LCHF diet and taking Simvastatin

There are a few reasons why pharma companies don't release all data, most of them down to commercial reasons. They don't want to give their competitors any intelligence. Sounds fair enough to me. People forget sometimes that these are private companies; they need to make money. It's papers like the Mail and Express that are up in arms about the cost of some novel cancer treatments. What they don't report is that it costs $1bn and 1 decade to bring a drug to market. Regrettably, pharma companies are not charities, if they don't make money, there will be no drugs at all. Say goodbye to controlling diabetes.

Secondly, studies might be flawed, they might not show any trends, there might be a large number of deaths (unrelated to the drug, but related to the disease), there may have been funding cuts, there might have been too many protocol deviations, or it might have been decided half way through the trial that for whatever reason it will be discontinued.

So, I don't believe that there are sinister reasons why data is not being released. If a trial has shown up intolerable, or life threatening adverse events, then the regulators would've know about it and the scientists would not have exposed patients to it.

SamJB said:

All drugs have adverse effects, some worse than others. Taking drugs is about balancing the risks - the perpetual battle of efficacy versus safety.

Clinical study phases are designed around safety, tolerability, efficacy, combination therapy (I.e combinations of drugs) and dose scheduling. Each of these phases can have dozens of individual studies that investigate all kinds of different cohorts; age, sex, race, fitness, medical history, alcohol consumption etc. They are very comprehensive, which is part of the reason why it takes 10 years of studying a drug before it comes to market.

Will some adverse effects be discovered when the drug has come to market? Possibly. Are there any malicious people at pharma companies knowingly putting patient safety at risk for the sake of pleasing the shareholders? Definitely not.

In addition, many people that take drugs for chronic conditions tend to be unwell, or prone to illness. It's very difficult, in a non-clinical setting, to isolate an adverse effect of a drug, to an adverse effect from a chronic condition or lifestyle factors.

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Then how to you account for the many fines that have been imposed on pharmaceutical companies for exactly this kind of misrepresentation?

Indy51 said:

Then how to you account for the many fines that have been imposed on pharmaceutical companies for exactly this kind of misrepresentation?

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Because as I said it's not usually misrepresentation. People often assume because safety trials haven't been disclosed, that it's some sort of malicious act, when there's all kinds of reasons why a trial is not used. If an experiment is flawed, it's best not to include it.

Let me state it again, I don't know a single person that will put patient safety a risk, from scientist to senior managers. People work at pharma companies to cure patients not make them ill. It really irritates me that we're branded as evil by the tabloids and their readers.

It's quite clear that many people overlook the fact we've, as an industry, changed the world for the better; most people on here would be dead if it wasn't for big pharma. Instead we're branded as evil drug overlords. It's not a balanced opinion.

I've always stated that I am wternally grateful to the dogs, cattle and humans that enabled insulin to be made and reaearchers etc...but the world has changed....and the biggest word to change it, is PROFIT.... Just likethe greed of the bankers the pharmaceutical companies are worried about their profits, and shareholders above anything else. What else is behind some Companies being investigated around the world for less than scrupulous dealings being raised in the media and then we have NICE... Why was it necessary for payments to NICE... Why weren't they independent?

I could review all drugs but insulin independently and at home without payment-- as I do actually because I then report any side effects to MHRA... But I don't get payments from Companies...even the Mhra haven't got the resources and funding they have to ask companies like accuchek etc to investigate themselves...

Profit is greed and where there is greed there's corruption..


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And it's not just the tabloids that are raising questions about the pharm companies. That's just a red herring.

Merck apparently once considered adding CoQ10 to their statin because they knew that its production (and dolichols) were inhibited by the statin. CoQ10 and dolichols are vital to the proper function of the body. They dropped it because none of the other pharm companies were doing it. So they all know this but choose not to publicise the fact. Why is this then? Doesn't sound like 'health comes first' to me.

sanguine said:

Doesn't sound like 'health comes first' to me.

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It seems to me there's a grey area that shades from "this medicine definitely saves lives, so the side effects are tolerable, and it brings in a profit, so it's worth manufacturing" through "this medicine is likely on balance to help, so the side effects are tolerable" and ends with "this medicine does no known harm and it makes a profit, and the side effects are tolerable, so it's worth manufacturing". None of these is illegal and none puts patient safety at risk, so although only the first could really be called "health comes first", it's hard for an outsider to know which one is the motivator for which medicine.

