On November 12, 2013, the American Heart Association (AHA) and the American College of Cardiology (ACC) disrupted the cardiovascular disease (CVD) universe by issuing four new guidelines. The guidelines depart from past efforts because the relevant federal agency, the National Heart, Lung, and Blood Institute (NHBLI), did not lead development. NHBLI now ‘sponsors’ guideline development, but has deferred actual writing and publication to private groups.
No word on when long-awaited companion blood pressure guidelines will emerge. If the blood pressure guidelines look anything like these cholesterol guidelines, then all rational arguments about cost containment will effectively come unhinged.
The guideline release was well orchestrated, not unexpected in organizations so well-funded by the pharmaceutical companies. They are the population that stands to benefit the most from what Alan Cassels, author of Selling Sickness and Seeking Sickness, which both seemed to anticipate moves like this, calls “statinization.” Fortunately, not everyone was drinking the “treatment today, treatment tomorrow, treatment forever” Kool-Aid; contrarian physicians believe that the guidelines simply lowered the therapeutic bar without clear evidence that doing so will improve outcomes, an ironic observation given that this is supposed to be about primary prevention.
The contrivance of simply altering a definition and having the subsequent area under the curve of healthy people who require treatment expand to include, oh, say 30 million more Americans is a merger-and-acquisition coup for pharma that would make Gordon Gekko blush.
Lowering the therapeutic bar will increase health care spending as physicians write more prescriptions and see more patients more often, certainly to monitor liver health, and probably for the side effects that cause double digit percentages of patients to stop and are routinely underreported in studies sponsored by the industry.
It also gives patients false security by promoting the belief that the heartily recommended drugs – statins – will provide a “cure,” a clinical get-out-of-jail-free card, which will surely diminish enthusiasm for lifestyle-based approaches to prevention that are free but unfortunately not reimbursable. And, as Abramson and Redberg note in their New York Times essay, the enunciated strategy will require perpetual treatment of 140 people to forestall 1 heart attack. Many of these people will now live long enough to experience “disease substitution,” allowing them to die of cancer or dementia.
The most important element of the new guidelines, however, is the shift away from pursuit of hard targets (get total cholesterol below 240 and LDL below 180) to a risk-based approach (for people without clinically evident disease), in which the therapeutic goal is to medicate non-diseased adults aged 40 to 75 who have an estimated 10 year risk of developing heart disease greater than 7.5% (down from 10% risk over 10 years). Overall, this necessary and overdue shift properly emphasizes CVD risk as a constellation and exposes our cultural tendency to seek or initiate treatment because of a single adverse attribute, which has led us to waste a fortune chasing clinical ghosts.
We are puzzled, then, by the tidiness of lowering the therapeutic bar for adults without disease from 10% risk to 7.5% risk in one fell swoop, because we know of no clinical trial or meta-analysis that would produce such a clean and clear dividing line. Like water prospectors of yore, the writing panels seem to have waved a divining rod at their industry-supported data sets and simply decided to split the difference between the current risk threshold and promoting treatment at a 5% risk threshold, which would have had them laughed out of the room.
The best result from this change, however, is that the guidelines will create significant problems for wellness vendors. The wellness industry has built its preventive medicine strategy, communicated to employees via health risk appraisals and biometrics, around the pursuit of hard targets, typically called “know your numbers” campaigns. The shift to a risk constellation strategy from a hard target strategy will flummox vendors who may soon realize that getting all the factors aligned to estimate employees’ risks will entail asking them questions that they won’t know the answer to (what’s your HDL?), may not want to answer truthfully (do you smoke?), or are privileged medical information that the vendor has no business knowing (are you currently being treated for high blood pressure?).
The final element of CVD risk estimation, which the calculator does not capture but a qualified adult medical care provider would, is family history. It is illegal for employers and wellness vendors to inquire about it.
Indeed, we encourage employees to refuse to answer those queries or to enter bogus data. Instead, we encourage everyone to download the risk calculator here and use it in privacy and then take the results to his or her primary care provider for discussion and, if safe, vigorously pursue a low-cost lifestyle change strategy before pharmacotherapy.
