advice

Drug Company Direct to Consumer Advertising – Costly and Dangerous

Television viewers in the United States watch an average of nine drug advertisements per day, or about 16 hours per year, far in excess of the time spent with their physician. That is because pharmaceutical companies spend huge amounts of money on direct to consumer advertising. In 2022 pharmaceutical companies spent 6.88 billion U.S. dollars on direct to consumer advertising! Pharmaceutical companies claim that these ads educate patients about treatment options they might not know about and foster conversations with their physicians. Pharmaceutical companies, however, are in the business of making money and these ads do a great deal to increase their revenue or they would not spend billions of dollars on them. This post will examine the claim that the ads are helpful to patients and doctors and will document the substantial harm that these ads do to both the health system and to individuals.

Almost all other countries besides the United States ban direct to consumer advertising of prescription medicines. The only other country that allows them is New Zealand.

History of Direct to Consumer Advertising

In the 1960’s congress granted the FDA the authority to regulate prescription drug labeling and advertising. The FDA was to ensure that prescription drug ads were: not false or misleading; presented a fair balance of drug risks and benefits; included facts that are material to a drug’s advertised use; included a brief summary that notes every risk described in the drug’s labeling. Because of these requirements, almost all drug advertising was directly to physicians.

In the late 90’s, the FDA changed the required risk information by stating that only major risks must be disclosed in ads and that they must provide resources that consumers can be directed to for full risk information. Because of this change, direct to consumer advertising has exploded since the late 90’s.

Compliance with FDA Requirements

Pharmaceutical companies are not required to submit ads to the FDA before they are used. They are required to submit ads to the FDA for review after they are in use, but the FDA lacks resources to review these ads in a timely manner. Many times the ad has already stopped running by the time the FDA gets around to reviewing it. A 2018 study published in the Journal of General Internal Medicine evaluated all broadcast direct to consumer pharmaceutical ads for 6 months for compliance with FDA regulations. The study found that only 26% of the ads were fully compliant with FDA regulations.

Online Direct to Consumer Advertising

Pharmaceutical companies have markedly increased online advertising through social media including FaceBook, Twitter (now X), YouTube and blog posts. This advertising reaches consumers in English speaking countries who ban direct to consumer prescription drug advertising. The FDA can only review a small portion of these. Here is a link to an article from an international policy journal about online direct to consumer ads by pharmaceutical companies: The Tip of the Iceberg of Misleading Online Advertising.

What the FDA does not require in direct to consumer advertising

Here is a list of important things that pharmaceutical companies are not required by the FDA to include in direct to consumer advertising.

Cost – Many of the medicines advertised are very expensive, especially cancer drugs. Pharmaceutical companies are not required to tell you anything about cost in their ads
If there is a generic version of the drug (a drug with the same active ingredient that might be cheaper) -Many times there is a generic version of the brand name drug that will do exactly the same thing as the drug advertised
If there is a similar drug with fewer or different risks that can treat the condition – There may also be a similar drug with fewer risks that could treat the condition advertised. The pharmaceutical companies are not required to tell you that in their ads
If changes in your behavior could help your condition (such as diet and exercise) – Eighty percent of chronic disease could be treated with life style changes. Ads are not required to tell you that
How many people have the condition the drug treats – The percentage of people who have the condition the drug treats may be very small. They don’t have to tell you that either
How the drug works (its “mechanism of action”)
How quickly the drug works
How many people who take the drug will be helped by it – It could be that only a small percentage of people who take the advertised drug will improve. Ads are not required to tell you that.

Evidence that direct to consumer drug advertising is helpful

There is evidence that direct to consumer drug advertising is beneficial for patients and their doctors. Here are the claims that have at least some evidence. This list come from a paper in the journal Pharmacy and Therapeutics: Direct-to-Consumer Pharmaceutical Advertising – Therapeutic or Toxic? The paper also summarizes the evidence for each of these claims

Informs, educates, and empowers patients.
Encourages patients to contact a clinician.
Strengthens a patient’s relationship with a clinician
Encourages patient compliance.
Reduces underdiagnosis and undertreatment of conditions.

I don’t find the evidence for any of these particularly convincing. None of the papers cited in the article disclose whether any of the authors have financial relationships with pharmaceutical companies.

Evidence that direct to consumer drug advertising is harmful

Despite pharmaceutical companies touting the educational benefits of direct to consumer advertising, remember that the main purpose of these ads is to sell a product, not to educate consumers. Here is a list of well documented harms of direct to consumer drug advertising:

Present incomplete or biased information – Most ads either leave out risk of the disease the advertised drug treats or use vague terms (like millions) Ads for drugs for which lifestyle modification is a viable alternative did not mention lifestyle changes. Over half of ads presented the advertised drug as a scientific breakthrough. See this paper from the Annals of Family Medicine: Creating Demand for Prescription Drugs: A Content Analysis of Television Direct-to-Consumer Advertising
Spur people to ask for medications they don’t need - A study published in the Journal of the American Medical Association found that “Fewer than one-third of the most common drugs featured in direct-to-consumer television advertising were rated as having high therapeutic value, defined as providing at least moderate improvement in clinical outcomes compared with existing therapies” (Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021)
Promote medications before long-term safety is known. In the case of Vioxx, a new pain relief drug, it was pulled from the market due to an unexpected rise in heart attacks and strokes — but not before millions of people saw the ad and began taking it. (Merck to pay $950 million for illegal marketing of Vioxx)
Create conflicts between patients asking for a drug and doctors who don’t recommend it – An article in Consumer reports reported that 78% of doctors report that patients at least occasionally ask them for medicines they saw in drug ads. 54% of those doctors said they often decline these requests (Consumer Reports Survey: Patients and Doctors Disagree on Some Essential Issues)
Drive up healthcare costs without adding health benefits – New drugs are much more expensive than generic drugs that may do the same job. Also, unfortunately doctors are much more likely to prescribe the medicines that patient’s ask for rather than an alternative less expensive and/or more effective treatment. This is the biggest societal harm of direct to consumer prescription drug advertising. See this paper: Effects of Patient Medication Requests on Physician Prescribing Behavior.

Bottom Line

The FDA simply does not have the resources to adequately regulate pharmaceutical company direct to consumer advertising. Even if they did, it is unlikely that the FDA could even partially mitigate the well documented harms of the tremendous spending by pharmaceutical companies on these ads. I agree with my friend and mentor Dr. Kurt Stange that the only viable recourse is to ban direct to consumer drug advertising as almost every other country in the world has done. Here is his editorial in the Annals of Family Medicine: Time to Ban Direct-to-Consumer Prescription Drug Marketing.

Artificial Sweeteners: Evidence for Benefit and Harm

It is expected that in 2024, 144 million people in the US will be using artificial sweeteners daily. The rationale for using non caloric or low caloric artificial sweeteners is of course to be able “to have your cake and eat it too.” That is, the sweet tooth can be satisfied without the known ill effects of sugar consumption. You can reduce your calories and therefore lose weight while still getting all the sweetness you crave. Is this true? Are artificial sweeteners safe? Do they help people lose weight? Are there ill effects from consuming artificial sweeteners over a long time? The answers to some of these questions are far from clear, but there is evidence to answer some of them.

There are six different sweetener compounds approved as food additives by the FDA. The FDA also approves the use of three plant and fruit based sweeteners as safe. To complicate things further, there are six FDA approved sugar alcohols (which have slightly less calories than sugar, but are metabolized differently). Below is a table listing all these sweeteners and their brand names. Scroll to the right to see the nutritive sweeteners in the table. Here is a link to the article containing the table

Non-nutritive sweeteners								Nutritive Sweeteners
Names	Aspartame	Acesulfame-K	Saccharin	Sucralose	Neotame	Advantame	Steviosides	Mannitol	Xylitol	Sorbitol	Erythritol
Brand names	NutraSweet®, Equal®, others	Sunett®, Sweet One®	Sweet’N Low®, Sweet Twin, Sugar Twin®, Necta Sweet®	Splenda®	Used as ingredient in food products.	Used as an ingredient in food and beverage products	Stevia®, Truvia™, Sun Crystals®, PureVia™, Sweetleaf Sweetener™	Used as ingredient in food products.	XyloSweet	Used as ingredient in food products.	Zerose

The only thing all these compounds have in common is that they stimulate the human sweet taste receptor. Some are absorbed in the small intestine and some are not absorbed. They have (or may have) different effects on metabolism. Some of them are 2000 times as sweet as sugar and some (the sugar alcohols) are as sweet or half as sweet as sugar.

In this post I’m going to write about the pro and con evidence for each of these different classes of sweeteners. I’m also going to write about the effects of using honey, maple syrup and agave as sweeteners.

Human Taste

Humans have only five kinds of taste buds, mostly on the tongue, but some on the roof of the mouth and the throat. They are sweet, sour, bitter, salt and umami (spicy). All tastes are combinations of activity of these five kinds of receptors. Artificial sweeteners stimulate primarily the sweet taste buds. A few of them in larger quantities stimulate the bitter taste buds as well.

