Here at Ethical Nag World Headquarters, it’s been quite the week ever since the American Heart Association and the American College of Cardiology released their new cardiovascular disease treatment guidelines, which I have taken the liberty of sub-titling:
“If you have a detectable pulse, you need to be taking statins!”
For more specifics on the guidelines – including the list of four newly-identified groups of people whose heart health will benefit from taking
cholesterol-lowering medication – oops, I mean statins only – every day for the rest of their natural lives, read yesterday’s Ethical Nag post, Can Statins Prevent My Head From Exploding?
What happens next? Your doctor will now review all 284 pages of the new guidelines, and then, in a bonding moment of shared decision-making, the two of you will soon sit down together to decide upon just the right
course of action – oops, I mean drug prescription – based on what the guideline authors have recommended, in turn based on an (allegedly) flawed risk calculator that’s predicted to significantly increase the very large pool of daily statin-using drug takers, even among healthy individuals formerly considered low-risk for future cardiovascular disease.
But first, let’s set off for a behind-the-scenes visit to the people who actually write these treatment guidelines.
Clinical practice guidelines are published recommendations intended to optimize our medical care. When doctors follow good guidelines, they’re less likely to order too many or too few tests, or to prescribe the wrong treatment for us.
But as reported by investigative journalist Alison Bass, author of the book Side Effects, red flags have been raised about the reliability of some guidelines, based on studies like this one reported in the journal, Archives of Internal Medicine:
“More than half of the doctors who wrote clinical practice guidelines in cardiology between 2004 and 2008 served as promotional speakers on behalf of industry, and a substantial number actually held stock in companies affected by the guidelines they wrote.
“Improper bias in the production of clinical practice guidelines can have a potentially more widespread adverse effect on patient care than individual practitioners’ conflicts of interest.
“That’s because such guidelines, which range from how to treat patients with various types of heart disease and stroke to how to do coronary bypass surgery, are often adopted as the standard of care throughout the field and taught in medical training programs at all levels.”
Increasingly, these guidelines also play an emerging role in national policy to guide reimbursement, and serve as the standard of care in medical malpractice cases.
Did I mention that Dr. Neil J. Stone, the chair of the lipid expert panel tasked with writing the cholesterol treatment section of the guidelines, appears to be a good friend of the pharmaceutical companies that make statins?
For example, according to the financial conflict of interest database Integrity in Science, the cardiology professor at Northwestern University Medical School has reported accepting money for consultations and speakers bureau presentations from what reads like a Who’s Who of Big Pharma companies, including Abbott, Merck, Pfizer, Kos, Novartis, Reliant, Wyeth, AstraZeneca, Bristol-Myers Squibb, Merck/Schering-Plough and Sankyo – several of them funders of the clinical research trials that have boosted multi-billion dollar blockbuster global sales of the very statins they also happened to manufacture.
Stone’s not alone, of course. Seven of the 15 guideline authors disclosed financial relationships with the drug industry.
We know that such relationships clearly influence the way medicine is being practiced. Here, for example, is Cleveland Clinic cardiologist Dr. Stephen Nissen‘s take on guideline committee membership:
“No conceivable logic can defend the practice of including promotional speakers and stockholders on clinical practice guideline writing committees.
“Physicians paid to serve on drug company speakers bureaus essentially become temporary employees of industry, whose duty is the promotion of the company’s products.”
And as the British Medical Journal reported on September 17th:
“Widespread financial conflicts of interest among treatment guideline authors and the sponsors of those guidelines have turned many guidelines into marketing tools of industry.”
To add some perspective here, try to imagine for a moment what would happen if referees, umpires and game officials in professional sports were to start admitting that they’re regularly taking cash from team owners.
If this type of conflict of interest were openly happening in sports instead of in medicine, such clearly inappropriate financial relationships would immediately render those on the take permanently unemployable in their chosen fields.
But in medicine, we call people who take cash from drug and medical device companies “thought leaders“ or “key opinion leaders“ or “experts” – and then we quote them in the media and are expected to blindly accept their (allegedly) flawed cardiac risk calculators.
One guideline committee member reassuringly answered a concerned questioner about these known financial disclosures among committee members like this:
“People [on the panels] who felt they were conflicted did not vote on the guidelines.”
Dr. Marcia Angell, former longtime editor of The New England Journal of Medicine, helped to explain the crux of this issue:
“Judges do not hear cases in which they have a financial interest.
“Reporters do not write stories about companies in which they have a financial interest.
“By the same token, doctors should not have a financial interest in treatments they are evaluating.”
The trouble is, it’s getting pretty darned tricky to line up enough experts to create treatment guidelines who aren’t already in bed with industry.
