Sick while black: an unhealthy combination

The Covid-19 crisis has highlighted many of the failings of the U.S. healthcare system, including the racial disparities that have always been present. If you have followed the news, you are aware that African Americans and Hispanic Americans have suffered more from Covid-19 than their white fellow citizens. In Chicago, where blacks make up 30% of the population, they make up 50% of Covid-19 cases and nearly 70% of the deaths. Similar statistics are found throughout the country. Part of the reason that blacks have suffered disproportionately is due to social and economic factors: blacks are more likely to live in crowded housing, which increases disease spread; they are more likely to depend on crowded public transportation, where “social distancing” is difficult or impossible; they are more likely to work in low-paid occupations considered essential which cannot be done from home. African Americans also suffer more from the diseases that increase the odds of dying from Covid-19: hypertension, diabetes, obesity and cardiovascular disease.

What you may not realize, however, is that the ravages of Covid-19 are just the icing on the cake of racial disparities. Pregnancy-related deaths, a marker of how well a country’s health care system works, is much higher in the United States than in comparable wealthy countries, even among white women, but is strikingly higher in black women. In countries such as Japan, Australia, France, Germany and Denmark, the number of maternal deaths per 100,000 births ranges from 5 to 8. In the U.S. it is 17 among all women, but in non-Hispanic black women it is 40.8!

Black Americans with cancer, lymphomas and leukemias die sooner than white Americans with the same diseases. Those with lower socioeconomic status, who are disproportionally black, have much more premature coronary disease and die younger of heart disease. Even when they receive “high tech” interventions such as coronary stents, black Americans had higher risk for major cardiovascular events in the years that followed. Black adolescents got fewer flu shots than did white and Hispanic teens.

Hispanic and black Americans are less likely to have a primary care physician, make fewer doctor visits and are less likely to get outpatient mental health care than white Americans. The Affordable Care Act (AKA “Obamacare”) increased access to health insurance for the overall population but benefitted white much more than black Americans. The largest number of Americans get their health insurance from their employers, but small employers are much less likely to offer insurance than large ones, and many blacks work in hazardous low-paying jobs with companies that do not offer many benefits.

What can we do? As the richest major country in the world, we cannot allow any of our citizens to starve or to not have a roof over their heads or die from treatable illnesses. Whether through adopting universal health care, expanding Medicaid or providing a public option for those without employer-based insurance, we must guarantee that everyone has access to basic healthcare.

Since much of an individual’s (and a nation’s) health depends on social factors rather than traditional healthcare, we should strive to see that everyone, white, Hispanic and black, has a living wage and affordable housing and access to healthy foods. New mothers would be less likely to have health issues if the U.S. joined most of the western democracies to mandate paid maternity leave.

We can do better and we must do better. Covid-19 will eventually be behind us, but the health disparities that have been made worse by this pandemic will remain unless we take this opportunity to create a better country for all.

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It's only natural

It is hard these days to shop for anything, whether at the supermarket, the pharmacy or the beauty shop, without seeing products touted as being “natural.” The term is used even more often than its frequent companion, “organic.” Over the past decade, while total food sales have risen 2%, sales of “natural” food have risen 12% and “organic” foods 15%. Clearly these words sell products, but is it always a good idea to buy a natural product over others? What does “natural” really mean?

When a food is using the USDA-approved label of organic, this does have some specificity. By law, products labelled organic must be grown with no genetically modified ingredients, no irradiation, no antibiotics, no synthetic feeds or pesticides, no hormones and no chemical fertilizers. The contents of a package must be over 95% organic to carry the label. (Note that in many parts of the world, “night soil” is used as fertilizer, and while this is organic, I would prefer not to eat food fertilized with the contents of an outhouse.)

There is no legal definition of “natural.” One is reminded of the line from Lewis Carroll’s book Through the Looking Glass, when Humpty Dumpty says to Alice: “When I use a word, it means just what I choose it to mean—neither more nor less.”

Perhaps because of the lack of a defined meaning, you will see “natural” used on supplements, food products, cosmetics and just about anything else you can buy. Unfortunately, many clearly natural products are dangerous. After all, botulinum toxin is a natural substance, found in nature with no human intervention, but it will paralyze and kill you when ingested. (In micro-doses, botulinum toxin is safely used as Botox.) Many natural products found in marketed “supplements” have dangerous potential. These would include cesium chloride and aconite (heart rhythm problems), lobelia (seizures), kava kava and celandine (liver failure) and germanium (kidney damage). If you are taking a “supplement,” look for these ingredients and toss the tablets if any of these products are in them.