Do artificial sweeteners increase the risk of cancer?

The answer to this question is almost certainly no. There were some early studies of aspartame in rats that showed an increased incidence of bladder cancer. This turned out to be related to physiology specific to rats and not humans. There is no evidence at present to suggest that any artificial sweeteners increase the risk of cancer in humans. Obesity does increase the risk of cancer and many overweight people use artificial sweeteners. There is no evidence that the sweeteners themselves increase the risk of cancer.

Do artificial sweeteners help with weight loss?

The answer to this question is no. Almost all human and animal studies to date show no effect on weight loss or weight gain for any of the artificial sweeteners.

Do artificial sweeteners increase the risk of cardiovascular disease?

The answer to this question is probably yes. A large study in France showed that consumption of artificial sweeteners was associated with cardiovascular disease. The main ones consumed were aspartame, acesulfime potassium and sucralose. Apartame was associated with increased risk of stroke. Consumption of acesulfame potassium and sucralose was associated with an increased risk of coronary disease. Here is a link to that study in the British Medical Journal.

Do artificial sweeteners increase the risk of type 2 diabetes?

The answer to this question is complicated. The large study in France did show some increase in type 2 diabetes in the group that took the largest amount of artificial sweeteners. Some studies suggest that this effect may be due to the artificial sweeteners’ effect on the microbiome. Only sucralose, saccharine, and the sugar alcohols seem to affect the composition of the gut microbiome. It appears that people with certain kinds of composition of their microbiome are at risk of developing diabetes.

Other side effects of artificial sweeteners

People with irritable bowel syndrome may have increased symptoms from artificial sweeteners. People with inflammatory bowel disease (such as ulcerative colitis or crohn’s disease may have exacerbation of their symptoms from artificial sweeteners.

What about using honey, maple syrup, or agave as sweeteners?

Honey and maple syrup have some antioxidants that may be good for you, but they also have as much sugar as regular table sugar. Agave has mostly fructose as opposed to glucose, so it tends to make your blood sugar higher for longer. It also is only metabolized in the liver, and too much fructose can lead to fatty liver. Any of these in small amounts not too frequently is fine. The same is true for sugar.

Bottom Line

There are no health benefits to using any of the artificial sweeteners, including the ones derived from plants and fruits, and including the sugar alcohols. Evidence is accumulating that many of them may cause harm by increasing the risk of cardiovascular disease and adversely affecting the microbiome. You are much better off to use small amounts of sugar, honey, or maple syrup no more than a few times a week. You should avoid foods advertised as sugar free if any of the artificial sweeteners are listed on the label. Refer to the table at the beginning of this post to see what they are called.

Flesh Eating Bacteria – How Worried Should You Be

There have been several articles in the news recently about so called “flesh eating bacteria” and about how the incidence is increasing. Flesh eating bacteria is a popular name for a condition called necrotizing fasciitis. Several different kinds of bacteria can cause this condition, primarily in people who have other risk factors. In this post I will write about the symptoms of necrotizing fasciitis, what kinds of bacteria cause it, where they can be found, who is at risk, and what treatments there are.

What is necrotizing fasciitis?

Necrotizing fasciitis is a soft tissue infection that causes death of the connective tissue around the muscles. This infection typically travels along the connective tissue, which has a poor blood supply, leaving the overlying skin and subcutaneous fat initially unaffected. This can cause a delay in diagnosis and treatment. The infection can rapidly spread and cause a secondary infection of the overlying and underlying skin, soft tissue, and muscle. If not treated quickly it can cause sepsis (blood poisoning) which can rapidly lead to multiple organ failure and death.

How is necrotizing fasciitis treated?

The treatment for necrotizing fasciitis includes both antibiotics and surgery. Prompt administration of intravenous antibiotics limit the spread of infection and surgery is used to remove the dead and infected tissue. Sometimes this can even involve amputation of a limb. Time is of the essence in treatment. Necrotizing fasciitis can progress to death within just a few days.

What causes necrotizing fasciitis?

The most common bacteria that cause necrotizing fasciitis are strep and staph that live on the skin and usually enter the body through a break in the skin such as a cut or scrape.

The organism that has been in the news recently is called vibrio vulnificus, which lives in warm salt water or brackish water. More about this organism shortly.

Vibrio Vulnificus

Vibrio vulnificus lives in salt water or brackish water, usually at a temperature of 68 degrees Fahrenheit or higher. Most infections have occurred on the Gulf coast, but because of increasing warm oceans, it has been found further north, moving north at about a half a mile a year. There have now been vibrio infections documented in North Carolina, Connecticut and New York. This is a rare cause of necrotizing fasciitis, but is increasing in frequency. Infections usually occur when someone wades in contaminated salt water with a cut or scrape on the leg. There is no clue to let you know whether salt water is contaminated or not. It is no less clear than uncontaminated sea water.

What are the risk factors for necrotizing fasciitis?

Anything that compromises the immune system increases the risk of getting necrotizing fasciitis if you are exposed. Here is a list of risk factors:

Diabetes
Chronic disease
Immunosuppressive drugs (eg, prednisolone)
Malnutrition
Age > 60 years
Intravenous drug misuse
Peripheral vascular disease
Renal failure
Underlying malignancy
Obesity (BMI greater than 30)

If you have none of these risk factors, your chance of getting necrotizing fasciitis, even if exposed is very very low.

What can I do to prevent necrotizing fasciitis from vibrio vulnificus?

Even if you are healthy and have no risk factors, it is not a good idea to wade in salt water at the beach if you have a cut or scrape on a leg or arm. If you do get cut at the beach, get out of the water immediately and wash the cut thoroughly with soap and water. Even though your risk of getting necrotizing fasciitis may be very low, you don’t want to take any chances of getting this life threatening disease.

Certainly if you have any of the risk factors listed above, these precautions are especially important.

Bottom Line

Flesh eating bacteria is a scary name. The news media seize on a name like this because of the shock value. Necrotizing fasciitis, which is the correct term, does not have the same shock value. Nonetheless, this is a very serious and life threatening condition caused by multiple different kinds of bacteria. Healthy people have a very very low risk of getting this condition. Vibrio Vulnificus can cause necrotizing fasciitis and lives in warm salt water or brackish water. You should not wade or swim in the ocean if you have a cut or scrape on your leg or arm, especially if you have any of the risk factors mentioned above.

Over the Counter Supplements to Improve Your Memory – Don’t Waste Your Money

Anyone who watches television these days is inundated by ads for supplements promising to improve your memory and your mental processing speed. In this post I will write about the evidence, or lack thereof that any of these supplements do what they promise.

Prevagen

The active ingredient in Prevagen is apoaequorin. It is a calcium binding protein found in luminescent jellyfish. When combined with calcium it causes bioluminescence (like a lighting bug). The manufacturer claims that taking Prevagen helps with brain health and improves aging related memory loss. The ads include testimonials from older people who say that Prevagen improved their memory.

There has been one clinical trial comparing apaequorin with placebo for improved verbal learning. It showed no benefit overall, but a subgroup analysis of people who had normal cognitive tests at baseline showed a slight improvement. Subgroup analyses in clinical trials are notoriously inaccurate. The FDA has not approved apaequorin for memory loss or for anything else.

In fact, apaequorin is a fairly large protein molecule, which means it is very unlikely to be absorbed into the blood stream at all. Proteins are broken down by acid in the stomach to their component amino acids and small peptides.

The bottom line is that Prevagen might combine with some calcium in your intestine and make the inside of your intestine glow in the dark, but it never leaves the intestine and so cannot possibly help your memory or your verbal learning. Any memory improvement that people report is almost certainly a placebo effect. The people giving testimonials on the Prevagen ads are actors reading from a script.

Balance of Nature

Balance of Nature sells fruit and vegetable supplements in capsules. The ads, like Prevagen, use actors reading a script. Like Prevagen, these fake testimonials report improvement in memory and learning. Here is the ingredients label for Balance of Nature fruit capsules:

Supplement Facts
Serving size: 3 capsules
Servings per container: 30
Amount per serving
Calories 10
Total Carbohydrate 2g
%DV*
<1%
Maintain Blend 731 mg
† Tomato (fruit), Papaya (fruit), Banana (fruit), Apple (fruit), Grape (fruit), Wild Blueberry
(fruit), Strawberry (fruit), Aloe Vera (leaf)
Protect Blend 719mg
† Orange (fruit), Tart Cherry (fruit), Cranberry
(fruit), Wild Blueberry (fruit), Grape (fruit),
Apple (fruit), Grapefruit (fruit), Aloe Vera (leaf)
Repair Blend 561mg Raspberry (fruit), Pineapple (fruit), Mango
(fruit), Sweet Cherry (fruit), Lemon (fruit),
Aloe Vera (leaf) * Percent Daily Values (DV are based
on a 2,000 calorie diet.
†Daily Value (DV) not established.
Other ingredients: Vegetable Capsules (cellulose).

