A number of colleges have mandated boosters for students returning to campus this fall. There are some points parents, teenagers, and whoever is coming up with policies at colleges may want to consider. Since no one has thought fit to actually generate any clinical data on boosters in college kids because of the continuous state of COVID emergency we have been in since early 2020, we are left to try to extrapolate from a vast amount of ecological data and surrogate endpoints.
While it would be impossible to include every single study ever done on the matter, there is clearly enough data to argue against their being the overwhelming scientific consensus that would be needed to underpin a policy that essentially forces individuals to receive a medical therapeutic.
This is part 2 of David Warmlash’s takedown of Robert W. Malone’s appearance (transcript) on the Rogan podcast. Part 1 is here
Menstruation and Fertility
Much more than the line about reproductive damage in the Wisconsin News clip that we used to open the story, Malone used the Rogan interview to dive more deeply into the topic, starting with:
…there’s a huge number of dysmenorrhea and menometrorrhagia…
By that, he meant excessive menstrual cramping and very heavy, often irregular, bleeding, which he followed up with:
…they DENY it…
Judging by other parts of the interview, ‘they’ means government health agencies, big pharma, mainstream media. Thus, it was quite an accusation, given that, months prior to Malone’s talk with Rogan, the National Institutes of Health (NIH) had announced a program to study COVID-19 vaccination effects in pregnant and postpartum women and then announced, very publicly, that it had awarded $1.67 million to five institutions (Boston University, Harvard Medical School, Johns Hopkins University, Michigan State University, and Oregon Health and Science University [OHSU]) to study vaccines and the menstrual cycle.
Rather than bringing up any of that NIH-funded research, however, Malone jumped into a description of haredi rabbis asking him to ‘testify’ at a rabbinical ‘court’ in Brooklyn:
..it turns out that the rabbis in the Hasidic jew community carefully monitor–we don’t need to go into how–the menstrual cycle of the fertile women in their congregations, closely monitor it because there is strict guidance about cleanliness and intercourse and they had a major problem because they these you know these are all 60 plus up to 80 long beards right here that had exquisite understanding about the menstrual cycle in all the women in their congregations and they all knew that these menstrual cycles were being disrupted all the time…
Robert W. Malone, MD MS, is a physician-scientist who will live in infamy, thanks to the Joe Rogan Experience Podcast boosting his visibility this past December regarding his criticism of COVID-19 vaccines, particularly the mRNA vaccines (Moderna and Pfizer-BioNTech). Subsequently, Malone was banned from Twitter, which further boosted his celebrity status. Describing himself as the inventor of mRNA vaccine technology, he has been reaching a growing number of people with a narrative that makes COVID-19 vaccination sound scary. We cannot embed clips from the Rogan interview, which lasted about three hours, because it is accessed only on Spotify. But we can pull quotes from the interview transcript and we can see how Malone addresses non-scientists in shorter appearances, like the following clip from Wisconsin Morning news aimed at parents:
…Before you inject your child – a decision that is irreversible – I wanted to let you know the scientific facts about this genetic vaccine, which is based on the mRNA vaccine technology I created…
There are three issues parents need to understand:
The first is that a viral gene will be injected into your children’s cells. This gene forces your child’s body to make toxic spike proteins. These proteins often cause permanent damage in children’s critical organs, including
○ Their brain and nervous system
○ Their heart and blood vessels, including blood clots
○ Their reproductive system
○ And this vaccine can trigger fundamental changes to their immune system
The most alarming point about this is that once these damages have occurred, they are irreparable
○ You can’t fix the lesions within their brain
○ You can’t repair heart tissue scarring
○ You can’t repair a genetically reset immune system, and
○ This vaccine can cause reproductive damage that could affect future generations of your family….
Along with the alarmist theme, there are some phrases in the excerpt that people with little knowledge of biology could take the wrong way. The ‘toxic’ spike protein terminology warrants unpacking later, because Malone’s more farfetched ideas rest upon his disagreement with experts who have worked on that very spike protein. This is a protein that SARS-CoV2 (the virus that causes COVID-19) makes and uses to enter body cells, and is the basis of most of the COVID-19 vaccines that are approved throughout the world. In the case of the genetic vaccines (the mRNA vaccines of Pfizer-BioNTech and Moderna and the viral vector vaccines of Johnson and Johnson and AstraZeneca), the vaccines do not actually contain spike protein. Instead, they contain a recipe for cells of a vaccinated person (not all the person’s cells, but just a small sampling) to make spike protein —in very small amounts and for a very limited time— and display it on the outer part of their cell membranes. This allows the immune system to use that vaccine-generated spike protein for target practice, so you can build immunity against the virus without the virus infecting you.
