OP-ED

The Cholesterol Gulag

Last week, we were amongst the very first opinion leaders to speak out against the new cholesterol guidelines from the American Heart Association (AHA) and the American College of Cardiology (ACC).

Our error was not going far enough.

Monday’s New York Times carried a devastating portrait of the development of the guidelines, leaving readers with the unmistakable impression that this absurd attempt to make people into patients was not just poor policy it was a hubristic, avoidable policy folly, sort of like the bridge to nowhere and federal housing policy pre-2008.

Trust is an interesting thing; once broken it almost resists reconstruction.  Public trust in the AHA and ACC is crumbling as we write and deservedly so, as what should have been clear becomes more confusing and conflicted by the minute.

Instead of giving generally healthy middle aged American adults (like the three of us) the safe haven of a cardiovascular disease (CVD) prevention framework that is understandable, sensible and actionable, we got a cholesterol gulag.  Only here in the land of the free, it’s not a government gulag imprisoning the political opposition.

No, in a phenomenon unique to the US, it’s a health gulag intended to take people who need advice, support, and guidance and give them a pill, which is the first step in an intentional ensnarement in the medical care system.  It’s the Hospital California…on steroids, and you can’t even checkout because that would be against this addled medical advice.

To clarify: we have zero objection to providing statins, especially low-cost generic ones, to people under age 75 with current CVD, diabetes, or extremely high cholesterol levels.  The drugs may very well save their lives.

Our beef is with the cockamamie reduction in the ‘risk-to-treat’ threshold from 10% risk of heart attack or stroke in the next 10 years to 7.5% for people with none of the above noted problems.


To make our objection crystal clear, here is the math that validates what we said last week, in concert with other objectors, that this policy effectively doubles the market for statins amongst generally healthy adults.

Like wellness math, this statin math didn’t seem to add up.  The purveyors of this recommendation said they wanted to put a third of all adults (44% of men, 22% of women) on statins because their 10-year event risk exceeded a threshold of 7.5%.  Suppose that the average (as opposed to threshold) 10-year risk of those 75-million adults is 10%, or about 750,000 events/year.

That estimate accounts for almost every event, leaving no heart attacks or strokes to allocate to the other 150-million adults whose 10-year event rate risk is less than 7.5%.   Hence using the AHA’s arithmetic, there are simply not enough events to go around for both the high-risk and low-risk populations.   The epidemiology supports our mathematical observations, as heart researchers just found that the AHA’s risk calculator overstates actual risk by a factor of two or thereabouts.

A criticism levied at us after last week’s piece is that the new guidelines really aren’t such a big win for pharma because the generics are so cheap.  Naiveté is not on our list of vulnerabilities.  The small win for pharma is getting more at-need and healthy adults to gobble generics because generics are a volume business.

The big win is coming: PCSK9 inhibitors, which are the next blockbuster class of anti-cholesterol drugs.   If press reports turn out to be true, the US FDA in its infinite wisdom will not require the makers of these products, including Amgen, Pfizer, and Sanofi, to prove that they save lives, just that they lower LDL cholesterol, which will only further pollute the dialogue about risk reduction.

Shouldn’t an approved drug that supposed to save lives actually prove that it can do so and not just that it can alter a biochemical marker?  Even more important, PCSK9s are injectable products, which means physician visits and, if the real world clinical conditions mimic trials, patients will need antihistamines, acetaminophen, and oral corticosteroids to manage side effects.

Undoubtedly, the pharma companies will drown us with celebrity-laden direct-to-consumer ads on improved side effects profiles and the urgency of getting your anti-cholesterol shots early and often; we’ll never hear about the potential trial participants who washed out in early testing because they suffered severe side effects or even learn whether the right side effects questions were asked.

No longer can we trust the supposedly responsible adults – the physicians on these panels – will act in the public’s interest.

Right now, the pharma companies and their legions of consultants are crafting marketing campaigns, news media exposure, and long-winded explanations of the advantages of the new drugs by their bought and paid for physician ‘thought leaders.’