Here is the ingredients label for the vegetable capsules:

Supplement Facts
Serving size: 3 capsules
Servings per container: 30
Amount per serving
Calories 5
Total Carbohydrate 1g
%DV*
<1%
Maintain Blend 720mg Broccoli (whole head), Spinach (leaf), Soybean (seed), Green Cabbage (head), Wheatgrass (leaves),
Kale (leaf), Cauliflower (whole head), Celery (stalk),
White Onion (bulb), Zucchini (fruit)
Protect Blend 713mg Garlic (clove), Red Cabbage (head), Red Onion (bulb), Soybean (seed), Carrot (root), Kale (leaf), Cayenne Pepper (fruit & seeds), Shiitake Mushroom
(whole), Wheatgrass (leaves), Sweet Potato (tuber)
Repair Blend 576mg Carrot (root), Kale (leaf), Green Onion (scape), Soybean (seed), Spinach (leaf), Cauliflower (whole
head), Celery (stalk), Zucchini (fruit) * Percent Daily Values (DV) are based
on a 2,000 calorie diet.
†Daily Value (DV) not established.
Other ingredients: Vegetable Capsules (cellulose). Contains: Soy.

There is no question that all of these fruits and vegetables are good for you, but only if you eat them! You could not possibly get enough fruits, vegetables and fiber to do you any good from capsules. There is absolutely no evidence that these supplement capsules have any effect on your memory or anything else except your pocketbook. A bottle of both kinds of supplements costs about $90.00. I would suggest you take that $90 and go to the grocery store and buy real fruits and vegetables!

Ginko Biloba

Ginko Biloba îs an extract from the leaves of the Ginko tree. It has been used in chinese herbal medicine for centuries. The extract contains numerous compounds and extracts sold over the counter are not standardized and may have different combinations of these various compounds. Claims for ginkgo biloba include improved blood circulation, effects on symptoms of old age, and improved memory.

Some older studies did show some effects, but newer well designed studies show that these effects are no greater than the people who take placebo. A meta analysis (a review of multiple studies) showed that ginkgo biloba extract had no effect in the prevention of dementia.

Does anything improve memory and/or prevent dementia?

The answer is yes, but it’s not a pill or a supplement. Here are some things that improve memory and decrease the risk of dementia (they are going to look familiar):

Staying mentally active (reading books, learning new skills, writing, etc)
Regular exercise (especially walking outside)
Eating unprocessed foods, especially fruits and vegetables
Maintaining an active social life (time spent with friends and family)
Getting 7-8 hours sleep per night

Bottom Line

Heavily advertised supplements work no better than placebo to improve brain health or memory in older adults or anyone else. Although ginkgo biloba has been used in chinese medicine for centuries, the evidence shows that it too works no better than placebo.

Lifestyle changes outlined above are the only things that have been shown to improve memory and decrease the risk of dementia.

New Drugs for Weight Loss – What are the Risks and Benefits?

Most people know these new effective weight loss drugs by their trade names: Ozempic, Wegovy and Mounjaro. Ozempic and Wegovy are different names for semaglutide. Mounjaro is the trade name for tirzepatide. All of these drugs are in the same class. They are called GL-P1 agonists. They mimic the action of a hormone called glucagon-like peptide. These drugs were developed to treat type 2 diabetes. They lower blood sugar by causing insulin release and also by delaying stomach emptying, which delivers less glucose to the bloodstream. The slowing of emptying from the stomach decreases appetite and causes an increased feeling of fullness. People on these drugs tend to reduce their calorie intake fairly markedly and that is how they work for weight loss.

Common Side Effects

The most common side effects of all these long acting medicines are nausea, vomiting, abdominal pain and diarrhea. These side effects usually disappear within a few weeks, and are less likely to happen if they are started at a low dose and increased gradually. Occasionally they are persistent. Some somewhat less common side effects include headache, fatigue, dizziness, constipation, heartburn, bloating, belching and flatulence (passing gas). People with diabetes can sometimes get low blood sugar. Again, most of these side effects usually go away within a week or two. Occasionally they can be persistent.

Rare Side Effects

These side effects are rare, but much more serious and can result in hospitalization. They include severe allergic reaction, acute pancreatitis, gall stones, acute kidney injury, suicidal thinking, and cancer of the thyroid.

Long Term Effects

The evidence so far is that stopping these medicines results in weight gain back to the original weight. That means that people are likely to have to stay on these medicines to maintain the weight loss. We know that the medicines are relatively safe when taken for two years, but we have no idea what long term side effects might be, or even if the medicines will continue to work past two years.

How well do they work?

The medicines are given by injection once a week and they work very well. These are the most effective medicines for weight loss that we have ever had, and there are some new ones in the pipeline that may even work better. As with any medicine, there are risks as I have documented above as well as benefits. You would not want to take one of these medicines unless the benefit exceeds the risk.

Who should take these medicines and who should not?

Obesity increases the risk of diabetes, heart disease and cancer, especially colorectal cancer. The best predictor of risk of disease from obesity is the waist circumference. Just take a tape measure and measure your waist at the level of the belly button. If you are female your risk of cancer starts to increase if your waist circumference is more than 31.5 inches. Your risk of cancer, especially colorectal cancer increases 5% for every inch above 31.5 inches. Above 35 inches the risk of diabetes, and cardiovascular disease starts to go up. For men the numbers are 37 inches for the risk of cancer going up and 40 inches for the risk of diabetes and cardiovascular disease.

The best treatment for obesity is prevention. That means eating unprocessed foods and regular exercise. If you are already overweight or especially if you are obese, it is very hard to lose weight and keep it off. Once you lose weight, your body thinks it is starving and all kinds of hormones and body changes kick in to try to get the weight back.

If your waist circumference is over 31.5 if your are female and 35 if you are male, then you are a candidate for one of these new weight loss medicines. For you the benefit likely outweighs the risk. If your waist circumference is less than those values, then the risk of taking these medicines is much higher than the potential benefit.

Cost

If your insurance does not cover medicines for weight loss the cost of these medicines may be prohibitive.

Wegovy costs $1,349.00 a month without insurance.

Ozempic costs $892.00 a month without insurance.

Muanjaro costs $1,300 a month without insurance.

Unfortunately many insurance plans do not cover weight loss medicines.

Diet and Heart Disease – Not as Simple as We Thought

We have all been told for years that the main dietary risk factor for heart disease and stroke is how much saturated fat we eat. We have also been told that eating foods high in cholesterol also increases risk of heart disease and stroke. Evidence is accumulating that consumption of saturated fat increases risk of heart disease and stroke little if at all. Since your body makes cholesterol itself, eating cholesterol rich foods has almost no effect on serum cholesterol. Other aspects of diet have a much greater effect on increasing the risk of heart disease and stroke. In this post I will summarize the evidence and spend some time discussing things we eat and drink that do substantially increase the risk of heart disease, stroke and other chronic diseases.

The Seven Country Study

The most famous study that led to the saturated fat hypothesis was carried out by Ancel Keys. The study started in 1956 and was published in 1978. He looked at the dietary patterns of 7 different countries. The countries included Finland, Greece, US, Italy, Yugoslavia, Netherlands and Japan. He found that saturated fat intake was correlated with increased risk of heart attack and stroke. The country with the lowest saturated fat intake was Crete in Italy, which also had the lowest incidence of heart disease and stroke of the 7 countries. The diet of Crete is the basis for the famous Mediterranean Diet.

Diets of free living humans are notoriously difficult to measure. Keys did his best to accurately determine diet. He had a subset of his subjects in each country weigh their food for a number of days, which is considered the gold standard for dietary studies. The problem with any population study like this is that populations in different countries differ in lots of other ways besides diet. Also diets are complex, so some other factor or factors in diet could account for the low heart disease incidence in Crete. Another problem was that diet was measured in Crete during Lent, when most people did not eat meat. All Keys could really say was that saturated fat intake was associated with heart disease, but he could not say that saturated fat caused heart disease.

People who adhered to the Mediterranean Diet did reduce their population risk of heart disease, but there is a lot more to the Mediterranean Diet than reduced saturated fats. It also includes little added sugar, lots of vegetables and fruit and mostly unprocessed foods. It is not clear that reduction in saturated fat is responsible for the health benefits of the Mediterranean Diet.

The Framingham Study

The next big population study was the Framingham Study. A large group of people in Framingham Massachusetts was followed over many years with surveys about diet, activity, smoking and laboratory measurements of total cholesterol, LDL, HDL and triglyerides among other measurements. Heart attacks, strokes, death from either of these things and death from any cause were recorded in the study group. This was the first large study that implicated cigarette smoking as a cause of cardiovascular disease and cancer. It was also found that the higher the total cholesterol and especially the higher the LDL (low density lipoprotein) the higher the risk of cardiovascular disease. It was also one of the first studies that showed that the higher the blood pressure, the greater the risk of cardiovascular disease. This was a tremendously important and well done study.

