associated with myopathy, muscle weakness and in rare cases, rhabdomyolysis. We sought to evaluate whether TDI and SI is able to identify changes in myocardial function associated with statin use.

METHODS: Myocardial function was evaluated in 28 patients via echocardiography with TDI and SI. We identified 12 patients (5 females) without overt cardiovascular disease (including hypertension, smoking, and diabetes) that were on statin therapy and compared their echocardiographic findings with 16 (12 females) age, sex, and cholesterol-profile-matched controls. Tissue Doppler imaging parameters of diastolic (E(')/A(') and E/E(')) and systolic (S') function were measured. Regional systolic function was obtained by SI in 4-chamber, 2-chamber, long axis, and average global views.

RESULTS: There was no significant difference in myocardial function as measured by Doppler and minor differences as measured via TDI among the 2 groups. There was significantly better function noted with SI in the control group vs the statin group in the 4-chamber (-19.05% +/- 2.45% vs -16.47% +/- 2.37% P = 0.009), 2-chamber (-20.30% +/- 2.66% vs -17.45% +/- 4.29% P = 0.03), long axis (-17.63% +/- 3.79% vs -13.83% +/- 3.74% P = 0.01), and average global (-19.0% +/- 2.07% vs -15.91% +/- 2.81% P = 0.004) views.

CONCLUSION: Statin therapy is associated with decreased myocardial function as evaluated with SI. Copyright (c) 2009 Wiley Periodicals, Inc.

PMID: 20027659 [PubMed - as supplied by publisher]

Kind regards,
Jeff Cable

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

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

[David Staup]

Jeff,

do not get discouraged, your efforts are much appreciated and the goal is just.

you are fighting against a very commom defence mechanism that Thomas Aquinas called "ignorantia affectata" (cultivated ignorance). it's an almost impossible battle to overcome this, especially when it is coupled with greed, hubris, and politics!

David

[Allen1]

The very fact that so many doctors either ignore or brush aside any possible connection to what a patient is experiencing to anything that their beloved statins could be doing to them is a BIG problem. This is possibly why there is so few yellow card reports plus how many patients even knew that they have the ability or right to use that system?

The other problem is the loss of financial support if the doctors fail to meet targets, that could have a major impact on what is deemed to be the choice of action when all possibilities of interaction and health issues are weighed up, after all no one else seems to be reporting significantly on these side effects so they must be OK right!

Looking back to after I had my triple bypass and my problems were getting worse, I recall my Cardiologist's assistant mentioning that he (the Cardiologist) was wondering if the statins were the problem as my other medications had been changed and the problems were still there. So it does show that many doctors are not as blind to the statin problems as others.

After reading your posts, I would have to say that Dr Elena Elliot-Smith being employed as a Scientific Assessor for the Vigilance and Risk Management of Medicines department or agency, does not appear to be very "Vigilant" when all around is evidence to dismiss Statins usefulness and even more to back up the harm they can cause.

Granted the people who work in this area will probably have 1000,s of files to look into but that IS their job. As you have pointed out, we do not have access to the vast amount of reports/information that they have and if people like those damaged by statins can find published reports where statins are scientifically shown to cause damage as well as the lack of necessity and scope of usage for this treatment, then surely those who work in that type of department/agency have failed dramatically to protect the population of this and other countries.

I am pleased you posted the replies here, it shows us all what needs to be done versus what will get done, it seems to me that the choice of biscuit with the morning coffee takes priority over anything else in areas of our national health.

Now hopefully someone who works for the departments or agencies involved in "Protecting" their population from harmful substances will read your post and DO something about the misinformation that they distribute and start to research the true facts about the harm that Statins do.

My other concern is, suppose someone IS already presenting all the adverse effects to those in charge and that information is being suppressed by their superiors, where does that leave us? After all the information that we know ourselves is also available to anyone who cares to look or maybe in the case of those departments etc can be bothered to look!

