Tag Archives: American College of Cardiology

Another point of view

As someone who considers myself to be a scientist, I thought I should present another view to you on statins. This piece (a transcript of a talk) can be seen on Medscacpe1.

Please read on, and see what you think of his arguments:

I am Dr. Frank Veith, Professor of Surgery at New York University Medical Center and the Cleveland Clinic. Today I am going to talk about what I call the “statin witch hunt” and why, despite it, we should give more patients statin drugs.

The question of whether to give statins to more healthy patients is one of considerable interest to the public and considerable debate in both the medical community and the lay press. In November, the American College of Cardiology (ACC) and the American Heart Association (AHA) released their long-awaited new guidelines on the treatment of blood cholesterol to reduce the risk for adult atherosclerosis. T

This guideline, among other recommendations, guided physicians to expand the number of patients being treated with statin drugs. The guideline was greeted with many objections in both the medical community and the lay press. Most notable was a November 14 New York Times op-ed by 2 respected experts, Drs. John Abramson and Rita Redberg, titled “Don’t Give More Patients Statins.”

Other New York Times articles about Drs. Paul Ridker and Nancy Cook, and another by Gina Kolata, expressed similar reservations about the ACC/AHA guideline recommendation to broaden statin administration. All three of these New York Times articles were part of what I call the “statin witch hunt” which has generated much confusion among the public.

The op-ed by Drs. Abramson and Redberg makes the case that the recent ACC/AHA cholesterol guideline is incorrect to advocate the expansion of statin usage to more patients because such expansion “will benefit the pharmaceutical industry more than anyone else.” They state that the guideline’s authors were not “free of conflict of interest.” In addition, they claim that “18% or more” of statin recipients “experience side effects” and that the increase in statin administration will largely be in “healthy people” who do not benefit and who would be better served by an improved diet and lifestyle.

Although the latter is true for everyone, Drs. Abramson and Redberg convey the wrong message. Statins are the miracle drug of our era. They have proven repeatedly and dramatically to lower the disabling and common consequences of arteriosclerosis — most prominently heart attacks, strokes, and deaths in patients at risk. Statins avoid these vascular catastrophes not only by lowering bad blood lipids but also by a number of other beneficial effects that stabilize arterial plaques.

 They have minimal side effects, most of which are benign. In several controlled studies, the patients who did not receive statins had an incidence of side effects equal to those who received them. Serious side effects are rare and manageable. Moreover, healthy patients are only healthy until they get sick. Many individuals over the age of 40 take a daily aspirin.

Statins are far more effective than aspirin in preventing the heart attacks and strokes that often occur unexpectedly in previously “healthy people.” Clearly it would be worthwhile for such healthy people to take a daily statin pill with few side effects, if it would lower their risk for such vascular catastrophes and premature death.

In contrast to what is implied in the Abramson-Redberg article, these drugs are an easy way for people to live longer and better, and statins cannot be replaced with a healthy lifestyle and diet — although combining the latter with statins is a good thing.

Lastly, with respect to the comments about the pharmaceutical industry benefiting from statin prescriptions, and the guideline authors’ conflicts of interest, both are less important than patient benefit, which has been demonstrated dramatically and consistently in many excellent and well-controlled statin trials. Moreover, most statins are now generic, so the cost for obtaining these miraculous drugs need not be prohibitive, and the guideline’s authors are experts who are eminently qualified to write them.

The statin witch hunt is a bad thing, and more patients should be on statin medication. I am Dr. Frank Veith, and that is my opinion.

1: http://www.medscape.com/viewarticle/822145?nlid=51963_1985&src=wnl_edit_medn_card&spon=2

(You will need to subscribe to Medscape to see the talk, and transcript. It is fairly straightforward to gain access. The site is www.medscape.com It is one of the biggest medical websites.)

