Consulo Indicium - 6/22/21

Information for your Consideration… 

The Controversy of the New Alzheimer’s Drug – I follow the Alzheimer’s saga with some interest. My Mom passed away this past year after almost a decade long journey through the ever-darkening tunnel of Alzheimer’s. On Friday, June 7th the FDA made a critical decision to approve the drug Aduhelm that is focused on use during the early stages of the disease when patients suffer from mild cognitive impairment. The major difference of this drug compared to prior submissions is that the focus of the treatment is on actual brain function rather than just the symptoms and, represents the first new Alzheimer’s treatment since 2003.

Solving the Alzheimer’s problem is a big deal. There are at least 6 million patients with Alzheimer’s and the number is anticipated to double over the next 30 years. The approach of the new medication is also quite unique amidst a growing field of drugs using the technique to solve various problems. It is a monoclonal antibody or, protein made in the lab that binds to the proteins causing the Alzheimer’s. Those proteins are the clumps of amyloid beta which researchers believe is the cause for damage to the brain. In essence, the drug triggers an immune response that removes the plaques.

The problem is that data presented from the clinical trials – by some accounts – was not up to snuff! In fact, the FDA advisory committee recommendation was against approval. The committee also approved a formal letter of criticism of the FDA findings in a rare admonishment of staff work. The data shows that there is a slowing of the disease’s advance, but resolution does not seem to occur. So, the question remains: Should we be spending billions on a drug that in the end does not resolve the problem? The nonpartisan Kaiser Family Foundation has estimated that of the over 6 million new Alzheimer’s patients we can expect in the coming decade if only 1 million were approved for use of the drug – the total cost to Medicare would be $57 billion annually or, about $20 billion more than was spent on all drug coverage under Medicare Part B in 2019.

The nation is currently at 18.5 – 19+% of GDP allocated for health care. These types of questions are moving to the forefront and we – as health care providers – need to consider the implications of expenditures on the greater health care investments. After all, there is only so much money available to support societal needs. I’m a big believer in health care as a right but, we also need to be prudent with where we place our bets.

 And, at the end of the day, please be aware that these thoughts are coming from someone who watched helplessly as his Mother descended into the abyss of Alzheimer’s. It’s the worst disease…

More Shots In More Arms Sooner Is Not Enough – A recent issue of The Economist posted a lead article entitled “Vaccinating the World”. I find that the magazine/quasi journal provides some of the most thought-provoking analysis on issues facing the world. They conducted data analysis of 121 variables associated with death in an effort to determine the true impact of Covid-19 on nation-states. Their model suggested that we have experienced worldwide between 7.1M – 12.7M deaths compared to cumulative reported death of about 1/3 of the model’s numbers. So, the nation-states are not reporting or perhaps simply not recording deaths. In places like India it’s quite likely the latter since that nation is experiencing about 20,000 deaths per day.

The answer that has been proposed by the Biden Administration and others is to accelerate jabs into arms. With the cost of jabs running about $4 for a two-dose course, basic economics suggest this is a good idea. The answer put forward by Biden has been to propose a waiver of intellectual property claims for the Covid-19 vaccines. What The Economist points out; however, is that the arduous process of the World Trade Organization for granting and implementing such a system will take at least six to twelve months – far too long to help with the problem of a looming crisis in the non-rich countries of the world. Not only is India bad but, Romania, Eran, Egypt, Peru, Pakistan, Nepal and others around the world are experiencing real-time tragedies. Another 6 – 12 months of waiting will not even come close to helping those countries. Then, there is Africa where the Covid-19 problem is coming to the fore. If we think those countries I mentioned above have a problem, wait till Covid-19 gets a grip on Africa – the poorest continent economically in the world.

Now, I’m not suggesting that accelerating vaccine production is not a good idea. In fact, the industry has done a great job (my perspective) in producing doses (= 1.7bn doses) where the total vaccine production capacity prior to the pandemic totaled 3.5bn. Don’t get me wrong! Vaccine production is good. But…we need to get ahead of the curve.