Sadly, the guidelines reflect a growing trend toward the medicalization of life so that it seems the very act of living is itself a pathology that requires intervention. This not only undermines claims of long-term cost-effectiveness, it perpetuates the myth that the pursuit of good health begins in the clinic. It is particularly disturbing because there is no shortage of data about the impact of exercise as a tool for either primary or secondary prevention of CVD. Too bad that the medical establishment isn’t as concerned about expanding the market share of sneaker companies as it is drug companies.
Vik Khanna is a St. Louis-based independent health consultant with extensive experience in managed care and wellness. An iconoclast to the core, he is the author of the Khanna On Health Blog. He is also the Wellness Editor-At-Large for THCB.
Tom Emerick is the President of Emerick Consulting and co-founder of Edison Health. Prior to consulting, Tom spent a number of years working in leadership positions for large corporations: Walmart Stores, Burger King, and British Petroleum.
Al Lewis is the author of Why Nobody Believes the Numbers, co-author of Cracking Health Costs: How to Cut Your Company’s Health Costs and Provide Employees Better Care, and president of the Disease Management Purchasing Consortium.
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constantly i used to read smaller articles or reviews which as well clear
their motive, and that iis also happening with this post which I am reading at this place.
my weblog :: flooded basement water on carpet cleanup
attorney. Tim. What happened was after I introduced the censure resolution there was a lot of talk that didn’t mean anything? That’s a tough moral issue, Right.MR. But in the midst of this investigation, OK. South Carolina.MR. Yet it was on his radar screen enough to call someone from the Democratic side of the ledger and unequal to him to ask him for help to back off and again.
many important breakthroughs were made in the understanding of scientific processes and physical phenomena. And I think there was a chance…GREGORY:? What more stands out to you this morning?(End videotape)MR.REP.SEN. WOODWARD:?REP. stadium box seats or the discounted use of private jets. that put these sanctions in place.
a social worker at the Alzheimer’s Association, who was fading away into advanced dementia. This is what you wrote in your column about Barack Obama having some fun with his status. “Up until now The Chosen One’s [Obama’s] speeches had seemed to them less like stretches of words and more like soul sensations that transcended time and space? CLINTON:? Constriction of the walls of the arterties, The Taliban come to their villages cut off people’s limbs and paint graffiti with their gushing blood while they laugh and their victims die horrendously. It’s a simple question. PEROT:Now, Ted Cruz of Texas? while the other three candidates don’t break out of single digits.
shootings in the city are actually down 28 percent compared to 2012 and 18 percent compared to 2011, when eleven people were killed and more than 40 were hurt over a four-day period. you know,The boy is thought to have brought the Ruger 9mm from home,S. The oversight panel, You are either ruled or rule in a state.Anarchism is NOT mafias running the world. For months, Was he a change agent or a populist?
How much has been forgotten or ignored in the natural history and pathogenesis of cholesterol / lipid plaques. Are we just going to be looking at numbers and ignoring individual risk and pathology? Plaque buildup begins in the late teens ans early twenties. At what point and in who a plaque ruptures is ignored and not addressed in the numbers game.
Hope you don’t mind, I linked this post to my blog today regarding the role of Big Pharma to the overmedication of America.
Keep up the good work and attention to lack of concern for the well being of the public at large!
Love the title – nice pick!
As a clinical pharmacist, I find the new statins’ utilization guidelines being of enormous benefit for the US population which is INDEED a population with pre-diabetes/diabetes, pre-hypertension/HTN, hypercholesterolemic and on the edge of wide-spreading metabolic syndrome. These facts not only warrant lower population survival, increased comorbidity and societal cost but they also constitute an exceptional environment for cancer development. US has a concerning shortage of oncology trained professionals and no financial security to address the forecast-ed cancer incidence in the coming two decades.
Statins are dramatically underused even when referring to old guidelines. We have a huge population with a constantly aggravating state of health as a consequence of statins’ underutilization and this occurs at the pocket-cost of all of us.
I want to remind you that simvastatin is over-the-counter in some countries (UK and other) and more than one statin was proposed for OTC status here, in the US. I personally reviewed the public FDA comments and at no point statins’ safety was a concern in these evaluations. Statins’ are some of the safest drugs and as a pharmacist I can tell you that you have nothing to blame on pharma this time. The role they play with regard to statin utilization is one of the most ethical one can ever wish to see from pharma. The discussions around statins utilization are a result of the clinicians’ demand for the benefit of their patients.