I though you should know if Frank Veith has any conflicts of interest. He works at the Cleveland Clinic, so he probably doesn’t, as most of the medical experts who work there state that they give all of their income from working with the pharmaceutical industry to charity. Steven Nissen, a man of whom you may have heard me speak on a regular basis, is the chairman of Cardiovascular medicine at the Cleveland Clinic.

Here, for example, is Steven Nissens conflict of interest statement

Dr Steven Nissen
Medical Director
Cleveland Clinic Cardiovascular Coordinating Center

Dr. Nissen has received grant/research support from AstraZeneca Pharmaceuticals, Atherogenics; Eli Lilly and Co., Lipid Sciences, Pfizer Labs, Sankyo Pharma, sanofi-aventis, and Takeda Pharmaceuticals North America with all reimbursement directed to the Cleveland Clinic Cardiovascular Coordinating Center; and has been a consultant for Abbott Laboratories, AstraZeneca Pharmaceuticals, Atherogenics, Bayer Corp., Eli Lilly and Co., Forbes Medi-tech, GlaxoSmithKline Pharmaceuticals, Haptogard, Hoffman-LaRoche, Isis Pharmaceuticals, Kemia, KOS Pharmaceuticals, Kowa Optimed, Lipid Sciences, Merck/Schering Plough, Novartis Pharmaceuticals Corp., Novo-Nordisk, Pfizer Labs, Protevia, Roche Pharmaceuticals, Sankyo Pharma, sanofi-aventis, Takeda Pharmaceuticals North America, Vasogenix, Vascular Biogenics, Viron Therapeutics, and Wyeth Pharmaceuticals, all fees are paid directly to charity with no reimbursement paid to Dr. Nissen; and has served on the speakers’ bureaus of AstraZeneca Pharmaceuticals and Pfizer Labs, all fees are paid directly to charity with no reimbursement paid to Dr. Nissen.

Cleveland Clinic physicians and scientists may collaborate with the pharmaceutical or medical device industries to help develop medical breakthroughs or provide medical education about recent trends. The collaborations are reviewed as part of the Cleveland Clinic’s procedures. The Cleveland Clinic publicly discloses payments to its physicians and scientists for speaking and consulting of $5,000 or more per year, and any equity, royalties, and fiduciary relationships in companies with which they collaborate. The Cleveland Clinic requires its doctors to approve the public disclosures of their scientific collaborations with industry. As of 3/21/2014 the review process regarding Dr. Veith’s disclosure had not been completed. Patients should feel free to contact their doctor about any of the relationships and how the relationships are overseen by the Cleveland Clinic. To learn more about the Cleveland Clinic’s policies on collaborations with industry and innovation management, go to our Integrity in Innovation page.

You need a statin – now what was the question?

As many of you are aware the American College of Cardiology (ACC) and the American Heart Association (AHA) came out with new guidelines on cardiovascular disease prevention a few days ago. As part of this, they produce a risk calculator. Using this calculator, if your risk of heart attack or stroke is greater and 7.5% over the next 10 years, you should take a statin – for the rest of your life.

I downloaded this calculator, and I have been playing around with it. I think I would tend to agree with the headline in the NY times 18th November 2013:

Risk Calculator for Cholesterol Appears Flawed

To be frank you can fiddle around with the figures on this calculator for hours. I think my OCD is getting worse. (Maybe I should take a statin to cure my OCD). One of the questions I wanted to find an answer to was the following, at what age would a perfectly healthy man (with ‘optimal’ risk factors) have to take a statin for the rest of his life.

So, I fed in the figures, and use the ‘optimal’ figures for cholesterol and blood pressure on the risk calculator

THE PERFECTLY HEALTHY MAN

  • Male
  • Age 63
  • Race: WH (white)
  • Total cholesterol 170mg/dl [This is 4.4mmol/l in Europe i.e. very low]
  • HDL cholesterol 50md/dl [This is 1.3mmol/l in Europe]
  • Systolic blood pressure 110mmHg
  • Non-smoker
  • No treatment for high blood pressure
  • Non diabetic

CV risk over the next 10 years = 7.5%

So, there you are. You can do absolutely everything ‘right’ be as healthy as healthy can be – according to the AHA and ACC. Yet, by the age of sixty three you need to take a statin – for the rest of your life.

