Friday, September 10, 2021

On "Liquid biopsies" and other screening tests

Coming to a mall near you! Or at your doctor’s office or via direct mail: the chance to have a “simple blood test” to detect very early cancer and perhaps save your life. What is the truth behind the hype?

The term “liquid biopsy” refers to the screening of a blood sample for traces of abnormal DNA that are felt to be the markers of a variety of cancers. These tests were approved by the FDA in 2020 for a very limited purpose: to detect DNA markers of specific subtypes of known cancers that meant the cancers would respond to specific treatments. The tests were meant to identify specific cancer-related genetic changes which could influence patients’ treatment choices or make them eligible to participate in clinical trials.

While that is a lucrative market, what has Wall Street salivating is a much larger potential: offering such tests to everyone, with the promise of detecting cancer long before it caused symptoms. We have been conditioned to believe that early detection = greater chance for cure, and in some cancers this is valid. If everyone had regular colonoscopies, the death rate from colon cancer would fall. Early detection of lung cancer in smokers using low-dose CT scanning has been shown to reduce lung cancer death and regular mammograms reduce death from breast cancer, though in neither of these latter cancers is the screening test “dramatically” effective.

Before we start recommending very expensive “liquid biopsies” for widescale use, it is critical to look at what they will accomplish rather than what they might.

The idea behind screening tests is to look for disease in apparently well people with the expectation that finding and treating disease before symptoms develop will lead to better health and/or longer life. In the case of colonoscopy, the theory has been validated, but this is not always the case.

Example 1: screening for atrial fibrillation (AF). We know that AF, a heart rhythm disorder that is very common as we age, is a major cause of stroke, and that by putting patients with AF on blood thinners we can reduce their stroke risk by as much as 80%. A recently published study looked at using small monitors implanted under the skin to detect episodes of AF that would never be found routinely. They did detect three times as many episodes of AF – BUT – when they treated these people with blood thinners, there was no real difference in strokes or deaths compared to the group not screened. It appears the brief asymptomatic episodes of AF that were found may not be as serious as AF found in routine practice.

Example 2: screening for thyroid cancer. In 1999, Korea embarked on an aggressive national cancer screening program. While ultrasound screening of the thyroid was not initially included, it quickly became a widely used study. As a result, by 2011 the rate of thyroid cancer diagnosis increased 15-fold over the rate in 1993. Thyroid cancer is now the most common cancer diagnosed in Korea. At the same time, the death rate from thyroid cancer did not budge. Almost all of these cancers are low-grade and small, and we have known for 70 years that low-grade thyroid cancer is very common and rarely kills. Thyroid surgery is not innocuous: patients can have vocal cord paralysis, accidentally have their parathyroid glands damaged and usually need to take thyroid hormone for life. All for a disease that would never have bothered them if not found.

SO: before the FDA approves “liquid biopsies” for screening use and before you consent to having one done, we need evidence that these tests not only detect cancers not otherwise easily found, but that finding these cancers will let you live a longer and/or healthier life. Otherwise, I fear, we are going to see your health made worse by extensive imaging studies looking for this possible hidden cancer and your life put at risk by having surgery that you do not need.

Let’s not put the cart before the horse.

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Thursday, August 19, 2021

Boosters - Needed? When?

This week saw an announcement from the Biden administration that a 3rd Covid-19 vaccine shot would be recommended for everyone 8 months after their second mRNA (Pfizer or Moderna) shot. Is this a good idea? What does it mean for you?

Since antibodies gradually fade over time, most vaccines are given in multiple doses over an extended time. If you get hepatitis B immunization, you get 3 shots over 6 months. Most childhood vaccines are spread out over years. The current shingles vaccine is given as two shots, 2 to 6 months apart.

The mRNA vaccines were tested (and thus approved for use) using a relatively tight time frame, 3 or 4 weeks apart. I am sure this was because of the urgency of getting these vaccines tested and available. Indirect evidence from Britain, where the second shot was deliberately delayed to permit as many first shots as possible, suggests a longer interval gives even better protection.

Real world evidence shows that these vaccines are extremely effective, even against the Delta variant, with 80%+ prevention of infection and 90%+ prevention of hospitalization out to 6 months. The one group where evidence strongly suggests a third dose is needed are those with depressed immune systems, such as transplant patients.

A recent study found that among nursing home residents, who got the vaccine early, the protection gradually waned, falling as low as 53% 8 months after vaccination. Another, looking at New York residents, found that protection against infection dropped from 92 to 80%, though protection against hospitalization remained over 90%.

A very small recent study, done by Pfizer, found a marked increase in antibodies when a booster dose was given 8-9 months after the second original vaccine.

SO:

1.Yes, a booster is probably a good idea.

2.If you have a depressed immune system, you should get this as soon as possible.

3.If you are otherwise healthy, there is no need to panic and seek one out before you are due.



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Monday, August 9, 2021

Has the FDA lost its way?

The FDA failed the U.S. public by approving Biogen’s new Alzheimer’s drug against the recommendation of its expert advisory panel and its own statisticians. That event led me to explore whether this was an aberrancy or part of a pattern, and what I found disturbed me.

The FDA’s origins lie in the Food and Drugs Act, passed by Congress in 1906 and signed into law by President Teddy Roosevelt, which prohibited interstate commerce in misbranded and adulterated foods and medications. Much of the impetus for getting this bill enacted was the revelations by such “muckraking” journalists as Upton Sinclair, whose novel The Jungle exposed unsafe and unsanitary conditions in the meatpacking industry.

Probably the high point of the FDA was in 1961, when Canadian-born Dr. Frances Kelsey refused to allow the sale in the U.S. of thalidomide without further safety data, and her judgement was rewarded when the drug, widely prescribed in Europe for morning sickness, was found to cause serious birth defects.

This episode in turn led to passage of the Kefauver-Harris amendment to the Food and Drugs Act which required that all new drugs demonstrate “substantial evidence” of efficacy as well as safety. This is where the recent FDA decision failed to meet the intent of the law, but it is not the only time.

Under pressure from AIDS activists in the early 1980’s, the FDA developed an accelerated pathway to approve promising new drugs for otherwise poorly treated diseases, with the proviso that on-going studies be done to prove that the drugs fulfilled their promise. A study published this year in the British Medical Journal found that many drugs approved under this accelerated pathway stayed on the market for years or decades without the required studies being done and with major doubts about their efficacy persisting.

