I’m exhausted. My hair hurts. My head’s about to explode, singed by the firestorm of media coverage about new cardiovascular disease treatment guidelines – specifically, the newly-expanded recommendations to prescribe the cholesterol drugs called statins to just about every middle-aged person who still has a detectable pulse.

Five years ago, I was told by my cardiologist that, as a freshly-diagnosed heart attack survivor, I was most definitely in the right demographic to benefit from taking a statin every day for the rest of my natural life (along with a fistful of other cardiac meds).  Statins, he explained, would help prevent another heart attack by controlling my specific target levels of low-density lipoprotein cholesterol, commonly known as LDL, or ‘bad cholesterol’.  Lots of studies (at least, those paid for by the folks who make statins) seemed to indicate that lower LDL numbers would decrease both my risk of suffering a future cardiac event as well as death.

But now, these new treatment guidelines are essentially telling us and our doctors not to obsess at all on those target LDL numbers in favour of expanding the pool of potential statin-users out there.

The guidelines, released by the American Heart Association and the American College of Cardiology (both non-profit entities that are coincidentally heavily supported by drug companies) were designed to provide physicians with expert guidance on cholesterol, obesity, risk assessment, and healthy lifestyles, but it’s figuring out who should be on statins that’s getting most of the media mileage out there.

The focus has broadened to cover treatment decisions based on individual risk status instead of setting a distinct numerical target for lowering LDL cholesterol like back in the good old days (i.e. last week).

So with hardly an explanatory whimper about backtracking, the general lack of credible evidence for those specific LDL targets (particularly in women) now explains why such targets have been dropped from the new guidelines. In fact, a central component of the new guidelines is that those arbitrary targets for cholesterol lowering all those years are in fact unsupported by scientific evidence.

Pay no attention to the man behind the curtain . . .

Instead of harping on getting those LDL numbers down to a very specific goal as we were told to do for years, guideline authors have now done a swift about-face by introducing a new improved list of four groups of people most likely to benefit from taking cholesterol-lowering drugs – but not just any cholesterol-lowering drugs. The guidelines explicitly tell doctors not to bother with any cholesterol drugs other than statins.

The four groups are:

• all people like me who have already been diagnosed with cardiovascular disease (this is known as secondary prevention)
• all people between the ages of 40 and 75 who have NOT been diagnosed with cardiovascular disease but who have an estimated 10-year risk of cardiovascular disease of 7.5 percent or higher (that’s down from the former 20% risk)  – based on using an (allegedly) flawed risk calculator that has unfortunately already been described as “a major embarrassment to the heart associations”
• all people with high LDL levels (190 mg/dL or higher) including those who a genetic predisposition called familial hypercholesterolemia
• all people with diabetes who are between 40 and 75 years of age

As explained by cardiologist Dr. Neil J. Stone, chair of the lipid expert panel that wrote them (and coincidentally, a physician also heavily supported by drug companies), the new guidelines now “focus on defining groups for whom LDL lowering is proven to be most beneficial.”

Now here’s the part of our story where my head begins to show alarming signs of exploding at any moment.

As reported in Larry Husten‘s column in Forbes, Stone also pointed out that there will be some people who may not be in any of the four groups, but who may still benefit from statin treatment:

“We provide guidance for physicians to try to determine whether or not these patients would also qualify.”

In other words, even if you don’t need to take statins every day for the rest of your natural life, you should probably just take them anyway.

What about those physicians Stone worries about who may still not be convinced that statins are necessary for a particular patient?  As the NPR report called A Shift In Cholesterol Advice Could Double Statin Use suggested, the new guidelines say such undecided docs could then additionally take into account a patient’s family history of cardiovascular disease, and could also consider ordering more tests.

In other words, ask doctors to keep looking and screening and testing until they find a reason to justify the drug prescription.

Dr. Noel Bairey Merz of Cedars Sinai Hospital in Los Angeles (and also a co-author of the guidelines) seemed to mirror that response when she spoke to fellow cardiologists attending this week’s American Heart Association scientific meetings in Dallas, specifically in response to a New York Times opinion piece pointing to this fine print about women and statins in the 284-page guideline document:

“Clinical trials of LDL-lowering generally are lacking for this risk category.”

After being reminded that the massive 2008 JUPITER study on statins also showed there was “no treatment benefit” when women who took statins were studied as a subgroup, Merz conceded to CNN that the “evidence isn’t perfect” and that “there are no clinical trials of statin use in women alone”.  But after repeating her opinion that even healthy women with no history of heart disease should still take statins for primary prevention anyway if the (allegedly) flawed risk calculator assesses them as appropriate, she added:

“I would say that it’s time to stop the controversy and do a trial.”

In the meantime, just take them anyway while you’re waiting for pesky science to catch up. I’m thinking that most women out there, however, would actually prefer that doctors do the evidence-based research trials first, and then come up with treatment guidelines only when they’re based on solid research – and not the other way around as seems to be happening here.

What if you have cholesterol numbers that are well within normal limits?  Statins can still help you!  Apparently, short of whitening your teeth or making your hair shiny, statins will fix just about everything that ails ya . . .

Just for fun, and using the (allegedly) flawed risk calculator included in the new guidelines, CNN reporters estimated that a 60-year old non-smoking, non-diabetic man whose cholesterol numbers were within normal limits – LDL 100 (‘bad cholesterol’), HDL 45 (‘good cholesterol’) – with good blood pressure should still be prescribed statins.

Even if guideline authors can convince doctors to put all of the 60-year old non-smoking, non-diabetic men with normal cholesterol and blood pressure numbers on a drug they’ll need to take every day for the rest of their natural lives, shouldn’t all of those healthy people be worried about the safety of such a drug?