In fact, as described by the Associated Press recently about the lipid guideline authors:
“It is practically impossible to find a large group of experts in the field who have no relationships to industry, according to Dr. George Mensah of the National Heart Lung Blood Institute.”
The NHLBI, by the way, is the same organization that famously issued guidelines two years ago calling for universal cholesterol screening of all nine-year old children.
In a stupefyingly side-stepping response to public concerns about the validity of these new guideline’s (allegedly) flawed risk calculator after the guidelines were launched, Dr. Robert Eckel, who is co-chair of the American Heart Association committee that wrote the new guidelines as well as the association’s past president, told CNN:
“I can’t speak to whether the calculator is valid or not. That needs to be determined. “
So let me see if I have this straight: a bunch of very intelligent brainiacs with the letters M.D. after their names spend five years working very hard writing these new guidelines, and their committee co-chair now says he just can’t be quite sure if the accuracy of the guidelines’ (allegedly) flawed cardiovascular disease risk calculator is trustworthy or not? By the way, you can download said risk calculator from the AHA website, but frankly, you might as well simply skip this step and tell your doctor you need to take statins.
Let’s see how flawed this risk calculator might actually be.
Just for fun, CNN’s Elizabeth Cohen said when she used the risk calculator, plugging in a 60-year-old man with normal cholesterol levels of 100 LDL (“bad” cholesterol) and 45 HDL (“good” cholesterol) and no risk factors – normal blood pressure, no diabetes and a non-smoker – the calculator assessed that he needed to take statins. So I’m going to stop using “allegedly” flawed from now on . . .
Cardiologist Dr. Steven Nissen of the Cleveland Clinic, who has long been an advocate of using intensive doses of statins in high-risk patients, explained to TheHeart.Org that the question for him is not about the efficacy of the drugs:
“But we have to treat the right patients, and the problem is that the risk calculator in the guidelines has never been previously published and therefore could not be independently verified.”
Dr. Mark Hlatky, who is professor of health research policy and of cardiovascular medicine at Stanford, added:
“The risk level is now set so low that many people who have optimal risk factor levels would be targeted for statin treatment simply on the basis of their age.”
Meanwhile, here’s a couple of handy dandy tips while you’re waiting for the AHA and ACC to figure out if their risk calculator should be trashed or not:
- Check out Mayo Clinic’s Statin/Aspirin Shared Decision Aid that’s been used at Mayo since 2005 to help their patients assess their heart disease risk. (Thanks Dr. Victor Montori at Mayo for your heads up on this patient decision-making tool).
- Another well-respected risk calculator is called The Absolute CVD Risk/Benefit Calculator, developed by Dr. James McCormack at Vancouver‘s Therapeutics Education Collaboration affiliated with the University of British Columbia. (Thank you, Dr. Mark McConnell for this enthusiastic recommendation of what you call: “the best risk calculator I’ve found!”)
The most disturbing issue here for me seems to be that this group of guideline writers have essentially expanded the potential statin customer base so significantly that some estimate one in three middle-aged adults could now be prescribed a statin drug, but with only minimal lip service to address significant concerns about longterm drug side effects or even the conflicting research results behind the guidelines’ recommendations, particularly in primary prevention.
Even more troubling, however, this move smells like a blanket endorsement of daily pharmaceuticals as an acceptable way to achieve good health.
So while the guidelines do mention tackling heart disease through proven non-drug lifestyle improvements like regular exercise, heart-smart eating, maintaining a healthy weight, smoking cessation and stress management, Harvard cardiologist Dr. John Abramson argues that statins offer little value to people with a 10-year risk of heart attack or stroke below 20%, as he told The Los Angeles Times:
“There is overtreatment that’s been built into the risk calculator, and this is a warning sign about the overtreatment that’s built into the guidelines themselves. There aren’t brakes being put on the enthusiasm and overreaching of the experts.
“There are statin believers, and when you hear these experts talk, they’re talking emotionally, not scientifically.”
Yesterday, Drs. Paul Ridker* and Nancy Cook from Brigham and Women’s Hospital in Boston said they support the guidelines’ statin recommendations for those with existing cardiovascular disease, but did have concerns about prescribing 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.”
Kentucky cardiologist Dr. John Mandrola, a tireless advocate for the cardioprotective benefits of exercise and heart-smart eating, 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.”
And in the words of Harvard’s Dr. John Abramson and JAMA Internal Medicine editor Dr. Rita Redberg in their recent New York Times opinion piece:
“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.”
* It’s worth mentioning here that Dr. Paul Ridker favours using LDL, HDL and C-reactive protein (CRP) levels to assess risk instead of the new guidelines’ risk calculator tool. (CRP is an indicator of inflammation, which studies like JUPITER in 2008 suggested can be as important as cholesterol in contributing to heart attacks). But Ridker himself led those landmark studies and also stands to gain financially should CRP testing become the standard for heart disease risk assessment because he shares the legal patent on the CRP testing technology. The plot thickens . . .