I am particularly concerned about the frequent approval of new cancer drugs, most with huge price tags and major side effects, based on “surrogate outcomes:” measures of changes in blood tests or imaging findings that might show the disease is responding, but which do not show meaningful results in terms of prolonging life.

The FDA is also responsible for regulating medical devices such as implants and pacemakers. Here too, as a ProPublica investigative report found, the FDA has often deferred to manufacturers and allowed dangerous products to stay on the market far too long.

How can these problems be improved?

First, as much as possible, the FDA, and the CDC, should be insulated from political pressure. The heads of these agencies should have terms that do not overlap with presidential terms and should be able to be removed only for malfeasance, so that they can make decisions based on science, not politics. Many public health decisions involve trade-offs but improving a president’s reelection odds should not be a factor when it comes to saving lives.

A much more “arms-length” relationship between the regulators at the FDA and the device and pharmaceutical industries must be enforced. No revolving door between agency and industry should color the regulators’ decision making.

The FDA should not be allowed to overrule the decisions of medical experts unless these decisions are close. If a vote is 6-5 with one abstention, there is room for the FDA to decide on approving a new drug based on their judgement. When there is a super majority vote, it should be respected.

Let us demand that the FDA uphold Dr. Kelsey’s standards.

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Wednesday, July 28, 2021

Do I need to wear a mask (AGAIN!)?

The headlines this morning were all about the CDC changing its guidelines about whether vaccinated people need to wear masks. In typically nuanced language, they tried to differentiate between those living in areas with high spread and low vaccination rates and those in areas with fewer cases and better vaccination uptake.

What should YOU do?

A few facts:

The Delta variant is now dominant. Nationally, over 80% of strains tested are Delta. Even in Massachusetts, which has one of the highest vaccination rates and lowest cases/population in the country, Delta now makes up over 50% of Covid cases.

Delta is not more deadly – hospitalizations and deaths from Delta are similar to those caused by the original strain.

Delta IS much more contagious. People infected with the Delta variant carry many more virus particles in their nose and upper airway, and thus are much more likely to transmit the virus to others. This is why case counts are rapidly rising in almost every state.

The m-RNA vaccines, in particular, are very good at protecting you from getting infected and even better at preventing serious illness and death from Delta, but they are not 100%. Even if you are vaccinated, you can catch COVID-19 and pass the virus to others.

So, my advice is:

Avoid travel to Florida and other hotbeds for now until they get their act together.

If you live in a state with low vaccination rates, I would wear a mask any time you are indoors with people you do not know are vaccinated and outdoors when you will be in crowds.

If you live in New England or another region with high vaccination rates, it gets more complicated. Life is never risk-free. Every time you get in a car, you are accepting some risk. At the same time, you do common sense things to lower the risk: you wear a seatbelt and you obey traffic laws.

What seems sensible is to wear a mask when you are indoors in crowded spaces: theatres, grocery stores, houses of worship. I would also wear one outdoors if it is a very crowded space where people are always close such as parades and stadiums. This will both reduce your risk and the risk that you could pick up a mild infection but pass the virus to others. It is thus particularly important if you have friends or relatives with poor immune systems.

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Saturday, July 17, 2021

Delta dawns

The news media have been filled with stories about the delta variant of the coronavirus, some factual, some scary. What do you need to know?

First, it is a fact of life that many viruses constantly mutate. That is why you get a flu vaccine every fall: not because your immunity from last year has faded, but because the expected influenza virus will be different than the one that circulated last season. Some of the changes in the virus’ genes make them more dangerous to humans, some less. Some mutations make them less easily transmitted, some more. If a variant is more infectious and/or more easily transmitted from one person to another, it eventually becomes the dominant strain.

This appears to be happening in the U.S. with the delta variant. Luckily it does not seem to be more lethal than earlier strains, but it is more easily spread, and is rapidly becoming the most common form of the virus. Along with the appearance of the delta variant, we are seeing a recrudescence of COVID-19 infections. The lifting of restrictions and decreased mask use is almost certainly also playing a role.

I track the virus in Massachusetts and a month ago our average of new cases was down to 57 a day, and the percentage of Covid tests that were positive had fallen to 0.3%. This week, we are seeing 250 new cases daily and 1% of tests are coming back positive.

This is true across the country. The head of the CDC noted on July 16 that the number of new cases had risen 70% from the prior week. Along with rising cases, hospital admissions had gone up 36% and deaths 26%.

The natural immunity acquired after a mild case of COVID-19 does not seem nearly as effective against the delta variant as it is against to original virus strain. The good new is that the available vaccines do seem very effective, and if you are fully vaccinated, you are extremely unlikely to get seriously ill or die.

Virtually all the recent hospitalizations and deaths have been in unvaccinated people.

While being unvaccinated is clearly dangerous to those individuals, it is also dangerous to others. People who get infected are the source of new variants, and the unvaccinated serve as incubators to produce potentially more lethal variants. Lambda anyone? This new variant now rampant in South America is less susceptible to current vaccines.

If you have not been, PLEASE get vaccinated, for your sake and for ours.

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Monday, July 5, 2021

Vaccines and the Heart

There has been considerable discussion in the media and medical journals about possible heart damage in young males who received the m-RNA vaccines against COVID-19. While we do not yet know enough to make absolute pronouncements, we are learning quite a bit and can make some informed decisions.

Some facts:

1.Myocarditis, inflammation of the heart, occurs from many causes, including COVID-19 infection itself. Some 1% of athletes who had mild COVID infections had evidence of heart inflammation when carefully studied, though most of them had no symptoms.

2.The “normal” occurrence of myocarditis in the U.S is about 10 cases/100,000 people/year. Based on studies in Israel and the U.S. military, the incidence in young adults receiving 2 doses of the Pfizer or Moderna vaccines was several times higher than would be expected, albeit still rare. In the U.S. military, 23 cases were reported after 2.8 million does had been given. The CDC reported 196 cases among young adults, 16-24, when 27,000,000 vaccine doses had been given to this age group.

3.To date, most of the reported cases have occurred in adolescent or young adult males and almost all were soon (less than a week) after the second dose of vaccine.

4.Symptoms included chest pain, and most had some combination of elevated enzymes showing heart muscle damage, minor ECG abnormalities and abnormal heart scans. Virtually all the reported patients had mild illness, with good recovery in about 4 days with a variety of treatments or with no treatment.