The Diet-Heart Hypothesis

The diet-heart hypothesis is that saturated fat is the main dietary cause of cardiovascular disease. It has been very influential over 60 years and is still promoted by the American Heart Association and many cardiologists. Here is the train of thought. The 7 country study implicated saturated fat as associated with cardiovascular disease. It has been found through multiple studies that saturated fat intake raises LDL (so called bad cholesterol). The Framingham study showed that increased LDL was a major risk factor for cardiovascular disease. Since saturated fat raises LDL, therefore saturated fat must cause cardiovascular disease.

That makes perfect sense, so many randomized trials were carried out to nail down the diet-heart hypothesis. Unfortunately, as is often the case with beautiful theories, further randomized trials did not consistently show the expected increase in heart disease from eating saturated fat. The other part of the hypothesis was that eating polyunsaturated fats would decrease the population risk of heart disease. That was based on the observation that consuming polyunsaturated fats decreased LDL levels. Randomized trials have generally failed to consistently show that eating polyunsaturated fats reduces the risk of cardiovascular disease.

Reduced Risk of Cardiovascular Disease in US

Heart disease was epidemic in the US, peaking in the 60’s. Since then, the incidence of heart disease in the US and most other developed countries has decreased by 60%! Scientists debate the cause for this decline. Although saturated fat consumption decreased some, Americans still eat much more saturated fat than the 5% of fat recommended by the American Heart Association. So the fact that we eat somewhat less saturated fat does not explain the remarkable decline in heart disease over the last 60 years. What else changed?

Cigarette Smoking

In the 1940’s half of all Americans said they smoked cigarettes. Smoking began to decline in the US in the 60’s and today only 11.5% of Americans smoke tobacco! This has to be a major factor in the decline of cardiovascular disease (and lung cancer).

High Blood Pressure

High blood pressure is a major risk factor for heart disease. The number of people with high blood pressure successfully controlled on medicine has more than doubled since 1960. This is clearly another major factor in the decline of cardiovascular disease

Trans Fats

The rise of trans fat consumption was an unintended consequence of the heart-diet hypothesis. Because animal fat (mostly saturated fat) was postulated to cause heart disease, the food industry started figuring out how to use vegetable oil to replace lard and butter, which were high in saturated fats. They needed something that would be solid, not liquid at room temperature. They discovered that if they partially hydrogenated vegetable oil, then it would be solid at room temperature and could substitute for lard and butter. They marketed these products as healthier because they were only partially saturated fats, not saturated fats. The medical establishment bought this story and recommended margarine as a substitute for butter and Crisco (the most successfully marketed shortening substitute) as healthier alternatives. I have been unable to find statistics on trans fat consumption in the US, but it was very large.

It turns out that consumption of trans fats markedly increased the risk of cardiovascular disease. For every 2% increase in the consumption of trans fats, heart disease increased by 23%. This is a shocking number! The consumption of trans fats certainly contributed to the epidemic of heart disease in the 50’s and 60’s. The FDA essentially banned the addition of trans fats to food in June of 1978. The elimination of trans fats is almost certainly another major factor in the decline of heart disease.

Interesterification

Since trans fats have been banned, food companies have come up with a new way to make vegetable oil solid and spreadable. It is called interesterification. It is complicated, but the simplest explanation is that it involves changing the arrangement of fatty acids on a glycerol backbone. These are fully hydrogenated fats, so are not trans fats. We know very little about how these new industrial fats affect human health, but the information we do have suggests that these new products may be just as bad for you as trans fats. You would do best to avoid them until we know more. More about how to do this later in this post.

Do we need to limit red meat consumption?

The main risk of consumption of any food is eating too much of it. It is total calorie intake that makes us fat, and being fat increases the risk of cardiovascular disease, diabetes and some cancers. Eating red meat by itself is very unlikely to increase your risk of heart disease as long as your total calorie intake is equal to the calories you burn up. So there is very little health risk to you in eating red meat, but there is a big risk to the environment. Cattle raising worldwide contributes about 16% of greenhouse gas emissions. Here is a link to a balanced discussion of greenhouse gas emissions from cattle raising: Livestock Don’t Contribute 14.5% of Global Greenhouse Gas Emissions.

The other thing to think about when consuming any meat product, including chicken is that almost all the meat you buy in the grocery store comes from giant factory farms, where animals are treated very inhumanely. That in itself is bad enough, but raising all those animals together increases risk of spreading disease to the people who eat them. Antibiotics are used in many factory farms to keep animals from getting sick. This contributes to the evolution of bacteria that are resistant to most antibiotics.

If you are not willing to give up eating meat entirely, try to find locally raised beef, pork and poultry. Farmer’s Markets are a good place to find meat from locally raised animals. It may be a little more expensive, but likely a lot safer.

What about eating fish?

If you are at high risk of cardiovascular disease or have cardiovascular disease then eating oily fish (salmon, sardines, anchovies, herring, mackerel, tuna, swordfish) twice a week reduces your risk of a heart attack by 50%. If you are at average risk, these fish don’t have unusual health benefits but if you like them, it’s fine to eat them. Because most of these fish contain some mercury they should probably be avoided by pregnant women and children. If you get canned tuna, get Pacific Island Tuna at Walmart. It is sustainably caught. Here is a link to an article from the Nature Conservancy about it: The Nature Conservancy. By the way taking fish oil is not nearly as good for you as eating fish.

Highly Processed Foods

There are convincing data that consumption of lots of highly processed foods leads to health concerns ranging from increased risk of obesity, high blood pressure, breast and colorectal cancer, to dying prematurely from all causes.These foods all also contain additives whose health effects have never been adequately tested. How do you recognize them? Just look at the label where the ingredients are listed. If there are more than two things you don’t recognize, put it back on the shelf. Here is an example of an ingredients list from a loaf of bread!

This is not bread you would want to eat! If you mostly stay out of the central aisles of the grocery store you will avoid most highly processed foods. Just be sure to look at the ingredients label before you buy anything.

It is all well and good for me to make these recommendations, but highly processed foods and factory farmed meat are cheap. People who are poor cannot afford to buy anything else. This is only one of the things that have led to the major health inequities that are present in this richest country in the world.

Foods that decrease risk of cardiovascular disease

Fiber

Increased dietary fiber has been shown to decrease risk of cardiovascular disease. This may well have to do with promoting a healthy microbiome in the intestine. Sources of fiber that promote growth of healthy gut bacteria are ones that contain inulin. The highest sources of inulin are leeks, asparagus, onions, wheat, garlic, chicory, oats, soybeans, and Jerusalem artichoke. Sourdough bread (no added sugar, honey, or high fructose corn syrup) is also a good source of fiber. Whole grains, fruits, nuts and vegetables are also good sources of fiber.

Fresh Fruits

Fresh fruits are a good source of fiber and also contain many beneficial nutrients including vitamins and antioxidants. Data from multiple studies show that eating fresh fruit daily reduces risk of cardiovascular disease.

Nuts

Eating a handful of nuts per day reduces your risk of heart disease by 20%. Peanuts are technically of legume, not a nut, but legumes reduce the risk of cardiovascular disease as well. Unsalted nuts are better for you than salted.

Whole grains

Whole grains are also a good source of fiber and other beneficial nutrients. Eating whole grains most days is associated with decreased obesity, diabetes and heart disease. Examples of whole grains are

Barley.
Bulgur, also called cracked wheat.
Farro.
Millet.
Quinoa.
Black rice.
Brown rice.
Red rice.
Wild rice.
Oatmeal.
Popcorn.
Whole-wheat flour.
Whole-grain breakfast cereals.
Whole-wheat bread, pasta or crackers.

Make sure to read the ingredients label for cereals and crackers. Don’t buy anything that has more than two ingredients you don’t recognize.

Fresh Vegetables

Fresh vegetables are also a good source of fiber. Sorry folks, but potato chips and french fries do not count as fresh vegetables! Once again eating fresh vegetables daily significantly lowers your risk of cardiovascular disease.

Bottom Line

Eating red meat and saturated fats does very little to increase your risk of heart disease, but it also does not reduce your risk. Raising livestock on factory farms causes significant harm to the environment and puts people at risk of infectious disease. Eating meat from locally raised animals is safer.

Eating high fiber foods, whole grains, nuts, fruits and vegetable does substantially reduce your risk of cardiovascular disease as well as cancer.

Eating highly processed foods, and this includes the new industrial fats made by interesterfication increases your risk of cardiovascular disease and cancer. The biggest risk of these is probably because they encourage people to eat more calories than they need and have almost certainly led to the epidemic of obesity.

The most concise recommendation for a healthy diet comes from author Michael Poulin: “Eat food (food is anything your grandmother would have recognized as food), mostly plants, not too much.”