Thank you for considering my thoughts – I am here because I healthcare as well
This change is as the authors write clearly a contrivance, but not necessarily a bad-intentioned one. In healthcare we have learned to “not” follow the money rather to follow the definitions.
So how might a layperson distinguish between the prior numeric-based approach and this new statinization effort? I suggest we begin with a single question: “Is this ‘healthcaring’?”
Like gauging our satisfaction, a beautiful thing about “healthcaring” is we each know it when we have it, and we know it when either we or someone else doesn’t.
This almost always works, however, can we actually figure out whether a definitional change like the stantinization one now being implemented is “healthcaring?” That’s a question on which we’d appreciate the authors’ guidance and comments from others.
Yours in healthcaring,
B.
Al, you’re absolutely right. Don’t know what it’s like in the US but in Canada we estimate 80% of statin use is by people without existing heart disease and hence unlikely to see any benefit whatsoever. O the waste…
I disagree with the premise that big pharma held sway here. Over 90% of statin use is now generic. The guidelines are also essentially a death knell for lucrative drugs like zetia which have never proven effective.
These numbers from Thennt.com give some sense of the magnitude of effect. Obviously in people without established heart disease the benefits would be much smaller. (But the harms would likely be the same)
Statins Given for 5 Years for Heart Disease Prevention (With Known Heart Disease)
http://www.thennt.com/nnt/statins-for-heart-disease-prevention-with-known-heart-disease/
Benefits in Percentage
96% saw no benefit
1.2% were helped by being saved from death
2.6% were helped by preventing a repeat heart attack
0.8% were helped by preventing a stroke
Harms in Percentage
2% were harmed by developing diabetes**
10% were harmed by muscle damage
In Summary, for those who took the statin for 5 years:
Benefits in NNT
1 in 83 were helped (life saved)
1 in 39 were helped (preventing non-fatal heart attack)
1 in 125 were helped (preventing stroke)
Harms in NNT
1 in 50 were harmed (develop diabetes*)
1 in 10 were harmed (muscle damage)
remember, these stats are for KNOWN heart disease. My issue is that when you draw the line at a much lower threshold, these statistics become far more skewed in the wrong direction.
It’s interesting that your numbers are so different from the ones I read and my own clinical experience. Only 4% saw benefit at all? People with known CAD or risk-equivalent? 2% develop diabetes? 10% are “harmed” by muscle damage?
First off, here’s a summary statement from uptodate.com on the risk of diabetes: “It appears likely that statin therapy confers a small increased risk of developing diabetes, and that the risk is slightly greater with intensive statin therapy than moderate statin therapy. As would be expected, given the evidence from clinical trials that statins reduce CV events in patient with diabetes (see “Clinical trials of cholesterol lowering in patients with coronary heart disease or coronary risk equivalents”), both randomized trials and observational studies suggest that the beneficial effects of statins on CV events and mortality outweigh any increased risk conferred by promoting the development of diabetes.”
10% “harm” from muscle damage? In nearly 20 years of practice, I’ve seen one person “harmed” (developed rhabdo because he kept taking it despite his pain). I’ve had people develop myalgia, but those were taken off of the drug. Some studies say you can try again and a percentage will not have that (or give coQ, which may or may not help).
I do realize there is flippant use of statistics by the drug companies to show a “50% reduction” in something that has only a 2% risk, making docs believe it helps 50% of the people, when it actually only helps 1%, but your loose use of statistics simply points to an anti-statin agenda. One stops doing science when one comes to a conclusion and then tries to find data to support it. I argued with Lipitor reps for years and didn’t use their drug until they had meaningful clinical endpoints (reduction in CAD, stroke, and death).
As already stated, there is very little financial gain to those lobbying for use of Statins, as only one major one (Crestor) is not generic. In my city, I can get 30 days of Lipitor for $5, Simvastatin for $2.50, and Pravistatin for $2 (you can split each of these pills in half to cut the cost 50%). One gallon of gas costs more than that. Nobody’s making much on these drugs any more.
I don’t know, but while I agree that the 7.5% needs to be justified, and we need to find better ways of predicting risk so we can focus prevention on high-risk populations, it seems like there are a lot of tin-foil hats around here.
