06Jun

With the approval last month of the Moderna vaccine by the Food and Drug Administration, we now have two COVID-19 vaccines available. Two more – one from Johnson & Johnson the other from AstraZeneca – are on the way and could be approved as soon as February.

Healthcare workers, residents of nursing facilities and some first responders have already received the Pfizer vaccine, the first one approved by the FDA. Moderna has begun shipping its vaccine with the first of the 25 million initial doses administered last month.

People eager to be immunized have inundated doctors’ offices and clinics asking when the vaccine will be available. The best answer is soon.

Which one, though, will you receive? And does it make any difference?

The answer to the first question is whichever vaccine can be obtained the quickest or, in some cases, whichever your health plan recommends. It really doesn’t make any difference to you.

Both vaccines require two separate doses to reach maximum effectiveness 21 days apart for Pfizer and 28 days for the Moderna version. Both protect about equally well. The FDA data shows Pfizer is 95% effective after both doses. Moderna is 94.1%.

Unlike most other vaccines, these two vaccines use pieces of protein from the SARS-CoV-2 virus to prompt the body to create antibodies. Conventional vaccines, like the annual flu shot, are manufactured from viruses typically grown in chicken eggs. These chicken grown viruses are then killed or weakened to become vaccines.

The COVID vaccines employ messenger RNA (mRNA), a newer technology. These vaccines “teach” the body to replicate the little bit of the CoV-2 protein, which, in turn, creates an immune response causing the body to make the antibodies that provide the protection against the virus.

The most significant difference between the Moderna and the Pfizer vaccines is how they must be stored. Both can survive for a few days in standard refrigeration. For longer periods, the less stable Pfizer vaccine must be kept in ultra-low temperatures below -94 F. That makes shipping and storing Pfizer’s vaccine somewhat more complicated, especially outside urban areas where the low temperature refrigeration is not easily available.

“At the end of the day, these two vaccines are pretty similar,” Dr. Thomas Russo, professor and chief of infectious disease at the State University of New York, tells Health. “Grab it while you can.”

Photo by Hakan Nural

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Green Key
Jun 6, 2023

Is It the Drug Or Fitbit Making the Difference?

As if clinical researchers and managers didn’t already have enough to worry about, now add activity trackers to the list.

Smartwatches, Fitbits and similar trackers have the potential to influence behavior, which matters in studies where physical activity is a study endpoint. (An endpoint in a clinical study is an event used to objectively measure the effect of a drug or other intervention.)

If the level of activity is an endpoint in a study of, say, a drug to improve fatigue, researchers need to be able to say that it is the drug that has made the difference. But anyone who has ever used a Fitbit or other activity tracker know how engaging – addicting, even – they can be. They prod you to get in that 10,000 steps with encouraging messages like, “Only 789 steps to reach your goal.”

As an article on the Clinical Research News website says, “Use of the devices could result in ‘activity peaks’ and ‘activity plateaus’ driven not by drug efficacy but as a response to the smartwatch/fitness tracker targets.”

In other words, who’s to say the increased physical activity was the result of the drug or the tracker prodding?

Before commercial trackers became so ubiquitous, researchers gave study volunteers devices that accumulated the data, but without making it visible to them. Commercial trackers make everything visible.

Besides simply counting steps, sophisticated wearables measure all sorts of activity related variables like heart rate, duration, intensity, distance, sleep and more. Because participants in studies of physical activity are able to see this data they can skew the results by working to reach targets and earn badges.

The authors of the article – “The Potential Of Activity Trackers To Bias Study Results” – suggest a number of measures researchers can take to mitigate the influence of these devices including prohibiting participants from wearing them, establishing baseline physical activity levels and choosing endpoints less likely to be influenced by the trackers.

Ultimately, the writers say, “Additional research is needed in this arena… More certain is that the unblinding of study data could have far-reaching if unintended consequences by introducing bias into the data analysis process.”

Photo by Andres Urena on Unsplash

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Green Key
Jun 6, 2023

Dramatic Changes Are Transforming the Legal Profession

The business of lawyering is undergoing a transformation that is as dramatic as it is still little recognized even by many in the profession.

As has been the case with so many other sectors of the economy, the COVID pandemic accelerated changes already occurring. Most obvious has been the rapid deployment of technology in ways that few in the field would have predicted even as recently as the beginning of this year.

Court appearances, hearings and chambers’ conferences that just months ago had to be conducted in person, are now routinely handled by video and phone. Legal filings are accepted online. Clients meet with their lawyer remotely. Law schools are teaching entirely online.

“The pandemic has liberated the legal industry from compulsory attendance at legal sanctuaries — offices, schools, and courthouses,” writes lawyer, legal entrepreneur and law professor Mark Cohen. “In a matter of weeks, the legal ecosystem became more agile, fluid, collaborative and efficient. This transition occurred with remarkable speed, pervasiveness, absence of resistance, and overall effectiveness.”

These innovations were born out of necessity. Courts couldn’t simply shut down completely, so judges and lawyers and their support staffs switched to the online model many other businesses did.

Now that the experiment has, as Cohen notes in his commentary on Forbes, “illuminated the opportunity for reimagining and improving upon old ways of delivering legal services, learning, and resolving disputes,” a complete return to tradition is unthinkable. “The genie is out of the bottle.”

The transformation, though, is not purely technological. Cohen points to Arizona and Utah, where the high court in each state approved sweeping programs to change law’s business structure and open the door to admit non-lawyers to the practice.

In August, the Utah Supreme Court unanimously authorized a pilot program to test changes enabling “individuals and entities to explore creative ways to safely allow lawyers and non-lawyers to practice law and to reduce constraints on how lawyers market and promote their services.”

Later that month Arizona’s high court removed a long-standing rule that prohibited non-lawyers from owning a law firm and other alternative business structures. The court’s order also permits the licensing of non-lawyers as paraprofessionals who will be able to provide some legal services to clients, including representing them in court.

The courts in both states established committees more than a year ago to study ways to improve access to legal services, so the two announcements didn’t come as complete surprises. Anticipating a loosening of the legal rules and recognizing the transformation of the profession, Deloitte, PwC, EY, and KPMG began enhancing their legal consulting practices.

Cohen says The Big Four “are each supplementing their legal talent pools by hiring well-known lawyers and business of law experts in an effort burnish their ‘legal’ credentials.”

As CEO of The Digital Legal Exchange, Cohen has a stake in promoting the transformation, especially the digital transformation, of the legal profession. Still, the evidence he cites and the articles he references, many written by him, makes a compelling case.

“Law,” he concludes, “Is not solely about lawyers anymore, and digital transformation, accelerated by COVID-19, will transform it just as it has its customers.”

Photo by Bill Oxford on Unsplash

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