Evidence-based Medicine: What You Need to Know

In this post I will write about how the evidence for how well medicines work, and the risk of side effects are not always what they seem. I’m going to show that relative risk reduction (or relative risk increase) always looks a lot bigger than absolute risk reduction or absolute risk increase. Journals and advertisements always report relative risk reduction for medicines or other treatments because they look more impressive. On the other hand, side effects are almost always reported as absolute risk increase because that looks a lot smaller. I will show you how to calculate both kinds of risk reduction and increase. I will argue that absolute risk reduction or increase is what you really want to know before deciding to take a medicine or other treatment.

Any study of a medicine or treatment always has a group that gets the treatment and a group that gets a placebo. That is the only way to know if the medicine or treatment really works. There is always a placebo effect for any medicine. That is, a certain portion of the people who get a placebo get better. If the number of people who get better from the actual treatment is higher than the number of people who get better from the placebo, then the treatment works.

People who participate in a study know that they might get the treatment or a placebo, but they don’t know which one they got until the end of the study. In medical terminology, they are blinded from knowing whether they got treatment or placebo. If the study is double blind (the most reliable kind) then neither the investigators who administer the treatment nor the participants know which study participants got the study treatment or the placebo until the end of the study.

If the treatment works better than the placebo, that result can be reported in several different ways

Relative Risk Reduction or Increase

Relative risk is the proportion of people who have the disease or condition being studied in the treatment group divided by the proportion of people who have the condition in the placebo group.

For example, let’s say we are testing a treatment to prevent diabetes. The control group and the treatment group each have 100 people. 30 people get diabetes in the control group and only 10 people get diabetes in the treatment group. The risk in the treatment group is 10/100 = 0.1 The risk in the placebo group is 30/100 = 0.3 To compare those risks we divide the risk in the treatment group by the risk in the control group. 0.1/0.3= .33. That means that the relative risk of diabetes in the treatment group is 1/3 of the risk in the placebo group. To change that to the relative risk reduction percentage we use the formula 100(1- Relative Risk). Plugging our values into that formula gives 100(1-.33)= 67%. In other words, the treatment reduces the risk of diabetes by 67% relative to the risk of diabetes in the placebo group. That sounds like a big treatment effect!

All medicines or treatments have some side effects. Placebos can have side effects too, especially if people are told (as they must be) what are the possible side effects of the treatment. Placebo side effects are called “nocebo” effects.

In the hypothetical diabetes study described above, let’s say that a side effect of the treatment is bladder infection. Let’s suppose that 5 out of the 100 people in the treatment group get a bladder infection while only 1 out of 100 in the control group get a bladder infection. The relative risk of a bladder infection in the placebo group is 1/100=0.01. The risk of bladder infection in the treatment group is 5/100=.05. The relative risk of getting a bladder infection in the placebo group compared to the treatment group is .01/.05=0.2. To change that to a relative percentage increase, we use our formula again. 100(1-.2)=80%, This means that the risk of the side effect of bladder infection is 80% more likely in the treatment group compared to the risk of bladder infection in the placebo group.

Absolute Risk Reduction or Increase

Relative risk reduction or increase does not take into account the baseline risk of getting the disease or condition. Absolute risk reduction does take into account the baseline risk.

In our example above the absolute risk reduction is 30% (risk of diabetes in the control group) minus 10% (risk of getting diabetes in the treatment group) = 20%. That means that treatment reduces risk of diabetes by 20%. Notice that this is a much smaller number than the 67% relative risk reduction, but it more accurately reflects how much the treatment would reduce your risk of diabetes.

In our example the absolute risk increase of getting a bladder infection with treatment is 5% (the risk of bladder infection in the treatment group) minus 1% (the risk of getting bladder infection in the control group) = 4%. That means that the risk of getting a bladder infection from the treatment is 4% more than no treatment. Again, a much smaller number than relative risk increase of 80%.

Number Needed to Treat (or Harm)

Another way to look at how well a medicine or treatment works compared to placebo is the number of people that need to be treated in order to help one person. This is called Number Needed to Treat, abbreviated as NNT. The NNT = 1 divided by the absolute risk reduction. In our example the absolute risk reduction of getting diabetes in the treatment group was 20%. 1 divided by 0.20 = 5. That means you would need to treat 5 people to prevent 1 case of diabetes with this hypothetical treatment.

Number Needed to Harm, abbreviated as NNH is 1 divided by absolute risk increase. In our hypothetical example NNH = 1 divided by .04 = 25. This means that you would need to treat 25 people for one person to get a bladder infection

A Real World Example: Fosamax to prevent hip fracture in women with osteoporosis

In the real world, we rarely see a treatment effect as big as in our hypothetical example. Let’s look at a real study on a real medicine. Here are some numbers from a big four year study on using Fosamax (generic name alendronate) to prevent hip fracture in women with osteoporosis (thinning of bones). This study was reported in the Journal of the American Medical Association (JAMA) in 1988. It was the first large study to show that alendronate reduced hip fractures in women with osteoporosis. The study included over 4000 women with osteoporosis (shown by a type of bone scan called a DEXA scan). There were 2,218 women in the placebo group and 2,214 women in the treatment group. In the placebo group 812 women (36.6%) had severe bone thinning in the hips by Dexa scan. In the treatment group 819 (37%) women had severe bone thinning in the hips by Dexa scan. Over the four years there were 18 hip fractures in the placebo group (2.2%) and there were 8 hip fractures in the treatment group (1%)

Now lets do our calculations:

Relative Risk = .01 divided by .022 = .45. Relative Risk Reduction = 100(1-.45)= 55%. . This large relative risk reduction is what the article describing the study reported.

Absolute Risk Reduction = 2.2% – 1% = 1.2%. As you can see, the absolute risk reduction is tiny. Taking alendronate for 4 years reduced hip fracture by only about 1%.

Number Needed to Treat = 1/1.2% = 83.3. That means you would need to treat 83 women for four years to prevent one hip fracture.

Side Effects

Muscle or bone pain

In other studies, muscle or bone pain, sometimes severe was reported by 4% in the treatment group and 2.5% in the placebo group.

Relative Risk = .025 divided by .04 = .625. Relative Risk Increase = 100(1-.625)=37.5%. That means that bone and muscle pain are 37.5% more likely in the treatment group relative to the risk in the placebo group.

Absolute Risk Increase = 4% – 2.5% = 1.5%. This means that there is only a 1.5% increase in risk of muscle or bone pain when taking alendronate.

Number Needed to Harm = 1 divided by 1.5% = 67. That means you would need to treat 67 people for one person to have muscle or joint pain. Notice that the number needed to harm is less than the number needed to treat to prevent 1 hip fracture!

Osteonecrosis of the jaw

This is a rare but very serious side effect of alendronate. Assuming treatment group effect of .01% versus placebo of essentially zero let’s do our calculations.

Relative Risk Increase: since this complication is so rare, there are no trials comparing it with placebo.

Absolute Risk Increase: .01 %.

Number Needed to Harm: 1 divided by .01 % = 1000. This means that 1000 people would be treated before you would see one person with this serious complication.

Bottom Line

Journal articles and advertisements almost always report relative risk reduction for medicines or treatments because it makes the effect of the medicine or treatment look bigger. Side effects are almost always reported as absolute risk increases because it makes them look smaller.

Absolute Risk Reduction or Increase is what you really want to know when you are considering taking a medicine or treatment. Most of the time you will not be able to calculate absolute risk reduction, because you won’t have the actual percentages from the placebo and the treatment groups. Don’t despair though. Dr. Google is there to help. Using the following Google search will usually give you the absolute risk reduction. Type in “absolute risk reduction for (name of medicine or treatment).

Once you have the Absolute Risk Reduction (ARR) or Absolute Risk Increase (ARI)you can calculate for yourself the Number Needed to Treat or the Number Needed to Harm. Just divide 1 by either ARR or ARI.

Too Much Medical Care – Just as Bad for You as Too Little

Medical care in the US is the most expensive in the world, but almost all our health outcomes are worse than other industrialized countries. We talk a lot about US populations that don’t have enough access to medical care, but this post is about people who get more medical care and procedures than they need. It turns out that too much medical care not only adds to costs, but is actually as bad for you as not getting enough medical care. I’m going to write about both diagnostic and surgical procedures that are unnecessary at best, and dangerous at worst.

Unnecessary Diagnostic Tests

Routine lab work at your annual preventive care visit

It is common for doctors to order “routine” lab work at preventive care visits. This often includes a complete blood count (CBC), a comprehensive metabolic panel (CMP), a lipid panel and a hemoglobin A1C (a long term blood sugar test).

Healthy people who are not overweight and have no symptoms don’t need any of these, except perhaps the lipid panel to screen for high cholesterol but not even that every year. If you are overweight and sedentary, then it makes sense to screen for diabetes or pre-diabetes with an annual hemoglobin A1C. If you have high blood pressure then it makes sense to do a basic metabolic panel, which includes a measure of kidney function once a year. Other lab work should be based on symptoms and risk factors.

One reason that doing unnecessary lab work is dangerous as well as costly is that the more tests you do on someone, the greater the statistical chance that at least one of them will be abnormal. That can lead to a cascade of further tests and even dangerous procedures.