Why not focus on the “Low T” marketing, and the gazillions of dollars made from that? Why not focus on the fact that 25% of pharma cost is in biological drugs which treat disease in less than 1% of the population? (Watch the evening news and see if you can get through it without a commercial for Psoriatic arthritis or RA treatments, both occurring in a minuscule portion of the population).
“So, let me get this straight. We give statins so we can eat sugar.”
What?
I never mentioned sugar; I simply said that knowing risk is a good thing, and that treating that risk (sometimes using statins) is better than treating a proxy marker like LDL.
I agree that lowering sugars consumption is highly likely to be a good thing, but am confused as to why I was put as someone who didn’t think that. But blanket statements demonizing one thing (sugar) as the cause of all wrong sound quite similar to those demonizing another (LDL). We focus on risk and risk-reduction. That is the job of doctors. If we can do that through diet and education, great. If we do it though use of medications guided by accurate predictors of risk which identify those who stand to benefit the most from medication, that’s what we should do.
This is not independent of the effort to identify those at highest risk of diabetes (which kills mainly by causing vascular events) and finding the best strategies (lifestyle, public health, or pharmacological) to reduce that risk. Your use of references at the end of your comment to “prove” that carbohydrate consumption and diabetes raise CVD risk are not new news for this internist.
Sorry, Rob – I didn’t mean to reply to you. Meant to further make the sugar point. While there are many things that are involved in risk, for sure, a very important one is not weighted apporpriately in risk reduction strategies.
I appreciate that the references are not news to you, but guess what, if they were news to the general public and policymakers, we’d be having the dialogue at a national level, not on a comment section of a blog.
not that there is anything wrong with it…
One concern would be that people think if they are on statins that they have carte blanche or close to it in lifestyle choices such as sugar consumption, just the way people with high-efficiency light bulbs are less vigilant about turning them off
So should we not talk about seat belts because they encourage people to drive recklessly?
There is zero evidence that seat belts promote high risk driving.
Hey Jordan, the comments section of THCB IS a national dialogue!
Is there a question that statins, when used in populations at high risk for heart disease, lower that risk? I would say there is little question, even when one accepts the challenges to the idea that the culprit is actually the LDL cholesterol. So it would seem to me that we need the most powerful tools available to identify CVD risk accurately so we can decide whether or not to use the treatments we know work in high risk populations. I applaud the attempt to take the focus off of the hard numbers and onto the idea of risk-reduction. Recommendations simply focusing on the LDL or total cholesterol resulted in inappropriate treatment of such numbers in low-risk individuals, ignoring the risk of treatment.
As to the question of why go to 7.5%, I would guess that this was done because the risk-reduction from the use of the statin would still outweigh the risk of the drug enough to warrant treatment. If the authors didn’t explain, then we are lert to guess.
But I believe this is a big step in the right direction: a focus on risk-reduction, which is a true form of prevention (I know, it’s a bad word). Knowing risk would identify the populations in which more aggressive intervention would be appropriate and decrease the practice of over-treating low-risk populations. I would hope that other risk predictiors (genetic) would offer an incredible benefit in this area, by identifying people genetically predisposed to disease who are, by definition, those who benifit the most by aggressive risk-reduction.
Or, perhapse this is a viscious attempt by manufacurers of generic statins to stuff their wallets with money from the arteries of innocent Americans.
There is growing evidence that sugar consumption in excess (the average american eats 22 tsp of sugar and the recommendation is 7tsp) leads to increase risk for heart disease. Futhremore, there is mounting correlation that sugar consumption leads to Type II diabetes (which is yet another risk factor for CVD).
So, let me get this straight. We give statins so we can eat sugar. Seems like we’re solving a second order problem here.
Basu S, Yoffe P, Hills N, Lustig RH. The relationship of sugar to population-level diabetes prevalence: an econometric analysis of repeated cross-sectional data. PLoS ONE. 2013;8:e57873.
Malik VS, Popkin BM, Bray GA, Despres JP, Hu FB. Sugar-sweetened beverages, obesity, type 2 diabetes mellitus, and cardiovascular disease risk. Circulation. 2010;121:1356-1364.
de Koning L, Malik VS, Kellogg MD, Rimm EB, Willett WC, Hu FB. Sweetened beverage consumption, incident coronary heart disease, and biomarkers of risk in men. Circulation. 2012;125:1735-1741, S1731.