Don’t worry, be happy, potential statin-users!  We already know that statins are safe, safe, safe – because physicians have been reassuring us of that for years.

Well, maybe not all of them. As Dr. David Newman observed in Number Needed To Treat:

“The harms of statins are less publicized than benefits, but are well documented.”

Statin side effects are generally dismissed by physicians and most others who don’t personally suffer them. As The New York Times reported, 18 percent or more of the newly expanded pool of statin users could experience significant side effects, including severe muscle pain or weakness (in some cases permanent), decreased cognitive function, increased risk of diabetes (especially for women), cataracts or sexual dysfunction among others.

Dr. Newman concludes:

“We believe that statin benefits are best-case, and harms may well be underestimated. Diabetes, a chronic condition with serious long-term morbidity, is more important to avoid for most patients than a single event such as a non-fatal heart attack or stroke.

“Finally, we believe that lifestyle interventions such as exercise and the Mediterranean diet are substantially more powerful than statin medications in achieving cardiovascular benefits, and come without harms.”

So what? Who cares? Big deal, you might be saying. It’s not as if treating millions of new statin users will be directly beneficial to Big Pharma, after all. That’s because most brand-name statins are now available as cheaper generics – Crestor (rosuvastatin) is the notable exception, still under patent protection until 2016. But new drugs to lower cholesterol and reduce heart attack and stroke risk are under development, and a potential pool of customers that’s estimated to top 45 million statin users can make such new drugs profitable for the industry.

The cardiologists writing guidelines that could now result in one out of every three adults taking statins for life are among the same ones who helped Big Pharma turn statins into the number one profit-maker for the drug industry in the first place. Lipitor, for example, became the world’s all-time biggest-selling prescription drug in history with cumulative sales topping $130 billion.

Thank you, doctors.

Some may be already dismissing my concerns as merely those of yet another dull-witted heart attack survivor ranting on about yet another example of marketing-based medicine.

Understandable, were it not for an emerging development. It’s the growing number of physicians who seem as concerned as I am about this wholesale embrace of pharmaceuticals in disease prevention.

Physicians like Kentucky cardiologist Dr. John Mandrola, a strong advocate for the cardioprotective benefits of regular exercise and heart-smart eating, who once wrote:

“If you don’t have heart disease, the best way to avoid getting it is so simple, so easy to understand, and so not up to your doctor.

“Pills should never be the basis of preventing heart disease. I believe that people, not doctors, can make the greatest impact on reducing the burden of heart disease.”

Or physicians like Harvard Medical School professors Dr. Paul Ridker and Dr. Nancy Cook, who met with guideline committee authors during this week’s AHA meetings in Dallas because they had noted that the risk calculator over-predicted risk by 75-150 percent, so much so that it could mistakenly recommend millions more people as candidates for statins.  Although they supported the guidelines’ statin recommendations for those with existing cardiovascular disease, they have concerns about blanket endorsement of statins to prevent it. They wrote in the medical journal, The Lancet:

“As described in the guidelines, these new criteria could result in more than 45 million middle-aged Americans who do not have cardiovascular disease being recommended for consideration of statin therapy.

“Other than age, the major drivers of high global risk are smoking and hypertension, for which the interventions of choice should be to eliminate cigarette use and to lower blood pressure, rather than to write a prescription for statins.”

Or physicians like Dr. Roger Blumenthal, director of the Ciccarone Preventive Cardiology Center at Johns Hopkins, who explained:

“Statin therapy should not be approached like diet and exercise as a broadly-based solution for preventing coronary heart disease. These are lifelong medications with potential side effects.”

Or physicians like Harvard’s Dr. John Abramson and JAMA Internal Medicine editor Dr. Rita Redberg, who wrote the following in their compelling New York Times opinion piece:

“This announcement is not a result of a sudden epidemic of heart disease, nor is it based on new data showing the benefits of lower cholesterol. Instead, it is a consequence of simply expanding the definition of who should take the drugs — a decision that will benefit the pharmaceutical industry more than anyone else.

“Statins give the illusion of protection to many people, who would be much better served, for example, by simply walking an extra 10 minutes per day.

“We believe that the new guidelines are not adequately supported by objective data, and that statins should not be recommended for this vastly expanded class of healthy people.

“Instead of converting millions of people into statin customers, we should be focusing on the real factors that undeniably reduce the risk of heart disease: healthy diets, exercise and avoiding smoking.

“Patients should be skeptical about the guidelines, and have a meaningful dialogue with their doctors about statins, including what the evidence does and does not show, before deciding what is best for them.”

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See tomorrow’s Ethical Nag post, “Statin Guidelines We Love to Hate – and the Docs Who Write Them”

See also:

• Can statin drugs really save your life?
• Women, controversial statin guidelines and common sense
• Evidence for caution: women and statin use
• Does the medical profession need to wean itself from its“pervasive dependence” on Big Pharma money?
• “Integrity in Science” – who’s paying the piper?
• Paying illegal kickbacks to doctors: just the cost of doing business for Big Pharma?
• When you use bad science to sell drugs
• Medical journals: “information-laundering for Big Pharma”
• “Heads they win, tails we lose”: the corruption of science
• Who’s running the show in industry-sponsored drug trials?
• When medical research is funded to favour the drug, not the facts
• How drug companies get the clinical trial results they want
• TheNNT website from a bunch of very brainy physicians working in emergency medicine has the most helpful explanation of the statistical concept called Number Needed to Treat that I’ve seen yet, along with a list of credible resource links to check NNT stats on several therapies currently recommended for a number of different conditions.

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