This podcast is a follow-up to the blog I wrote about the JUPITER study that was published this week in the New England Journal of Medicine.  When do drug companies go too far in shaping medical care?  How do you feel about drug company funding of medical research?  Leave your comments and join a discussion on this topic in the Fitness Rocks Social Network.

Monte

JUPITER Study

Editorial on JUPITER Study

Lancet Editorial - (You have to register at the site, but it’s free)

Lifestyle Risk Factors for Cardiovascular Disease

Primary Prevention of Coronary Heart Disease with Lifestyle

Diabetes Prevention Program

]]> http://fitnessrocks.org/2008/11/16/big-money-bad-science-whats-the-best-way-to-prevent-heart-disease/feed/ http://fitnessrocks.org/2008/11/13/what-im-working-on/ http://fitnessrocks.org/2008/11/13/what-im-working-on/#comments Fri, 14 Nov 2008 03:16:11 +0000 drmonte http://fitnessrocks.org/?p=425 This week has been busy.  As all of you have heard by now there is a new study that was published in the New England Journal of Medicine that is being touted all over the lay press as demonstrating that millions of people are at risk for cardiovascular disease even though they have a normal cholesterol and should therefore be prescribed a drug called Crestor.  Crestor is a statin drug - a drug that has traditionally been used to reduce the risk of cardiovascular disease by lowering cholesterol.

Did I lose you?

I’ve been fond of quoting an interesting statistic about cholesterol for a very long time.  It is a statistic that I didn’t hear very often from companies selling cholesterol-lowering drugs, like Crestor.  Fifty percent of people who die of atherosclerotic cardiovascular disease have a normal cholesterol.  Obviously, if you’re trying to convince the public and prescribing doctors to use cholesterol-lowering drugs, you don’t want them to remember that high cholesterol is only one of the risk factors for heart disease and there are many other risk factors that also need to be addressed - like smoking, poor diet, overweight and obesity, diabetes, lack of exercise, high blood pressure, psychological stress, depression, and others.  Cardiovascular disease has many causes - and they all matter.

Now a new study has shown that people with normal cholesterol lab tests but an abnormal C-reactive protein can have their risk of heart attack or stroke decreased by taking a statin drug.  In this study the statin drug is Crestor.  They make a point of telling us that fifty percent of people who die of a heart attack have a normal cholesterol and so we should check the C-reactive protein, and if it’s too high Crestor can help.

Crestor and the other statin drugs have other effects in our body besides lowering cholesterol and one of these is an antiinflammatory effect.  We’ve talked in previous Fitness Rocks podcasts about the role of chronic inflammation in promoting cardiovascular disease.  Chronic inflammation in a person’s body can be identified by an elevated C-reactive protein measured in a blood sample.  C-reactive protein is made by our liver and has a role in the inflammatory response.  From here the biology starts to get complicated and I’m not going to elaborate on it in this blog post.  The drug company that makes Crestor can now safely say that fifty percent of people who die of a heart attack have a normal cholesterol because they have a new study and a new lab test to justify prescribing their drug, Crestor, even for people with a normal cholesterol.  This will mean that tens of millions of people who previously were not candidates for treatment with a statin drug are now good candidates - if you believe the conclusions of this study. Of course, all of the people with high cholesterol are still good candidates for drugs that lower cholesterol, like Crestor.  It’s a win-win, if you’re selling Crestor.

The company that makes Crestor is Astra-Zeneca.  They are also the company that paid for the study.  They are also the company that pays consulting fees and lecture honorariums to eleven of the fourteen doctors who published this study.  And, Astra-Zeneca is also the company that licensed the patent on the C-reactive protein lab test from the lead author of this study who owns the patent.  Is all of this shocking financial conflict of interest merely coincidence and generally irrelevant to the conclusions drawn by the study authors?  That’s what the study authors are saying.