The demand wind-up will deliver fastball after fastball about why the new products are so great, so effective, and so integral to CVD prevention.  Except that we won’t actually know any of that based on the coming FDA approval; all we’re likely to know is the drugs lower cholesterol.

One thing overlooked in the cholesterol debate of the past week is that these drugs can do bad things to your brain, because sufficient cholesterol is critical to healthy brain function.  If you ask us, it appears that some people have already lowered their cholesterol levels too much.

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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  2. Last year, these lenders issued new restrictions on mortgages to homeowners participating in PACE programs. Under PACE, if a homeowner defaulted, the municipal loan would get paid back before the mortgage. That riled Fannie and Freddie, which argued that they should get paid back first. So, the Federal Housing Finance Agency instructed them to enforce very strict guidelines on homeowners receiving PACE loans, forcing many communities to halt their programs. That put a virtual freeze on this important economic driver.

  3. Let me take this opportunity to step back from this one particular instance of Big Corporations Behaving Badly and offer a heterodox perspective on the macro economic issues surrounding it. Please don’t interpret my comments below as implying that I would oppose the death penalty for executives who do things like push Effexor as the first SSRI to try. (More than one of my loved ones was a victim of that malmarketing.)

    It is fundamental to market capitalism that the managements of all corporations must, at all times and under all circumstances, be striving to increase their organization’s profits. Adam Smith taught that an “invisible hand” will channel human greed towards maximizing social welfare. This mechanism does work when it’s bakers competing to supply bread, but what about globalized pharmaceutical companies adept in manipulating regulators into approving new therapies of dubious value and practitioners into using them? Given the value that people place on “health”, or even the *promise* of health, executed well, this will make Big Pharma (/”Big Health”) the most profitable industry segment in the world!

    Curiosity question: In a market-capital system, the most profitable industry has first call on the economy’s/society’s best physical, intellectual, and, especially human capital. So what industry segment *ought* to be the most profitable? There can be only one.

    I am taking nominations, and I would appreciate REPLY posts with candidates. I saw an article in BUSINESS WEEK some time ago that *brewing* (making beer) was, that quarter, the most profitable American industry, not Pharma. How many on this blog would vote for brewing as having first claim on the best and brightest minds coming out of our universities? Or should it once again be Wall Street as it was after the Dot-Com bubble burst but before the world economic collapse that the financial boom led to? Or perhaps they should be going to work for Big Food, formulating ever-more-irresistable combinations of sugar, salt, starches, and fat on the back end and ever-more-clever marketing strategies on the front end to get Americans to shove more of *their* companies’ calories down their gullets?

    Big Food *is* in dire need of help on the profits front, at least according to

    http://www.newyorker.com/talk/financial/2013/08/12/130812ta_talk_surowiecki


    “… a typical McDonald’s franchise earns around six cents on the dollar [of revenue] before taxes, according to an analysis from Janney Capital Markets. In fact, the combined profits of all the major retailers, restaurant chains, and supermarkets in the FORTUNE 500 are smaller than the profits of Apple alone. Yet Apple employs just 76,000 people, while the retailers, supermarkets, and restaurant chains employ 5.6 million.”

    So it looks like the company painting its main electronic gadget gold so it can sell more of it is the big individual-company winner, with its market segment lamentably weighed down by all the electronic gizmo also-rans. But how about casino gambling? Perhaps the Big(gest) Bucks should be moving it online and making it available 24X7?

    Me, I nominate Big (and medium-sized and little) Pharma to be the world’s most profitable industry. At least on paper they are in business to fight mankind’s war against its oldest and most remorseless enemies, disease, injury, and the incapacitation that comes with aging.

    And yes, there is the “danger” that Big Pharma will manipulate the system so that there is so much money being spent on treating heart disease that venture capital companies will start just throwing money at new companies with new ideas to address that market, because suddenly a 0.01% market share is enough to make them rich. This creates the very real risk that my young children might hit middle age in a society where heart disease is so rare as to be almost unknown. And yes, if we let the robber barons of biomedicine beat heart disease, there is no guarantee that they will demobilize. Cancer and Alzheimer’s might be their next targets!

