Of life’s two certainties, death and cataracts, it seems statins defer one and prompt the other, although not necessarily in the same person. If you blindly love life you may be blinded by your love for life.
In the HOPE-3 trial, ethnically diverse people without cardiovascular disease were randomized to 10 mg of rosuvastatin daily and placebo. The treatment group had fewer primary events – death from myocardial infarction (MI), non-fatal myocardial infarctions, and non-fatal stroke. For roughly ten MIs averted there were seven excess cataracts. Peter may be blinded without being saved. Paul may be saved without being blinded. And then there is Rajeev who may be blinded and saved. But the very nature of primary prevention is that you don’t know you’re Peter, Paul or Rajeev. So everyone is grateful to statins. Not even God of the Old Testament had such unconditional deference.
Once you’re taking statins there is no way to disprove that any and every breath you draw is because of statins. Statins enjoy the metaphysical carapace, the immunity from falsification, which not even God enjoys. At least you can experiment with God. Don’t pray for a week and see if you’re still alive- you know if God really cares about prayer-adherence. Even if you die at age 55 on statins, you can never disprove that you wouldn’t have died sooner if you weren’t taking statins.
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.
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.