Tag Archives: simvastatin

A farewell to statins – part two

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And so it begins:

‘ …..a Pfizer rep confirmed to me that they were now telling all GP’s that statins do have side-effects and shouldn’t be prescribed anymore but to prescribe the new post-statin drugs…………. how two-faced can you get!!!!’

This was in an e-mail from a friend and supporter of mine, who has close contacts with the pharmaceutical industry.

Well, if you are going to challenge the dominant position of statins, the first thing that you have to do is to attack them. What is the best line of attack? Go after their greatest weakness, which is that they cause serious adverse effects, and damage the quality of life of many people. Something I have been saying for a long, long, time.

For years the experts have informed us that this is utter rubbish, statins are wonder-drugs, and adverse effect free. All of a sudden, now that the pharmaceutical industry is about to launch new cholesterol lowering agents, we are suddenly going to find that, why, after all, statins do cause a whole range of nasty adverse effects.

If you want to see exactly how this is going to be done, watch this discussion on Medscape.  The Medscape site needs a password, however you can get one fairly simply. In this ‘educational’ discussion we see three professors talking about the new cholesterol lowering agents that are soon to arrive. The dreaded PCSK9-inhibitors.

The names of these three professors are Prof Christie Ballantyne, Prof Stephen Nicholls and – yes, you guessed it – Prof Steven Nissen. Is there a new cardiovascular drug in development that he does not get involved with?

The first part of the discussion focusses entirely on the terrible problem of people being statin intolerant; people being unable to take high doses of statins, and the high burden of adverse-effects from statins.

A slide is shown from the PRIMO observational study showing that 15% of people taking atorvastatin have significant adverse effects, and 20% of those taking simvastatin suffer significant adverse effects. These, of course, are the two statins with by far the greatest market share. My, what a coincidence.

The discussion then opens out into the worrying problems with statins causing both diabetes and cognitive dysfunction (something vehemently denied for many, many years). Ballantyne was particularly eloquent on these issues.

The entire tone is one more of sorrow than anger. ‘Statins….great drugs….hate to see them go, but you know, their time is passing.’ Professor wipes a small tear from his eye at the thought.

I watch this stuff with a kind of morbid fascination. The marketing game is on, billions are about to be spent pushing PCSK9-inhibitors. The Key Opinion Leaders who tirelessly promoted the wonders of statins, and who told us that they were virtually side-effect free, are now singing a completely different tune.

Here is what one the panellists Prof Christie Ballantyne had to say about statin adverse effects in his book ‘Dyslipidemia & Atherosclerosis Essentials 2009’. This can be found on page 91, under the heading Adverse Effects and Monitoring.

‘Statins are very well tolerated with infrequent and reversible adverse effects. In large placebo controlled studies the frequency of adverse effects was similar to placebo (2-3%).’

Here, however, is what he said in March 2013

“Some people have hereditary disorders and have extremely high LDLs. And so the statin has some efficacy but not enough to get them down as low as they’d like.  Then some people have less response than others, and we don’t understand all of that. Some of that may be genetic. And it turns out there’s an even probably larger group of people that have a hard time taking a high dose of a statin.”

Even though statins are safe for most people, there are those that can’t take them because they experience side effects.

“Many people complain of some muscle pain, soreness, weakness, excessive fatigability.  There’s some slight increase in diabetes also. That can occur with high dose statins, and some people [who] say that they may have problems with their nerves or cognition.”1

Well, that is all nice and consistent. Finally, here he is on Sunday 8th Dec, quoted as part of a discussion on the new AHA/ACC guidelines.

“Clearly, the focus is to get people on statins,” said Dr. Christie Mitchell Ballantyne, the chief of cardiology and cardiovascular research at Baylor College of Medicine, in Houston. “But if someone has seen four doctors and tried six statins and tells me they can’t take them, what am I going to do? Tell them they are a failure?”

Ballantyne said he would give such patients a non-statin drug, despite the guidelines.’2

….Ballantyne said he would give such patients a non-statin drug, despite the guidelines.’ I wonder what he could possibly mean by this. Perhaps George Orwell had it right.

‘Four legs good, two legs bad’……becomes….’Four legs good, two legs better.’

“The creatures outside looked from pig to man, and from man to pig, and from pig to man again; but already it was impossible to say which was which.”

