New Writing Adventures

As of March 2021, I began focusing my writing energy on the development of new books and blogs that will cover a number of subjects when completed, some fun and some serious, and most having nothing to do with the practice of law or the legal industry. As a result, I am no longer working with law firms and other professional service providers and enterprises on content creation for the web or print media.

Speaking and Consulting Engagements

However, I am still available for speaking and consulting engagements regarding the topics I have covered for many years as a writer and reporter, as well as topics about which I am knowledgeable due to my experience as a former general counsel and chief legal officer.

New Business Development Training Program

I have also collaborated with a long-time friend and colleague to create a unique business development training program that engages lawyers in simulated mock meetings with their most coveted real-life prospective client targets. We launched the program last spring, and it received outstanding reviews that we hope to be posting online soon.

Thank You to My Clients and Colleagues

As I enter this new and likely final phase of my career, I would like to thank all of the many clients I have been privileged to serve as a writer and content creator. I would also like to thank all of the wonderful people I have met through that work, including my wonderful referral sources and friends, particularly the members of my “gang” who remain very dear to my heart. I will keep you all updated on the next iterations of my work, which I look forward to sharing with you over time.

Two encouraging developments in the fight against COVID-19 were announced this week.

First, FIERCE Biotech reported that Johnson & Johnson has initiated a phase 3 assessment of its COVID-19 vaccine that will include 60,000 volunteer subjects. Unlike some other vaccine candidates, J&J’s vaccine appears to work as a single-shot regimen with no need for any subsequent inoculation.

The J&J candidate is also stable for three months when stored at temperatures typical of other common vaccines (about 36 to 46 degrees F) so no change would be needed to delivery and storage infrastructures. The company believes this will enable them to make, deliver and store enough doses to treat about one billion people per year.

Second, Axios reported that a computer startup called “Gauss” and a biotech company named “Cellex” have teamed up to concoct the first rapid COVID-19 test that can be performed by people at home without involving a laboratory.

While other diagnostics have been developed that allow users to test themselves at home, those methods still required people to send in samples to a lab for processing. The new diagnostic can be done and interpreted at home with the help of a small swab, a vial filled with buffering solution, and a tiny test surface cassette.

According to Cellex, the test generates a correct positive result nearly 90 percent of the time while producing correct negative results close to 100 percent of the time. Accurate, quick and easy home testing will greatly facilitate recognition of viral transmission and the need to quarantine in timely fashion.

According to NBC News, the University of Arizona may have stopped a corona outbreak before it started with the help of wastewater-based epidemiology. This novel approach involves analyzing sewage samples for traces of the coronavirus, which gave the university a clue that traces of the virus were popping up in discrete groups of people — those in university dorms — as part of an early warning system.

Researchers in the UK and Israel are also working on urban sewage early detection systems, and UArizona is now tracking sewage from NYC and LA to provide potential early warnings in those areas.

There are also some early returns on the monoclonal antibody trials being conducted by Eli Lilly, as reported in STAT News and Eli Lilly. The test was conducted on 450 patients with mild to moderate COVID-infections, so the sample size was small and results only point to whether there is promise for further study on larger populations.

But the good news is that the results were encouraging. One of the tested dosages significantly reduced levels of the virus in blood taken 11 days later, and overall, the patients who received the monoclonal antibody candidate vs. placebo were 72 percent less likely to need hospitalization or emergency room treatment. This should pave the way for larger and more intense final phase studies.

Also, Bloomberg News and Astrazeneca have reported that trials of its vaccine candidate have resumed after a voluntary pause to determine that one patient’s condition after treatment was not related to vaccination. This particular candidate trains the immune system to attack the corona-virus spike protein (used to latch on to human tissues) by exposure through injection.

The company now plans to enroll 30,000 volunteers to test the vaccine on a broader scale, but so far it has produced promising antibody responses. According to PharmaNews Intelligence, neutralizing antibody responses were detected in 91 percent of early participants after a single dose when measured in microneutralization assay, and in 100 percent of participants when measured plaque reduction neutralization assay.