The Advisory Committee on Immunization Practice has strongly advocated that the vaccines’ benefits for adolescent males exceed their risk, and this is probably true. The benefits of vaccination do outweigh the risk, even in this select group, but how vaccination is done can take the myocarditis risk into account.

One could argue that healthy young males might prefer to receive the J&J one-shot vaccine, in which this condition has not been reported. I would also argue that young males who have recovered from COVID-19 could be considered safely immune after a single rather than both doses of the m-RNA vaccine and thus avoid the second dose that seems to be the trigger.

Stay tuned. I am sure we will learn more.

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Sunday, June 27, 2021

It is not all someone else's fault!

As regular readers of these posts know, I think that all parties in the U.S. healthcare “non-system” overcharge for what they do, and often under-deliver. While hospitals, insurance companies, the pharmaceutical industry and many doctors clearly contribute to our excess spending, the under-performance of the U.S. in health outcomes is largely not their fault.

Most public health experts agree that 75-80% of a nation’s health is the result of factors other than the quality of its hospitals and doctors. Things such as housing, travel, air and water quality and poverty are much more important to our life expectancy. Also outside of the control of the healthcare system are our personal behaviors.

This post was prompted by a recent study out of Michigan looking at the modifiable risk factors in patients found to have advanced coronary disease. We know that beyond age, major risk factors for coronary disease include cigarette smoking, hypertension, hyperlipidemia, diabetes and obesity. Almost all (95.5%) patients undergoing angioplasty had one or more of these risk factors, and half had three or more. Current smokers presented a full decade earlier than non-smokers and obese patients four years younger than those at normal weight with their advanced coronary disease.

These findings dovetailed nicely with a 2018 study in the journal Circulation. That study looked at five factors almost entirely in our control: a healthy diet, not smoking, modest or no alcohol use, regular aerobic exercise and keeping a healthy weight. Doing more of these things resulted in fewer cancers, fewer heart attacks and longer lives. They calculated that a 50 year old woman who did all five of these things right would live 14 years longer than a woman who did none; a 50 year old man who was 5/5 would live 12 years longer than one who did none.

So, get off that couch, put down the remote and the chips and get out there!

To quote William Shakespeare, "The fault, dear Brutus, is not in our stars, but in ourselves.."

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Saturday, June 12, 2021

The FDA Fails

On June 7, the U.S. Food and Drug Administration (FDA) over-ruled the advice of its own expert advisory panel and approved for sale Biogen’s aducanumab, a manufactured monoclonal antibody that will be marketed as Aduhelm, for the treatment of Alzheimer’s disease (AD). Since then, at least three of its experts have resigned from their advisory roles in protest. The drug, which requires monthly IV infusion, will be priced at $56,000 per year.

The stock market certainly applauded the FDA decision: Biogen’s stock price rose 38% on the day of the announcement. The Alzheimer’s Disease Association took out a full page ad in the Wall Street Journal applauding this “breakthrough” approval. The response of the medical community has been much more muted, with a majority of experts who treat dementia urging caution in its adoption.

Why the sharp difference? Amyloid, an abnormal protein made of clumps of naturally occurring proteins, is a hallmark pathologic finding in the brain of patients with AD. Whether it causes AD or is simply a marker is unclear. A variety of similar drugs have been tested over the years and while many have reduced the amount of amyloid in the brain, none have produced any clinical benefit.

Biogen sponsored two trials of aducanumab and both were stopped by their steering committees because no benefit was seen. Biogen then reanalyzed one of the trials and did show some benefit. Despite the claim of “breakthrough,” even the benefit found by Biogen’s scientists was at best modest. The difference in a score of AD severity between treated and untreated patients was 0.39, on a scale of 0 to 18 – statistically significant according to Biogen but hardly overwhelming.

Additional concerns raised by objectors were that 1% of patients receiving the active drug had major side effects, primarily due to the brain swelling that occurs early in treatment, and this was in the setting of a clinical trial, with very close patient monitoring and dose adjustments made based on brain imaging – conditions unlikely to be met in the real world. Finally, patients in these trials were very carefully selected, with mild AD and with specific findings in the brain on PET scans, scans not covered by Medicare or most health insurers.

AD is such a devastating illness, with tragic impact on both the sufferers and on their caregivers, that I fear the pressure on physicians will be overwhelming to prescribe aducanumab to every AD patient for want of any good alternatives. This is likely to harm more patients than it helps. It will also add to the already enormous cost burden faced by patients and their families, as the cost of the drug is unlikely to be paid by many commercial insurers and no insurer will pay for the associated scan costs.

The FDA’s role is to protect the public from pharmaceutical companies’ natural desire to market products on which they have spent huge amounts of development and testing money. In the case of Biogen, the FDA has failed the public.

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Monday, June 7, 2021

COVID-19: animal origin or lab leak? Which is true? Does it matter?

There is one thing we all agree on: COVID-19 originated in Wuhan, a major industrial city in China, and spread from there around the world. What is still being hotly debated is whether the virus causing COVID-19 crossed over to humans from bats, probably via an intermediate host such as the pangolin, or whether it originated in a Chinese virology lab and accidentally escaped.

What do we know with reasonable certainty?

1. Previous coronaviruses, including those responsible for SARS and MERS, followed the animal-to-human route.

2. The Wuhan Institute of Virology has done extensive research on bat viruses, including coronaviruses and could have created this variant.

3. The World Health Organization (WHO) expert panel that concluded that the animal-to-human model was most likely did not have full access to all the data they requested.

So: lab leak or animal to human transmission? On-going studies of the virus’ genome may push the evidence one way or the other but will almost certainly not be 100% conclusive.

I contend that while it will give China a huge black eye if the lab-leak hypothesis seems most likely, because they have stone walled the investigation, in the end it really does not matter all that much. How can I say that when the media are so obsessed with the issue?

A. In either scenario, most experts agree that the safety protocols at the Wuhan Institute of Virology were not adequate, and this may be true at other labs around the world that study dangerous infectious agents. Going forward, an independent body should be empowered to inspect all labs in all countries that are studying infectious agents. Do you want a biohazard lab in your city that does not meet the highest safety standards?

B. Even if this particular virus did escape from a lab, we know there are literally thousands of nasty viruses in animal hosts around the world that have the potential to cause the next pandemic at any moment.

