The New Shingrix Vaccine

MY TAKE: As with any new drug or device, it is best to wait a year or two to find out if there are any unexpected adverse effects.

Shingrix, the new shingles vaccine, is all the rage among the over-50 set. It is hard to drive by a Walgreens without seeing a sign advertising that it is available. As you may know, shingles occurs when the same varicella zoster virus that causes chickenpox becomes reactivated in later life. In most people older than 50, shingles virus is dormant in the nervous system, and a person’s risk for shingles rises sharply after age 50.

The previous shingles vaccines, Zostavax, was made from a live, inactivated virus while Shingrix uses a protein on the surface of the virus. Shingrix also contains two adjuvants to boost the immune response, one of which has not been used in humans before now.

PROS of Shingrex–

-Provides 80-90% protection against shingles with two doses, compared to 50-60% from one dose of Zostavax
-Appears to last longer than Zostavax

CONS of Shingrex–

-Requires two shots 2-6 months apart instead of just one
-Has more side effects- 75% of people reported pain at the injection site, 17% with reactions severe enough to prevent normal activities. Also, about 1 in 10 people reported systemic effects such as muscle pain, fatigue, headache, shivering, fever, or gastrointestinal illness.
-More expensive- can cost up to $300, not always covered by Medicare or insurance.

What bothers me the most is that the CDC panel evaluating Shingrix split 8-7 over whether to recommend it above Zostavax, a highly unusual lack of consensus. Several panel members advocated collecting safety data on Shingrix for a year or two before endorsing it over Zostavax. One member noted that the adjuvant in Shingrix that boosts the immune response “has never been out in the real world before.” So waiting a year or two before getting the vaccine seems prudent.

As for me, I’ll take my chances without either vaccine. There are several homeopathic remedies that have an impressive track record in treating shingles, should I get it. But infections more often occur when the immune system is weak and shingles is probably no exception. Eating a healthy diet, exercising, getting enough sleep, and dealing effectively with stress should make you less susceptible to getting shingles.

Should You Take Statins?

Cholesterol is only one of several factors that affect the risk of heart disease. Others include high blood pressure, smoking, lack of exercise, family history, poor diet, and being overweight or obese. One study estimated that 80 percent of heart disease could be prevented by changes in three lifestyle factors- diet, exercise and smoking. And yet the medical establishment remains focused on cholesterol levels and taking statins.

When I was in medical school, a total cholesterol below 240 mg/dL was considered acceptable, but over the years that was lowered to 220 and then to 200 by various advisory groups. In 2004, new guidelines that made LDL cholesterol the primary factor in deciding to prescribe statins were so stringent that millions more Americans were prescribed these drugs. Subsequently, it was reported that all but one of the nine members of the panel that wrote the guidelines had received funding from statin manufacturers.

A consortium of heart organizations came out with yet a new set of guidelines in 2013, based on your risk of heart attack in the next ten years, determined by an online calculator. You should take a statin, they advised, if your risk is 7.5 percent or more. Using the results of the online calculator, upwards of 70 million Americans, including almost everyone over age sixty-five, should be taking these drugs. Fortunately, a recently revised calculator (https://sanjaybasu.shinyapps.io/ascvd/) dials back the number of people advised to take statins.

Missing from these advisories is any consideration of the dangers of taking statins:

-One in five patients taking statins have side effects, with muscle pain being the most common.
-The FDA has issued safety announcements cautioning statin users about memory problems, diabetes, and liver function.
-Acute memory loss is four times more common in statin users in the first days of treatment.
-People taking statins have nearly a 50 percent higher risk of developing type 2 diabetes.
-Other side effects include cataracts, liver and kidney damage, fatigue, and mood disorders.

If you have had a previous heart attack or stroke and/or if you have a 20 percent risk of having one in the next ten years using the new calculator, you should consider taking a statin if you are not able to reduce your ten-year risk using lifestyle methods alone. In people with familial hypercholesterolemia, a genetic defect causing high levels of LDL cholesterol, statins are usually recommended. These people can also lower their risk of heart disease, as well as the dosage of statins needed, by diet, exercise, and smoking cessation.

While it is easier to take a pill, most of us could take a thirty-minute walk three times a week, up our intake of fruits and vegetables to five servings daily, and cut down on highly refined carbohydrates. Losing weight and stopping smoking are more difficult but can be done with proper motivation. Given the choice, what would you do? Change your lifestyle or take a pill? As the evidence of serious side effects from statins continues to grow—diabetes, cataracts, muscle damage, even dementia—the risk benefit equation tilts dramatically toward not taking them at all.

Should You Take Multivitamins?

I have never been a fan of high-dose vitamin or mineral supplements. My philosophy, however naive, is that if we were meant to take these megadoses, they would grow in the ground or on trees. In fact, vitamins and minerals do grow in nature- in the form of fruits, vegetables, legumes, nuts, and grains. Our bodies evolved to digest these into the nutrients that are necessary to keep us healthy. Eating a well-balanced diet should provide us with all we need.