As recently reported in STAT News, inexpensive and common steroids can reduce the risk of Covid-19 mortality by roughly one-third. Subsequent to the study on which this report was based, the World Health Organization issued treatment guidelines making a seven-to-10 day dose of corticosteroids a recommended “standard of care” for patients with “severe and critical” Covid-19. The Journal of the American Medical Association has published the study on which the recommendations are based, concluding that “administration of systemic corticosteroids, compared with usual care or placebo, was associated with lower 28-day all-cause mortality.”

Another story that came out recently involves the beneficial effects of masking. The article published in the New England Journal of Medicine summarized some of the data coming from epidemiology studies, noting that facial masking appears to reduce transmissions, but also may reduce the viral loads associated with transmissions. In doing so, it appears to increase the number of people who are asymptomatic because their immune systems can defeat smaller viral loads (at least that is the theory).

The data were summarized as follows:

In an outbreak on a closed Argentinian cruise ship, for example, where passengers were provided with surgical masks and staff with N95 masks, the rate of asymptomatic infection was 81% (as compared with 20% in earlier cruise ship outbreaks without universal masking). In two recent outbreaks in U.S. food-processing plants, where all workers were issued masks each day and were required to wear them, the proportion of asymptomatic infections among the more than 500 people who became infected was 95%, with only 5% in each outbreak experiencing mild-to-moderate symptoms. Case-fatality rates in countries with mandatory or enforced population-wide masking have remained low, even with resurgences of cases after lock-downs were lifted.

Of course, there are some downsides associated with greatly increasing the rates of asymptomatic transmission, but one of the upsides involves raising the level of herd immunity without dramatically increasing death rates. Ultimately, driving down overall transmission rates AND severity of infections is a good thing, and population-wide facial masking appears to provide both benefits.

As Dr. Anthony Fauci noted in a recent interview with MedPage Today, monoclonal antibodies were very important in defeating Ebola-virus, and have huge potential in the fight against COVID-19 because they “can either be used as prophylaxis to prevent infection or to actually treat someone who’s already infected.”

As pointed out in a recent Bloomberg News report on MSN, monoclonal antibodies also have the greatest potential to protect senior citizens, whose immune systems do not always respond to vaccines. With a vaccine, you have to hope for a strong immune response (which is apparently promising with current vaccine candidates) but with monoclonal antibody treatments, the patient is getting large doses of fresh antibodies cloned from those with strong immunity. Also, if there are side effects with any vaccine, or if the vaccine arrivals are delayed, monoclonal antibodies may be able to fill the gap. They also can treat patients who are already sick, which vaccines cannot.

NewsMedical, an open access life science publishing hub, also pointed out why monoclonal antibodies may be superior to convalescent plasma, which is currently in use on some patients who are already very sick. “It is clear that treatment using convalescent plasma provides only partial protection, and only in instances when plasma with high neutralizing titers is used,” according to Dr. Tomislav Mistrovic. In the MedPage interview, Dr. Fauci added that “the difference between a monoclonal antibody and plasma is that plasma has a lot of other things in it that could lead to allergic and other reactions. Whereas monoclonal antibodies are really very pure in the sense that they are monoclonal, which is, by definition, means they’re extremely pure.”

It is encouraging that the VIR-GSK partnership has already launched late-stage clinical trials of their monoclonal antibody candidate, according to MedCity News, and earlier testing showed very promising results. The same publication noted that several companies have developed monoclonal antibody candidates to treat Covid-19, and some of them are using a “cocktail” of antibodies (similar to what was done with AIDS drugs) on the theory that a cocktail approach can overcome multi-pronged viral resistance mechanisms.

As documented previously on this blog, the various monoclonal antibody candidates that are currently under testing should be available by late this year and early next year if final testing phases go smoothly. It is incredible that these treatments are being developed within the space of a year when it took humanity years to just identify and isolate HIV, and years more to develop effective treatment protocols. Hats off to the scientists and researchers who have been working at a furious pace to win the war against COVID.