The lessons we should take from the COVID-19 pandemic are that we must prepare NOW for the next one, whatever its origin. The WHO must be empowered to go to all countries without limits or preconditions like those imposed by China.

The U.S. must take immediate steps to insulate public health from politics. There is no “Democratic” or “Republican” science, only valid science or bad science. Just as the Chair of the Federal Reserve has the independence to take the long view of the economy, the heads of the NIH and FDA must be able to offer advice based on science rather than political pressure.

Since it is not a question of if we will have another pandemic but when, we should start now to prepare by stockpiling necessary supplies and building up a more robust and nationally coordinated public health system. Whether it comes from a bat or a lab, it is out there and we must be ready.

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Tuesday, June 1, 2021

Why medications cost so much

This post was prompted by a short news item noting that even many patients with “good” commercial health insurance saw their out-of-pocket costs for medication rise 15% last year.

As readers of Prescription for Bankruptcy know, the U.S. is a dramatic outlier when it comes to the cost of pharmaceutical products. A RAND study published online January 28 showed that in 2018, prices for drugs in the U.S. were 256% higher than the average in 32 OECD comparison countries – 2 ½ times as expensive! This was driven by the cost of brand-name drugs, as our generic prices were slightly lower.

Why are drug prices in this country so high? The major reason is that the pharmaceutical manufacturers can get away with it. Medicare is prohibited by law to negotiate prices and the “middlemen,” the prescription benefit managers, keep most of any price reductions they get.

Brand name manufacturers have developed many strategies to maintain their monopolies, often skirting the law to prevent generic competition. They may make minor tweaks to a product to get an extension of their monopoly or may simply pay generic manufacturers to not make their products.

Big pharma, which usually cites the high cost of R&D to justify their profits, spend more on marketing than on R&D, usually by a wide margin. They bribe doctors to prescribe their products – not overtly, of course, but by sending in attractive young “detail reps” bringing lunch and samples. There is solid data showing this is money well-spent, because even though most doctors may feel they are not influenced by this type of marketing, studies have repeatedly shown they are. Considerable sums are also spent on direct-to-consumer ads to drum up demand for new expensive products.

Do high prices matter? Yes, as they not only hurt middle income earners badly in the pocket, they also lead to patients simply stopping their medications. Several recent studies have shown high rates of people skipping or stopping important medications and suffering serious health consequences as a result.

What can be done? Major change must begin at a national level. The most obvious step is to allow Medicare to negotiate for lower drug prices. Both the VA system and the Department of Defense do this, so there is clearly no philosophical objection. Since the older we get, the more prescriptions we tend to use, this step would make a huge difference in national health spending.

We can piggyback on the effective drug price strategies our peer countries all use by setting a ceiling on allowable drug prices based on the average price in Western European countries and Canada.

In the meantime, and my cynical side says that the deep pockets of the pharmaceutical industry are likely to thwart or delay any major changes, here are some ideas you can use now.

Always ask your doctor if the medication you are taking is available generically, or if a very similar drug is. For new ultra-expensive biologic drugs, ask about “biosimilars,” very close matches that work as well. If you are using tablets rather than capsules, it is often much less expensive to get a larger strength tablet and cut it. SHOP: the difference in price between different pharmacies can be dramatic.

Finally, if you or a family member are taking many drugs, ask your primary doctor to review them and see which you may be able to stop. This can be good for your health as well as your pocketbook.

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Tuesday, May 25, 2021

OK, what's the skinny on masks?

The CDC recently announced that fully vaccinated people could do away with masks indoors and out (with limited exceptions). If the change in advice has left you uneasy and confused, you are not alone. Many infectious disease and public health experts experienced a bit of vertigo after hearing this news. I would like to make things as simple as possible for you.

A few facts (and while everyone is entitled to his/her own opinion, they are not entitled to their own facts):

1. Vaccinations are extremely effective at preventing serious illness and death and very effective at preventing even mild illness and transmission of Covid-19 to others.

2. Masks, while not nearly as effective, cut down viral transmission.

3. Transmission is much more likely indoors than outdoors.

4. People with immune deficiency, from disease or immune-suppressing drugs, may not respond as well to vaccination.

So, what should you do? The easy ones first:

1. Masks are still required for all people on planes, buses, trains, and other forms of public transportation traveling into, within, or out of the United States and in airports and stations.

2. Masks are still recommended (and may be required) for anyone visiting a healthcare setting, correctional facility or homeless shelter.

3. You can safely forget the mask for all outdoor activities (unless you are packed like sardines with strangers).

4. Omit the mask indoors when everyone is fully vaccinated and/or from the same household or when you are unlikely to be close to others for an extended time.

More problematic is what to do when you are indoors in close quarters, such as having a haircut or manicure or sitting very close to strangers, as in a packed theatre. You are probably safe, but if you feel more comfortable and/or want to help protect others who may not be vaccinated, go ahead and wear your mask – there is certainly no harm in doing this.

If you have a disease likely to leave you with a weakened immune system such as cancer, or if you are taking immunosuppressive drugs, you should ask your doctor to have your antibody levels checked. There have been many reported cases of fully immunized people in these categories who have no detectable response to vaccination. (Note that many DO get protection, and there is no harm in getting vaccinated, but the response is not as predictable.)

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Saturday, May 22, 2021

What's new in Alzheimer's disease?

Dementia is a huge and growing problem. An estimated 50 million people around the world suffer dementia, with Alzheimer’s disease the most common cause. It is estimated that some six million Americans are living with Alzheimer’s disease. The impact on the person with dementia is exceeded by the impact on their family, as the enormous care-giving needs are rarely covered by health insurance.

While there are genetic factors (particularly the APOE4 allele) that increase one’s risk of developing AD, and a rare familial form that occurs in younger people, the major risk factor is age. While rare in young adults, dementia occurs in some 10% of adults over 80. Thus, as we live longer, the incidence of AD will inevitably rise. The diagnosis of AD remains clinical. While all primary care clinicians should be able to detect dementia, a specialist should be consulted at least once to confirm the diagnosis and try to distinguish AD from other less common causes of dementia.

In 2021, the laboratory plays little role in routine care. After a new diagnosis of dementia, both serum vitamin B12 levels and a test of thyroid function such as TSH should be done. While uncommon, both B12 deficiency and an underactive thyroid can cause dementia and are easily treated. Some form of brain imaging should also be done to look for uncommon but surgically treatable conditions.

