Are Cholesterol Lowering Drugs Right For You?

Do Statins Really Work?

Author: Dr. Stephen Chaney

Do statins really work?Statins – those ubiquitous drugs used to lower cholesterol levels – are big business!

Over 20 million Americans are currently being treated with statin drugs at a cost that runs into billions of dollars every year. And cardiologists have just recommended that another 20 million Americans consider using cholesterol lowering drugs. 44% of the men and 22% of the women in this country are now being told that they should be using statin drugs.

Some of my cardiologist friends are so convinced that statin drugs prevent death from heart attacks that they have said, only half-joking, that we should just add statins to the water supply.

Are Cholesterol-Lowering Drugs Right For You?

Is the faith of doctors in the power of statin drugs to prevent death from heart disease justified? To answer that question in full we need to look at people who have already survived a heart attack and people who have never had a heart attack separately.

If you’ve already had a heart attack the evidence is clear cut.

  • If you have had a heart attack, there is good evidence that statins will reduce your risk of dying from a second heart attack.
  • In the technical jargon of the scientific world that is referred to as secondary prevention.

But what about those millions of Americans who are being prescribed statin drugs who have never had a heart attack? This is something we scientists refer to as primary prevention.

What Do The Studies Actually Say About Statins And Primary Prevention?

Here the evidence is not clear at all. Two major reports have cast doubt on the assumption that statins actually do prevent heart attacks in people who have not already had a first heart attack.

In the first study, Dr. Kausik Ray and colleagues from Cambridge University in England performed a meta-analyis of 11 clinical studies involving over 65,000 participants (Ray et al, Arch. Int. Med., 170: 1024-1031, 2010). They focused on those participants in the studies who had not previously had a heart attack (primary prevention).

  • They found that the use of statins over an average of 3.7 years had no statistically significant effect on mortality. In short, statins had no effect on the risk of dying from heart disease or any other cause.
  • Dr. Sreenivasa Sechasai, one of the doctors involved in the study, said “We didn’t find a significant reduction in death despite having such a huge sample size. This is the totality of evidence in primary prevention. So if we can’t show a reduction with this data, it is unlikely to be there.”

The second study was a Cochrane Systemic Review of statins published January 19th, 2011.  It stated that there was not enough scientific evidence to recommend the use of statins in people with no previous history of heart disease with some caveats (see below).

To help you understand the significance of that conclusion, let me give you a bit of background:

  • First you need to understand that the Cochrane Collaboration is an independent, non-profit organization that carefully reviews the scientific evidence behind medical treatments and proposed medical treatments.
  • Cochrane Reviews are considered the “Holy Grail” of evidence-based medicine (ie. medicine based on the best scientific evidence rather than what the pharmaceutical companies would have you believe).
  • So when a Cochrane Review concludes that there isn’t enough evidence to recommend use of statins in patients with no prior history of heart disease that is pretty big news in the medical world.

How Should These Studies Be Interpreted?

Please don’t misinterpret what I am saying. The Cochrane Review said that statin drugs are overprescribed, but it did not say that everyone who has not had a heart attack will not benefit from statins. It said that there are a number of risk factors that need to be considered in evaluating individual patients for statin use.

  • Simply put, that means that it is not as simple as saying that everyone with no previous history of heart disease should not be on statin drugs.
  • If you are currently taking statin drugs and you have no previous history of heart disease, you may want to discuss with your physician whether the Cochrane Review of statin drugs changes their opinion of whether se of those drugs is still warranted for you.
  • But the bottom line is that only your physician is trained to take into account all of the factors that increase your risk of heart disease and the best therapeutic approach for reducing your risk of heart attack.

There Is A Double Standard In The Medical Community

More importantly, these studies highlight the difficulty in showing that anything works when you start out with a healthy group of adults with no prior evidence of disease (primary prevention).

And, the way that doctors have responded to primary prevention studies shows that there is a double standard in how primary prevention trials are interpreted in the medical community. For example:

  • There is no good evidence that statins prevent fatal heart attacks in healthy people.
  • However, because statins do work in high risk patients, most doctors recommend their use by millions of Americans who have never had a heart attack.
  • There is also no good evidence that nutrients like vitamin E and omega-3 fatty acids prevent fatal heart attacks in healthy people.
  • However, there is evidence that both vitamin E and omega-3 fatty acids prevent heart attacks in high risk patients, yet most doctors will tell you they are a waste of money.