Kate

And if the side effects aren't tolerable? Who makes that judgement?

Absolutely, pharma companies are shareholder and profit-driven. Personally I think they're too shareholder driven. I too also disagree with underhand tactics such as doctor bribery etc.

My point isn't about that. It's that, it's that drug trials run by pharma companies are extremely safety and regulatory driven. There will always be exceptions when something hits the headlines, but even in those cases, there was likely to be a reasonable answer as to why safety statistics weren't reported.

Sanguine, I do believe that CoQ10 is prescribed to people who suffer from statin-induced muscle aches. If you don't suffer from the symptoms of CoQ10 deficiency, then chances are, you don't have the deficiency, or it is tolerable. I wouldn't want to take drugs I don't need. Taking CoQ10 can cause stomach upsets, loss of appetite, nausea, diarrhea, skin rashes and low blood pressure. So, there probably were safety considerations when deciding to not include it with the statin.

Coq10 was never, ever discussed with me, ever... I bought my own after researching the internet... Certainly never prescribed. I hope that someone comes forward and differs with the advice I was given.

If it is known by the companies to deplete coq10, then why isn't this listed as a side effect or a precaution... May lower coq10..?

Why is it the public have had to research this? Perhaps I'm the only person with 3 **** gp's and 2 different consultants, and a research consultant in QE2 hosp that discussed statins with me but never once has anyone ever discussed coq10...


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I think the instructions that come with statins report that users may suffer from muscle aches, which is the symptom of CoQ10 deficiency. I'm sure they state that you should go to your doctor if you suffer this. I think this is sounds advice.

Sam, I applaud you for putting your point of view into what is an interesting discussion, you must feel you are in a small minority flying the flag for the pharm companies against an army of total cynics! Anyway,

SamJB said:

Absolutely, pharma companies are shareholder and profit-driven. Personally I think they're too shareholder driven. I too also disagree with underhand tactics such as doctor bribery etc.

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OK good

SamJB said:

My point isn't about that. It's that, it's that drug trials run by pharma companies are extremely safety and regulatory driven. There will always be exceptions when something hits the headlines, but even in those cases, there was likely to be a reasonable answer as to why safety statistics weren't reported.

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Ah, but you understand our point that it's not the safety and regulatory aspects of the trials per se that's the issue (well it is a bit), but the availability of the data in those trials to entities that can carry out a truly independent review and audit of them. You say commercial confidentiality is an issue here, but again I would assume that all major pharm companies are doing very similar things and can certainly analyse each others' products, so what exactly is at stake, especially in the case of assessment of side effects?

Of course, if all the companies pooled their trial data and saved all that money for the common good - no, stupid idea, why would that work ...

SamJB said:

Sanguine, I do believe that CoQ10 is prescribed to people who suffer from statin-induced muscle aches. If you don't suffer from the symptoms of CoQ10 deficiency, then chances are, you don't have the deficiency, or it is tolerable. I wouldn't want to take drugs I don't need. Taking CoQ10 can cause stomach upsets, loss of appetite, nausea, diarrhea, skin rashes and low blood pressure. So, there probably were safety considerations when deciding to not include it with the statin.

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But as Indy has pointed out (elsewhere if not here, maybe in the statins side-effects poll thread http://www.diabetes.co.uk/forum/threads/poll-side-effects-from-statins.58409/ CoQ10 is a natural product - are you saying the natural CoQ10 that the statins inhibit also has these effects? I think I'd sooner have the 'real' one left intact thanks (the pharm companies are desperately trying to find something that focusses on cholesterol further down the biochemical evolution tree to avoid CoQ10 and dolichol inhibition, so what does that tell us?).

SamJB said:

I think the instructions that come with statins report that users may suffer from muscle aches, which is the symptom of CoQ10 deficiency. I'm sure they state that you should go to your doctor if you suffer this. I think this is sounds advice.