There is a growing interest in new diagnostic tools including advanced brain imaging techniques such as PET scans and measuring specific proteins in the spinal fluid, but Medicare does not pay for these expensive tests and their use is generally confined to clinical trials. On the horizon are blood tests that may confirm a diagnosis of AD.

To date, treatment of AD has largely been limited to a class of drugs called cholinesterase inhibitors that improve transmission of nerve impulses. The first, donepezil (Aricept), was approved by the FDA in 1996 and was soon followed by rivastigmine and galantamine. A different type of medication, memantine, targets glutamate, another “neurotransmitter.” None of these drugs cure AD but they do slightly improve symptoms and will often allow the sufferer to be able to avoid the need for nursing home care for several months longer.

Despite immense amounts of research, no new drugs for AD have been approved since 2003. Many promising candidates showed no benefit or even worsening. Recently there has been an explosion of research on a new class of drugs called monoclonal antibodies that target the pathologic markers of AD in the brain: proteins called tau and amyloid-beta.

This post was prompted by a full page ad in the Wall Street Journal from the Alzheimer’s Association calling on the FDA to approve one of these new agents, aducanumab, based on a trial reporting a 22% reduction in decline compared to placebo. I also found a more recent trial of another monoclonal antibody, donanemab, that also reported positive results.

Delving into these trials showed several factors that gave me pause. The first was the very small group that were entered into the trials after screening. The donanemab study began with 1955 people 60 to 85 with mild dementia, but entry required specific findings on PET imaging and in the end, only 272 were entered into the trial. The generalizability of the study was thus clearly limited when thinking of the broad group of people suffering dementia. Secondly, while there was a “statistically significant” difference in a score evaluating AD severity, the absolute difference was only 3.2 points on a score that ranged from 0 to 144. Hardly a “miracle.”

The data on aducanumab similarly showed an absolute difference of 0.39 on a different scoring system that ranged from 0 to 18, and this was in one of two studies, the other showing no benefit. Almost 1% of the patients receiving aducanumab had major side effects.

This class of drugs clearly warrant further study, but delaying their approval for general use seems prudent. While they have been shown to be of some modest benefit in a carefully selected subset of patients, FDA approval would almost certainly lead to an explosion of use in patients who were not studied in the trials and who might as likely be harmed as helped.

In the interim, some lifestyle changes have been shown beneficial and are both safe and free: regular aerobic exercise (walking), diet rich in leafy greens and flavanols (berries, nuts), staying socially active and trying to learn new things.

We should also be pressuring the federal government to do more to assist caregivers and improve payment for such things as adult day care and home health aides.

I am optimistic that within a few years, we will have both better and less invasive ways to diagnose Alzheimer’s disease and better treatments.

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Wednesday, April 28, 2021

"Long Covid:" does it exist? What is it?

Hopefully most of you realize that Covid-19 is not “just like the flu.” The death rate is much higher and there are many more complications involving other organ systems, including blood clots. As we (hopefully) dig our way out of the pandemic thanks to vaccinations and see fewer desperately ill patients on ventilators and many fewer deaths, another issue has been getting attention. Many people who have recovered from the worst of the illness, and many who had only mild symptoms or none are complaining of on-going problems.

The medical profession does not yet understand the cause of these symptoms, and there is vigorous debate over whether the complaints are psychosomatic or physical. The NIH plans to fund research into Covid “long-haulers,” but that research is unlikely to answer our questions in the near future.

The issue is two-fold: persisting symptoms in those who were seriously ill and new symptoms in those (often younger people) who had no or only mild symptoms when infected.

It is not surprising that the sickest Covid-19 patients, those hospitalized, remained sub-par for many weeks or months. An Italian study looked at 143 patients 60 days after onset of illness and 36 days after hospital discharge and found that only 12% felt back to normal. Half still complained of fatigue and shortness of breath and a quarter had joint and/or chest pain. A Swedish study found that among patients needing ICU care, over half still had abnormal lung function four months after discharge. A French study contacted 478 patients who had been admitted to a university hospital for Covid, also four months after discharge, and found that half had at least one complaint not present pre-Covid. Those who complained of shortness of breath were offered a chest CT scan and 61% of these showed persisting abnormalities.

We can hope that time will resolve or at least lessen these persisting symptoms.

More difficult to understand are the new complaints in patients who were not seriously ill.

A Swedish group looked at 323 health care workers who had serum evidence of Covid but had not reported symptoms. Compared to their co-workers with no evidence of prior infection, 5 times as many (15% vs 3%) had at least one moderate or severe complaint 8 months or more after their exposure. In Mexico, researchers looked at 115 patients with mild symptoms and a positive PCR who recovered at home with no treatment; 30 days after the positive test, some 60% had persisting fatigue and shortness of breath. In California, of 1400 patients with a positive PCR and minimal symptoms, 27% studied 60 days later reported symptoms. The symptoms in all of these groups included chest pain, cough, shortness of breath, joint pain and impaired thinking (“brain fog).

While skeptics might say these were all due to anxiety, there is evidence of very “real” and very severe illness coming after infection with the coronavirus. In Singapore, where the virus spread rapidly among “guest workers” from other Asian countries, there was mass testing. Researchers there reported a series of strokes in young (mean age 41) men who had positive Covid antibody testing but had never experienced obvious illness. A larger study in the U.S. used electronic medical records to compare patients diagnosed with Covid-19 with a matched group who had been diagnosed with flu or other respiratory illnesses at six months after diagnosis. The Covid patients had 2.5 times as many brain hemorrhages, ischemic strokes and new diagnoses of dementia. They also found higher numbers with insomnia, anxiety, psychosis and substance use disorders.

What is “long Covid?” The only honest answer is that at this point we really do not know. One theory is viral persistence. Another is auto-immunity. Favoring the former are reports that many patients with persistent symptoms report marked improvement after vaccination. Favoring the latter is that women are disproportionately affected, and we know that women have more auto-immune disorders than do men. And yes, some of the symptoms may be psychosomatic. Having a scary illness would tend to make one focus on bodily symptoms.

What can we do?

If you are a physician, I would ask you to maintain some humility and remain open-minded about an illness still under study. Do not dismiss the complaints as being due to anxiety.