While there is no way to guarantee safety in the classroom this fall, there are some things we can learn from other countries about minimizing risks associated where in-person schooling is taking place.

As reported in Nature magazine, the most critical component to successful reopening is low community transmission – without that there can be no safe schooling. And even with it, there is always the risk of a local outbreak returning as it has in some South Korean towns.

But, as reported in the UK Guardian, some countries, such as Denmark, have keep children in school without any recurring outbreak thus far.

NPR has published a nice piece summarizing some of the keys to minimizing risk, emphasizing the importance of mandatory hygiene measures, small classes, staggered schedules, lenient absentee policies and good ventilation (just cracking windows open and installing HEPA and/or UV filters in the HVAC system is a huge help).

Of course, we are operating in a frontier world now, so as Science magazine notes, the future necessarily involves some degree of speculation. The Science article also notes, however, that epidemiology studies indicate that people under age 18 are between one-third and one-half as likely as adults to contract the virus, they are much less likely to transmit it, and children under 12 seem barely able to carry it to others. The reasons are not yet clearly understood, but the epidemiology is offering a glimmer of hope.

There has been a good bit of confusion arising from recent news reports about the convalescent plasma treatment for COVID-19. Here is a basic summary of what we know from medical sources:

1. As demonstrated in an analysis published by Critical Care Forum, the efficacy of any medical therapeutic is hard to measure precisely and accurately when multiple variables are involved, such as age and condition of patients receiving the therapeutics and the administration of other therapeutics or use of devices (such as ventilators). Nonetheless, measurements and data are essential, and we do have some data to support the notion that convalescent plasma is likely helpful (including data showing that the plasma itself has sufficient levels of antibodies to fight the virus).
2. According to STAT News, there is a convalescent plasma study from the Mayo Clinic that is based on a very diverse population of 35,000 hospital patients with severe cases of COVID-19. While there was not a placebo group in the study, the patients receiving treatment did show favorable outcomes beyond what would be expected without convalescent plasma treatment. “Those who received transfusions within three days of diagnosis had a seven-day death rate of 8.7%, while patients who got plasma after four or more days had a mortality rate of 11.9%,” according to the report.
3. Of course, there has been progress in treating severely ill patients in other ways with anti-inflammatories, oxygen and other therapies. As a result, the initial death rates of patients on ventilators (over 80 percent) have declined to somewhere in the 30 to 50 percent range, and similar progress has been made for all patients entering the intensive care units, according to the Philadelphia Inquirer.
4. MedRxiv has also published an abstract of study results on the patients receiving convalescent plasma therapy between April 4 and July 4 in more than 2,800 acute care facilities. A total of 52.3% of patients were in the intensive care unit (ICU) and 27.5% were receiving mechanical ventilation at the time of plasma transfusion. a gradient of mortality was seen in relation to IgG antibody levels in the transfused plasma. For patients who received high IgG plasma, seven-day mortality was 8.9%, and for recipients of medium IgG plasma mortality was 11.6%, and for recipients of low IgG plasma mortality was 13.7%, which compares very favorably to mortality rates without treatment. “The relationships between reduced mortality and both earlier time to transfusion and higher antibody levels provide signatures of efficacy for convalescent plasma in the treatment of hospitalized COVID-19 patients,” according to the abstract.

More study will definitely help to ascertain more precisely what the impact of convalescent therapy is, but it certainly appears to be beneficial at this point in time. Furthermore, the virus is in circulation even as we continue to gather data so doctors on the front lines do not have the luxury of waiting for completely conclusive evidence before making a decision on how to treat patients. This treatment looks like it is helping patients to recover, and until we have clear information from monoclonal antibody studies and studies of other therapies, there is no way to know for sure what the most effective treatment is. The human race is still figuring it out, but we will do so, and we will be victorious.

Dr. William Petri, a professor of medicine at University of Virginia, recently penned an article for The Conversation in which he predicted that multiple COVID-19 vaccinations will be widely available by January.

