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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Air Structure Triax 91
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Serious Medicine Strategist
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Serious Medicine Strategist

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… Read more »

sj
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sj

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… Read more »

Vik Khanna
Guest

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… Read more »

GLUCOSAMINE HCI
Guest

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.

Serious Medicine Strategist
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Serious Medicine Strategist

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… Read more »

Alan Cassels
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Vik Khanna
Guest

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… Read more »

LeoHolmMD
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LeoHolmMD

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.

Vik Khanna
Guest

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.

Bubba for President
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Bubba for President

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.”