If you have persisting symptoms and have not been vaccinated, I would encourage you to get the vaccine, as patients with mild or no symptoms are at risk of reinfection and many of your fellow sufferers have improved after vaccination.

If you have never had Covid, take this as one more reason to get a vaccine as soon as you can.

All of us: stay tuned!

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Tuesday, April 13, 2021

J &J Vaccine "paused." Should you worry?

The news media and our email in-boxes this morning were filled with the news that the CDC had recommended a pause in use of the Janssen/Johnson & Johnson Covid-19 vaccine pending investigation of six reported cases of an unusual illness that occurred following its use. Of the 6.8 million doses given in the U.S. to date, 6 women aged 18 to 48 had developed severe clotting disorders along with low platelets. [Platelets are the body’s first line of defense against bleeding, and you expect low platelet counts to be accompanied by bleeding, not clotting.]

This mirrors the concerns raised earlier in Europe about a similar illness that followed use of the AstraZeneca vaccine, leading many European countries to stop using it or to restrict its use to older people, since there, also, the rare illness was reported in younger people only. In Great Britain, which has given more than 20 million doses of the AZ vaccine, there have been 79 cases of blood clots associated with low platelets. In two papers published in the New England Journal of Medicine, 13 of 16 patients described were women, and their ages ranged from 22 to 54, with most being in their 30’s.

The common thread seems to be that both the AZ and J&J vaccines share similar technology, using harmless adenoviruses to get Covid spike protein code into human cells to produce antibodies. This is different than the mRNA technique used by the Pfizer and Moderna vaccines, which to date have not been linked to this rare disease.

Is there any similar disease unrelated to vaccines? There are two. A condition called TTP (thrombotic thrombocytopenic purpura) occurs at a rate of about 3 people per million per year, is commoner in women and has an average age of onset of 41. While this disease has clotting, the clots occur in very tiny vessels, unlike the vaccine-associated illness. Much more similar is HIT (heparin-induced thrombocytopenia). This disease, caused by an immune reaction to the blood-thinner heparin, occurs in some 2% of patients receiving heparin and is commoner in women, but tends to occur in older individuals, being very rare in people under 40. This does cause the type of clotting now being reported. Our best guess at this point is that the vaccine-associated illness is caused by an immune reaction like HIT, albeit to what is still unknown.

What are the important things you should know?

1. This is a rare side-effect if it is indeed a side effect, occurring in 1 to 4 people per million.
2. There is no reason to believe that it would happen with the Pfizer or Moderna vaccines.
3. It has so far only been reported in younger vaccine recipients, predominantly women.

What should you do?

1. If you have a chance to get the Pfizer or Moderna vaccine, get it!
2. If you are over 65 and have the choice of the J&J or AZ vaccine or no vaccine, I would personally take the vaccine.
3. If you have recently had the J&J or AZ vaccine, relax. You are VERY unlikely to have this illness happen to you.

Remember that all medications have side effects. It is your doctor’s job, working with you, to decide if the benefits exceed the risks of any medication you may take.

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Sunday, April 4, 2021

You can teach an old dog new tricks!

Colchicine is one of the longest-used remedies in the modern medical armamentarium. It was mentioned in the Ebers Papyrus, dating from Egypt in 1500 BC, and its use to treat gout was described by the ancient Greeks. It is derived from the autumn crocus, scientifically named Colchicum autumnale. The active ingredient was isolated in the early 1800’s and it has been widely used to treat gout ever since.

When I was a pup, the dictum was to treat an acute gout attack by taking one colchicine tablet every hour until either the gout was resolved or the diarrhea was so bad that the patient did not care about the gout. In the intervening years we have learned a much more civilized approach. Lower doses work just as well and have much less GI side effects.

Readers of Prescription for Bankruptcy know that colchicine is also a sordid example of pharmaceutical company greed, with this ancient remedy manipulated into becoming a high cost branded product.

My focus here, however, is to note that this “one trick pony,” which 50 years ago was considered as useful only to treat gout has become a hot new product, with a rapidly expanding portfolio of uses.

Amazingly for a product of this lineage, the exact mechanism of action of colchicine is still being studied, but it clearly has strong anti-inflammatory properties, and works to reduce the effects of the body’s white blood cells. It is this anti-inflammatory property that is being exploited to treat a broad and growing range of diseases. The first new use was to treat a rare disease, Familial Mediterranean Fever, a disease whose victims suffer repeated attacks of fever, joint and abdominal pain, and many of whom go on to develop chronic kidney failure. Two trials published in 1974 showed that colchicine could dramatically reduce the frequency of acute attacks, and it was later shown that it largely prevented the kidney disease.

A variety of rare skin diseases characterized by local inflammation also respond to colchicine. More recently, colchicine has shown the ability to reduce recurrences of pericarditis, a non-fatal but very painful inflammation of the sac surrounding the heart.

As most of you know, the leading cause of death in the U.S. and most western countries is coronary disease. While we tend to simplistically think of heart attacks as caused by build up of cholesterol deposits in the coronary arteries, inflammation has long been felt to play a part. It is thus not surprising that several trials have looked at the effect of colchicine on heart attack. Two large trials, one in patients who had recently suffered an acute heart attack and one in patients with stable coronary disease found that daily low-dose colchicine reduced the risk of heart attacks, stroke, coronary surgery and cardiovascular death. Before we anoint colchicine the Fountain of Youth, it must be noted that overall death rates were not reduced, and may have even been a bit higher, in the colchicine group than in those taking placebos.

Finally, it would be remiss in 2021 not to note the potential role of colchicine in the fight against Covid-19. You may be aware that cortisone-type drugs, which have an anti-inflammatory effect, have been proven to improve outcomes in very sick Covid-19 patients, so a trial of colchicine was obvious. A small trial done in Brazil at the beginning of the year gave colchicine or placebo for 10 days to 72 patients hospitalized with Covid-19. Those given colchicine had shorter time in the hospital and less need for oxygen. While the small size of the trial prevented conclusions about the effect on survival, the only two deaths were in the placebo group.

A much larger trial was conducted by a group from Montreal. They studied 4159 patients not sick enough initially to be hospitalized. Half were given 0.5 mg of colchicine 3 times daily for three days and then once daily for another 27 days. Since this was a less sick group, the absolute numbers were not high in either group, but the patients given colchicine had reduced rates of needing to end up in the hospital, require a ventilator or die.

