I’m going to start this with a little personal info. I am an ideal candidte for a life-time regimen of statins. I’m 40 years old. I have high-ish cholesterol and have had for a while, and my father had a  life-saving quadruple by-pass when he was 64. I do exercise but I’m careless about my eating habits and actually I’m sitting here eating a mid-afternoon snack of potato chips. (Incidentally, the chips are Safeway’s own brand Barbecue flavor, the best since the very evil Frito-Lay bought and closed Eagle Chips, whose Mesquite Thins BBQ were so good they must have been laced with crack cocaine. Where the hell was the Anti-trust guy at the DOJ when that happened? But I digress….).

As you know, statins lower "bad" cholesterol (LDL) and hence reduce heart disease.  There’s not too much dispute about that.  There’s also not too much dispute about the fact that they are financially the most important class of prescription drugs in the pharma marketplace and, as I posted about here, their future can make or break huge companies. Baycol’s removal from the market nearly broke Bayer, and Lipitor’s current success is responsible or keeping Pfizer top of the heap. Hence there’s an enormous amount riding on statins, and it’s a classic case of spend now, recoup later. For instance, after taking them for 25 years an at-risk 40 year old may avoid heart disease.

There are, though, repercussions from taking statins.  The side effects from Baycol included killing enough patients due to the kidney disease it created that it was withdrawn from the market.  A rational economist might say that the deaths of 52 patients were worth the millions Baycol would save from heart disease, but that’s not how humans work.  We like seeing the "identified life" (or conversely don’t like seeing the "identified death") and we don’t care too much about the unidentified lives that might be saved in years to come.  And of course in the case of Baycol there were alternative statins like Lipitor on the market. Lawyers who have already won over $500m with more to come from Baycol’s maker Bayer, are closely monitoring this situation! Here was a list from some class-action lawyers of various side-effects of Baycol, put above those the same lawyers claim are related to Lipitor.

Baycol’s alleged Side effects                           
>  Fibromyalgia                                                
>  Kidney Failure                                              
>  Memory Loss                                                
>  Myositis (muscle pain)                                 
>  Rhabdomyolysis  (leads to kidney failure)    
>  Hip Joint Problems
>  Nausea
>  Kidney & Urinary Tract Disorders
>  Liver Problems

Lipitor’s alleged Side effects
>  Fibromyalgia
>  Kidney Failure
>  Memory Loss
>  Myositis (muscle pain)
>  Rhabdomyolysis  (leads to kidney failure)

By now you’ll see where this is going.  If only a very few people have fatal complications from any drug, the trial lawyers will jump all over the pharma companies.  Of course the pharma’s fight very strongly to protect their turf and they are only really vulnerable when they "agree" with the FDA to withdraw a drug from the marketplace; something that has happened with increasing frequency in the past decade.  However, the sheer size of the statin market is so huge that it attracts pharma cos and trial-lawyers like moths to a lamp.

Last weekend, though, something new entered the picture. The world’s oldest and one of its most respected medical journals The Lancet came right out and said that a new statin, Crestor from Astra-Zeneca, had been rushed onto the market by the company and that the company had effectively pressured the FDA and authorities in other countries in the approval process.  For details go read The Lancet’s editorial and the accompanying rebuttal from the CEO of A-Z, Tom McKillop. The science of the issue is well covered by bloggers like Derick Lowe at In The Pipeline, and the impact on medical practice and how treatment patterns actually get adopted are well covered by the renaissance-doc Medpundit. But before you go look at their articles, let me end my market analysis and then my personal story.

Analysis: The Lancet says, while statins work to reduce LDL, we have enough of them about already. Meanwhile it says that Crestor–for which it criticizes the legitimacy of some of the clinical trials–reduces LDL but hasn’t yet been proven to reduce heart disease. As such it is being rushed to market for the primacy of A-Z’s profits. (I’ll refrain from going "Duh!). To my recollection only Pravachol (or is it  Mevacor?) which has been around for years, has had the time for a follow-up and can thus boast that it reduces heart disease and associated mortality as a consequence of lowering LDL.  It may well be that Lipitor, Zocor, etc and Crestor do, but as McKillop points out, they haven’t had time to prove themselves in that end-point, though they are all rushing through the clinical trials trying to prove so. The real development here is that a respected journal has cried foul on the whole pharma company process of getting a drug onto the market as quickly as possible. And they’ve directly linked that process to the withdrawal of Baycol due to its (fatal) side-effects. The ubiquity of those side-effects versus the positive saving of lives many years into the future is the key to the future use of statins. If physicians are essentially pushing statins onto patients based on "incomplete" clinical trials slanted towards a particular drug, the Lancet is right to raise a warning flag. Plus it will inevitably encourage other stories of side-effects, lawsuits and possibly reforms in how the FDA conducts approvals. However, don’t forget that the side-effects might be very, very rare, and so drugs that are good for the vast majority of people may be taken off the market. Watch this space very carefully.

My personal analysis I actually talked to my doctor about this a week or so ago. I asked about his view on statins without mentioning my fear of side-effects. Tacitly acknowledging my concern about doing something now with a potential near-term cost for an uncertain long term pay-off, he told me to think again when I’m 45.  Perhaps my early 60s and the threat of heart disease will seem closer then.  There’ll certainly be a ton more research for me to look at to assess the long-term use of these new statins.  Plus as an added bonus, if they’re off patent, they’ll be a darn site cheaper too!