As I noted for another commenter, the long-term benefit for phrama is the opening of the door to a much larger population to which it can sell new products. While many new patients will use generics in the short term, there are expensive new “blockbuster” statins in the pipeline, and, despite all the best efforts to limit access to those drugs, there will be intense pressure to prescribe them.
Further, given that the generics business is a volume business, those manufacturers are no doubt pleased with the effective overnight doubling of their market. Even when you make only pennies on the dollar, a doubling of market share is pretty powerful.
OK, so the question then comes down to this:
1. Do statins save lives?
2. If so, then are the folks recommending this in these in the pocket of pharma or are they interested in saving lives?
3. Why not educate doctors that “blockbuster” drugs (of which I have no knowledge) must prove significant endpoints (i.e. Not the lowering of cholesterol, but the reduction of heart events and prolongation of life) before we use them in the place of drugs with strong evidence that supports that.
You use a straw-man argument here. Just because someone is going to make a profit off of it, you say we should ignore the benefits of stain drugs? Just because doctors are idiots and will check out the drug reps legs and prescribe $200/month drugs over the generics, then we should not see the benefits of the generics? I use lots of statins in my high-risk populations because I believe they are more likely to be with me in a year if they do. I don’t use new drugs until they have shown they are able to justify the expense by showing they are able to give my patients more birthdays and less heart attacks and strokes.
I do agree that the drug companies will be shameless in pressuring patients to “as their doctor if HealthCor is right for you,” but this doesn’t mean that I don’t prescribe simvastatin or atorvastatin to my people with diabetes and with a high risk of CAD. It’s fair to call into question the 7.5% mark, but to imply that there is no science here is pretty weak.
No one is objecting to statins for high risk populations.
The point of our objection and that of many, many others is that the new guidelines expand the definition of who’s at risk in an arbitrary manner by shifting the threshold for use in adults without disease.
Tim, thanks for asking the question and I wonder why no one else has. I’ll bet on evolution over pharmaceutical company data any day
I have a real problem with the use of statins, this is a totally irresponsible and lazy way of treating those who may develop heart disease. LDL cholesterol has been villanized to being the cause of blockages in the heart arteries. At the same time LDL is acknowledged as essential to repairing cell walls throughout the body. On top of that your liver creates 80% of your total LDL…your liver isn’t creating this stuff for the heck of it. I’m hoping the day will come where studies confirm my suspicion that LDL is found in heart artery blockages because the LDL is trying to assist the body’s attempt to heal fatigued and perhaps rupturing heart arteries…or something like that.
Vik,
Would you be intereseted in presenting to the SF Health Services Systems Board. I am a commissioner and we are active in designing benefits for 47,000 employees and retirees of SF. I went off yesterday at commission about how we’re trying to lower costs and promote healthy eating and then this malfeasance!
Best,
Absolutely. Let’s take this offline. Please email me at:
vik.khanna.health@gmail.com or call 443-226-7009 (I am in St. Louis, so Central Time) and we can set up a telecon to discuss.
Thx.
When I saw the new guidelines the soundtrack running through my head was Bobby McFerrin’s song “Don’t Worry, Be Happy” which includes lyrics like these:
…In every life we have some trouble,
But when you worry you make it double
Don’t worry, be happy
Don’t worry, be happy now… (and so on ad infinitum)
Not to trivialize peoples’ desire to want to do something to reduce their risk of cardiovascular disease, haven’t we known for a long time that our collective obsession with “lower is better” around cholesterol levels is mostly a misguided waste of time?
It’s debatable whether these guidelines will dramatically increase statin prescribing, but we need to give the average intelligent patient the benefit of the doubt: when people discover through a risk calculator how altering their blood cholesterol with drugs has such a trivial effect, (maybe reducing a five year CV risk by 1% at best, in otherwise healthy people) they might seek out less costly and safer ways to lower their risk of heart disease. And the bonus? They might stop worrying.