Just because a drug has been around for a long time, it can still be very useful, and there are always new things to learn about it.

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Tuesday, March 16, 2021

Vaccines and clots: Is it a worry?

Recent headlines announced that European countries have halted use of the AstraZeneca Covid-19 vaccine because of fears that it causes clots. This was first done by Norway and Denmark, and more recently they were joined by Germany, France, Italy and Spain. The basis for this decision was the report of 37 clotting illnesses among some 17,000,000 people who had received the vaccine. The conditions reported were 15 people with clots in the legs (deep venous thrombosis, or DVT) and 22 with clots that had travelled to the lungs (pulmonary embolism, or PE).

Is this a rational decision? To help you think about it, you must realize there is a difference between correlation and causation. Let’s say you wash and polish your car and it rains, or a bird deposits its droppings on your windshield. Did the act of washing your car cause it to rain or motivate the bird to alter its flight path? Probably not. Or postulate that in years in which the American League team wins the World Series, the stock market goes up. Would you put all your savings in the market when the Red Sox win a World Series (if they ever do again)? I hope not.

Vaccines prevent or at least dramatically reduce the incidence of the infection against which they are targeted. They do not confer immortality or prevent unrelated illnesses (or make you taller, smarter or better looking).

How common are clotting diseases in general? Best estimates are that DVT and PE occur in about 1 person in a thousand per year. These conditions are very rare in children and get commoner as we age. This means that if you were to follow 17 million Europeans for a year, you would expect 17,000 cases of DVT and PE. Let’s be very cautious and estimate that of the vaccinated population, only an average of two weeks had passed since they were vaccinated. This would lead you to expect 654 cases to occur (17,000/26). I could argue that the numbers suggest that the vaccine protects against clotting rather than causing it. I will not, but I will argue that stopping vaccination based on a fear of clotting is irrational and dangerous.

Israel leads the world in vaccination, having administered 106 doses for every 100 people in the country. (They are using the 2-shot Pfizer vaccine.) They have also seen a halving of new cases in the past month. The larger European countries have been near the back of the pack in vaccine administration and are now seeing a spike in cases and imposing new lock downs. Which strategy would you prefer?

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Saturday, February 20, 2021

Tell me about these new vaccines

In February 2021, the only Covid-19 vaccines available in the United States are the very similar mRNA-based vaccines from Pfizer and Moderna, both of which were reported to be 94-95% effective at preventing symptomatic Covid-19 in study participants who got the vaccine. A “real world” test, following the results of vaccinated people in Israel, has reassured us that the trial results were valid. Among 600,000 people who got the Pfizer vaccine, there was a 94% drop in symptomatic cases, only 4 severe cases and no deaths.

The problems with these vaccines are that there is simply not an adequate supply to vaccinate everyone in the U.S. soon enough, and that the price, need for two shots and the logistics of storing and transporting the vaccines limit how widely they can be used. Given the interconnectedness of the modern world, mass vaccination of the entire planet will be needed before any of us are truly safe. Happily, many other vaccines are well along in development.

A vaccine from Johnson and Johnson is closest to getting emergency use authorization in the U.S. This vaccine uses an adenovirus, a generally harmless virus, modified to carry the gene for the Coronavirus “spike protein” into human cells, which then produce this protein, which induces our immune system to recognize and fight off Covid-19 if we are exposed to it. This vaccine has many desirable qualities: it only requires one shot and it can be stored for months at normal refrigerator temperatures, making it much easier to distribute and administer.

You may have seen headlines indicating that it was only 66% effective at preventing symptomatic Covid-19, well below the efficacy of the mRNA vaccines. To some degree this is not a fair “apples to apples” comparison. The J&J vaccine was tested later than the mRNA vaccines, and it was tested in South America, Mexico and South Africa as well as in the U.S., while the Moderna vaccine was only tested in the U.S. The J&J shot thus had to contend with the new strains of virus, and we now know that the mRNA vaccines are less effective against these new strains than the original Coronavirus. Importantly, the J&J vaccine was 85% effective at preventing severe Covid-19, and there were no deaths in the vaccinated group.

Another candidate on the near horizon is from U.S. biotech firm Novavax. This vaccine combines a protein mimicking the virus’ spike protein with a “adjuvant,” a non-specific immune system stimulator. Preliminary trial results have shown 95% efficacy against the original SARS-CoV-2 virus and 86% against the B.1.1.7 (British) and 60% against the B.1.351 (South African) variants. Trials have been done in Great Britain and South Africa, and the vaccine requires two shots, 3 weeks apart, and can be stored at normal refrigerator temperature.

The Russian “Sputnik V” is another two-shot adenovirus-based vaccine. While the Russians were criticized for rolling out the vaccine before testing was complete, the preliminary trials have shown a 92% efficacy at preventing symptomatic Covid-19. Efficacy was similar across all age groups, and there were no severe cases in people who received both shots.

The Oxford/Astra Zeneca vaccine uses a modified adenovirus with DNA coding for the spike protein to generate an immune response. It got a lot of bad press when preliminary results showed better protection in those who had mistakenly gotten a lower dose than planned for their first dose followed by the planned second dose. This did not make biologic sense and put the trial into question. The larger trial has now shown 76% efficacy after one dose and 82% after a second. There were no Covid-19 hospitalizations in the vaccinated group. The vaccine has been approved for use in the United Kingdom.

Which vaccine should you get? To answer that question requires you to grasp one crucial fact: there have been essentially NO DEATHS from Covid-19 in people who got any of the available or soon to be available vaccines. We are not going to “wipe out” Covid-19. There have been and will continue to be coronaviruses circulating among us. What we need to get life back to normal is to eliminate deaths and markedly reduce hospitalizations from the SARS-CoV-2 virus. If Covid-19 can become just another cold that we catch and get over, we can go back to eating out, attending concerts and hugging each other.

So: take which ever vaccine you are offered!

Wednesday, February 3, 2021

A "cure" for Covid-19?

When a new disease appears, doctors must try unproven remedies based on things that “might” work, based on test tube data or what seem like logical extrapolations from similar conditions. As time goes on, better data allows them to change their approach. In an ideal world, all therapeutic decisions are based on scientifically valid trials in which different therapies are compared in similar patients, the so-called “controlled clinical trial.”

