Health for life

If you read my last post about cholesterol-lowering drugs, then you understand some of the problems that can arise from their use.  Statins can produce some nasty side effects.  But side effects aside, statins save lives right?  I mean, doctors prescribe them to just about everyone, they must be effective.  Not quite... the story is not as simple as it may seem.

When looking at the statin drug clinical trials, its important to keep a few things in mind.  Firstly, and most importantly... total mortality is more important than heart disease mortality.  If a drug prevents you from dying of heart disease but doesnt affect your chances of dying in general, then that drug is not worth taking.  Whats most important is whether or not the drug will extend your life.  Secondly, you must consider that different groups of people may respond differently to the drug.  Women, middle-aged men, the elderly, and those with preexisting heart disease may all respond differently to treatment. 

Id like to begin by talking about women... both because I like women, and because they dont respond well to statins.  Although many statin studies notoriously neglect to reveal the all-cause death data for women, there are a few studies that do.  Check out the Scandinavian Simvastatin Survivial Study (4S), which was one of the most positive trials to date.  The big pharma folks must have been partying it up when this one came out.  This was a secondary prevention trial, meaning that participants all had pre-existing heart disease (previous heart attack or angina).  For future erence, a primary prevention trial would be an experiment in which the participants did not have pre-existing heart disease.  So, half of them took simvastatin and half of them took a placebo.  The results were great across the board: heart attack numbers were reduced, along with deaths from heart disease and all-cause mortality.  But there was one group that clearly didnt benefit:  women.  Over the duration of the 5.4 years of the trial, 27 (6.6%) of the women taking the statin died, while only 25 (6%) of the women taking the placebo died.  So despite the rest of the data, which was very supportive of statins, there was actually a slight increased risk of death in women from taking the statin.  As youll soon see, this finding is consistent throughout all of the statin trials, yet it is completely ignored by mainstream medicine.  These drugs simply dont work for women.


Now, men are a bit of a different story.  Its important to split men up into two distinct groups:  those with diagnosed heart disease (previous heart attack or angina), and those without diagnosed heart disease.  In those without heart disease, statins appear to be largely ineffective.  Both the University of British Columbia and Dr. Graham Jackson in the UK have published review articles looking at many of the primary prevention statin trials.  These were both reviews of the existing research, and they did not pick and choose studies that would support one side or the other.  Heres a key statistic from the UBC paper:  "71 primary prevention patients with cardiovascular risk factors have to be treated with a statin for 3 to 5 years to prevent one myocardial infarction or stroke."  And heres one from Dr. Jacksons study:  "Long term use of statins for primary prevention of heart disease produced a 1% greater risk of death over ten years versus placebo when the result of all the big controlled trials reported before 2000 were combined."  Although both studies showed reduction of cardiovascular deaths in those taking statins, overall deaths were either the same or higher.  Oh, and they also found zero effect on cardiovascular deaths in women.  Sounds like statins arent so effective in those without pre-existing heart disease. 

And Ive got more.  In 2005, a study called ASCOT-LLA, which studied Lipitor on high blood pressure patients, was stopped early due to the supposed "massive" reduction in cardiovascular deaths experienced by the Lipitor group.  The researchers considered the benefits so great that it was unethical to continue to deprive the placebo group of proper treatment. This study is considered to be one of those landmark trials that proved once and for all the life-saving benefits of statins.  Well, lets look at the data... youll have to click to enlarge it.



In that first set of data, Id like to draw your attention to the "all-cause mortality" graph in the bottom right.  See that vertical line there that Ive drawn in?  Thats a little trick I learned from Dr. Malcolm Kendrick in his book The Great Cholesterol Con.  The reason that line is drawn in there is because the trial ended at 3.3 years.  The graphs, however, show data until 3.5 years.  If you look closely at the graph, at 3.3 years there is almost no difference between the Lipitor group and the control group, but for the last 0.2 years of the study, the two lines begin to suddenly separate.  WTF mate?  How does one acquire data for a study after the study has ended?  Something seems fishy to me...  tampering of evidence perhaps?  No way to know for sure, but I can say with certainty that there was no reason to shut down this study early.  Theres virtually no difference in the all-cause mortality data.  Oh, and that second graph... thats showing the effectiveness of Lipitor on cardiovascular mortality (note: NOT all-cause mortality).  Notice women in this trial had an increased risk of dying from heart disease on the drug.

To sum up the statin drug data, heres a convenient table copied again from Dr. Malcolm Kendrick:


You can see here that the 4S trial, which I discussed earlier, was overall very supportive of statin use.  This trial was purely a secondary prevention trial.  And I must admit that statins do appear to save lives in men with previous heart disease.  But that is the ONLY group for which they save lives.  Purely primary prevention trials, like EXCEL, actually showed in increase in all-cause death on statins.  And then there are trials like WOSCOPS, which was a mix of primary and secondary prevention, and those trials typically yield results somewhere in the middle of the extremes.  Even in the most positive statin data for those with pre-existing heart disease, however, the results are really underwhelming.  You would think that with all the hype surrounding these supposed "life-saving" drugs, the data would be a little stronger.  Even if you do have pre-existing heart disease, and are a man, you can only expect about a 3% reduction in the chance of dying over the next several years.  That is just unimpressive to me.