All of the statin drugs, including the ones currently available as inexpensive generic drugs, have an antiinflammatory effect and tend to decrease C-reactive protein.  Astra-Zeneca, however, is claiming that their drug, Crestor, has special molecular qualities that make it especially good for people who have normal cholesterol and elevated C-reactive protein and should therefore be the drug of choice when doctors identify patients with this lab profile.

We don’t know if a cheaper statin drug would have done just as well as Crestor in this study because the study design did not include a comparison to other statin drugs, only to placebo.  Is it possible that a different statin drug would have been as effective?  We don’t know and since studies like this aren’t cheap I guess we may never know.

Interestingly, the study design also did not compare the effects of Crestor in these study subjects to an intensive lifestyle intervention - eat right, exercise and stop smoking (sixteen percent of the people in the study were smokers, which is a very strong risk factor for heart disease and a reason for having an elevated C-reactive protein).  Would lifestyle have been just as effective, or more effective, than Crestor at preventing heart attacks in these study subjects?  We don’t know. I don’t expect Astra-Zeneca to fund a second study looking at Crestor versus Lifestyle.  However, the abundant data available on the benefits of healthy lifestyle habits at preventing heart disease makes me believe that lifestyle would have fared favorably compared to Crestor in this study.  That’s only an opinion.

I wrote an email to a medical researcher who has published articles on the importance of lifestyle in preventing heart disease and asked him if he would do an interview about this study.  He wrote back that he is currently out of the country at a meeting of the World Health Organization, but offered this comment: You are right on with this issue.  High C-Reactive Protein is fundamentally caused by adiposity, low physical activity, and poor diet.

Will we be essentially prescribing Crestor to treat obesity, lack of exercise, and a poor diet?  One can only speculate.

Did I mention that Crestor costs $3.45 per day, $1259.00 per year per person times millions of people?

Crestor may or may not be good for your health - talk your doctor about that.  Astra-Zeneca will definitely be good for your 401K - buy-buy-buy!

Monte

Here on Fitness Rocks there is a new feature - a social network where people can upload their own photos, videos, and comments.  Please join the conversations and share your thoughts and pictures from your part of the world.

Click on the “FR Social Network” link under “pages” in the right-hand column.

Monte

References:

Primary Prevention of Stroke by Lifestyle

This week on Fitness Rocks I review a study from the journal Circulation that looks at the relationship between lifestyle and the risk of stroke.  It’s a good-news/bad-news story.  Lifestyle habits can have a huge impact on the risk of stroke, but practically nobody is living the sort of lifestyle that will really reduce their risk of stroke or other chronic diseases like type 2 diabetes, heart disease and cancer.

This week I am trying out a service called Ning that provides a platform for creating social networks.  You can click on the link for the Fitness Rocks Social Network in the right sidebar under the “Pages” heading.  Check out the network and tell me what you think.  The network allows you to create your own page where you can post photos and videos and write forum posts.  I thought it would be a great way for people to inspire one another to live healthier lifestyles by sharing fitness tips, recipes, and inspirations.  If it doesn’t work out I’ll take the link down.  I hope you’ll give it a try.

Transcript for Fitness Rocks Podcast 120 - Lifestyle and the Risk of Stroke:

Stroke is the third leading cause of death in America and a leading cause of disability.  Doctors use the term stroke to refer to disruption of blood flow to the brain.  For clarification, a heart attack is the result of disruption of blood flow to heart muscle.

Strokes can occur as a consequence of a blood clot forming in the heart that breaks apart and moves to a blood vessel in the brain, thereby obstructing blood flow.  Alternatively, strokes can be a result of a weakened blood vessel in the brain that ruptures.  Or, most commonly, strokes can happen as a consequence of atherosclerosis, so-called “hardening of the arteries,” developing in the major blood vessels going to the brain - the carotid arteries.  Atherosclerosis in arteries going to the brain causes the arteries to become progressively more narrow as plaques form and grow into the lumen of the blood vessel.  These atherosclerotic plaques can become unstable and break apart causing fragments to dislodge and move upstream where they get stuck in smaller parts of the artery and block blood flow.  This process of atherosclerosis in the carotid arteries is essentially the same as atherosclerosis in the coronary arteries that supply blood to the heart.  Atherosclerosis in coronary arteries can lead to a heart attack.