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Well it does, once you get past the screaming 'don't take with grapefruit' bit. But how disingenuous is it not to mention CoQ10 in that respect if that is 'the symptom'? You can get muscle aches for all sorts of reasons, I haven't seen anyone on the statin poll thread say they've been to the GP complaining about muscle pain, and the GP says 'Oh that must be due to CoQ10 inhibition'. It usually seems to be more like 'well what do you expect at your age?. If the patient even realises the connection AND bothers to report it at all, AND if the GP then relays that back to NICE.

donnellysdogs said:

Coq10 was never, ever discussed with me, ever... I bought my own after researching the internet... Certainly never prescribed. I hope that someone comes forward and differs with the advice I was given.

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Not me, even though I have a genetic Q10 deficiency even without any help from statins. What happened was that the db consultant said looking at at my age and weight at diagnosis, my pattern of high fasting bg but normal OGTT results, the very slow progress of my db and my history of stroke at a young age without risk factors, he suspected MIDD or MELAS. He gave me some articles to read about them, and this was shortly after I'd had intolerable side effects from simvastatin. In the literature it mentioned Q10 deficiency as a common symptom of these db syndromes and said statin use was contraindicated, so at the next appt I raised it my statin problem with him, he got me tested, and bingo! Q10 deficiency was diagnosed!

My point is that even when a specialist suspected I had a condition that commonly includes Q10 deficiency, he didn't connect it with statins or think to warn me. To be fair the simva had been prescribed by my GP on his own initiative, not in consultation with the specialist. Even when I went back to the GP before seeing the consultant and told him about the side effects he didn't mention Q10.

So this reinforces your point that it's rare for HCPs to make any connection between Q10 and statin use. When I mentioned it to another GP in the group practice he treated me as if I were a batty old dear extolling the virtues of homeopathic oil of evening primrose and said he was sure taking supplements wasn't likely to do me any harm if it made me feel happy. Grr.

Kate

I'm not a Samjb basher, and I do fully understand (don't agree) with his thoughts, it is interesting to hear some thoughts from people within these industries like Sam.

Thnx Sam for your insight to how you perceive drug companies, it is very enlightening...


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I posted this on another thread it is also relevant to this discussion.

If your on simvastatin check out the The new draft NICE guideline on lipid modification, you might want to discuss this with your GP.

"In this respect, NICE’s suggestion that fixed doses of atorvastatin are used (simvastatin is out, following emerging data on its higher rhabdomyolysis risk) will be a relief to GPs and practice nurses, who will not face the burdensome exercise of titrating the dose against an arbitrary cholesterol level."

http://www.gponline.com/viewpoint-n...scular-system/hyperlipidaemia/article/1295573

Seeing simvastatin has been on the market for many years wonder why it's taken so long for this emerging data to be discovered !

sanguine said:

Sam, I applaud you for putting your point of view into what is an interesting discussion, you must feel you are in a small minority flying the flag for the pharm companies against an army of total cynics! Anyway,

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Thanks, I think!

sanguine said:

Ah, but you understand our point that it's not the safety and regulatory aspects of the trials per se that's the issue (well it is a bit), but the availability of the data in those trials to entities that can carry out a truly independent review and audit of them. You say commercial confidentiality is an issue here, but again I would assume that all major pharm companies are doing very similar things and can certainly analyse each others' products, so what exactly is at stake, especially in the case of assessment of side effects?

Of course, if all the companies pooled their trial data and saved all that money for the common good - no, stupid idea, why would that work ...

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A great deal of effort goes into competitor intelligence; I myself have worked in this area. Competitor intelligence can save (or cost, depending on which end of it you're on) a lot of time and money. For example, I work in oncology and I recently wanted to find what chemo drug in combination with a competitor's drug (which was similar to ours), produced the most adverse events. Combination trials are costly and difficult to do because you have more than one variable drug.

I agree that in a utiopia world, all pharma companies would get together and share data; and we are moving towards that with the new regulations coming in. In particular, trials are increasingly being contracted out to smaller companies, but data is the greatest asset a drug company has before a drug is brought to market and understandably, they don't want to share that.

sanguine said:

But as Indy has pointed out (elsewhere if not here, maybe in the statins side-effects poll thread http://www.diabetes.co.uk/forum/threads/poll-side-effects-from-statins.58409/ CoQ10 is a natural product - are you saying the natural CoQ10 that the statins inhibit also has these effects? I think I'd sooner have the 'real' one left intact thanks (the pharm companies are desperately trying to find something that focusses on cholesterol further down the biochemical evolution tree to avoid CoQ10 and dolichol inhibition, so what does that tell us?).