To date, there has been no formal proposal for a worldwide Universal Disease Monitoring and Management System (UDMMS). Fashioned after the CDC, it would be responsible for worldwide monitoring of diseases. In the short-term, it should focus on pandemics and other transmissible problems that could affect populations across the globe. Not only does this make sense from the standpoint of pandemic control but also given the onset of global warming, we are seeing the beginnings of insect, fishery, animal and even people migration. I recently spoke with a veterinarian who is a specialist in ticks. He noted that due to global warming, a new species of tick has invaded the US from Mexico and south which has been crossing the border at will (BTW – no wall high enough or thick enough will prevent these ticks from getting through). It is changing the very nature of what types of infections are occurring throughout the Southwest and soon, into the upper Rockies. It’s just one example among many.

Long story short – we need to get ahead of the curve. Vaccinations are for the here and now. The implementation of a UDMMS with appropriate reporting and managing policies for all nations is a course that will help to foster continued economic growth of the global community along with sustaining their health! Now is the time when the lessons are fresh before we forget.

Psst – Pass The Word – A new study was just released and the risk of being hospitalized with the Delta covid-19 variant is roughly double that associated with the original Alpha strain, according to a study published in The Lancet on the Delta variant. It represents essentially a doubling of the risks associated with the Alpha strain which originally spread across the USA. AND, more importantly, the data shows clearly shows that the Pfizer/BioNTech vaccine was 79% effective beginning two weeks after the second dose and the Oxford/AstraZeneca vaccine was 60% effective following the same two week window. This is important news because in a study from Public Health England the infectivity of the Delta variant is 64% MORE infective than the Alpha variant. For more details check out MIT Technology Review for a complete analysis.

The Covid Long Haul Problem – Without getting into a long medical lecture, it is clear that we are at the formative stages of a generic “long haul” problem with those who are recovering from Covid-19. Based on a study coming from the Karolinska Institute in Sweden, the four most common post-Covid-19 problems include loss of smell, loss of taste, shortness of breath, and fatigue. All four appear to be related to invasion of the selected neurologic sensitive areas of the body via the arterioles which supply these areas with oxygenated blood. But, I forewarn you – the theory is only just at the formative stages and may change as we get more data and experience with the problem. Regardless, it is clear that the long-haul problem may be just as significant as the shorter-term acute infection derived from Covid-19. We don’t know the full extent of the problem. What we do know is that careful monitoring and follow-up of previously infected patients will be crucial. And, we should anticipate that the sequalae may not fully exhibit symptomology for years if not decades.

Whoops - World’s Population Is Flattening – The Pew Research Center recently released a new analysis of United Nations data revealing that for the first time in modern history, the world’s population will flatten by the close of the century. Why? You guessed it – falling global fertility rates. There are a couple of key takeaways from the Center’s report:

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  • Global fertility is down and the population will flatten by 2100. In other words, China is ahead of the curve in announcing that it is OK to have 3 children. The call for more children is based on the economic analysis that population growth is a requisite foundation for continued economic growth of a nation. Hmmm – what about the role of robots and machines replacing certain human producing functions?
  • The population – on average – will be getting considerably older moving from an average of 24 (1950) to 32 (now) to 42 (2100) – we’re headed for “Medicare-for-All” anyway so perhaps we should get started now to create a fund balance for the future!
  • North America’s aging population will be offset by continuing immigration. If history is any map for the future, it will likely be immigrants from economically deprived countries (e.g., Irish due to the potato famine, Germans due to the economic devastation from the Bismarck wars, Indians due to highly trained individuals with no domestic job opportunities, etc.
  • More than half of the 3.1bn increase in population is projected to occur in Nigeria, the Democratic Republic of the Congo, Tanzania, Ethiopia and Angola, along with one non-African country (Pakistan). In other words, Africa will be a people-growing place for the remainder of the century even if the pandemic hits them the hardest at the end of the day!

I highly recommend that you read the entire report. It provides valuable insights on the future and where we are likely to see evolving immigration, economic, and societal shifts that will affect us all far beyond the confines of any specific boundary used as a marker by nation-states.

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