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The Vaccine Brawl – A Legal Battle in Process

By MIKE MAGEE

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. 

Questions anyone?

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Correlative Adventures with COVID

By ANISH KOKA

“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. 

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Medable’s CEO: Covid19 Vaccine Will Start Big Pharma’s Era of De-Centralized Clinical Trials

By JESSICA DaMASSA, WTF HEALTH

Covid 19 vaccine development may have mainstreamed questions about how to hasten drug development timelines, but Medable, a health tech startup that offers researchers a way to de-centralize clinical trials, has been working to solve this problem for five years. Freshly funded with a $91M Series C raise, co-founder and CEO Michelle Longmire talks through the benefits of “liberating” clinical trials from academic research centers and sending them onto devices into patient’s homes. Traditionally, drug development processes average more than 10 years, cost millions of dollars, and are limited in the diversity of patients they can recruit because of the heavy focus on the geographic location of the research team conducting the trial. Medable’s digital platform breaks these limitations, reducing drug development timelines and costs by making it easier for researchers to draw study participants from anywhere. More importantly, it makes the novel medicines being tested by the trial available to a bigger, more diverse array of patients. Despite the gains made in 2020 toward the de-centralized clinical trial model (Medable’s revenue shot up 500%), there’s concern that Big Pharma may return to the business processes of old once the pandemic is under control. Does Michelle think last year make enough of an impact to change their business model for good? Find out what’s ahead for the future of pharma.

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