Also over the last couple of years the public have become more aware of the failings of government policies and dubious recommendations when it comes to health issues. Just take a look at the latest disaster ie for Swine Flu with its falsified number of cases and more, there are even adverts on TV to try to get people to get the injection, it seems to be just another Experts, Expert stupidity at play again, how much does this and other silliness cost in financial terms as well as the health implications?

Anyone who was in a position where they have passed on information to the right department only to be suppressed or ignored, could maybe post that information here even if it is anonymously. It would be nice to see what is going on behind closed doors or even to see that DR Smith and colleagues are hard at work sorting out this mess as a top priority and putting their intelligence to good use, mind you we are all in trouble is they end up the way I did

Keep on going Jeff, not everyone ignores what is in front of them, I sincerely hope that there are things happening in the background to end this stupidity. As Dr Smith says they will review any important new evidence and will, if necessary, take further regulatory action to minimise any risk to patients. Maybe she hasn't had time to read all the evidence against Statins or maybe she has only been given access to files that in the real world are made up fiction ie those studies that cherry pick and alter the results from tests/studies, if that is, so then she should do something about it.

All the best,
Allen.

[xrn]

Thank you both, David and Allen1, for your encouraging words. It is to be hoped that officialdom will start to take notice soon. I will continue to make a nuisance of myself until someone takes official notice. I look forward to Dr James Le Fanu referring to my report in the Daily Telegraph on Monday next. :)))

Kind regards,
Jeff (aka xrn)

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

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

[Nancy W]

Jeff,

Thanks for posting that letter and your well considered reply. And thanks, too, Allen and David for your thoughts.

It has become increasingly clear to me that most doctors can't begin to keep up with the medical literature, much less figure out what are the most important articles to focus on. One would think that "adverse effects" of any medication should be of interest, especially if that doctor prescribes that medication.

My husband, who remembers statistics much more easily than I do, has told me that only a very small number of doctors ever change their practices to reflect new information, preferring instead to practice as they were taught in medical school (who knows how many years before?). Perhaps this number was around 10-15%. I don't remember. I know that, for myself, I am required under the law to take 40 hours of continuing education every two years in order to keep my PT license. This is NOT very much new information to take in in 24 months as compared with all the new information that is out there in my field. It is very easy to be selective and take things that I am interested in, while avoiding much of what is out there that I probably ought to learn.

Most of the physicians I have seen this last year exhibited a certain level of rigidity with respect to the issue of statins. They don't even want to take down the reference to Bernice Golumb's study. Only my naturopath wanted the reference, as well as the references for this site and Dr. Graveline's books. I am guessing they don't present the same lack of interest to the friendly drug reps who come bearing gifts and free samples to their offices, along with jaded information.

If, statistically speaking, there are a limited number of us who have adverse reactions, I understand their bias, but what about their Hippocratic Oath to do no harm? And even 10% of all the people who are on statins is a very large number these days!

I am one of those folks who might be called the proverbial canary in the mine...I am sensitive to many medications, as well as many other things including chemicals in processed foods, such as MSG. When the canary died, the miners got out quick. If this "small" population is affected now, I bet more will be later as the downstream effects of cholesterol medications affect more and more people. Interesting that the "cards" are YELLOW!

Those of us who are able and willing need to keep on fighting the system. I am working to learn the language of the biochemistry of statins, as well as the spectrum of downstream functions, so that all of it all rolls off my tongue like the Pledge of Allegiance. I want to be able to counter any doctor who thinks he has all the answers in the form of a statin pill with a well-educated reply.

I fully appreciate the knowledge that some of you have and are willing to share in this cause!

Nancy

[xrn]

Nancy:
Jeff,

Thanks for posting that letter and your well considered reply. And thanks, too, Allen and David for your thoughts.

Jeff:
Thank you Nancy.

