Secrets of Statins (6/6/13)
Statins are portrayed as the “wonder drugs” of the last two decades. Officially HMG-CoA reductase inhibitors, their ability to decrease heart attack and stroke was originally laid down to their ability to decrease cholesterol synthesis.
They did lower cholesterol. But that was not the main reason they worked.
Statins, like many drugs, were found to have numerous indirect effects. One was to lower overall inflammation levels. That really changed cardiovascular death rates. Now some prominent doctors, like David Agus, argue statins should be given to every older adult because of their presumed ability to decrease cancer and other “inflammatory” diseases.
So a recent study from Ontario looking at 1.5 million elderly – pretty much everybody over 66 in the province – needs our close look. It can tell us a lot about how drugs are used, and how they might be used better.
How Was the Study Done?
A data base for all Ontario was used to see who took different statins. Of the 1.5 million people, about a third were eventually put on statins.
What Was the Study Looking At?
Incidence of diabetes.
What Did They Find?
Some statins increased diabetes incidence, while others did not. Atorvastatin, also known as Lipitor, increased rates by about 20-30%. Pravastatin (pravachol) did not. Rosuvastatin (crestor) was nearly as bad as atorvastatin.
What Drug Was Prescribed the Most?
By and away it was atorvastatin. It took over half the new prescriptions. Rosuvastatin was second in terms of prescriptions.
In other words, the drugs that caused thousands of excess cases of diabetes were the most popular and most frequently given. Marketing is powerful.
Also of note – Ranbaxy, which sells the generic version of atorvastatin, has been sanctioned by the FDA for putting out substandard drug.
What Other Side Effects Do Statins Provoke?
According to FDA data, the biggest problems are myopathy and rhabdomyolysis – inflammation and death of muscle tissue. Interestingly, rhabdomyolysis is increased in people with diabetes. So another irony – drugs used to decrease heart disease may increase diabetes, which itself increases heart disease and then increases the risk of rhabdomyolysis.
Statins, working as they do in the liver to decrease cholesterol synthesis, also can cause liver problems.
Are These the Only Side Effects of Statins?
No, nor will the list remain static. Lots of drug side effects are only noted years or decades after first use. So the good effects are checked quickly; the long term negative (and positive) effects are noted belatedly –if they’re noted at all.
Why Else is the Ontario Study Important?
1. It’s real data. Many clinical drug trials only look at patients who have one problem, are younger and less afflicted than most who will be put on a drug, and are followed for very short time periods.
Most commercial drug studies will maximize the possibility of showing positive effects while neglecting close looks at negative ones – which also tend to show up later. More importantly, the people studied in clinical trials often are entirely unlike the ones who will eventually be put on a drug. These more typical – and numerous – patients often have numerous other medications and medical problems, which makes it far more likely that they will experience other side effects than study populations.
2. It’s a large group of people. Looking at 1.5 million people and following them for over a decade is a much better way to look at results than amalgamating small studies with different inclusion and exclusion criteria, and hoping all the differences wash out.
3. It demonstrates that big databases which use the same or very similar software and look at whole regions can be used effectively to study large populations with hard endpoints (new diagnoses, death, heart attack, stroke).
This should push forward the use of electronic medical records and databases, right?
Wrong. They’ll work only if the systems are compatible and pretty much the same. The present plans in the US will involve thousands of vendors with conflicting software that will provoke Balkanization, confusion, and major redundancies.
In other words, other countries which have national databases run on similar systems – because they have functioning national health services – will provide much better, more usable data than we will. That will cost us – perhaps hundreds of billions of dollars.
1. Different drugs from the same class – in this case statins – have very different results – even if the clinical trials done against placebo, the standard American practice, don’t show those differences.
2. Often cheaper, older drugs have less side effects and death rates – which you’ll never know about unless you have long term regional and national data. A classic example, as described by Ben Goldacre in his book “Bad Pharma” , was chlorthalidone versus amlodipine – the old fart versus the new, supposedly more effective drug. Chlorthalidone saved a lot more lives.
3. Side effects often show up late.
4. Regional and national databases can give you actionable, useful intelligence – if the systems are compatible. And that can save you lives and money.
Knowledge industries are the future of industrial societies. But in health care as in other areas, you have to know how to access and use knowledge – and create systems that let you do that. We are not doing that in the U.S.
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