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.