Relevant and even prescient commentary on news, politics and the economy.

On trial

Commenter and blogger, Professor Joel Eissenberg, Department of Biochemistry and Molecular Biology, Saint Louis University.

Introduction: “A group of clinicians and researchers is petitioning the FDA to delay fully approval of any COVID-19 vaccines before clinical trials have been completed, calling the notion of approval to stimulate vaccination rates ‘backward logic.’

The group, led by Linda Wastila, BSPharm, MSPH, PhD, professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, includes 27 petitioners, including 16 experts outside the U.S., primarily based in Europe.

The message of our petition is ‘slow down and get the science right. There is no legitimate reason to hurry to grant a license to a coronavirus vaccine.’ We believe the existing evidence base, both pre- and post-authorization, is simply not mature enough at this point.”

Taken from a blog post published in The BMJ.

If the FDA listens to us, they won’t give serious consideration to approving a COVID-19 vaccine until 2022.” 


I enrolled in the Moderna phase III COVID-19 vaccine trial last August. The trial lasts two years. Initially, it was a double-blind trial, although I knew I was in the vaccine arm 12 h after the booster and unblinded myself with the spike antibody test a month later. In January, all subjects were offered unblinding and the placebos were offered the vaccine.

Meanwhile, the Moderna vaccine has emergency use approval for everyone over age 12, so the number of people vaccinated outside the trial dwarfs the number in the trial.

So the issue is whether the FDA should relent and give full approval to this (and the Pfizer, J&J and AstraZenica) vaccine before the phase III trial is done. Trial participants like me are subject to a much higher degree of surveillance than the rest of the vaccinated public (weekly phone log, monthly wellness calls, six month clinical visits and blood samples) for research purposes. I can understand why the FDA would want the trials to be completed, but what if granting full FDA approval would convince more folks to get vaccinated?

A bunch of physicians just weighed in on the side of withholding full approval pending completion of the trial. As a scientist, I get the importance of data-driven decision making, but the horse is already out of the barn and way down the road on COVID-19 spike protein vaccines. Here’s an article. You decide.

Docs, Scientists Call on FDA to Delay Approval of COVID Vaccines, MedPage Today, June 10, 2021

Genetically Modified Mosquitos Released in the United States

First Genetically Modified Mosquito Released in the United States, Nature (News in Focus), Emily Watz, presented by Professor Joel Eissenberg commenter at Angry Bear.

Biotech firm Oxitec launched a controversial field test of its insects in Florida after years of opposition from residents and regulatory complications. The issue at hand is whether it is ethical to eliminate a species even though it causes human contagions. This is the first time science has moved to eradicate a carrier of a virus rater than eliminate the transmission of the virus (small pox and polio in the US).

Fighting infectious diseases can be difficult. Our toolkit includes drugs and vaccines to combat the diseases often times transmitted by bites. However, there is an arms race between the bugs and the drugs (and with COVID-19 and flu, the vaccines).

In some diseases, the transmission requires an insect or mammalian vector. Recent technology advances in genome editing have enabled so-called “gene drives” that are, in principle, capable of driving a host species to extinction at least in a region of the planet.

Gene drives to extinguish the anopheles and aedes mosquito vectors for malaria, yellow fever, zika, Dengue and others have been in development for years, and now one has been released in Florida. A bit of knowledge and history:

Anopheles is a genus of mosquito first described and named by J. W. Meigen in 1818. Approximately 460 species are exiting, while over 100 can transmit human malaria. Only 30–40 commonly can transmit parasites of the genus Plasmodium (unicellular eukaryotes that are obligate parasites of vertebrates and insects) which causes malaria in humans in endemic areas. 

The other type of mosquito is the Aedes a genus of mosquitoes inhabiting tropical and subtropical zones. It is now found on all continents except Antarctica. Some species were spread by human activity. Aedes albopictus is an  invasive species spreading to the New World and the United States by the used-tire trade.

From the link First Genetically Modified Mosquito Released in the United States:

“The genetically engineered males carry a gene that passes to their offspring and kills female progeny in early larval stages. Male offspring won’t die, but instead will become carriers of the gene and pass it to future generations. As more females die, the A. aegypti population should dwindle.”

The decision to release a GMO animal is certainly fraught with ethical complications. Unlike plants, mosquitoes and other animals (rats, kissing bugs, deer ticks) are not sessile organisms and can cross international borders. There are also genetic kill-switches that could be used to stop gene drives short of complete extinction, but those are untested in the field.

 Is it ethical to deliberately drive a species to extinction? Who gets to vote on such a decision? Weighed against that is the suffering and deaths of millions of humans, many of them children. Compassion or hubris?

CRISPR and the Ethics of Genome Editing

Joel Eissenberg, Professor of Biochemistry and Molecular Biology and Associate Dean for Research at Saint Louis University School of Medicine. 

In Our Image: The Ethics of CRISPR Genome Editing , Joel C. Eissenberg, De Gruyter | 2021

Humanity has been busily modifying plant and animal genomes for centuries. It has long been a dream to speed up and target that process. Additionally, the promise of molecular cloning included the hope of curing genetic disease once the gene is identified. These aspirations are being met, incrementally. Now, the CRISPR technology for genome editing promises to deliver on those hopes. The economic impact of genome editing in crops and livestock will be felt in short order. In the sphere of human health, there is both the prospect of editing the human genome to correct inherited disorders, as well as extinguishing plagues that have devastated human populations for millennia. There are a number of clinical trials underway to exploit CRSPR technology to treat inherited disease. The genetic tools to drive pest species (insects, weeds) to extinction are being developed and tested.

We can now do all these things, but should we?

The ethics of genome editing limited to the somatic cells (all cells except sperm and egg and the cells that can give rise to them) are no more complicated than the ethics of drugs or vaccines. The consequences of editing in these cases are limited to the treated individual and die when the person dies. Where genome editing becomes ethically fraught is when the products can enter the human gene pool through reproduction. That horse left the barn a couple years back when Dr. Jiankui He infamously announced the birth of twins that he had engineered as embryos to be resistant to HIV. There is no assurance that either of these twins don’t carry off-target mutations as a result of the editing mechanism. Further, the CCR5 gene mutation that was engineered in the twins may affect their susceptibility to other diseases. Since they carry the edited chromosome(s) in their germ lines, they can pass these edits to future generations.