It is food for thought.

The Bottom Line

1)    Statin drugs clearly save lives when used by people who have already had a heart attack.

2)    On the other hand, there is no proof that statin drugs prevent heart attacks in people who have not previously had a heart attack

3)    Statin drugs do have side effects. Increased risk of diabetes, liver damage, muscle damage and kidney failure are the best documented, although memory loss has also been reported.

4)    I am not recommending that you stop using statin drugs without consulting your doctor. I am suggesting that you discuss the benefits and risks of statin drug use with your doctor.

5)    Perhaps the most important poin tto come out of these studies is that it almost impossible to prove the benefit of any intervention in a primary prevention trial. If you can’t prove that statins work in healthy people, it is not surprising that it is difficult to prove that other interventions work.

6)   Finally, the way that these studies have been interpreted shows that there is a clear double standard in how the medical community evaluates primary intervention trials.

  • Statin drugs don’t show any benefit in a primary prevention setting, yet most doctors still recommend them.
  • Vitamin E and omega-3 fatty acids don’t show any benefit in a primary prevention setting, and most doctors recommend against them.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

Do Omega-3 Fatty Acids Decrease Risk Of Depression In Women?

Do Happy Fish Make Happy Women?

Author: Dr. Stephen Chaney

Woman playing with autumn leaves The days are getting shorter, and those shorter days can lead to depression. You may have seen the recent headlines saying “Omega-3 fatty acids may decrease the risk of depression in women”. If you suffer from seasonal depression, should you be stocking up on fish oil capsules? Let’s look at the study behind the headlines.

The Theory Behind The Study

Depression appears to be increasing in modern society. For example, between 1991 and 2002, the prevalence of major depression has more than doubled in the United States from 3.3% to 7.1%.

There are many causes of depression, but some experts blame the dramatic increase in omega-6 fatty acids in the diet.  For example, per capita consumption of soybean oil, much of it in processed foods, has increased 1000-fold during the past century. That’s a concern because omega-6 fatty acids interfere with the body’s ability to convert vegetable sources of omega-3 fatty acids into the longer chain omega-3 fatty acids thought to be effective in reducing depression.

This has lead to the hypothesis that omega-3 fatty acids in the diet may help prevent depression, and a number of clinical studies have supported that hypothesis.

How Was The Study Designed?

The study (M. A. Beydoun et al, J. Nutr., doi: 10.3945/jn.113.179119, 2013) looked at 1,746 adults age 30-64 living in Baltimore Maryland. The participants were a representative sample of African Americans and whites, men and women. Omega-3 fatty acid intake was based on two 24-hour dietary recalls. Depressive symptoms were based on something called CES-D, which is a 20 item, self-reporting symptom rating scale.

What Did The Study Actually Show?

The results were pretty dramatic for women:

  • Women with the highest intake of omega-3 fatty acids/day were 49% less likely to suffer from depression than women with the lowest intake.
  • No significant effect of omega-3 fatty acid intake on the prevalence of depression was seen for the men in this study. This was the first study to look at men and women separately, so it’s not yet clear whether this is a true sex-specific difference or simply due to the relatively small sample size and reduced incidence of depression in men.

Limitations Of The Study:

There were numerous limitations to this study, but the most important were:

  • It did not ask whether the participants were taking fish oil supplements, and it did not substantiate the dietary recalls by measuring actual levels of omega-3 fatty acids in the blood.
  • It just measured associations, not cause and effect.

The Bottom Line:

This is not a particularly strong study, but it is consistent with a least half a dozen other studies that have obtained similar results. So, based on the total body of published studies my recommendations are:

1)     If you are a woman and you’re suffering from mild depression you might want to talk with your doctor about increasing your omega-3 fatty acid intake before you start taking an anti-depressive medication. Omega-3 fatty acids may reduce heart disease risk, lower inflammation and provide other benefits. The drugs generally have side effects rather than side benefits.

2)    We don’t have any good data yet on what dose of omega-3 fatty acids are needed, but the 500-1,000 mg/day that the NIH recommends for heart health might be a good starting place.

3)     If you’re a guy, this paper suggests that the jury is out about whether omega-3s can help you with depression. More studies will be required. In the meantime, just remember that omega-3s have lots of other health benefits.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

Do Omega-3 Fatty Acids Cause Prostate Cancer?