“Natural skin care” has become a multi-billion-dollar market, carving out 25% of the $5.6 billion spent in 2018 on skin care products. “Clean beauty” evangelists such as Gwyneth Paltrow have ignited fear in consumers about using many products such as sulfates, parabens and propylene glycol, not on the basis of facts but by using scary statements such as “do you want antifreeze in your moisturizer?” Dermatologists have pointed out that many of the “natural” products touted are more likely to cause allergic reactions than the products they are replacing. [See JAMA Dermatology, December 2019.] A widely used web site from the Environmental Working Group touts safe skin products, but in many cases gets a percentage of sales from products it deems safe, an obvious conflict of interest.

So, when shopping, remember that just as beauty is in the eye of the beholder, natural is in the claims of the seller, and don’t pay up for something unless there is a good reason to do so.

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Lowering cholesterol? How, why?

This post was suggested by a reader, who had read enough about the coronavirus, and it is a topic that merits attention. Cardiovascular disease remains by far the number one killer in the developed world and is rapidly rising to that spot in the developing world as well, and our ability to prevent heart attacks is in large part related to lowering cholesterol.

The first point to note is that cholesterol is not arsenic – cholesterol is part of normal cells, and no one dies of cholesterol. It has, however, been known for many decades that an elevated level of cholesterol, along with high blood pressure and smoking, increases the risk of developing coronary disease. Norwegian researchers in 1939 described families with abnormally high levels of blood cholesterol and premature heart attacks. This led, beginning in the 1950s, to attempts to lower cholesterol with diet and medication. Most of the medications which were then available, which included nicotinic acid, fibrates and cholestyramine, were not very effective and/or were difficult for people to take for any time, and their use did not reduce the risk of heart attack by a large amount.

A breakthrough in cardiology occurred with the development of the class of drugs technically known as HMG-CoA reductase inhibitors and widely known as “statins.” The first in this class, lovastatin, was discovered in 1978 and first tested in humans in 1980. Multiple similar drugs followed, and we now have seven on the American market. They vary in potency, but all work in a very similar way. The first major trial of using a statin to prevent CV death was conducted in the west of Scotland, among men at high risk of heart attack. Participants were enrolled between 1989 and 1991 and the results of the trial were published in 1995. Those taking the active drug, which in this trial was pravastatin, had about 31% fewer heart attacks, and there was about a 9% reduction in total mortality (from 38.6% to 34.7%) over an extended 20-year follow-up. Multiple later trials, done in lower risk patients, all showed similar results: fewer heart attacks and a trend to lower overall deaths in statin-treated groups.

I do not own stock in any healthcare companies, so have no conflict of interest in stating that the statins as a class are one of the best medicines in our armamentarium. Most are now available generically and are dirt-cheap in the big picture of pharmaceutical products; they are well-tolerated by most people; and have very few bad side effects. There was a flurry of concern a few years back about them contributing to dementia, but this has been disproven by many large studies. They do seem to slightly hasten the onset of diabetes in people prone to it, but the benefit far outweighs the risk.

There is one fly in the ointment: many people develop muscle aches from taking a statin. Only a tiny number have muscle damage (which can be measured with a blood test), and in my opinion if you fall in that tiny number you should never take any statin, but 5-10% complain of muscle aching that goes away when you stop the drug. In some cases, taking a different statin can be done without the problem recurring, but some get the same reaction to every statin they try. What options are available if you are in this group?

The first step is to decide with your doctor if you truly need to have your cholesterol lowered. While statins seem to have a similar relative reduction in heart attack risk in all groups, there is a difference between relative and absolute risk. Let’s say that taking a moderate dose of a statin reduces your risk of having a heart attack in the next 10 years by 25%. If that risk is 40%, then reducing it by 25% means you have reduced your odds by 10%. If that risk is 4%, reducing it by 25% means your actual benefit is a 1% risk reduction – perhaps not worth it in your mind. There are on-line risk calculators that will help you calculate your personal risk.

If you feel that lowering your cholesterol is important and cannot take a statin, there are several choices available, but NONE of them has been studied for risk reduction when taken alone – all have been shown to lower your risk of heart attack when added to a maximally-tolerated dose of a statin.

Ezetimibe (Zetia) inhibits absorption of cholesterol from the intestine and reduces cholesterol by about 18% (compared to 25-60% reduction with a statin). There are two new injectable drugs, called PCSK9 inhibitors, that are very potent, but are extremely expensive and require self-injection every 2-4 weeks. Unless you have a very high risk, your health insurance company is likely to balk at paying for these. The newest entry is bempedoic acid (Nexletol), which also lowers cholesterol by about 18%, and it has also only been tested as an add-on.

Finally, do not forget lifestyle changes: a better diet, weight loss, moderate aerobic exercise. If you are a smoker, quitting will do more to reduce your heart attack risk than any pill.