Nancy:
It has become increasingly clear to me that most doctors can't begin to keep up with the medical literature, much less figure out what are the most important articles to focus on. One would think that "adverse effects" of any medication should be of interest, especially if that doctor prescribes that medication.

Jeff:
It should be essential for every medic to understand what drug they are prescribing. I hint at that issue in my informal report. It is absolutely unacceptable for a doctor to prescribe any therapy without understanding where and how the drug acts and what are the adverse reactions and the antidote to them. That was the minimum that I was required to understand for every single preparation I had to give to patients when I was a nurse. Even though the medic prescribed the drug, I would have been culpable if I did not have sufficient pharmaceutical knowledge to know whether the drug was working.

Nancy:
My husband, who remembers statistics much more easily than I do, has told me that only a very small number of doctors ever change their practices to reflect new information, preferring instead to practice as they were taught in medical school (who knows how many years before?). Perhaps this number was around 10-15%. I don't remember. I know that, for myself, I am required under the law to take 40 hours of continuing education every two years in order to keep my PT license. This is NOT very much new information to take in in 24 months as compared with all the new information that is out there in my field. It is very easy to be selective and take things that I am interested in, while avoiding much of what is out there that I probably ought to learn.

Most of the physicians I have seen this last year exhibited a certain level of rigidity with respect to the issue of statins. They don't even want to take down the reference to Bernice Golumb's study. Only my naturopath wanted the reference, as well as the references for this site and Dr. Graveline's books. I am guessing they don't present the same lack of interest to the friendly drug reps who come bearing gifts and free samples to their offices, along with jaded information.

Jeff:
One can always find that the lazy are prepared to find any excuse they can. I have no tolerance for stupidity and far too many of the clinicians whom I have worked with have no interest in their work. The most work they appear to do is to see who can add another foot to the yacht each year. The clinicians I trained with were not of that ilk and I am saddened by the rush for power and status that I see now.

Nancy:
If, statistically speaking, there are a limited number of us who have adverse reactions, I understand their bias, but what about their Hippocratic Oath to do no harm? And even 10% of all the people who are on statins is a very large number these days!

Jeff:
It is not a case of if but when statins damage the patient. As explained in the small piece that appears on the e-petition web page, there are far to many casualties of statin use to suggest that there is no clinical significance. I wonder how many medical doctors would suggest that their nearest and dearest family members start taking statins at an early age. i could not believe that there is now a group of doctors who seriously think that we should all take statins, even when our cholesterol level is normal!

Nancy:
I am one of those folks who might be called the proverbial canary in the mine...I am sensitive to many medications, as well as many other things including chemicals in processed foods, such as MSG. When the canary died, the miners got out quick. If this "small" population is affected now, I bet more will be later as the downstream effects of cholesterol medications affect more and more people. Interesting that the "cards" are YELLOW!

And Dr. Reckless indeed! Statins in the water supply! Absolutely reckless...

Jeff:
I have had some discussion with Dr Reckless but I don't hold his words in high esteem. He is just another person who adds a whole list of statin making drug companies to the conflict of interest section of any research he conducts. It makes his viewpoint worthless.

Nancy:
Those of us who are able and willing need to keep on fighting the system. I am working to learn the language of the biochemistry of statins, as well as the spectrum of downstream functions, so that all of it all rolls off my tongue like the Pledge of Allegiance. I want to be able to counter any doctor who thinks he has all the answers in the form of a statin pill with a well-educated reply.

I fully appreciate the knowledge that some of you have and are willing to share in this cause!

Nancy

Jeff:
I am trying to avoid the technical language. If the questions are asked simply, it demands replies in simple language and it provides a smaller amount of wiggle-room for the snake-tongued medicine men. Please keep on fighting. Disseminate the report and the correspondence to whoever you will. I am still awaiting specific replies from the New York times because of the failure of the FDA/CDER to have a system that permits me to make any report.