As we enter the third year of the Covid pandemic, with perhaps a partial end in sight, the weight of the debate shows signs of shifting away from genetically engineered therapies, and toward a social science search for historic context.
Renowned historian, Charles E. Rosenberg, envisioned a similar transition for the AIDS epidemic in 1989. He described its likely future course then as a “social phenomenon” with these words, “Epidemics start at a moment in time, proceed on a stage limited in space and duration, follow a plot line of increasing and revelatory tension, move to a crisis of individual and collective character, then drift toward closure.”
Misinformation and disinformation (intentionally wrong information) have plagued the storyline of the Covid19 vaccine since the early days of its development, creating a healthcare communications crisis that has not only stalled U.S. vaccination rates, but has also raised questions about how medical and scientific experts will ever again win trust across audiences and communications platforms that are becoming increasingly fragmented, and sometimes hostile.
Yesterday, on the two-year anniversary of the first Covid case in the U.S., I sat down with Dr. Carlos del Rio, Professor of Infectious Diseases & Epidemiology at Emory University, and Jon Reiner, Editorial Director at 120/80 MKTG, to check-in on the vaccine conversation and, more generally, what we in the health innovation community can learn from this situation as we attempt to introduce other new medicines, breakthrough technologies, and scientific advances to the world.
Dr. del Rio served as a vaccine expert in a public service campaign that 120/80 MKTG put together called “Just the Facts on Vax,” which sought to combat vaccine disinformation early-on with a series of bite-sized, social-media-ready videos that put infectious disease experts front-and-center to answer common questions about the vaccine. The full campaign can be viewed on 120over80 MKTG’s YouTube channel, but can it still have an impact? And, in the grand scheme of things, when it comes to people’s personal health, evolving medical or scientific information, and a litany of communication platforms that can position nearly anyone as an expert, how do real experts build trust? An interesting – and timely – chat about the power of information and the “trusted expert” archetype in the context of one of the most unique healthcare stories of our lifetime.
The power to mandate vaccines was litigated and resolved over a century ago. Justice John Marshall Harlin, a favorite of current Chief Justice Roberts, penned the 7 to 2 majority opinion in 1905’s Jacobson v. Massachusetts. Its impact was epic.
In 1905, Massachusetts was one of 11 states that required compulsory vaccinations. The Rev. Henning Jacobson, a Lutheran minister, challenged the city of Cambridge, MA, which had passed a local law requiring citizens to undergo smallpox vaccination or pay a $5 fine. Jacobson and his son claimed they had previously had bad reactions to the vaccine and refused to pay the fine believing the government was denying them their due process XIV Amendment rights.
In deciding against them, Harlan wrote, “liberty for all could not exist under the operation of a principle which recognizes the right of each individual person to use his own [liberty]…”
Of course, a state’s right to legislate compulsory public health measures does not require them to do so. In fact, as we have seen in Texas and Florida among others, they may decide to do just the opposite – declare life-saving mandates (for masks or vaccines) to be unlawful. At least 14 states have passed laws barring employer and school vaccine mandates and imposing penalties in Republican-controlled states already.
So state powers are clearly a double-edged sword when it comes to health care.
But these systems can be tuned to reflect and address key concerns.
What follows is a list of ten separable concerns, and responsive design strategies. The concept of separation of concerns in technology design offers a path to better health policy. Because each concern hardly interacts with the others, any of them can be left out of the design in order to prioritize more important outcomes. Together, all of them can maximize scientific benefit while enhancing social trust.
An inspector should be assured that a vaccine certificate was not tampered with and that it was issued to the presenter. This need not imply any privacy risk, or even need a network connection. One such method for authenticating vaccine credentials adds a human-recognizable and machine-readable face photo to a standard 2D barcode. It works with paper as well as mobile phone presentations.
The digital divide
For this concern, paper credentials have equity and privacy advantages. Equity, because paper is cheap and well understood. Privacy, because there is no expectation that a person must unlock and show a mobile phone. Digitally signed certificates that also include a photo, like #1 above, can be copied for convenience without risk of fraud.
“The patient in room 1 should be a quick one, its an addon, they just need a prescription for ivermectin”
I’m a bit puzzled by this sentence from my assistant doing his best to help me through a very busy day in the clinic that I’m already behind in. I walk into the room, a script pad stuffed into my hand as I enter the room, to meet a very nice couple. The wife sits patiently with hands crossed on the exam table.
“So, you’re here for Ivermectin?”, I ask.