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Health care: black and white

The Covid-19 pandemic has brought into sharp relief the failings of the U.S. health care system to give adequate priority to public health: our woeful performance in testing, contact tracing and availability of personal protective equipment. It has also highlighted the marked social disparities in how we deliver health care.

Across the United States, the death rate from Covid-19 per 100,000 among non-Hispanic whites is 22.7, among Asian-Americans 24.3, among Hispanics 24.9 and among African Americans 54.6. The strikingly higher death rate reflects many factors. Blacks are more likely to live in crowded housing, making “social distancing” more difficult; they are more likely to have to depend on crowded public transportation; they have a higher incidence of such medical conditions as hypertension and diabetes that increase mortality; and they are more likely to work in such “essential” jobs as meat packing, nursing homes and home health care and grocery stores, and less likely to be able to work from home.

The racial disparity in health care exposed by the pandemic is not new. Overall deaths per 100,000 in the U.S. in 2018 were 725 for non-Hispanic whites and 852 for African Americans. The maternal death rate in this country has been (or should have been) an embarrassment for a long time. While the death rate per 100,000 live births in most of the western world ranges from 5 to 8 and has been falling, in the U.S, during the decade 2007-2016, it rose from 15 to 17. Here too there was a marked racial disparity. The maternal death rate among white women averaged 12.7/100,000 in the most recent figures, while it was 40.8 among black women. Poverty alone is not the explanation; among women with at least a college degree, the maternal death rate of black mothers was 5.2 times that of whites.

Too often, minority populations live in the least safe housing, are less likely to have health insurance and have less access to health care.

As detailed in Prescription for Bankruptcy, some 80% of a nation’s health, as measured by factors such as our life expectancy at birth, is determined by social factors rather than the traditional health care delivery system. To lead healthy lives, people need safe housing, access to healthy food, green spaces, educational opportunity, social support and, most important of all, a living wage.

Whether through development of a vaccine or the gradual development of effective treatment and herd immunity, the pandemic will end. The racial disparity in health and health care will not unless we make a conscious decision to make societal change.

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What do Covid-19 tests tell us?

To understand what various tests for Covid-19 mean, you must first accept one important fact: medical tests are not perfect. Even the most accurate tests we have at our disposal may say that someone has a disease when they do not (a “false positive”) or that they do not have the disease when they do (“false negative”). All tests must be interpreted together with the clinical findings and the likelihood of someone having the disease in question.

Let’s look at how Covid-19 is diagnosed. The “gold standard” is detection of the virus’ RNA in specimens from the respiratory tract of a sick person. These tests go by the highfalutin label of “reverse transcriptase-polymerase chain reaction” or RT-PCR, and this describes a technique by which the presence of viral RNA is measured and quantified. This technique can be used on any specimen, but the earliest and still most common specimen has been a swab taken from the very back of the nasal passage. It has also been used on sputum (spit), throat culture, stool samples and even semen.

In most people who develop symptoms of Covid-19, viral RNA becomes detectable in the nasopharyngeal swab as early as day 1 of symptoms and in over 98% within the first week. Detection falls off after week 3, though positive tests have been reported as late as six weeks after symptoms begin. Tests for Covid-19 RNA in the stool and semen have also been found positive long after patients recover. It appears that late tests often do NOT indicate that the person is still contagious, and that they may simply be shedding decayed viral remnants.

The RT-PCR is highly accurate when positive. False negative tests do occur because of technical problems: the specimen may have not been taken properly or not transported properly to the lab, or there may have been a problem with the way the test was conducted.

The other type of test about which you will read is the antibody test. When we are exposed to an infectious agent (or a vaccine), our immune system gears up to fight it off by producing proteins called antibodies that both directly fight the infectious agent and call in various cells to do the same. It takes time for antibodies to be produced, so they are unlikely to be found very early in an illness. In the case of Covid-19, some antibodies have been found as early as 4 days into symptoms, but it is generally in week 2 or 3 that they are reliably found. First to appear are a group called IgM antibodies, that fall off by week 6, while IgG antibodies appear slightly later but persist, for months or years.

Antibodies are commonly measured in blood samples and provide proof of prior exposure to an infectious agent. In many, but not all, cases, presence of antibodies indicates at least some immunity to the agent against which they are targeted. The degree to which the presence of antibodies means immunity to the disease varies a lot. If you have measles antibodies, you are safe, but that is less true for whooping cough or for the coronaviruses that cause the common cold. We simply do not yet know if antibodies against Covid-19 will protect one from re-infection. It is clearly premature to use these tests to offer “immune passports.”

The other major problem with current Covid-19 antibody tests is that many of the tests now available are far from reliable. Many were rushed to market with limited testing and have a high number of both false positives and false negatives. Remember that Covid-19 is one of a group of coronaviruses, many of which cause the common cold, and a poorly designed antibody test may simply be detecting a prior exposure to one of these other viruses.