    In spite of these very real dangers, I nominate Pharma to be the most profitable industry in the market, and further propose that we stuff the “corn” of government grants and incentive awards down the throat of that industry “goose” until it is fatter than the geese from which we get foie gras and is helplessly excreting new antibiotics and other classes of drugs that otherwise could not compete with injectable statins for research dollars. What can I say? I am the prisoner of a value system that prioritizes health over…, well, everything, now that I think of it.

    But other people have other values, so the floor is open for other nominations. How about corn-into-ethanol to starve more Third World peasants and generate greater unrest in the Middle East? The government subsidies that made it profitable to do that are being withdrawn, but we could press for them to be reinstated if that industry were the winning candidate for “Most Profitable”! And finding some way to expand the Third World market for caffeinated+carbonated sugar water would make Things Go Better for Coke. Or if we could repeat what “W” did in Iraq in Syria, Halliburton & Co. might once more be contenders…

    As a personal aside, the drug I take to ward off atherosclerosis is doxycycline. I was put on low-dose antibiotic therapy right out of college by an overly aggressive dermatologist–my particular case of acne was not that bad. But had he not put me on *something*, there would have been no reason for me to come back for follow-on visits. For the first few decades I was on tetracycline, and then other derms tried other, newer (= more profitable) antibiotics. But always something.

    A decade ago, when we were both 55, my identical twin, who never fell victim to predatory dermatology, came down with severe angina and ended up with three sents in his chest. Upon learning that he had an identical twin, his cardiologist called me in for a stress test. It was completely negative, which seemed logical to me because it was not nearly as strenuous as just the bike ride in the New York City Triathlon. The cardiologist proceeded to recommend that I undergo a *heart cath*, and my insurer even paid for it.

    No atherosclerosis at all. That mystified the cardiologist and seemed strange to me until I came across, years later:

    http://www.isteve.com/infectious_causation_of_disease.pdf

  4. Yes, I saw Lipitor ravage the muscles of my aging mother and turn her into a cripple (her Assisted Living nurse helpfully supplied her with a glass of grapefruit juice to wash her pill down with), so when my internist told me I should go on statins to get my LDL level down, I declined and simply asked, “What number would you *like* to see?” I came back three months later and my new blood work showed that level. All that I had to do is diet down to a normal weight for a 50-year-old (= what I would weigh if I were a male ballet dancer half that age).

    Losing weight is *incredibly* unpleasant. For my body, it requires giving up all sugars and starches and going seriously hungry for extended periods of time. I can understand why so few Americans are willing to do that. I am not sure that I am willing to bankrupt America’s middle class to pay for the care of non-compliant type-II diabetics, though. It all depends on how much they insist on costing us…

  5. In our first essay on this topic, we were very clear that we support the idea of moving toward a view of risk that more accurately reflects the fact that CVD risk is a constellation and not a discrete point.

    ATP III urged initiation of therapy for people with 2+ risk factors (but not diagnosed CVD or a comorbidity) with 10 yr risk > 10% if LDL is > 130 and for people with 10 yr risk of < 10% if LDL is greater than 160. That appears to us to make 10% the old break point for initiating statin therapy and that threshold is now lowered to 7.5%.

    The new guidelines recommend use of non-statin cholesterol lowering drugs only as adjunctive, and the goal of therapy articulate in the guidelines is very clearly to lower cholesterol.

    The FDA does not approve guidelines, and it isn't going to take these guidelines into account when considering approval of the new compounds. But, the drug companies will certainly take them into account because they will come to market likely claiming the ability to reduce cholesterol, which is consistent with the goals articulated in the guidelines.

  6. I believe there are two ways that this piece has two major misunderstandings.

    First, re: the “cockamamie reduction” from 10% to 7.5%. Where’s the 10% from? 10% played no role in the old guidelines at all. Personally, I wish they’d chosen a cutpoint of 10%, but it’s not a reduction from anything. You’re ignoring what an advance the movement towards risk is.

