So what's this mean for you & me? Well, the evidence was given a B grade. In other words, USPSTF believes that there is high certainty that net benefit is moderate or that there is moderate certainty that net benefit is moderate to substantial. Did you catch that? It's not an A grade in which USPSTF would believe that there is high certainty that net benefit is substantial.
High certainty means that the available evidence is consistent and derived from well-designed & well-conducted studies, and as such are unlikely to be affected by future data. OK, that's fine but if you read the systematic review itself, the USPSTF could only find 4 trials, of which only one was large & of good quality showing significant benefit in lung cancer & all-cause mortality. The other 3 were small (underpowered) & did not demonstrate any benefit (insufficient duration to evaluate effectiveness). So how is the evidence consistent? And how is it that underpowered studies of insufficient duration were judged well-designed & well-conducted?
Before you jump to conclusions and rush out for your own LDCT scan, read the evidence review yourself. And ask the USPSTF (by commenting on their website) if the evidence is really that good & strong enough to support these draft recommendations?
But this isn't the first time that we've promulgated that bit of advice. Yet in the article published yesterday, over the last 12 years, we've been ordering more CT scans & MRIs and prescribing more narcotics, none of which really helps. Unless you have numbness, tingling, weakness, incontinence, fever, sweats, chills, unexplained weight loss or known cancer, what you really need is time. But from personal experience, that was the longest 4 weeks of my life!
In case you weren't aware, no dietary supplements are "FDA approved". In fact, there is no legal requirement that the manufacturers prove the safety of their product or truthfulness of their advertising claims prior to selling to unsuspecting individuals ready to grab at any ray of hope. Unfortunately, there are really no quick fixes. Granted, not every barrel of apples has a rotten one, but two recent stories are worrisome for the overall picture.
In the first, published last week in USA Today, the author focuses on the serial havoc just one person has managed to create with dangerous substances, not listed on "all natural" "all organic" product labels, to achieve advertising claims with harmful consequences. The very next day, the FDA issued a warning about another dietary supplement which contained two anabolic steroids which were, of course, not listed on the "all natural" "all organic" product labels. But what I find most egregious about this second case is that the manufacturer is refusing to admit any wrongdoing or harm, much less remove its product from grocery store shelves, thus continuing to place the (uninformed) public at risk. Caveat emptor.
I made a house call yesterday and met an elderly lady who'd fallen, broken her arm, spent some time in rehab, and then returned home independently. Obviously, she is a success story in that she has regained a relatively high level of function. Interestingly, she did not make the connection between an elective hip replacement for chronic ongoing pain vs urgent repair of broken hip. Granted, both lead to loss of function but she kept referring to having had a hip replacement despite being fully functional, running even, prior to her fall. When I pressed further, she finally admitted that she'd broken her hip. So I tried to explain why she hadn't had a hip replacement per se.
In any case, she'd been without a physician for the last several months as her primary care provider had retired. She insisted that she needed her Temazepam 30mg nightly for sleep, which she'd taken for the last 15-20yrs after failing Dalmane & Ambien. On the other hand, she had a bottle or two of Norvasc which she wasn't taken despite an elevated blood pressure. Now, she was a well educated person, who was aware that hypertension is a silent killer. Yet, when pressed, she couldn't explain why she was taking something that would reduce her risk for stroke while insisting on something that might increase her risk of falls & fracture (she insisted that her 2 falls had nothing to do w/her benzodiazepine).
I bring up this vignette because an analysis of the Global Burden of Disease was published 2 days ago in JAMA looking specifically at the state of our country's health from 1990 to 2010. What's striking is that while all-cause mortality has decreased over this 2 decade period of time w/concomitant 3yr increase in healthy life expectancy, the number of years lived w/disability actually increased. In other words, while our quantity of life has increased, our quality of life has decreased. Even more striking is that while US life expectancy has increased, increase in life expectancy in other countries has outpaced ours such that we're slipping backwards on a global scale.
Which brings me back to my new patient who is well aware of hypertension's reputation as a silent killer. And despite this knowledge in a well educated patient, she couldn't explain why she wasn't doing more to maintain her current level of function & quality of life. This is why our national health is circling the proverbial drain. We know what we need to do but we don't have the collective conscience to act upon our knowledge.