It’s undeniable that the ‘treat to target’ approach is a paradigm fondly nurtured by the pharmaceutical industry, driving irrational behavior in both patients and prescribers. It forces people into drug therapy in a frantic attempt to reach ‘targets’, and then saddles many with angst when they never hit the target despite swallowing a daily weapons-grade statin.
It’s hard to say whether these new guidelines will change the soundtrack on cholesterol. If this new advice gets people to listen to a different tune that might actually reduce their risk of heart attack (like a healthy diet, adequate exercise, not smoking, the banal triumvirate of ‘healthy living’ advice) can it be bad? Now, hum along with me… Don’t worry, be happy, (and stop obsessing about your cholesterol numbers).
The problem is the sugarization of our food supply. 80% of food has added sugar.
We cause the problem with sugar subsidies and then we medicalize (which is a second order phenomenon). We are hacking at the leaves and no one cutting the roots.
Watch for the Insitute for Responsible Nutrition….It’s on. Sugar is the new Tobacco.
Sugar is an issue we already addressed once on THCB and we will be poking at it again soon from a different angle.
Great post. I totally agree with your statement about how the lower threshold of 7.5% while ignoring other factors such as family history, CRP, or CAC, seems suspect. In fact using the calculator and entering information as healthy 59 year old your risk is much less than the 7.5% risk threshold but once you turn 60, bam, your risk triples.
I would disagree with you that these guidelines will result in increasing the cost of care infact these guidelines will DECREASE the cost of care. From a physician stand-point it sets the way for a “set-it and forget it” mentality. No chasing targets, no adding extra medications that aren’t evidence based to optimize lipid profiles, obtaining multiple lipid panels, no follow up visits etc. Meet the criteria? Start a statin. Done. Nothing left to do! (Unless you have FH of course.)
Justin,
Thanks for your comment. Theoretically, there will be at least one more physician visit for at least 30M Americans who’ve now been led to believe that they need “help.” At even a conservative estimate of $100 each, this is $3BN in spending just to review the risk calculator results and get the script.
In addition, my reading of the literature leads me to conclude that statin therapy compliance is much greater in people who see their physician periodically than in people who don’t, and we still have to deal with the side effects (possibly up to 20% of patients) and liver function issues (2% of all patients). And, we are still in a predominantly fee-for-service system, so physicians will not have an immediate imperative to control utilization.
UK’s NICE recommends that people on statins see their docs at least twice yearly. Will American physicians tell their statin patients to just phone in prescription refill requests? I don’t think so.
BTW, the reason that the risk jumps so much after manipulating the age to 60 is that a man’s lifetime risk of CVD is 50%, and the longer you live the more likely you are to develop it unless you manage all the risk factors successfully.
Great post guys, I was waiting for it. And your observation of the medicalizing/monetizing the act of living our crazy modern life is spot on. I’ve done the lifestyle change and it works wonders. No drugs for me:)
You, sir, have it figured out. Not everyone will have your success (or mine), and, for them, drugs will certainly play a role. But, drugs rarely cure, they control and even when on pharmacotherapy, a proactive lifestyle management strategy can add significant clinical and quality of life value.
This is the problem I have with new studies, especially ones that promote more treatment or “medicalization”. How do we really believe this is reasonable data and a reasonable approach to ongoing health care of the population?
Pre-hypertension, pre-diabetes, pre-hyperlipidemia, really?
Now are we going to have pre-obesity?
Not to mention more ADHD, more treatment with stimulants which have major side effects and adverse reactions?
It seems to me we have to start at the beginning with encouraging wellness with education and lifestyle recommendations before resorting to massive medication usage. While these drugs may not be exceptionally expensive, it’s still a cost issue, not to mention the cost of side effects.
Whatever paths are taken regarding the future of healthcare, we as practitioners need to use common sense in addtion to research protocols.
I agree with the substance of your post. Mainly, do we swap one (?) flawed risk model for another. You surmise, and again, I cant disagree, that the new iteration might cause more harm than benefit.
What you dont do however, is back your post with data.
More adverse effects. Probably. More doctor visits. Probably.
However, assuming NNT of 130 (stroke or MI/death) for primary prevention and 30% risk of ADEs of all stripes–many of which are minor to inconsequential; generic statins selling for $10/3 mos supply; and assuming rx administration incorporated not into a wellness program, but mainstream practice, the cost/QALY may net (+).