[A farewell to statins – Part three will arrive at some point.]

P.S. Please watch the video clip soon, as I suspect it may not last very long after this blog.

1: http://www.houstonpublicmedia.org/articles/1362665170-Promising-Baylor-Research-Reduces-Bad-Cholesterol.html

2: http://www.staradvertiser.com/news/20131114_New_cholesterol_advice_startles_even_some_doctors.html

Real Life vs. Pharma Company Studies

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At what point, exactly, does credibility snap? When does the difference between what we are told, and what we observe, reach such a state of dissonance that it is no longer possible to believe both. Sometimes it seems the answer is ….never.

Here is one example. The clinical trials on statins found that they have virtually no adverse effects. Or, to be a little more accurate, that adverse events were virtually identical to placebo. Here, for example, is part of the press release from the Heart Protection Study (HPS).This was the last major placebo controlled statin study done in people with already diagnosed cardiovascular disease.

As the benefits of statins are now thought so wonderful it would be considered unethical to do a placebo controlled study anymore. You would be withholding statins from people who need them. Which means that you are not going to get any more evidence in this area – ever again. The HPS results were published around ten years ago, and the press release contained the following

‘Although muscle pain was reported by the participants, this happened about as commonly among those allocated the active simvastatin as among those allocated the placebo tablets. Despite 20,536 randomised patients having been followed for an average of five years, blood tests among people reporting muscle symptoms found only 11 simvastatin-allocated patients and 6 placebo-allocated patients with a rise in the muscle enzyme creatine kinase (CK) to more than 10 times the upper limit of normal Of these, 14 met the definition for “myopathy” (i.e. muscle symptoms associated with such CK elevations) of whom 10 were in the simvastatin group and 4 in the placebo group.’

http://www.ctsu.ox.ac.uk/~hps/June02QandA.shtml

Teasing these figures out a little more it seems that an extra six people taking simvastatin suffered muscle ‘problems’ than those taking the placebo. This is six people, out of more than ten thousand taking simvastatin. This represents in one thousand seven hundred and eight 1/1708 (over five years).

If this were true, then muscle problems should be exceedingly rare. The average GP with about two hundred of their fifteen hundred patients taking a statin should see a patient with muscle pains/problems about once every twenty five years. At this rate, you would not even know you had a problem.

Yet, wrapped around my copy of the BMJ last week was an advert for rosuvastatin [Crestor]. The strap line shouted out ‘Myalgia on his initial statin?’ [Myalgia is the medical word for muscle pain]. The main message the advert was… ‘If your patient was suffering muscle pains on their initial statin, they should switch to Crestor 5mg.’

Their ‘initial statin’ will almost certainly be Simvastatin 40mg. The drug, and the dose, used in the HPS study. The same drug, and the same dose recommended by the National Institute of Clinical Excellence (NICE).

Now, you do not run an expensive advertising campaign without doing a lot of market research first. What the market research must have told AstraZeneca – who make Crestor – is that a lot of people are suffering muscle pains on 40mg simvastatin.

Which means that simvastatin, which caused no discernible increase in muscle pains in the clinical study…… actually creates such a massive burden of muscle problems that a pharmaceutical campaign is running a major advertising campaign highlighting this, exact, adverse event.

What does this tell us, gentle reader? It tells us many things. Some of which would be considerable slanderous if I said them out loud. The most outstanding thing it tells me is that, although we have all been repeatedly informed that statins have no more side-effects than placebo, I now find that AstraZeneca encouraging doctors to switch statins due to the burden of side-effects.

F Scott Fitzgerald opined that …“The test of a first-rate intelligence is the ability to hold two opposed ideas in the mind at the same time, and still retain the ability to function.’

I would suggest that there comes a point where you have to decide between which idea is right, and which is wrong. With regard to statins, I did this many years ago when I recognised that they cause a gigantic burden of adverse effects, with muscle pain the single most outstanding. I knew that the clinical trials had somehow or another managed to bury this fact.

Yet, when I speak to most doctors they continue to tell me that statins have very few side-effects, as do most opinion leaders. This belief, whilst AstraZeneca starts up an advertising campaign based on side-effects reported by doctors. F Scott Fitzgerland would be impressed by all these first class intellects. I just despair of them.