Petri, who is an infectious disease specialist, noted that a number of vaccine candidates have successfully disabled the virus in clinical trials by training the immune system to attack the spike protein that enables the germ to latch on to human tissues.

He also noted that at least seven companies have produced monoclonal antibodies that could provide effective treatments for those who already have the virus, or who get it in the future. These antibodies could prove particularly beneficial for older and vulnerable populations.

Reuters has also posted an article quoting a German biochemist who says that vaccines could be approved for use by that country’s general populace starting in January as well. The article also noted that several companies are ramping up to make one billion doses as soon as possible so that the mass vaccination process can proceed quickly following expected safety and efficacy confirmations in Phase III testing underway now.

Progress in testing is also accelerating with a number of states now offering free or low-cost virus testing to all citizens who desire a test. The Massachusetts “Stop the Spread”program is just one example of the excellent forward progress being made in some states now. The Bay State’s program is free of charge for anyone who wants to be tested.

Also, Science Daily has reported that an international team of scientists has invented a novel coronavirus breathalyzer test that is quick, easy and inexpensive. The researchers used gold nanoparticles that interact with volatile organic compounds in human breath to detect unique electrical signatures in the breath of infected subjects. The researchers used machine learning to train a sensor how to detect COVID-19 by comparing the pattern of electrical resistance signals obtained from the breath of 49 confirmed COVID-19 patients with those from 58 healthy controls. This ingenious device is still being refined to produce optimal results, but researchers are confident that they can produce a highly effective breathalyzer test soon !

The scientists and researchers advancing these tests and therapies deserve to be recognized for the hard work they are doing at breakneck speed. The advances they are making will serve all of humanity not just in the fight against this virus, but in future battles against other germs that are sure to come.

 

As recently noted in a Politico article on August 19, colleges across the U.S. are testing contact-tracing apps in an effort to minimize the spread of any COVID-19 outbreaks on campuses this fall.

Many tracing apps were launched by Google, Apple, Facebook and other tech companies early in the pandemic, but voluntary adoption of the apps has been slowed by privacy concerns and some general skepticism of what companies are doing with the data. But college campuses could provide contained platforms of tech-savvy young people who are less afraid of downloading and using the apps.

As the Politico piece pointed out, states can only “ask nicely” that their residents use these apps but colleges could require students to download them, which might provide some protections against spreading while garnering important data about how the unproven technology could work on a larger scale.

Some of the tracking tools already in existence that could help minimize COVID exposures include:

1. A real-time community mobility reporting tool by Google
2. A BioButton being used by one school in Michigan (it monitors heart rate, skin temp, and respiration changes)
3. A privacy-preserving contact tracing tool developed by Googe and Apple together
4. A Facebook map and mobility dashboard (reported by Business Insider) showing COVID clusters and movements
5. A BlueDot algorithm that charts and analyzes global movement by humans with the ability to track movements to and from highly infected areas

Adoption and refinement of these technology tools could prove to be critically helpful until a vaccine and optimal therapeutic arsenal can be deployed, and it could be immensely important to stopping the next global pandemic BEFORE it spreads out of control.

Earlier this month, the Rockefeller Foundation reported that six states (now seven) were teaming up to purchase millions of rapid-result COVID-19 antigen tests of the type used to confirm infections in symptomatic people. The Rockefeller Foundation will be facilitating financing mechanisms to support this large-scale interstate testing compact,  the goal of which is to provide workers, teachers, students, and vulnerable people with greater access to quick and inexpensive testing.

At about the same time, STAT News reported that the Novavax Covid-19 vaccine candidate showed a promising immune response in a small, early trial. Novavax enlisted about 130 volunteers in its trial and gave each either a placebo or one of four escalating doses of its vaccine. Everyone who received the vaccine developed neutralizing antibodies. Those subjects who received two injections developed four times the number of neutralizing antibodies typically found in patients who recovered from COVID-19.

None of the volunteers suffered any lasting side-effects, but many had mild aches and discomfort, and eight of them had more significant reactions that went away within days.

Continued progress on widespread testing and vaccine development is an encouraging sign that the virus can and will be totally defeated !