Kind regards,
Jeff (aka xrn)

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

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

[xrn]

More dialogue between myself and the MHRA. This is the response from the officials at MHRA to my last letter. It adds to the paper trail and I am busy drafting my response... :D

Dear xrn
Thank you for your further two emails on the subject of statins. I apologise for the delay in this response. I will try to address the issues which you have raised.

Statins do indeed inhibit HMG-CoA reductase, which leads to a depletion of compounds such as coenzyme Q10, dolichol etc in addition to cholesterol. However, the clinical significance, if any, of these other effects is not clear at this time.

Total cholesterol levels are not necessarily a helpful measure and the evidence suggests that low cholesterol levels are not necessarily a predictor of early mortality. As you are aware, cholesterol travels through the circulation in several different complex particles, for example LDL (low-density lipoprotein) and HDL (high-density lipoprotein). It is widely acknowledged that a high level of LDL-cholesterol is a significant risk factor for cardiovascular disease. Conversely, for the majority of people high levels of HDL-cholesterol are understood to have a protective effect. It therefore follows that a person with high total cholesterol may have a low risk of CV disease, because they have high HDL and low LDL-cholesterol – and visa versa.

As you suggest, there is, however, some debate regarding the relationship between cholesterol levels and survival in patients with, for example, moderate to severe heart failure, in whom lowering cholesterol levels might in fact prove harmful.

Whilst some cholesterol is obviously essential to life, much of the adult population has a far higher level than necessary and although other risk factors for CV disease have been identified (smoking, high blood pressure etc), it is widely recognised that excessive LDL-cholesterol is a modifiable major risk factor.

Regarding the development of NICE guidance further details including information on the involvement of companies can be found at: *http://www.nice.org.uk/nicemedia/pdf/GuidelinesManualDevelopmentProcess.pdf. It is NICE guidance that determines prescribing practice on a national basis

With regards to the abstract you have provided, as I am sure you are aware, the nature of experimental science is that it provides conflicting information and a consensus of opinion can only be achieved by considering each new piece of robust evidence in the context of previous data.

You may be interested to know that a similar strategy to the further research you propose, in which patients are given a questionnaire to complete when they are taking a statin so that their experiences are captured, has already been undertaken for rosuvastatin (Crestor). This Prescription-Event-Monitoring study was carried out by the Drug Safety Research Unit in Southampton. In this study 20,000 GPs were sent a questionnaire on which to record every event experienced by patients in the 6 month period after starting Crestor, whether or not they suspected that the event was related to the study drug. The conclusions of this study, which provided information on 11,680 patients, were that rosuvastatin is a reasonably well tolerated drug, with muscle pain being the most frequently reported side-effect. No cases of rhabdomyolysis (serious, potentially life-threatening muscle breakdown) were reported.

I apologise if my previous letter came across as dismissive of your report in the Journal of Independent Medical Research – this was not the intention. Through our experience with the Yellow Card Scheme and particularly the extension of the scheme to patients, the MHRA is well aware of the benefits of obtaining information directly from those who use medicines. However, these need to be considered in conjunction with all other available data.

[Allen1]

Hi there Jeff,

its good to see that some of the problems are being recognised as in the depletion of compounds issue. The effects of being depleted of those compounds and the eventual health problems that ensue for many of us has not by the looks of things, been realistically looked into as being of any importance. We all know that the medical system has serious flaws in it, heck it took 10 years of Statin abuse before even one doctor thought of a possible link for me, and that was only because of raised CK levels, that is how bad the system is and how good the problems have been hidden or brushed aside.

I doubt if Dr Smith is as blinkered as she appears from the reply, she must be aware of the infective yellow card system and the under reporting of problems by doctors, she will also be aware that most people do not know about being able to use the system themselves even if they suspect that a problem is related to a drug.

Anyway congratulations on getting things moving, these may be small steps at first but they are going in the right direction. :)

Keep up the good work, it is making a difference, Allen ;)