Imaging for low back pain

There is no reason to do x-rays. CT scans or MRI scans for acute low back pain unless it lasts for more than 6 weeks. Imaging should be done sooner if “red flag” symptoms are present such as:

Fever or chills
Recent illness or surgery
Recent severe back injury
History of cancer
Unexplained weight loss
Night pain or pain at rest
Urinary or fecal Incontinence
Saddle anesthesia (loss of feeling in the buttocks and inner thighs)
Weak, numb, or painful leg muscles

Abnormalities on imaging, especially CT and MRI are often present in people who have no back pain. Imaging without red flags, could lead to unnecessary surgery or back injections.

CT or MRI scan for headache with no findings on neurologic physical exam

Headaches are common and the vast majority do not have a serious cause. Headaches without any other symptoms or history of head injury do not need any imaging. Headache in people who have a history of migraine headaches also do not need imaging. There are certain “red flag” symptoms that do require an immediate CT or MRI scan. These include:

Abnormal neurological examination (e.g. papilledema, altered mental status).
Signs of systemic illness (e.g., fever, stiff neck, rash).
Worst headache ever.
Progression in frequency and severity of headaches.
New headache in patients older than 50 years.
Sudden onset of headache – “thunderclap headache.”
New-onset headache in an immunocompromised or cancer patient.
Headache after head trauma.
Headache worsening with Valsalva (straining like you do to have a bowel movement).

DEXA scan for osteoporosis in low risk women before age 65 and in low risk men before age 70

The risk of fractures due to osteoporosis is extremely low in women under 65 and men under 70 who have none of the high risk factors outlined below. DEXA scans in people in this low risk population are not only unnecessary but also result in unnecessary radiation exposure. Radiation exposure is cumulative and can increase the risk of cancer.

Risk factors for osteoporosis include: a family history of osteoporosis, previous fractures, dementia, poor nutrition, cigarette smoking, alcoholism, low weight and body mass index, estrogen deficiency, early menopause (i.e., before age 45) or prolonged lack of menstrual periods in premenopausal women, long-term low calorie intake, history of falls, and inadequate physical activity.

Ultrasound of carotid arteries (carotid dopplers) in people who have no symptoms

People who have no symptoms are unlikely to benefit from carotid stents or surgery even if they have partial obstruction of the carotid arteries. They are much more likely to be harmed by surgery including risk of stroke, heart attack, or even death.

Carotid dopplers are only indicated for people who have symptoms suggestive of a stroke or mini stroke (TIA)

Routine PSA screening for prostate cancer in men

Although a few men’s lives will be saved by routine PSA testing, many, many more will have surgery for slow growing prostate cancer that would never affect their health, resulting in urinary incontinence and sexual dysfunction for a good portion of those.

PSA screening for prostate cancer should always involve shared decision making with the patient. Some people who have a strong family history of prostate cancer or other risk factors may opt for screening. It should never be routine.

Prostate cancer screening should not be done at all in men over 70. The chance of finding anything other than low grade prostate cancer that does not need treatment in men over 70 is very low.

Annual EKG’s (or any other heart screening test) in low risk people without symptoms

Heart screening tests, including resting EKG and exercise stress testing in people in a low risk population have a much higher false positive rate than true positives. This can result in unnecessary invasive procedures including cardiac catheterization and unnecessary heart surgery.

People with multiple risk factors might benefit from screening tests. Here is a link to a heart disease risk calculator: CV Risk Calculator. You will need to know your LDL and HDL levels to use this calculator. If your 10 year risk is over 10%, you might benefit from one of the heart disease screening tests.

Pap smears under age 21 and over age 65

A pap smear is a screening test for cervical cancer, which is caused by chronic infection with the HPV (wart) virus. Women under 21 who are infected with HPV most often clear it without treatment. It therefore makes no sense to screen women under 21 for cervical cancer. Women over 65 whose last pap smear or HPV test was normal have almost zero risk of contracting HPV, so no longer need pap smears.

Annual pap smears are no longer needed for anyone. Pap smears are recommended every 3 years for women age 21-29 and every 5 years from age 30-65 as long as an HPV test is done also.

Unnecessary Procedures

Stents for stable angina

Stents in the coronary arteries can be life saving for heart attack or unstable angina (heart pain that is getting progressively worse). Many people, however have stable coronary disease. They get pain with a predictable amount of exercise that goes away when they rest. It stays the same and does not get worse with time. People with this kind of stable heart disease do just fine when treated with medicines and lifestyle changes. They do not need stents. In fact, stents do not decrease all cause mortality (death) 4 years later compared to treatment with medicines. Some studies suggest that up to half of coronary stent insertions are unnecessary. Stent insertion is an invasive procedure that can have complications including death. You definitely don’t want to have one if it isn’t likely to extend your life significantly.

Hysterectomy (removal of the uterus) for benign disease

Most “elective” hysterectomies are done because of fibroid (benign) tumors, excessive vaginal bleeding, or endometriosis. All of these conditions have alternative less invasive effective treatments. Fibroids that are causing symptoms can be removed without a hysterectomy. Persistent vaginal bleeding can be treated with hormones or with removal of the lining of the uterus without doing a hysterectomy. Endometriosis can usually be treated effectively with hormones. Hysterectomy should be done only for cancer or when alternative treatments for benign disease have been tried and have not been effective.

Knee arthroscopy for arthritis

Osteoarthritis of the knee is one of the most common chronic healthcare conditions. It involves gradual deterioration of the joint surfaces including tears of the menisci. Knee arthroscopy involves using a tiny camera to look inside the knee through a small incision. Another small incision is made to insert small surgical tools. When orthopedists recommend this procedure to patients, they often say that they are going to “clean out” the knee. This means removing fragments of torn cartilage and pieces of meniscus.

People get temporary relief if any from this procedure. It is considered unnecessary surgery. It exposes one to the risks of general anesthesia and possible infection from the procedure.

Vertebroplasty for osteoporotic compression fractures

Compression fractures of the spinal vertebrae are relatively common in women (or men) with osteoporosis. Many times these are not painful and are found incidentally on x-rays. Sometimes they are painful, especially when they first happen. Vertebroplasty involves injecting cement into the fracture site to stabilize it and reduce pain. Most of the time short term pain medicines and temporary spinal braces provide adequate pain relief. There have been no well conducted double blind studies of vertebroplasty, so it is not known how much of the pain relief from this procedure is simply a placebo effect. It may help in very selected patients, but should only be done for persistent pain when conservative measures have failed.

Spinal fusion for back pain

Chronic back pain is a common condition. It can result from arthritis of the spine or can still be present even with normal x-rays. Spinal fusion surgery connects two or more spinal vertebrae together with small screws. Bone chips from the hip bone are used at the site of surgery as a bone graft, which eventually fuses the vertebrae together.

Spinal surgery of any kind, but especially spinal fusion is never appropriate for people with chronic back pain who have normal back x-rays. Osteoarthritis of the lower back, which does show up on x-rays, is best treated conservatively with physical therapy, non-narcotic pain medicines and walking as much as tolerated.

Spinal fusion is only indicated when there is severe instability of the spine that is causing pressure on the spinal cord. This is not a common finding, so spinal fusion is only rarely indicated.

One problem with spinal fusion is that there is increased mobility of the spinal facet joints above the level of the fusion, which can cause recurrent pain. This can lead to another fusion, which is caused by the first one.

Bottom Line

Unnecessary diagnostic tests and lab work increase the probability of unnecessary surgical procedures. You should ask your doctor or nurse practitioner the reason for any diagnostic tests or lab work that they order. If the answer is “routine” then you should consider declining the test.

If any elective surgery (that means not emergency surgery) is recommended you should ask if there is a more conservative option. You may also always request a second opinion. For any of the low value procedures outlined above you should be very wary of having that procedure unless you have one of the red flag indicators.

Palliative Care and Hospice: What Families Need to Know

Despite all our activities to reduce our population risk of disease and death, illness, suffering and death eventually come to all of us. This post is about what resources you can draw on when illness and suffering happen to your loved ones. The terms palliative care and hospice are often misunderstood. Hopefully after reading this post you will be clear about what these terms mean and how you can use services that provide either or both palliative care and hospice to reduce suffering in your loved ones who have serious illness or are approaching the end of their lives.

Palliative Care

Many people think of palliative care as end of life care. That is a misconception. Palliative care aims to reduce suffering in anyone who has a serious illness, even if they are likely to recover. Palliative care specialists are available in most hospitals and in some areas will do home visits. Palliative care can improve quality of life and can help patients understand their choices for medical treatment. Palliative care services may be helpful to any older person having a lot of general discomfort and disability very late in life. People receiving palliative care can continue other treatments such as chemotherapy for cancer, surgery, or any other potentially curative treatment.

Palliative Care Team

There is usually a palliative care team made up of one or more palliative care specialist doctors and may also include nurses, nutritionists, social workers, chaplains and physical therapists.