I cant say yes or no, but looking at policy through lens of wellness exclusively sells broader purpose short.
I am still agnostic though. I want to see an analysis of how new policy might translate at population level. I have seen good arguments on both sides, yet solid cost utility analysis elusive. If you worked off one, would love the reference.
Additionally, what I also wont say is this is a giveaway to pharma. We have good, cheap generic rx available. Not a pocket liner by any stretch.
Brad
Brad,
Thanks for your very thoughtful note. Our swipe at the wellness implications of the new guidelines is only a very small piece of this puzzle, but, as we are amongst the most vociferous critics of conventional wellness programs, it was not a point to leave behind.
Based on what I’ve read from Cochrane (Jan 2013) and the CMAJ (Nov 2011), you may be right that there is a net QALY + for statins, but coming to that conclusion appears to require more than one leap of faith. First, that the therapy is continues for a long period; second, that the therapy is targeted appropriately and my reading of the Cochrane analysis is that statins have greatest potential utility in people at high risk, but perhaps not in people at lower risk, which makes the 10%-.7.5% shift (presumably leaving 5% at low risk) seem a very arbitrary artifice.
It’s also true that uncertainty about adverse impacts is a persistent concern about statins; what don’t we know because industry forces suppress the release of data? I know from my own work with pharma companies at an early stage in my career that the companies and legions of consultants who advise them on clinical trials as well as reimbursement issues, are quite comfortable with convenient lapses in memory and would jettison potentially negative information as easily as they throw away a candy wrapper.
We don’t disagree with you that today’s generic statins are cheap. But, the horizon looks much different. If, as news reports indicate, the FDA approves PCSK9 inhibitors solely on the basis of their ability to lower LDL (but not to demonstrate fewer MIs or strokes), the door gets opened for pharma’s next blockbuster drug class. For pharma cos, to have a ‘captive’ audience to which they can appeal with DTC ads is to build the gold mine for them. And, of course, they will besiege doctors with ‘data’ to support upgrading patients the new products to take full advantages of all the new benefits (whatever they turn out to be).
It’s nice to think that health plans and PBMs will resist all this so nicely, put the new drugs into pricier tiers, and have restrictive coverage and reimbursement criteria. Yes, those tools have worked so well, haven’t they? Everyone gets rich except patients.
We stand by our overarching theme, that this is just the leading edge of a new wave of inappropriate and eventually destructive medicalization of our culture that will continue to erode the trust between people, the healthcare system (inclusive of both plans and providers) and the government. We aren’t all just patients waiting to happen.
BTW, I read your bio. Nice to hear from a fellow Schenectadian.
Funny. Yes, Schenectady cooked into the DNA (Slicks sandwiches?? 🙂
Good response. Measured and open minded.
My only comments would be:
1) On ADEs, we can only continue to measure. If we assume entire enterprise corrupt–and no doubt we have criminals–we will paralyze any efforts to improve care. Please note, my insight has no naiveté attached.
2) ALong similar lines, we will always have new RX introduced to market. If drug A good value, and drug B bad, we either fix the system or drown in it. I dont buy the slippery slope, assuming ref pricing, tiering, etc, embeds in system like I anticipate. The days of “give them what they want” coming to an end. Please note, my insight has no naiveté attached.
Also, an FYI, no LFT monitoring required with statins. Rec sundowned sometime back.
Thanks for the thoughtful response Vik
Brad
I love the title alone of this post, but , extrapolate it to the agenda of what the law will do to health care interventions as a whole, irregardless of a specialty.
Oh, speaking of Stalinization, it will be handled by the IPAB, which everyone is conveniently ignoring as of now. The usual suspects of partisan assassinating anyone who dates note real and current dangers to PPACA, watch and read them stoop to the usual defenses for antisocial agendas: denial, projection, deflection, minimizing, and lastly, pure pathological rationalizing.
It’s what the partisan agenda of both sides to this polluted aisle of Republocrats do with ugly ease.
Nice post!
“It’s what the partisan agenda of both sides to this polluted aisle of Republocrats do with ugly ease.”
Great line, Joel. Thanks for your comment, and we agree that there are many potential ramifications that people are ignoring.