When Covid-19 swept the world, there was no proven therapy, and patients were dying. A variety of remedies were tried and, in some cases, seemed to work. These results were posted on-line and rapidly adopted even when the evidence was sketchy. We now have good trials of many different agents, and I can summarize by saying that none of them are a magic bullet.

First out of the gate: hydroxychloroquine, an anti-malaria drug that is also used to treat lupus, and which appeared to have anti-viral effects in the test tube. KILL IT! Put a stake through its heart! There are now good trials that show that hydroxychloroquine has no benefit when used preventively in health care workers or spouses of Covid-positive patients or in moderately ill patients. A World Health Organization-sponsored trial in hospitalized patients found higher mortality in patients receiving the drug.

On the caveat emptor front, I saw a news item recently indicating that the state of Oklahoma is trying to get the wholesaler to take back 1.2 million hydroxychloroquine pills the governor insisted on buying, none of which were used. (This is the same governor who has refused calls for a mask mandate.)

Next up were antibodies, the chemicals our immune system makes to help fight off invading microorganisms. The whole basis of vaccines is to get the body to produce these antibodies before it is invaded by the virus, so that we can promptly mount a defense. It made sense to give transfusions of plasma from patients who had recovered from Covid-19 and who had high levels of antibodies to the virus to patients now sick, Like many things that “make sense,” giving convalescent plasma to hospitalized patients was of no benefit. A well-conducted trial in Argentina did find that this treatment given to older adults within 72 hours of their developing mild symptoms cut in half the number who went on to develop severe disease (16% vs 31%).

We have also seen trials of synthetic, laboratory-produced antibodies. Using these avoids the risk of infusing plasma from possibly unmatched donors and having a transfusion reaction. A “cocktail” of bamlanivimab plus etesevimab given to patients with mild to moderate disease showed a modest reduction in the amount of virus excreted and reduced the combination of ER visits plus hospitalizations from 5.8% to 1.5%. There were no deaths in either group. Another synthetic antibody, toclizumab, given to sicker patients who needed oxygen, showed no benefit and a trend toward worsening.

How about vitamins? These have the great virtue of safety. One trial of IV Vitamin C shortened hospital stays but had no benefit in reducing deaths or the need for ventilators. Vitamin D has had a lot of buzz, largely because of published data showing that patients deficient in Vitamin D were more likely to die. My take on this is that low Vitamin D levels are a marker of poorer overall health. There is no evidence that low Vitamin D patients are more likely to catch the coronavirus, but they are more likely to die, as are frail elders and those with other serious diseases. No trials have shown benefit from giving Vitamin D, but it clearly falls in the category of “it cannot hurt,” and I would support routinely giving it to patients. Note: one newly published study found that a single large oral dose had no benefit.

The one FDA-approved treatment for Covid-19 is remdesivir, an anti-viral drug. Patients receiving it showed fewer complications and less need for ICU care, but there is little mortality benefit.

For decades, doctors have used cortisone-like drugs as a “hail Mary” treatment for severely ill patients with a variety of conditions. These are potent anti-inflammatory agents, and the sickest Covid patients seem to have an over-reaction of the body’s inflammatory system, so again it “made sense.” The best evidence we have is that use of corticosteroids reduces mortality in very sick patients but increases mortality in less sick patients. The best guidance we have suggests that patients who require oxygen or ventilators to breath should receive these drugs while they should be avoided in the majority.

The latest on the scene, and a spin on the anti-inflammatory angle, is colchicine. This ancient drug has been used for centuries to treat gout and more recently to treat other inflammatory diseases such as pericarditis. A large well-controlled Canadian trial showed that giving oral colchicine to non-hospitalized patients with proven Covid-19 reduced the combined endpoint of hospitalization or death from 6% to 4.6%. The only adverse effect was increased diarrhea in the colchicine group, which is a known side-effect of the drug.

My main takeaway? Don’t count on cure. Prevention is much better. Get vaccinated as soon as you can – any vaccine is better than none – and continue to wear a mask and practice social distancing.

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Sunday, January 17, 2021

The virus mutates

The Boston Globe sent out a flash bulletin, clearly intended to worry its readers: “State health officials Sunday announced the first case of a more transmissible COVID-19 variant involving a Boston woman who developed symptoms after returning from the United Kingdom earlier this month. The woman, who is in her 20s, had traveled to the UK and became ill the day after she returned to Massachusetts, the department said.”

Be afraid. Be very afraid! Or not?

A key point to remember is that viruses mutate, particularly RNA viruses like the coronavirus and influenza virus. You are urged to get an annual flu vaccination not because your immunity has disappeared since last year’s shot but because the virus that circulates each winter is usually different than the one infecting people the prior year.

Mutations occur frequently; whether they become the prevailing strain depends on whether they give the mutated virus an advantage over the existing strains. Mutations that allow the virus to spread more easily, to reproduce faster or to be harder for the host immune response to destroy will have a selective advantage and soon become the dominant strain. Early in the pandemic, a mutation in the part of the viral RNA coding for the spike protein emerged and soon became the major strain. This was later found to be due to its higher transmissibility. The outbreak in Danish mink was due to a mutation that allowed the virus to better attach to receptors in the animal’s respiratory tract.

The most recent concern has been a new variant, called B.1.1.7, that appeared in the United Kingdom and which rapidly became common there. By the end of December, this strain had gone from undetected to causing 28% of all cases in the kingdom. Its “selective advantage” is clear: it spreads 56% more rapidly than the original strain. Similar but different mutations have been found in South Africa and Brazil, but as of this date seem confined to those countries.

The “UK strain,” however, has been detected in small numbers in at least 10 U.S. states as of Friday according to the CDC – and now 11 per the Globe report.

First the good news: this strain, while it spreads more rapidly, does not appear to cause more severe disease. Another piece of good news is that small studies done by Pfizer found that the neutralizing antibodies produced by their vaccine work on the B.1.1.7 variant virus.

The bad news is that because this variant spreads more easily, it is likely to become the dominant strain in the U.S. by March, and the increased transmissibility may lead to many more cases.

What does that mean for us? It adds urgency to the need to get as many people vaccinated as possible, and it means we cannot let down our guard. Basic hygiene measures: masks, social distancing, isolation and quarantine and hand washing must be maintained until a large majority have been vaccinated. So, don’t be afraid, but be sensible and cautious.

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