Would You Like Statins With That?

Photo by corpse reviver

As we wrote on this blog the other day about research which raised questions about the efficacy of statins for those who have not yet experienced a heart attack– an off label prescription–the WSJ pointed to a new paper in the American Journal of Cardiology from authors at  Imperial College, London, U.K., which suggests that  statins should be made available free of charge to consumers along with the purchase of fast food. The press release from Imperial College can be found here.

Low level doses of statins may be purchased over the counter in England.

In a prior post, I  wrote about meeting with a cardiologist who suggested I commence taking statins because of my various cardio risk factors. A point, however uncomfortable at the time, made ultimately moot by the favorable results of my stress test, echocardiogram and calcium scoring. I had, prior to my surprisingly clean bill of cardiac health, relented mentally to the prospect of what would become a life long prescription. Of statins, I wrote:

“If one has risk factors, it is prophylactic and is prescribed to reduce the risk of heart attack, stroke and other heart diseases. It is doubtful whether once I start taking this drug I will ever stop. There is no foreseeable time (while alive) that I will wish to stop reducing the risk of heart attack or stroke. And that I suppose is the essence of the onset of age– piling up prescriptions. A daily regimen that will follow one to the grave–only the dosages or the brand names changing as each day welcomes a regimen of pills. In short, this prescription feels like the onset of dependence. The forward guard, if you will. A harbinger of a pharmaceutical future.”

One might say I didn’t take the news well. But crucial to my decision to relent were the words of my cardiologist and another heart doctor. I wrote:

Seeing my, shall we say, chagrin, the cardiologist told me that, like over 50% of the cardiologists he knows, he takes a statin. “We’ve seen the data.” Another recently told me  “Yeah, I take it. They should put it in the water.”

And now, apparently, in burgers.

But, we wrote of some  important (and conflicting) recent findings regarding statins here at HRW last week:

A LA Times article has recently highlighted the problems of off label prescriptions.  In the article, it has come to light that the off label use of statins, one of the world’s most prescribed medication, may not have the efficacy that many doctors had previously thought.  The LA Times reports,

Statins were initially approved by the Food and Drug Administration for the prevention of repeat heart attacks and strokes in patients with high cholesterol who had already had a heart attack. And used for that purpose - called “secondary prevention” - the drugs are powerful and effective medications, driving down patients’ risk of another heart attack or stroke by lowering their levels of LDL (or “bad”) cholesterol.

Then physicians came to believe statins could also reduce the risk of a first heart attack in people who have high LDL cholesterol but are nonetheless healthy. This use of statins - called “primary prevention” - has driven the growth in the market for statins over the last decade.

Statins certainly decrease rates of heart attack in people who have clear signs of cardiovascular disease but it’s not so clear they work that way in people who are healthy. In spite of that uncertainty, statins’ use for primary prevention has sky rocketed.

One wonders how so many physicians came to believe that statins could also reduce the risk first time heart attacks.  Dr. John Abramson, from Harvard Medical School, attributes statins’ off label growth to a “conspiracy of false hope.”  He states, “[t]he public wants an easy way to prevent heart disease, doctors want to reduce their patients’ risk of heart disease and drug companies want to maximize the number of people taking their pills to boost their sales and profits.”

So, with all these interests pushing for statins’ off label use, it should not be a great surprise that extensive research has not been performed regarding statins’ primary preventive effects- and conflicting results have emerged.  The LA Times reports,

In the first of three studies published in the Archives last month, medical researchers found that, contrary to widely held belief, statins do not drive down death rates among those who take them to prevent a first heart attack. A second article cast significant doubt on the influential findings of a 2006 study, called JUPITER, that has driven the expansion of statins’ use by healthy people with elevated blood levels of C-reactive protein, a measure of inflammation. A third article suggested potential ethical, clinical and financial conflicts of interest at work in the execution of the JUPITER study and concluded the widely hailed trial was “flawed” and raises “troubling questions concerning the role of commercial sponsors.”

So??? Statins anyone?

Limit Physicians’ Off Label Prescribing Practices?

Off label prescribing has become fairly common practice for many medical professionals.  Once a drug has been approved by the Food and Drug Administration (FDA) for a specific purpose, physicians are given the freedom to prescribe the approved drug “off label” for other beneficial uses of the drug.  There is a great interest for physicians to retain this autonomy of  prescribing drugs off label as the practice expands treatment options.  Both the American Medical Association and the FDA have recognized that physicians are in the best position to determine the method of treatment for their patients.

However, the practice of off label prescribing has not been without controversy.  Many politicians and regulators view off label prescribing as a way to avoid clinical testing and FDA approval process.  In addition, studies have shown that many physicians prescribe off label with little or no scientific rationale.  According to the Daily News Central, an example can be found in a particular study: “in all, the study estimated that 1 in 7 prescriptions were written [by doctors] without good medical evidence that they would work.”

A LA Times article has recently highlighted the problems of off label prescriptions.  In the article, it has come to light that the off label use of statins, one of the world’s most prescribed medication, may not have the efficacy that many doctors had previously thought.  The LA Times reports,

Statins were initially approved by the Food and Drug Administration for the prevention of repeat heart attacks and strokes in patients with high cholesterol who had already had a heart attack. And used for that purpose — called “secondary prevention” — the drugs are powerful and effective medications, driving down patients’ risk of another heart attack or stroke by lowering their levels of LDL (or “bad”) cholesterol.