Palliative Care Example

Mrs S.is a 75 year old woman who lives alone. She has recently been diagnosed with ovarian cancer. She has a good chance of cure with chemotherapy and she has decided to agree to chemotherapy. Her doctor recommends palliative care during her chemotherapy to help her with pain, fatigue, loss of appetite. The nutritionist on the team helps her find foods that she can eat and monitors her weight. The palliative care specialist helps with medicines to manage her pain to keep it at a tolerable level. The social worker on the team helps find volunteers to do her grocery shopping when she is too tired to go herself. The physical therapist on the team helps her with balance and does a home assessment to decrease her risk of falling. The chaplain on the team calls her periodically and visits as needed to help her deal with the emotional pain of her illness.

Palliative Care Resources

Here is a link to a website that lets you put in your address to find palliative care resources in your area: Palliative Care Provider Directory.

Hospice

Hospice provides comfort care at the end of life. It is available if a physician certifies that death is likely to occur within 6 months. Hospice services make the end of life much more comfortable for almost all patients. Unfortunately many people do not access hospice services until days before death. More than half of Medicare patients who are eligible for hospice received hospice care less than 30 days before they died. One fourth of these die within a week of beginning hospice.

There are many reasons why families tend to delay seeking hospice benefits. Here is a link to an excellent website that discusses reasons why families delay and that also describes how hospice helps people nearing the end of their lives: Why Family Members Wait Too Long to Call Hospice.

Hospice Benefits

Hospice covers all medicines needed for comfort including pain medicines. Hospice also covers certain medicines for chronic disease like blood pressure and diabetes medicines, since stopping these could increase patient discomfort. Hospice also covers hospitalizations for certain acute illnesses or injuries where hospitalization is necessary for patient comfort. Hospice is almost always delivered by a team that may include a physician, nurse, hospice aide, social worker, volunteer, chaplain, and bereavement specialist.

Hospice Eligibility

People who are undergoing curative care are eligible for palliative care, but not hospice. People who have a projected life span of 6 months or less are eligible for hospice. If a person lives longer than 6 months, that does not mean hospice benefits are terminated. If the person still has a projected lifespan of 6 months, hospice benefits continue no matter how long they actually live. If the prognosis improves to the point that the projected lifespan is more than 6 months, then that person is no longer eligible for hospice. If the prognosis worsens again, then hospice benefits are available again. For Medicare, at least, hospice benefits are never exhausted, no matter how many times a person goes on and off hospice.

For people who do not have Medicare, private insurance usually pays for hospice care. Medicaid also pays for hospice care.

Who delivers hospice care?

In rural areas there may be only one hospice provider, but in most areas of the country there are several different agencies that provide hospice care. Although they all have to provide the same basic services, there are differences between providers that make a difference to hospice patients and their families. Your doctor may recommend a hospice provider, but there are some important questions to ask the hospice provider. Here is a link to the Hospice Foundation of America website that gives advice about how to choose a hospice provider and what questions to ask: How to Choose a Hospice Provider.

Hospice Example

A 93 year old man living with his daughter has gotten progressively more frail and with mild dementia. He cannot perform activities of daily living such as toileting, bathing and dressing. His doctor certifies that he is likely to die within the next 6 months, so he qualifies for hospice care. Because of the excellent care he gets from hospice, his condition improves and hospice care is discontinued. He also has congestive heart failure, and over time this gets much worse. He again qualifies for hospice, and the same agency takes care of him again until his death about 8 months later at age 94.

Bottom Line

Palliative care and hospice are not the same thing. Palliative care focuses on comfort for people with serious diseases even when those diseases are curable. Hospice care is end of life care and is a Medicare benefit. It is available for people who have a probability (not certainty) of dying within 6 months. Both palliative care and hospice are seriously underused by people who could benefit from them.

Ticks – Nuisance or Carriers of Disease? Depends on Where You Live

Ticks are found all over the US except in the desert southwest. They can carry many diseases, but ticks that carry diseases are usually localized to certain regions of the country. Whether you should worry about a tick bite depends on where you live. In this post I’m going to write about the diseases that ticks carry and what parts of the country have the majority of cases. I will also provide advice that will help you avoid getting tick borne diseases even if you live in a part of the country where a tick borne disease is prevalent.

Lyme Disease

Lyme disease is the most common tick borne disease. It is so named, because the bacteria that causes it (borelia bergdorfori) was discovered in Lyme, Connecticut. The bacterium is a spirochete, and like syphilis, which is also a spirochete, if untreated it can cause disease in many organ systems of the body.

Symptoms

The first symptom of Lyme Disease is a circular rash that spreads from the site of the tick bite. It usually develops in 7-10 days but can be delayed for up to 30 days. It is called erythema chronicum migrans. Often there are no symptoms, but sometimes the rash is associated with fever and muscle aching. At this early stage, the antibody,blood test for Lyme Disease is negative. Only about 80% of people infected with Lyme Disease have the characteristic rash of erythema chronicum migrans. The other 20% may have flu-like symptoms at the beginning of the infection. A few people have no symptoms until swollen painful joints develop several weeks or months after the initial infection.

If left untreated, the rash disappears and any associated fever and muscle pain disappear as well. Weeks to months later arthritis may appear especially in the knee joints, usually with fluid in the joints. The disease can go on to infect the nervous system and/or the heart. Other symptoms can be persistent fever, chronic fatigue, and recurrent skin rashes.

Treatment

The treatment for Lyme Disease at any stage is 2-4 weeks of an antibiotic called doxycycline 100 mg twice a day. High dose amoxicillin also works. At the stage of erythema chronicum migrans, the treatment is for two weeks. For later stages the treatment should be continued for 3-4 weeks.

Four weeks of doxycycline or amoxicillin kills all the organisms. There is no reason to treat longer than that with antibiotics. Unfortunately, a few people have persistent joint pain or other symptoms even after adequate treatment. This is not persistent infection with the Lyme Disease organism, but it seems that rarely the Lyme Disease organism can cause an autoimmune reaction that persists even after all the Lyme bacteria are killed. Some so-called Lyme Disease experts treat people with chronic symptoms with very long courses of intravenous antibiotics. There is absolutely no evidence that this does any good for these unfortunate people and may do them considerable harm.

Where in the country do ticks carry Lyme Disease?

Lyme disease occurs almost exclusively in the east, particularly the northeast. Here is a map showing where ticks transmit Lyme Disease.

How to prevent getting Lyme Disease

If you live in one of the high Lyme Disease parts of the country, there are several thing you can do to prevent getting Lyme Disease.

When walking in an area where there may be ticks, wear long pants with pant legs tucked into your socks. Insect repellant, especially DEET decreases the chance of a tick bite.
When you have been walking or working in high grass or in the woods, check yourself for ticks every day. A tick has to be attached for 36 hours to transmit Lyme Disease. If you remove all ticks within 24 hours, there is no risk of getting Lyme Disease. You may need to have a partner check the spots on your skin that you can’t see. The correct way to remove tick is to grasp the tick with a tissue or a pair of tweezers and just pull it straight out. The head of the tick does not stay in the skin, so don’t worry about that.
Ticks tend to get on your clothes first and then move to the body. If you put all your clothes in your clothes dryer when you return from tick country, twenty minutes on high setting will kill any ticks on your clothing.
If you find a tick that could have been on for more than 24 hours, call your doctor for prophylactic doxycycline. As single dose of 200 mg of doxycycline will keep you from getting Lyme Disease.

Tularemia

Tularemia is caused by a bacterium called Francisela tularensis. It is most commonly transmitted by ticks, but is also carried by bites of deer flies and by rabbits. People who hunt wild rabbits and clean them can be exposed that way. It can also be carried by squirrels and other rodents.

Symptoms

The symptoms of Tularemia depend on how you get infected. Tularemia from tick bites or deer fly bites is called ulceroglandular tularemia. Symptoms usually begin anywhere from 3-15 days after the tick or fly bite. The bite looks red, swollen and infected with tender lymph nodes on the side of the bite. Fever is almost always present. It takes about 4 weeks after symptoms begin before the antibody test turns positive, so lit is important to treat based on typical symptoms rather than a blood test. Untreated tularemia is a severe disease and can cause death in both animals and humans. There are several other types of tularemia, named by the site infected. Infection starting in the eye is called oculoglandular tularemia. The most severe form results from inhaling contaminated dust or hay. It is called pneumonic tularemia and can be lethal if not recognized and treated promptly.

Treatment

Antibiotics used to treat tularemia include streptomycin, gentamicin, doxycycline, and ciprofloxacin. Treatment usually lasts 10 to 21 days depending on the stage of illness and the medication used. Symptoms may last for several weeks, but people who are treated appropriately almost always recover completely.

Where in the country do ticks, deer flies and rodents carry tularemia

Although there have been a few small epidemics in the east on Martha’s Vineyard, the vast majority of cases occur in Arkansa, Missouri and Oklahoma. I practiced medicine in Arkansa for many years and regularly saw cases of tularemia every spring and summer. Here is a map showing the distribution of tularemia cases in 2020.