Doctors have known for a long time that healthy lifestyle habits significantly reduce the risk of having heart attacks.  It has been assumed that these same lifestyle habits would also reduce the risk of stroke because of the similarities in pathology revolving around atherosclerosis, but there was not as much direct evidence for the connection between lifestyle and stroke.

Researchers at the Harvard School of Public Health looked at data collected on more than 71,000 women and over 43,000 men followed since 1984 in the Nurses Health Study and the Health Professionals Follow-up Study to determine the relationship between multiple healthy lifestyle habits and the risk of having a stroke. The scientists looked specifically at five lifestyle habits and two forms of stroke.

The five lifestyle habits were: Not smoking, exercising regularly, eating a healthy diet high in fruits and vegetables and low in red meat, maintaining a healthy body weight and drinking small amounts of alcohol - one drink a day for women and two for men.

The two forms of stroke were ischemic and hemorrhagic.  Ischemic stroke is a consequence of atherosclerosis and hemorrhagic stroke is a consequence of a weakened blood vessel bursting.

The results were impressive.  People who adhered to all five healthy lifestyle habits had about an 80% reduction in the risk of ischemic stroke and a 70 - 80% reduction in the overall risk of stroke compared to people with none of the healthy lifestyle habits.  The more healthy lifestyle habits a person in the study had the lower was their risk of having a stroke.

The role of alcohol consumption was not as convincing as the basic four healthy lifestyle habits of not smoking, exercising, eating a healthy diet, and maintaining a healthy weight.  Consuming more than two drinks a day was actually associated with an increased risk of stroke.

The bad news part of this study is that only 2% of women and 4% of men had lifestyles that included all five healthy habits - a dismally low number of people living an optimally healthy lifestyle that has been documented in other studies as well.

Monte Ladner, M.D.

References:

FDA article about supplement regulation

Doctor’s Lack of Awareness about Poor Supplement Regulation

How Safe is Your Dietary Supplement?

The dietary supplement industry is a multibillion-dollar business and tens of millions of Americans consume various forms of dietary supplements.  Most of these consumers are unaware of the poorly regulated status of dietary supplements.  Poor regulation of dietary supplements is mostly a consequence of the 1994 Dietary Supplement Health and Education Act, which essentially deregulated the industry.

Dietary supplements include vitamins, minerals, herbs, amino acids and additional substances like enzymes.

An article from the FDA on consumer health published online in August 2008 makes the following cautions about dietary supplements:

Federal law does not require dietary supplements to be proven safe to the FDA’s satisfaction before they are marketed.

Claims made on the labels of dietary supplements to not have to meet any FDA standard for truthfulness or accuracy.

The FDA’s role with a dietary supplement product begins after the product enters the marketplace.

Dietary supplement manufacturers do not have to get the FDA’s approval before producing or selling supplements.

It is not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease.

There are limitations to FDA oversight of claims in dietary supplement labeling.

An unfortunate event highlighting the danger of this lack of FDA regulation for dietary supplements occurred with the use of the drug ephedra in dietary supplements.  One hundred and fifty-five deaths were reported in connection with taking dietary supplements containing ephedra before the FDA finally banned its use in April 2004.

In this same FDA report the authors comment that people should discuss any supplement(s) they are taking with their doctor.  This sounds like reasonable advice on the surface, but an article in the May 14, 2007 issue of the Archives of Internal Medicine offers some sobering insights into how much doctors don’t know about dietary supplements and their lack of regulation.  According to the study authors about a third of doctors were unaware that the FDA does not regulate supplements, and most doctors did not know that there is a mechanism for reporting of adverse consequences associated with supplements.

If you take a dietary supplement you are taking a chance that may not be worth the perceived benefit. Talk to your doctor about supplements and give her the reference for the two articles mentioned in this report.