- Can statins prevent my head from exploding?
- Women, controversial statin guidelines and common sense
- Key Opinion Leaders in medicine are paid to have an opinion
- Is your doctor a “thought leader”?
- Does the medical profession need to wean itself from its “pervasive dependence” on Big Pharma money?
- Clinical practice guidelines vs. routine screening mammograms
- “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.
This is an excellent summation of the problem with the guidelines. I heard an interview with one of the people on the panel on NPR, didn’t catch his name. He kept admitting that most of panel had ties to big pharma, but that they didn’t vote. Right, they only sat in on the meetings for years and colored the thinking of everyone there. This is disturbing on so many levels.
Will the new guidelines become the new standard of care?
Thanks Allison – that’s a fair question. A review in Lancet of the effect of clinical guidelines on medical practice found that of 59 studies, all but 4 detected “significant improvements in the process of care” after the introduction of guidelines. Of course, I guess that brings up the definition of “improvement”. According to these new guidelines, improvement could be millions more people eventually taking statins.
“Just for fun, CNN’s Elizabeth Cohen said when she used the risk calculator, putting in a 60-year-old man with normal cholesterol levels of 100 LDL (“bad” cholesterol) and 45 HDL (“good” cholesterol) and no risk factors – normal blood pressure, no diabetes and a non-smoker”. Have YOU used the calculator yourself? This description gives a risk of 1%.
I got 7.5%
A real can of worms was opened the day medicine went from treating what is there (illness) to treating what might happen one day. Risk calculators are crystal balls dressed up as science.
Agreed. And this particular risk calculator seems especially flawed – as Michael O’Riordan of TheHeart.Org asked out loud at the American Heart Association scientific meetings in Dallas this week: “How do you have a serious discussion about the patient’s risk if the risk calculator doesn’t accurately calculate risk?”
I’ve enjoyed your posts on this issue.
You’ve had a heart attack. Do you take a statin? And what dosage?
I’ve had a heart attack, too. I’ve gone back and forth in the intervening five years about whether or not I should take my current cardiologist-recommended statin. He’s never told me how much statin I should take; he just tells me any amount will help stave off another heart attack. I’m currently on a low dose – 10mg – regimen, because I think a low dose is as effective and much safer than a high dose.
I’m 65. I eat healthy foods, I exercise a lot. I’ve passed my stress test and my cardiologist tells me I can run a marathon (I do ride my bike 100 miles in a day a couple of times a year).
However, I also have heart disease, as did my father, not to mention my heart attack. So my cardiologist would like me to take a statin. Statistics from studies I’ve seen seem to show the risk of all-cause mortality is lowered by about a 1/3 for those who take statins, compared to those who with heart disease who don’t take statins. So taking a statin seems reasonable. (By the way, off of statins, I have very good cholesterol/triglyceride readings. There is some tenuous evidence, though, that heart disease can be reversed with low LDL, so for now I’m willing to get closer to that optimal LDL number).
Furthermore, even though exercise and healthy eating might be better at protecting me from a heart attack than a statin, what’s wrong with adding protection, if that’s what a statin can do? After all, we don’t say, if we drive a car, that we won’t worry about tire pressure or if the engine has enough oil or if the brakes work, just because we wear seat belts. All the protective measure we take when we drive a car, from wearing seat belts to basic maintenance, add up to a better chance of surviving an accident.
Dave, you and I share very similar concerns about our statin prescriptions, and even a similar 5-year time span since our cardiac events. Like you, I was also prescribed a statin in hospital following my MI (Crestor 20 mg). Like you, I’ve read all the studies suggesting that statins for secondary prevention in patients like us show good outcomes (and really, what all patients care about more than hitting a specific intermediate endpoint like a lower LDL #, e.g. will this help prevent another heart attack?) Yet what I’ve learned (and written about here, here, here, here) about pervasive drug research practices like selective outcome reporting, data mining, publication bias, medical ghostwriting, marketing-based medicine, blahblahblah leaves me highly skeptical of even the most well-publicized of studies.
Like you, I eat healthy and exercise every day. Your comment re ‘optimal’ LDL numbers, however, is just what the new guidelines are telling us we can forget about! What’s a poor patient to believe when all is said and done?!
Before taking the statin, analyze why you probably had the heart attack. Were you over stressed? If so statin drugs will not reduce your stress. Were you overworked… statins don’t reduce this as well. Consider that approx 100 people need to take statins over a five year period for one person to benefit. While approx 50% stop talking them due to side effects.
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