    Second, while FDA might approve them and unlike the old guidelines, the new guidelines are very explicit about not using medications that don’t help major clinical endpoints. In fact, the new guidelines are quite strongly negative to all of the highly-profitable non-statin cholesterol medications, including fibrates, ezetemide, etc. This piece is an unfair conflation of FDA decisions and the new guidelines. When it comes to preventing people from using mis-tested medications, these guidelines are great progress.

  7. Vik, what a fantastic analogy! When we focus so much on therapies that require continues use of drugs and not lifestyle changes, we turn people into medical slaves! Everybody know that if you lose 20 to 30% of your weight you have o good chance that you may not need statins nut i do not see the campaigns towards lifestyle changes.

  8. Alan: I love your cynicism. I predict that there is zero chance of the FDA not giving its approval, especially since it has already telegraphed its intent to approve only for lowering cholesterol and not for actually making a difference in outcomes. It’s been ages since pharma or biotech companies produced a blockbuster that would justify interrupting my favorite TV shows and sports events to tell me to see my doctor needlessly for a drug unsuitable for me. They need this approval because getting people — large numbers of people — on to drugs that require continuous use for decades is the secret to financial success. It’s one reason no one is developing blockbuster antibiotics; five days of therapy just isn’t anywhere as lucrative as 15 years of it.

    Thanks for chiming in.

  9. Great blog post to keep the conversation going.

    If you want to memorize a catchy phrase to drop into cocktail party chatter with ease try this one on for size: “Humanized IgG2Δa Monoclonal Antibody Binding Proprotein Convertase Subtilisin Kexin Type 9.” Now try saying that baby three times fast. Or you might just want to shorten it to RN316, one of the new PCKS-9 inhibitors soon to flow from the pipeline, promising to be the next best thing to lower your LDL since Lipitor.

    It is still early days and despite no evidence (yet) that RN316 reduces heart attacks or strokes this fact shouldn’t stop it from heading to the blockbuster stratosphere given the way the “lower is better” mantra colonizes our collective psyches.

    I wonder if we all have forgotten that Lipitor, the largest selling prescription drug in the history of the planet, also came to the US market in 1996 only being able to make one claim: that in addition to diet and appropriate “lifestyle modification” it could alter a person’s cholesterol levels? By 2003 Pfizer was selling about $5.5 billion a year worth of it and it wasn’t until the middle of 2004 (call it the seven-year itch?) that Pfizer was allowed to make the health claim that Lipitor could reduce the risk of myocardial infarction.

    The product label at the time came with some very quaint caveats, telling us that atorvastatin was only indicated in “adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age 55 years, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease..”

    So will RN316 enjoy a seven year, multibillion dollar run before it demonstrates more than a superfluous tinkering of our cholesterol levels or will we wise up to the incredible (and probable) waste such a large-scale experiment will entail and call the bluff now?

    Just a thought.

  10. Leo

    Thanks for the note and the praise. We have no doubt that you are correct about this initiative pushing disease mongering forward. We also have no doubt that the next shoe to drop will have to do with whether or not treat pre-hypertension, which will advance the cause of making disease out of non-disease.

    For an interesting take on that topic, I suggest this essay by David Cundiff, who helped to write the Cochrane report: http://www.healthnewsreview.org/2013/11/the-economics-politics-of-drugs-for-mild-hypertension/

    Stay tuned.

  11. Nice shot. I think presenting patients with data they can understand like absolute risk reduction or the number needed to treat would be far more useful. This lifetime risk thing is confusing and magnifies the actual risk, without addressing how much risk is reduced given the addition of statins. The calculator is awkward and difficult to use. The one I downloaded has an embarrassing GUI. Makes Pac Man look like an advanced civilization. The guidelines are presented as a solution to cholesterol mongering, but push disease mongering to unprecedented realms.

  12. Key Takeaways:

    “A criticism levied at us after last week’s piece is that the new guidelines really aren’t such a big win for pharma because the generics are so cheap.

    Naiveté is not on our list of vulnerabilities. The small win for pharma is getting more at-need and healthy adults to gobble generics because generics are a volume business.

    The big win is coming: PCSK9 inhibitors, which are the next blockbuster class of anti-cholesterol drugs.”

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