Then physicians came to believe statins could also reduce the risk of a first heart attack in people who have high LDL cholesterol but are nonetheless healthy. This use of statins — called “primary prevention” — has driven the growth in the market for statins over the last decade.

Statins certainly decrease rates of heart attack in people who have clear signs of cardiovascular disease but it’s not so clear they work that way in people who are healthy. In spite of that uncertainty, statins’ use for primary prevention has sky rocketed.

One wonders how so many physicians came to believe that statins could also reduce the risk first time heart attacks.  Dr. John Abramson, from Harvard Medical School, attributes statins’ off label growth to a “conspiracy of false hope.”  He states, “[t]he public wants an easy way to prevent heart disease, doctors want to reduce their patients’ risk of heart disease and drug companies want to maximize the number of people taking their pills to boost their sales and profits.”

So, with all these interests pushing for statins’ off label use, it should not be a great surprise that extensive research has not been performed regarding statins’ primary preventive effects– and conflicting results have emerged.  The LA Times reports,

In the first of three studies published in the Archives last month, medical researchers found that, contrary to widely held belief, statins do not drive down death rates among those who take them to prevent a first heart attack. A second article cast significant doubt on the influential findings of a 2006 study, called JUPITER, that has driven the expansion of statins’ use by healthy people with elevated blood levels of C-reactive protein, a measure of inflammation. A third article suggested potential ethical, clinical and financial conflicts of interest at work in the execution of the JUPITER study and concluded the widely hailed trial was “flawed” and raises “troubling questions concerning the role of commercial sponsors.”

Potentially, new findings regarding the efficacy (or lack thereof) of statins can have seismic effects.  If it is found that statins’ primary preventative effects are overstated or  nonexistent, this would amount to what has been a tremendous amount of healthcare waste (time, money, and effort) due to the popularity of the drug.  According to IMS Health, U.S. patients filled 201.4 million prescriptions for statins last year alone.

While there is a strong interest for physicians to retain their autonomy when assessing the best treatment for the patient, due to the potential of healthcare waste, there may be an equal or if not stronger interest for some regulation regarding the practice of prescribing off label drugs. As to industry funding of research, there seems little incentive for a pharmaceutical company with a blockbuster off label hit to do anything which would upset the apple cart– or should I say money cart?

A Trip to the Cardiologist, A Lipitor Future, and “Why Doesn’t My Health Insurer Want Me to Know if I’m Likely To Have a Heart Attack?”

I visited with a cardiologist last week. My inadvertent but no less harmful dalliance with two different kinds of drain cleaner having set off an entire chain of long past due check-ups. A little more than two years shy of fifty, I listened intently as I was told that although I had had a good run, a diet composed of grease, chocolate, quick carbs, coffee and unfiltereds was simply not going to cut it as I ventured into the last half of life (last third is more likely, but also more painful to consider– and I suppose for the doctor, harder to say).

I now look forward to a battery of tests. The first, done today, is designed to detect artery calcification: “Coronary calcium is specific for atherosclerotic plaque and can be detected with high sensitivity and accurately quantified by computed tomography (CT) to help predict future cardiac events related to coronary artery disease.” I had to pay for the test out of pocket as it seems my insurance company deems such screening unworthy of coverage– despite the tests highly vaunted predictive power. Quite a few people in this country die each year from heart disease–hard to understand how it wouldn’t be worth the $318 to know who was vulnerable–and if unchecked, destined for the very expensive Intensive Care Unit.

Tomorrow brings an echocardiogram and my first ever stress test. I readily assented to the tests as it is good, I suppose, to know where one stands. But in addition to testing and making dietary changes, the doctor also wants me to start taking Lipitor. A statin prescribed to lower cholesterol. I did not react well.  The prescription it seems is, in more than one sense, a life sentence.

And I am generally suspicious of the pharma zeitgeist. And terribly so as it concerns myself.

The prescription is not, in this instance, a treatment for an acute condition, it treats the endemic. If one has risk factors, it is prophylactic and is prescribed to reduce the risk of heart attack, stroke and other heart diseases. It is doubtful whether once I start taking this drug I will ever stop. There is no foreseeable time (while alive) that I will wish to stop reducing the risk of heart attack or stroke. And that I suppose is the essence of the onset of age– piling up prescriptions. A daily regimen that will follow one to the grave–only the dosages or the brand names changing as each day welcomes a regimen of pills. In short, this prescription feels like the onset of dependence. The forward guard, if you will. A harbinger of a pharmaceutical future.

Seeing my, shall we say, chagrin, the cardiologist told me that, like over 50% of the cardiologists he knows, he takes a statin. “We’ve seen the data.” Another recently told me  “Yeah, I take it. They should put it in the water.”

And so I will take this drug. But I am not happy. I am loath to think of myself in these terms. Only 12 or so years ago I played starting defensive tackle on a semi-pro football team. Soon I will be discussing my cholesterol numbers and God only knows what other numerical health indicators at cocktail parties.

The essence of good health is simply not having to think about it. It is not an issue. I have to think about it now. And I have a sneaking suspicion, that like when I first became a parent, the terms of my existence have just changed.

UPDATE

Photo credit to incurable_hippie.