As a quick refresher, WOSCOPS is the West of Scotland Coronary Prevention Study in which 6,595 participants 45-54yo were randomized to 5yrs of pravastatin vs placebo. The participants were then followed out to 15yrs for this publication. Even after taking into account cost of medications, use of pravastatin accounted for decrease rate of cardiovascular events, fewer hospital admissions yet short inpatient stays, plus less heart disease, heart failure & stroke plus less need for revascularization.
So bottom line, statins are safe to use and even cost effective in lowering risk for cardiovascular & cerebrovascular events, even in those who've yet to suffer such an incident. However, as I noted yesterday, despite this study, statins, like all other medications, are not w/o risk. Thus, we should not reach out to make use of them unless the patient has failed maximal non-pharmacologic therapy, eg nutrition & physical activity.
Depending upon to whom you listen, medications are either poison or miracles. Personally, I think the truth is somewhere in between. I believe there's a large but misguided attempt to label anything natural as better for you than something manufactured by Big Pharma. After all, as I noted in a recent post earlier this week, would you wipe your behind w/poison oak or poison ivy just because it's natural? Along those lines, there are those who believe red yeast rice is better & safer than dangerous statins as promulgated by those uninformed lackeys of Big Pharma, us physicians. But if you read some of the recent literature on red yeast rice, you'll find that its manufacture leaves much to be desired in terms of safety & contaminants (which isn't to say that Big Pharma and even compounding pharmacies are blameless).
While I believe that physicians too easily pull out their pen or tablet/laptop these days to (electronically) prescribe medications, I also believe that some of the onus for the need for stronger & more powerful statins lies at the dinner table in front of the patient. After all, we didn't become a nation of overweight & obesity by eating healthy. Yet, when faced with the evidence before us that we need to change our lifestyles, too many of us would rather take the easy way out and pop a pill. And those of us in busy practices too often find it easier to "treat 'em & street 'em", rather than take the time to explain (over & again) the impact of nutrition & physical activity on our health, cholesterol & atherosclerotic disease risk.
Of course, this makes us easy targets for others to point out the side effects of the poisonous statins we're prescribing: diabetes, elevated liver functions, muscle soreness/breakdown, memory loss, etc. And so whenever there's an outcry about some new side effect, many patients stop their statins just like that, rather than considering whether the risk is worth the benefit (prevention of some cardiovascular, cerebrovascular or peripheral vascular event). So it's good to the some good news come out of the statin camp in the form of a review & meta-analysis published online yesterday in Circulation: Cardiovascular Quality and Outcomes, in which the authors concluded that side effects of statins are not at all common.
In fact, the safety profile of simvastatin & pravastatin rank above the rest. This isn't some small rinky dink study but rather the analysis of data from 55 placebo-controlled trials and 80 active-comparator trials involving 246,955 participants. Admittedly, use of statins was linked to an increase risk of diabetes, liver function abnormalities and increase in liver functions. But the overall benefit in terms of clinical outcome from this drug class outweighed the potential for adverse events. As with all medications, take them as directed if you need them. But if you can get away w/nutrition & physical activity, why not focus on lifestyle, save your money, & reduce your risk for side effects.
Estrogen remains the gold standard which we have to offer women suffering from menopausal symptoms. That's why the Women's Health Initiative was arranged to compared women 10 years post-menopause such that they were unable to tell if any decrease in menopausal symptoms was due to estrogen or placebo. Fine but what about those women can't/shouldn't use Estrogen to control their menopausal symptoms? Well, many physicians have been recommending off-label use of Paroxetine to control the hot flashes.
You are what you eat. How many times have you heard that phrase? Chances are you won't turn into a hot dog or potato chip but study after study demonstrates the impact of good nutrition on our health. Most observational studies demonstrate benefit to making better choices and even a recent randomized controlled trial was able to demonstrate cause & effect benefit from the Mediterranean diet. In general, the studies looking at fish (oil) have suggested heart disease & memory benefit. But what about cancer?
Sure, they looked at 687,770 participants regarding fish intake, 527,392 regarding omega 3 PUFA intake, and 405,592 regarding ALA intake. So just how does marine-derived omega 3 PUFA get linked to lower breast cancer risk while fish intake doesn't? Let's remember that the devil is in the details. Not every fish is chock full of omega 3 PUFA. Unfortunately, a meal comprised of fish & chips won't help. And my guess is that farm-raised salmon won't either. You need the wild-caught salmon that's been feasting naturally in order to get your fill of omega 3 PUFA. Think about that the next time you look for fish in your grocery store.