Bottom line: until we have more consistently reliable antibody tests, and until we know if the presence of antibodies is a reliable way to guarantee immunity to re-infection, I would not be in a hurry to get tested.

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Musings on masks

Let me start with the punch line and then work backwards.

You do not wear a face mask to protect yourself, though it may offer some modest protection. You wear one to protect your fellow human beings. Refusing to wear a mask does not indicate bravery and toughness but rather a lack of concern for others.

How does the coronavirus spread? It spreads almost entirely when viral particles are expelled from the respiratory tract of an infected person and inhaled by another person. Huge numbers of viral particles are spread when an infected person coughs or sneezes, large numbers when they sing or shout, and fewer but enough to spread with normal talking or even breathing.

Who can be a virus spreader? Alas, it is not only people who are obviously ill. There are still gaps in our knowledge, and it is hard to give exact numbers, but all experts agree, backed up by increasing data, that many people who harbor coronavirus and can spread it have minor or no symptoms. The most recent study I found, published in a British medical journal, found that 81% of passengers on a cruise ship who tested positive had no symptoms when they were tested. Moreover, even those who develop symptoms are most infectious just before symptoms develop. Lack of symptoms seems to be more common in women than men, and in younger adults. Roughly half the Covid-19 patients in China appeared to have been infected before the patient from whom they caught it knew they were sick.

How much do masks protect the wearer? Probably not a lot. Only N95 masks, which remain in short supply and are needed by healthcare workers, filter out most viral particles, which are very small and can pass through the fabric of cloth or disposable surgical masks. They do offer modest protection against moist droplets which carry viral particles from a sneeze or cough.

The masks do cut down on spread of the droplets generated by speaking, coughing or sneezing. The key point is not that masks do not block every virus particle, but that they filter out many. Every virus particle that does not escape into the air is a virus that will not be inhaled by others or fall on surfaces and perhaps be picked up on the hands of others.

Just as wearing a seat belt does not confer immortality if you get in a car accident, but does cut down on deaths, wearing a face mask will not prevent all spread of coronavirus but will reduce it. Wearing a mask is an easy, inexpensive and harmless way to show that you care about others.


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Surrogate or real?

The dictionary defines surrogate as “a person appointed to act for another,” and to the general public probably the most common use is in terms such as surrogate parent

In medicine, it is common to have surrogate decision-makers, such as the parents of a minor child, or the spouse or child of a person who is incapable of making their own decisions. Such surrogate decision makers have all-too-often been put in the difficult position during the COVID-19 pandemic of making dread decisions such as whether to have a loved one put on a ventilator. It is very common for an elderly patient to undergo intensive care when they have asked this not be done, and researchers have also found that many surrogates’ wishes are not followed by the medical staff. It is always best, and Covid-19 has just underlined this, for a older person (or a person of any age with serious medical problems) to be sure their wishes regarding the trade-off between possibly life-sustaining care and comfort be explicit, in writing, and discussed with family.

I want to focus, however, on another form of surrogate – the use of “surrogate end points” to approve a new drug.

The gold standard for proving that a new treatment works, or works better than an existing one, is the controlled clinical trial. A large group of patients are randomly given Drug X or Drug Y, or, if there is no existing useful treatment, Drug X or a placebo. They are then followed until a pre-specified outcome occurs and the results of the two groups compared. As regular readers of these posts know, I am much more impressed with a trial that uses death as the outcome being measured. For many of the events reported, the definition is often fuzzy. The research group frequently establishes a committee to “adjudicate” whether an event occurs. You do not need a committee to decide if a patient is alive or dead.

From a researcher’s perspective, the problem with using death as the outcome is that to establish that one treatment is better than another may take a large sample followed over a long time unless the disease is rapidly lethal. Large trials over a long time are costly to perform.

Enter the “surrogate.” The trial of a cancer drug may use “shrinking of the tumor by 50% on CT scan” or “reduction of a biomarker (blood test)” as the outcome studied. While these MAY correlate well with outcomes of more value to the patient, such as lifespan or quality of life, they may not. More and more cancer drugs are now being approved by the FDA based on surrogate outcomes. A recent study published in JAMA Internal Medicine found only a very weak correlation between these end points and overall survival. While a drug approved on this basis is supposed to have further tests done that do track overall survival, in a large percentage these studies are never done. Since these new drugs are often very expensive and have many major side-effects, it appears that patients are often exposed to potential harm with minimal potential meaningful benefit.

So, when the latest “wonder drug” is suggested, be sure to ask just HOW wonderful it really is. The reported results may be “statistically significant,” but are they clinically significant? Can anyone tell you this treatment will make you feel better or live longer, or will there just be a meaningless "surrogate" improvement?

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