Fish, Fish Oils And Prostate Cancer

Author: Dr. Stephen Chaney

Pure Fish OilMy phone has been ringing off the hook. My email in-box is full. It seems that everyone wants to know if the headlines about omega-3 fatty acids and prostate cancer are true.

In case you have just gotten back from a vacation on some deserted island with no newspapers and no internet, let me bring you up to date. The headlines are saying things like “Fish Oils May Increase Your Risk of Prostate Cancer” and “Latest Study Links Fish Oils to Prostate Cancer”.

Once again, it seems like just when you’ve figured out which foods that are good for you, someone tells you they could actually kill you. It’s no wonder so many of you have been asking me to cut through the hype and put this latest study in perspective.

What the study actually says:

As usual, let me start with the study itself (Brasky et al., Journal of the National Cancer Institute, doi: 10.1093/jnci/djt174). On the surface, it appears to be a reasonably well designed study, and the conclusions were dramatic. They reported that subjects with high levels of omega-3 fatty acids in their blood were 43% more likely to develop prostate cancer, 44% more likely to develop low grade prostate cancer, and 71% more likely to develop high grade prostate cancer compared to those with low levels of omega-3 fatty acids in their blood.

The flaws in the study:

Case closed you might be tempted to say. However, once you dig a little deeper, the study does have two important weaknesses.

1)     It used data from another study that was designed for a totally different purpose. They went back and analyzed blood samples from a previous study that was actually designed to measure the association between vitamin E and selenium intake and prostate cancer. That’s a scientific no-no.  Let me explain why.

If they had designed a study to investigate the association between omega-3 fatty acids and prostate cancer, they probably would have selected participants with a wide range of omega-3 fatty acids in their blood at the beginning of the study. The subjects in this study actually had a very narrow range of omega-3 fatty acids in their bloodstream.

They also would probably have done a diet analysis and found out whether the subject’s omega-3 fatty acids were coming from fish or fish oil supplements. They might have even asked whether the omega-3 fatty acids were from farm-raised fish or inexpensive fish oil supplements known to be contaminated with PCBs. This study collected none of these data.

2)     This is a single study, and individual studies often provide misleading results. For example, if you examine their data closely, it looks like heavy drinkers and smokers might have a decreased risk of prostate cancer. I think that’s unlikely, but weird associations like that often pop up in individual studies.

What do you find when you look at other studies?

Expert scientists aren’t swayed by individual studies. We prefer to look at the “big picture” that emerges when you combine the results of many studies. For example, a meta-analysis of 24 studies with 461,402 subjects (Symanski et al, American Journal of Clinical Nutrition, 92: 1223-1233, 2010) found no association between fish consumption and prostate cancer risk.

Individual studies ranged from a 61% decrease in risk to a 77% increase in risk, but the overall effect was zero! Even more importantly, fish consumption decreased prostate cancer deaths by 63%.

The Bottom Line:

1)     Don’t panic. Don’t change what you are doing based on the latest sensational headlines. This study has been way overblown. We have come to expect sensational headlines and hype from journalists and bloggers because that’s how they get people to read what they write.

However, I find the comment from the senior author that “We’ve shown once again that use of nutritional supplements may be harmful” to be very irresponsible, especially since they have no data showing that anyone in their study actually used fish oil supplements.

2)     The benefits of assuring optimal omega-3 fatty acid intake clearly overshadow the risks. Omega-3 fatty acids have been shown to lower triglycerides and blood pressure, reduce inflammation and depression, and may even help prevent dementia.

3)     This study does raise a caution flag, but I would not recommend reducing your omega-3 fatty acid intake on the basis of these data alone – especially since most published studies show no increased risk of prostate cancer. There are much better designed studies underway that should clearly show an increase in prostate cancer risk if it is a real effect. I will monitor those studies closely and keep you abreast of any new developments.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

Omega-3 Fatty Acid Deficiency And ADHD: Do The Effects Worsen From Generation to Generation

The Seventh Generation Revisited

Author: Dr. Stephen Chaney

Angry boy portraitDo the effects of omega-3 fatty acid deficiency on ADHD get worse from one generation to the next?

When I was a young man I read an article called “The Seventh Generation” in Organic Gardening magazine. That article was based on the old Indian admonition to consider the effects of everything we do on the seventh generation of our descendents.

