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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