The next question I wanted to find the answer to was, at what age does a ‘normal’, very healthy man have to start using a statin? In the UK, the average total cholesterol for men is 5.0mmol/l. [this is 193mg/dl in the US]. The average blood pressure in the UK systolic is 129mmHg.  (To be frank, I think the average cholesterol level for men is higher than this, but the WHO says not).

Feed these figures in, and you would need to start taking a statin, for the rest of your life, by the age of fifty eight. Which means that very healthy men, with no real risk factors for cardiovascular disease – at all – have to start statins at fifty eight.

What of women. Well, they get another seven years of statin free life. A super healthy woman, with optimal risk factors, reaches the dreaded 7.5% risk aged 70. An ‘average’ healthy women, with average BP and cholesterol levels, would have to start a statin aged sixty three.

In summary, using this risk calculator, extremely healthy men will be starting statins at fifty eight, and very healthy women at sixty three. This, then, marks the age at which life becomes a statin deficient state. You can be as healthy as healthy can be. You can do everything right, have no risk factors at all for cardiovascular disease, and yet you still need to take medication to reduce the risk of cardiovascular disease.

Sorry, what was the question again?

European cardiovascular disease statistics can be found here.

A simple Question – that opens a can of worms

A day or so ago I received this e-mail from a doctor in London.

Dear Dr Kendrick,

I work as a GP in Wandsworth London and I read that you don’t
believe that much in cholesterol and CHD.

I do agree up to 50% of MI patients have normal cholesterol
but some say what’s normal for UK is actually high. Is this argument valid?

Best wishes

Define ‘normal.’ Does normal mean average? If we took the average height of everyone in the UK we would find (very nearly) that 50% of those dying of CHD (coronary heart disease) were above average height and 50% below. So average is clearly normal, but then again so is being tall, or short.

However, if we decided that average height of everyone living in the UK was above ‘normal’, and we then lowered the definition of ‘normal height’ by three inches, we would find that the vast majority of people dying of CHD were now above average height. At which point we could decree that being taller than normal was a risk factor for CHD.

This would obviously be a completely bonkers thing to do. Yet, you can do it with cholesterol levels and everyone nods in general agreement.

Aha, but the argument goes that our lives are completely different than the lives of our ancestors, which has caused our cholesterol levels to be unnaturally high.

An article in the Journal of the American College of Cardiology best summed up this line of thinking. Under the heading ‘Why average is not normal’, O’Keefe, the lead author, made the claim that: ‘Atherosclerosis is endemic in our population, in part because the average LDL (“bad” cholesterol) level is approximately twice the normal physiologic level.’ In short, according to O’Keefe, our cholesterol level should be about 2.5mmol/l, not 5.2mmol/l.

He based his argument, in part on looking at the cholesterol levels of various animals e.g. elephants, and boars, and suchlike. He also used the argument that very young babies (neonates) have cholesterol level of about 2.5mmol/l. Now, in my opinion, anyone proposing this argument should have their medication increased. We should base our cholesterol levels on those found in other animals species….yes, of course we should. You mean those animal species with an average life expectancy of ten years, for example.

However, this argument is now pretty widely accepted by the medical community. We are all, everyone, living in the West, living in such an ‘unhealthy’ way that our cholesterol levels are unnaturally high. The true normal cholesterol levels is 2.5mmol/l.

Fine, if we re-set normal at 2.5mmol/l we will find that 99% of people dying of heart disease do have a ‘high ‘cholesterol level. Problem sorted, average is no longer normal, and the hypothesis that a high cholesterol level is a risk factor for heart disease is now true.

Hold on, I’ve got an idea…