Some people are concerned that with modern food production, many of the natural nutrients are lost. This is especially true with processed foods–any that have been altered from their original state. Unfortunately, it is difficult to eat these days without consuming some processed foods. So taking a simple daily multivitamin can help to cover your bases if you think you aren’t getting enough nutrients from food itself.

Vitamin D, which our bodies make from sunlight, is one supplement which some people should consider taking. It can be deficient in people living in northern climates with little sun exposure. My book goes into detail about how much Vitamin D to take and its benefits. Suffice it to say that depression, cancer, heart disease, and dementia have all been associated with low Vitamin D levels.

The vitamin and supplement industry is huge. Americans spend more than $30 billion a year on them and 68 percent of those over age sixty-five report using them. And yet, there has been little evidence that they are beneficial. One quandary- the people who mostly use them are well-educated and affluent, a group that is already healthier than other members of the population. So it is hard for studies to separate this factor out from the benefits of taking supplements.

On the other hand, there have been studies showing increased risks of cancer and heart disease in people taking megadoses of certain vitamins. These studies are not conclusive, but gives one a reason to be cautious. High-dose Vitamin E, once thought to lower the risk of heart disease, was found to increase the risk of heart failure, prostate cancer, and death from any cause.

One final note–it is possible that the chemicals in the fruits and vegetables on our plates work together in ways that scientists don’t fully understand — and which can’t be replicated in a tablet. So go to the food store or a farmer’s market and enjoy nature’s bounties!

Is Exercise Better Than Statins?

If you are one of the 36 million Americans taking a statin drug, or if you have been advised to take one, you should know about a new study that compares statins to exercise. Statins (Lipitor, Zocor, Crestor) are the most widely used drugs in the world, with $29 billion in sales in 2013. They are prescribed to lower cholesterol, which most doctors think contributes to heart disease.

Whether or not to take a statin is a dilemma for many, since official guidelines recommend them for virtually everyone over age 65. But as many as one in five people taking statins develop muscle aches and pains, which causes them to stop exercising. This is bad news, since exercise is important for preventing heart disease. So a group of researchers looked at ways that people taking statins could avoid muscle problems and continue to exercise.

Their surprising conclusion after analyzing dozens of studies? People are better off stopping their statins and exercising instead! The researchers reported that:

Exercise is equivalent to statins in preventing heart attacks and strokes, but it is better in reducing overall deaths.
Exercise can delay or prevent diabetes while statins increase the risk of diabetes.
Exercise is associated with decreased obesity while statins sometimes cause weight gain.
Exercise has been shown to increase quality of life, while statins have not.
Exercise benefits the elderly (over age 75) while statins have not been shown to do so.
There is more evidence of the benefits of exercise over the long-term (more than 10 years) than with statins

Not mentioned in the study were the many other side effects of statins, including memory loss and dementia, cataracts, liver and kidney damage, excessive fatigue, mood and sleep disorders, and sexual dysfunction. You can read more about these in my book.

How much exercise is enough? The authors were not specific, but a minimum of 30 minutes of moderate exercise (fast walking, biking, dancing, swimming, running) three times a week is the recommendation by many expert groups.

For those of you interested in more details about the study, it was published in the Journal of the American Board of Family Medicine in 2016, Volume 29, pages 727-740.

Great News About Heart Disease

My father died of a heart attack when I was only sixteen. He was 58 and it was the third one that he suffered, his first at age 44. So heart disease is a subject close to my heart, no pun intended. And as you probably know, heart disease tends to run in families.

That’s one reason I am excited to tell you the great news about a recent medical study. The authors reported that your chances of having heart disease can be cut in half by following only three of four positive lifestyle practices—not smoking, not being obese, exercising regularly, and eating a healthy diet. This was true even for people like me with a strong family history of heart disease. And these lifestyle practices are easy enough for most of us to achieve. Specifically, they are:

Not currently smoking
Not being obese—this means a Body Mass Index less than 30. You can google BMI to get the formula for determining yours, based on your height and weight
Exercising regularly—this was defined in the study as physical activity once a week or more, less than I would expect
Healthy diet pattern—eating an increased amount of fruits, nuts, vegetables, whole grains, fish, and dairy products and a reduced amount of refined grains, processed meats, red meats, and sugar-sweetened beverages

The study found that those having three of the four lifestyle factors had half the risk of heart disease compared with those with one or no factors, even in people with a high genetic risk of heart disease. Having four of these factors should reduce your risk even more, although the authors did not report this in the study.

If you are already meeting these goals, Good on ya! as my friend from North Dakota says. If not, get busy making these positive lifestyle changes. Not only will you decrease your risk of heart disease, you will also feel better and improve your overall health.