How to avoid getting infected with tularemia.

If you live in Arkansa, Missouri or Oklahoma you are at risk for getting tularemia. All the same things for avoiding getting Lyme Disease also work for tularemia. The only difference is that insect repellant is even more important because deer flies carry tularemia also. If you hunt wild rabbits, use gloves to clean them. It is not certain how long a tick has to be attached to transmit tularemia. It is at least several hours, but probably less than 24 hours. Immediate tick checks after you come in from tick country will help you avoid tularemia. There is no prophylactic antibiotic treatment for tularemia, so if you remove an attached tick, be on the lookout for the symptoms of uleroglanular tularemia. The sooner you start treatment, the better.

Anaplasmosis and Ehrlichiosis

Both of these tick borne diseases are indistinguishable from a symptom standpoint. They have different names because they are caused by slightly different organisms. Anaplasmosis is caused by Anaplasma phagocytophilum. Ehrlichiosis is caused by Ehrlichia chaffeensis, E.ewingii, or E.muris eauclairensis.

Symptoms

symptoms of anaplasmosis and ehrlichiosis include fever, severe headache, muscle aches, chills and shaking and, less frequently nausea, vomiting, loss of appetite, weight loss, abdominal pain, cough, diarrhea, aching joints. and confusion. Lab work often shows a low white blood cell count and elevated liver enzymes.

Treatment

The treatment for both anaplasmosis and ehrlichiosis is doxycycline, 100 mg twice a day for 10-14 days. Fever is usually gone and symptoms start to improve within 24 hours of treatment. Once again, treatment should be based on typical symptoms in spring and summer in areas where both diseases are common. It takes 4 weeks before the antibody test becomes positive. The low white blood cell count and the elevated liver function tests occur at the same time as symptoms, so bloodwork showing these things helps to make the diagnosis.

Where in the country do ticks transmit anaplasmosis and ehrlichiosis?

Anaplasmosis and ehrlichiosis are most commonly reported in northeastern and upper midwestern states. Here is a map showing annual cases of anaplasmosis and ehrlichiosis.

How to avoid getting infected with anaplasmosis or ehrlichiosis

Ticks have to be attached for 12-24 hours to transmit either one of these diseases. If you live in one of the high risk areas for either of these diseases, all of the same strategies listed under prevention of Lyme Disease work to prevent anaplasmosis and ehrlichiosis.

Rocky Mountain Spotted Fever

Rocky Mountain Spotted Fever is probably the most serious of the tick borne diseases. It is caused by a rickettsial organism called Rickettsia rickettsii. It can cause loss of fingers and toes and death.

Symptoms

The initial symptom is fever. Shortly after the fever develops there is a characteristic rash on the wrists, forearms, and ankles and spreads to include the trunk and sometimes the palms of hands and soles of feet. Other symptoms include headache, nausea, vomiting, stomach pain, muscle pain and lack of appetite. If left untreated clots can form in the small arteries in the fingers and toes.

Treatment

Again the treatment is doxycycline 100 mg twice a day until fever subsides and symptoms have improved. The minimum length of treatment is 5-7 days.

Where in the country to ticks transmit Rocky Mountain Spotted Fever?

Rocky Mountain Spotted Fever has been reported throughout the continental United States, but five states account for 50% of the cases. These states are Arkansas, Missouri, North Carolina, Tennessee, and Virginia. It is transmitted by the American Dog Tick and cases tend to occur where there are lots of free roaming dogs. Here is a map of cases from the CDC.

How to avoid getting infected with Rocky Mountain Spotted Fever

In addition to all the things mentioned under avoiding Lyme disease, the one other thing that will help you avoid getting Rocky Mountain Spotted Fever is to make sure your dog or dogs maintain one of the three month treatments to prevent fleas and ticks.

Babeseosis

Babeseosis is sometime called “tick malaria” because, like malaria, the organism if a parasite that infects red blood cells. It is caused by two organisms: Babesia microti and Babesia divergens.

Symmptoms

Many people who are infected feel fine and do not have any symptoms. Some people develop nonspecific flu-like symptoms, such as fever, chills, sweats, headache, body aches, loss of appetite, nausea, or fatigue. Because red blood cells are infected, some people develop anemia. People who have have had their spleen removed are at particular risk of severe disease from babesiosis that can be life threatening.

Treatment

For ill patients, babesiosis usually is treated for at least 7-10 days with a combination of two prescription medications — typically either: Atovaquone PLUS azithromycin; OR. Clindamycin PLUS quinine. People with babeseois who are not ill don’t need to be treated. The infection will resolve on its own.

Where in the country to ticks transmit babesiosis?

Tickborne transmission primarily occurs in the Northeast and upper Midwest, especially in parts of New England, New York state, New Jersey, Wisconsin, and Minnesota. It is spread by ticks in the nymph stage, so they are very small and easily missed. Many people with babesiosis do not recall a tick bite. Here is a map of cases of babesosis. Some states don’t report cases, so cases in those states are unknown.

How to avoid getting infected with babesiosis

Ticks have to be attached for 36-48 hours to transmit the babesiosis parasite. Tick checks have to be done very carefully though because the nymph ticks are so small. Otherwise use the same tick precautions for Lyme Disease.

Tick Borne Relapsing Fever

Tick-borne relapsing fever (TBRF) is a rare infection linked to sleeping in rustic cabins, particularly cabins in mountainous areas of the western United States. It is caused mainly by a bacterium called Borrelia hermsii. Other organisms can cause the disease too. It can also be transmitted by body lice.

Symptoms

High fever (e.g., 103° F), headache, muscle and joint aches. Symptoms can reoccur, producing a telltale pattern of fever lasting roughly 3 days, followed by 7 days without fever, followed by another 3 days of fever. Without antibiotic treatment, this process can repeat several times.

Treatment

Doxycycline for 10 days or azithromycin.

Where in the country to ticks transmit tick borne relapsing fever?

How to avoid getting infected with tick borne relapsing fever.

In addition to the measures that are the same as the ones to prevent Lyme Disease, avoid sleeping in rustic cabins in the west!

Powassan Virus

So far, Powassan virus is a rare disease, which is a good thing. Although many people have no or only mild symptoms, some people get a severe encephalitis (infection of the brain). This is one disease that is transmitted in minutes by a tick bite.

Symptoms

Those who have symptoms have fever, headache, vomiting and weakness. People who get encephalitis or meningitis can have confusion, loss of coordination, difficulty speaking and seizures. About 1 out of 10 people with severe disease die from it. About half of the people who survive severe disease have long-term health problems such a recurring headaches, loss of strength and memory problems.

Treatment

There are no medicines to treat this virus. Treatment consists of supportive care. People who have no or only mild symptoms recover without long term health problems.

Where in the country to ticks transmit Powassan virus?

Powassan virus disease (Powassan) has been reported primarily from northeastern states and the Great Lakes region. Here is a map showing cases in the US.

How to avoid getting infected with Powassan virus

All of the tick prevention measures for Lyme disease are relevant if you live in the northeast or upper midwest. Tick checks only work if you find the tick before it attaches, since ticks can transmit the disease within minutes of a tick bite.

Other Tick Borne Diseases

There are several other tick borne diseases. Many of them have just recently been recognized. Here is a link to a CDC webpage that has a comprehensive list of tick borne diseases: Diseases Transmitted by Ticks.

Bottom Line

Ticks carry lots of diseases, but only in fairly limited parts of the country. If you don’t live in one of those areas, then tick bites are a nuisance but not a serious problem. If you do live in one of those regions, you should definitely take the precautions outlined under the section on Lyme Disease. I will reiterate those here for emphasis.

When walking in an area where there may be ticks, wear long pants with pant legs tucked into your socks. Insect repellant, especially DEET decreased the chance of a tick bite.
When you have been walking or working in high grass or in the woods, check yourself for ticks every day. A tick has to be attached for 36 hours to transmit Lyme Disease. If you remove all ticks within 24 hours, there is no risk of getting Lyme Disease. You may need to have a partner check the spots on your skin that you can’t see. The correct way to remove tick is to grasp the tick with a tissue or a pair of tweezers and just pull it straight out. The head of the tick does not stay in the skin, so don’t worry about that.
Ticks tend to get on your clothes first and then move to the body. If you put all your clothes in your clothes dryer when you return from tick country, twenty minutes on high setting will kill any ticks on your clothing.
If you find a tick that could have been on for more than 24 hours, call your doctor for prophylactic doxycycline. As single dose of 200 mg of doxycycline will keep you from getting Lyme Disease.

Ticks are likely to be found in brushy areas, areas of high grass and in the woods. Here is a picture of a tick in “questing” mode. If you brush by this tick, it will attach itself to you, either your clothes (most likely) or to your bare arms or legs if they brush by the questing tick.

I will leave you with that somewhat scary image!