Why yes, a trip to Texas is planned.. COVID is in the air, the internet, and some important people who have ‘inside knowledge’ have raised doubts about the vaccine. Some other people who quite possibly could be the same people, have also suggested prophylactic ivermectin is the better bet to prevent these good people from catching COVID.
Ivermectin is a drug known to work against parasites. The virus angle relates to in vitro data that suggests Ivermectin inhibits the host importin alpha/beta-1 nuclear transport proteins, which are part of a key intracellular transport process that viruses use to enhance infection by suppressing the host’s antiviral response. In addition, ivermectin may interfere with the attachment of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein to the human cell membrane. Ivermectin demonstrates a broad spectrum of activity in-vitro against a variety of viruses like dengue, Zika, HIV, and yellow fever. Unfortunately, despite this in vitro activity, no clinical trials have reported a clinical benefit for ivermectin in patients with these viruses.
Ivermectin does inhibit Sars-Cov2 viral replication in cell cultures. However, pharmacokinetic studies suggest that achieving the plasma concentrations necessary for the antiviral efficacy detected in vitro would require administration of doses up to 100-fold higher than those approved for use in humans. Even though ivermectin appears to accumulate in the lung tissue, predicted systemic plasma and lung tissue concentrations are much lower than 2 µM, the half-maximal inhibitory concentration (IC50) against SARS-CoV-2 in vitro. Subcutaneous administration of ivermectin 400 µg/kg had no effect on SARS-CoV-2 viral loads in hamsters, though there was a reduction in olfactory deficit and a reduction in the interleukin (IL-6:IL-10) ratio in lung tissues.
Since the pandemic began, there have been a number of small randomized controlled trials of ivermectin in mild COVID patients that show more rapid viral clearance, but not too much else. The prophylaxis data is considerably more sparse, and is of the retrospective variety. Basically take a number of countries that use Ivermectin variably and compare the incidence of COVID in those countries.
This week J&J gained FDA approval for their 1-shot COVID vaccine, leading optimists like Pfizer Board member, Scott Gottlieb, to predict that we will have 100 million shots out there by the end of April, and on-demand offerings for the general public. In the race toward herd immunity, we could easily ignore a revolutionary change in pharmaceutical design and manufacturing occurring under our noses.
Case in point: Moderna – subject of a recent case study by Marco Iansiti, Karim Lakhani, Hannah Mayer, and Kerry Herman in the Harvard Business Review.
Moderna – labeled by its CEO as “a technology company that happens to do biology” – was founded in 2010, with $5.1 billion in venture capital backing, “designed from the ground up as a digital biotech company with a factory for in-house manufacturing capabilities.” Up to this point, as they entered their 11th year, they had not brought a single product to market.
Moderna was the child born of Cambridge-based Flagship, run by Noubar Afeyan, an MIT bioengineer and world leader in bio-instumentation. His raison d’etre was “radical innovation.” He not only wanted to do big things, but do them faster than anyone else. As he said, “Asking ‘What if?’ questions propels you far into the future. It may be unrealistic or overly optimistic, but that’s how radical innovation happens.”
To accomplish this outsized ambition, he invested in a four-step process:
On January 26th, Philadelphia discovered that the 22-year-old organizer of its largest COVID-19 vaccination site, Andrei Doroshin, had turned away elderly members of the Philadelphia community from their vaccine appointments. Instead, he pocketed extra vaccine vials to administer to 4 friends and girlfriend. An RN witnessed the event and reported it to authorities.
For the people in the back: One can’t simply “Elon Musk” healthcare. We have seen this too many times – a privileged young upstart with little experience believes that s/he can transform healthcare and make millions – or billions – doing so. Examples abound: we only have to look a couple years into the past to remember Elizabeth Holmes, the Stanford dropout who founded Theranos and misrepresented its technology, or to Outcome Health, whose former CEO Rishi Shah defrauded investors by overinflating business metrics. If “move fast and break things” works in other sectors, many reason, why won’t it work in the 4 trillion dollar industry of healthcare?
Healthcare is simply not the kind of business where one can shoot a rocket into the sky and accept the risk that it might explode. Simply put, this is people’s lives we’re dealing with. But a deeper layer involves trust in the medical establishment. U.S. healthcare is already marred by multiple grave issues: a complex bureaucracy, serious health inequities, and astronomical costs that can bankrupt a person in just one hospitalization. The trust that people have in U.S. healthcare has steadily dropped over the years. Further, the politicization of the COVID-19 pandemic and the U.S. government’s bungled response to it has only sowed further distrust, especially among marginalized andminoritized communities.