Well it does, once you get past the screaming 'don't take with grapefruit' bit. But how disingenuous is it not to mention CoQ10 in that respect if that is 'the symptom'? You can get muscle aches for all sorts of reasons, I haven't seen anyone on the statin poll thread say they've been to the GP complaining about muscle pain, and the GP says 'Oh that must be due to CoQ10 inhibition'. It usually seems to be more like 'well what do you expect at your age?. If the patient even realises the connection AND bothers to report it at all, AND if the GP then relays that back to NICE.

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Maybe it's just not possible to produce a statin that doesn't trigger whatever the CoQ10 receptor is. I personally don't think it should be included by default in statins because many people don't suffer from the symptoms of CoQ10 deficiency. I think it's clear from packaging that there are adverse events associated with statins. I think it's more on the onus of the doctor to monitor a patient taking a drug for a chronic ocndition.

Edit: removed nested quotes.

donnellysdogs said:

I'm not a Samjb basher, and I do fully understand (don't agree) with his thoughts, it is interesting to hear some thoughts from people within these industries like Sam.

Thnx Sam for your insight to how you perceive drug companies, it is very enlightening...


Sent from the Diabetes Forum App

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Don't worry, I'm not taking anything personally! I don't want to give the impression that I think pharma companies are whiter than white. They're not, there's bad eggs working in every industry and no-doubt some of them are making bad decisions at pharma companies.

I'll say it again, since you think I'm disengeuous saying this; everyone I've worked with at pharma companies are committed to regulations and safety. They're driven by it. People spend their working lives devoted to it. So it's sad that you don't agree with me when I have first-hand experience.

As mentioned, I take statins. Am I worried about adverse events from them? Yes, or course. I'm also worried about hypos from insulin. All drugs have adverse events. If you don't want these events, don't take the drug.

I too, am a natural cynic. You have to be to be a scientist. I'm extremely cynical about dietary advice given to diabetics, I'm doing something about it (more to follow in a few months, hopefully). I'm even cynical on the need to take statins in the first place. I'm less cynical about patient safety in pharma companies because I have day-to-day experience in it.

kesun said:

Not me, even though I have a genetic Q10 deficiency even without any help from statins. What happened was that the db consultant said looking at at my age and weight at diagnosis, my pattern of high fasting bg but normal OGTT results, the very slow progress of my db and my history of stroke at a young age without risk factors, he suspected MIDD or MELAS. He gave me some articles to read about them, and this was shortly after I'd had intolerable side effects from simvastatin. In the literature it mentioned Q10 deficiency as a common symptom of these db syndromes and said statin use was contraindicated, so at the next appt I raised it my statin problem with him, he got me tested, and bingo! Q10 deficiency was diagnosed!

My point is that even when a specialist suspected I had a condition that commonly includes Q10 deficiency, he didn't connect it with statins or think to warn me. To be fair the simva had been prescribed by my GP on his own initiative, not in consultation with the specialist. Even when I went back to the GP before seeing the consultant and told him about the side effects he didn't mention Q10.

So this reinforces your point that it's rare for HCPs to make any connection between Q10 and statin use. When I mentioned it to another GP in the group practice he treated me as if I were a batty old dear extolling the virtues of homeopathic oil of evening primrose and said he was sure taking supplements wasn't likely to do me any harm if it made me feel happy. Grr.

Kate

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I was looking for a ROLF smiley but couldn't find one. Sorry, I know it isn't a laughing matter,, batty old dear but I am still laughing.

Hi my grown up son has been on Statins for 6 weeks now, he wasn't feeling well. His Cholesterol was 6.5 ( btw he's not diabetic) and he's vegetarian, he had to go on a very low fat diet. Last week his cholesterol was 3.6 the GP was astonished, but my son says he take's a low dose, it's called Atorvastatin and with no side effects.

ps I know it's not Simvastatin, but wanted tell you all about it.

With best wishes