So despite the relentless pushing of these drugs by big pharmaceutical companies, mainstream doctors, and my Anatomy and Physiology professor, caul examination of the data shows a surprising lack of evidence to support their use.  Statins decrease the risk of dying of heart disease; thats good.  But they dont decrease the risk of dying overall in the majority of the population; thats bad.  So then, if heart disease deaths are decreasing but overall deaths are not, statins must be increasing the risk that youll die of something other than heart disease.  Im even going to go as far as to say that they cause these non-cardiovascular-related deaths. Unfortunately, most studies fail to specify exactly what these non-cardiovascular deaths are, but take a look at my previous post for an idea.  If youre a woman, statins wont even reduce your risk for heart disease, and they actually increase your risk of dying overall.  The only population for which statins can save lives is men with pre-existing heart disease, which is less than 5% of the population.  If youre one of those people, take your statin if youre so inclined.  But if youre anyone else, especially a woman, you are barking up the wrong tree.

This week’s Ask the Internet question comes from right here at home, and addresses an issue many of us might be facing in our post-Christmas hazes.

Q: Two years ago, I received several bread mixes and a jar of chocolate sauce for Christmas. The breads were baked and eaten within a month, but the sauce still lingers in the bottom of my pantry. What should I do with it? What do YOU do with food-based Christmas gifts you don’t use and/or never intend to?

A: While the generosity and thoughtfulness of a food present is wonderful, there are zillions of pepperoni sticks and Jordan almonds that will go uneaten this year. What makes it tougher: many of them (see: chocolate sauce) would be of little use to a food bank.

So, readers – what’s your plan for this stuff? Will you re-gift? Will you bring the edibles to a party, or try to pawn them off at the office? Will they simply go in the garbage? Any and all suggestions are welcome in the comment section.

P.S. Good Christmas food stories are highly encouraged.

Want to ask the interweb a question? Post one in the comment section, or write to Cheaphealthygood@gmail.com. Then, tune in next Tuesday for an answer/several answers from the good people of the World Wide Net.

While the Disease Management Care Blog is pretty good at spotting current health policy silliness, its track record at predicting the future has been rather spotty.  Regular readers have undoubtedly forgotten this brazen attempt at 2012 health care augury, but the transparent DMCB uses to bury its mistakes.

So how did it do with its Ten 2012 Predictions?

1. Mitt Romney will win the Republican nomination and avoid discussing health care.  The DMCB got some of this right, but who would have predicted that the President would cleverly upend his opponents by embracing the term "Obamacare?"

2. A close election will hinge on an improving economy, not on Obamacare. In the end it wasnt really that close, but the DMCB was correct in foreseeing that Mr. Romneys candidacy would be undermined by dropping unemployment levels and the bottoming out of the comatose housing market.

3. The Supreme Court will rule Obamacare unconstitutional: Boy, the DMCB got that wrong.  But in its defense, few foresaw that SCOTUS would ignore the Affordable Care Acts statutory language and rule that a penalty was really a tax all along.

4. There will be no generalizable and published peer-review studies on the electronic record of the medical home that conclusively show that either saves reduces health care costs.  "Bingo!" says the DMCB.  It hopes 2013 is different and that a p value is < 0.05.

5. ACOs will not criticize CMS about the tardy delivery of claims data necessary to manage its assigned populations. The DMCB says the silence over this issue is deafening, which means either a) CMS has overcome its dismal track record on providing timely information or b) the ACOs are reluctant to go public with any concerns.  The DMCB has heard rumors that the latter is true.

6. Speaking of ACOs, their physicians will trump patient perences over savings.  The DMCB says the jury is still out on this, but time will tell if its call about this ACO Achilles heel is as important as it thinks it is.

7.  Health exchange deadlines will be pushed back. To the DMCBs knowledge, CMS is holding firm on the fall 2013 implementation date.  The DMCB takes some credit, however, for being among the first to spot this issue and bring it to its readers attention.

8. CMS will kick the Sustainable Growth Rate (SGR) down the road. "Bingo again!" says the DMCB.  It got his one right and looks forward to how Congress will deal with this in 2013.

9. Medical academics will increasingly turn to social media instead of print to make their mark on the scientific world. The DMCB believes this trend is continuing but has yet to reach a tipping point.

10. CMS Interim Administrator Tavenners status will remain in recess limbo.  OK, it wasnt all that hard to bank on continued partisan bickering, but the DMCB got this one right too.

Will the DMCB offer up predictions for 2013?  Stay tuned!