The article was written before the environmental movement had co-opted the seventh generation concept. It was also written at a time when the food industry and the public had really started buying into the “better living through chemistry” concept. Processed foods, fast foods and artificial ingredients had just started to replace real foods in the American diet.

The author envisioned a world in which, if we continued to eat nutrient depleted foods, each generation would be sicker than the previous generation until by the seventh generation our descendents would live miserable, sickly, shortened lives – and nobody would know why.

That article made a powerful impression on me. I always like to keep my mind open to new ideas, especially ideas that challenge my preconceived thinking.

So I asked myself “Could it be true? Could eating nutrient depleted foods actually make each generation sicker than the previous generation?”

The author did not have the foresight to predict the obesity epidemic, so he did not envision a world in which we might live sicker, shorter lives in as little as one or two generations.

In addition the author was not a scientist, and his whole premise seemed scientifically implausible at the time. In those days we thought of DNA as the sole determinant of our genetic potential and as something that could not be influenced by our environment. Now we know the DNA and the proteins that coat the DNA can be influenced by the foods we eat and other environmental factors – and that those changes can be passed down from generation to generation. This has lead to a whole new scientific discipline called epigenetics.

Could it be true?

All of that leads me to this week’s article (Bondi et al, Biological Psychiatry, doi:10.1016/j.biosych.2013.06.007). Let me start by pointing out that this is an animal study. It was done with rats. I usually base my health tips on human clinical trials, but it is simply not possible to do multi-generation studies in humans.

The authors hypothesized that omega-3 fatty acid deficiency could be associated with psychiatric disorders such as ADHD, autism, schizophrenia and depression. They based this hypothesis on the known role of omega-3 fatty acids in both brain development and maintenance of normal brain function. They also pointed to numerous clinical studies showing that omega-3 fatty acids could either prevent or reduce the severity of these diseases in humans.

They focused on adolescent rats as well as adult rats because these diseases frequently emerge, and are sometimes more severe, during the adolescent years in humans. Finally, they included second generation rats in the study because the change in our food supply that created an excess of omega-6 fatty acids and a deficiency of omega-3 fatty acids started in the 1960s and 1970s. They reasoned that if the effect of omega-3 deficiency is multigenerational it would be more severe in today’s human adolescents. As I said before, you can’t do multigenerational studies in humans, but you can do them in rats.

They separated litters of rat pups from omega-3 sufficient parents into two groups. One group was fed a diet sufficient in omega-3 fatty acids, and the second group was fed an identical diet except that it was deficient in omega-3 fatty acids. When the omega-3 sufficient group reached adulthood, they were mated and their offspring were continued on the same omega-3 sufficient diet. Similarly, when the omega-3 deficient group reached adulthood, they were mated and their offspring were raised on the same omega-3 deficient diet.

They put each group of rats through a series of behavioral tests when they were adolescents and again when they were adults. It is beyond my expertise to analyze the validity of rat behavioral assays, but the authors claim that the tests they employed were good measures of behavioral traits in human that would be classified as hyperactivity, anxiety, attention deficit disorder and reduced behavioral flexibility. [If you have adolescents in your household, some of those behaviors may sound awfully familiar].

The results were thought provoking. They found little evidence that omega-3 fatty acid deficiency triggered these behaviors in the first generation rats. However, they found strong evidence that omega-3 fatty acid deficiency triggered each of those behaviors in the second generation rats – and the effect was much stronger in the adolescent rats than in the adult rats.

The Bottom Line

At the present time, it isn’t possible to predict the significance of this study for you. This is a single study. And, it is an animal study. It could mean nothing, or it could mean everything.

We do know that the incidence of ADHD in US children has increased by 38% from 2003 to 2012 – and nobody really knows why. We also know that some studies have shown that the American diet is often deficient in omega-3 fatty acids. These same studies have suggested that providing adequate amounts of omega-3 fatty acids in the diet may prevent or reduce the symptoms of ADHD.

I’m a hard-nosed scientist. So I’m not going to be one of those bloggers who writes sensational headlines claiming that omega-3 fatty acid deficiency, or some other nutritional factor, is the cause of our skyrocketing rates of ADHD.

But, it is enough to make you wonder “What if? Could it be true?”

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

Health Tips From The Professor