The Pledge, AstraZenica's Hiccup, An Important WCRI Study, And An Homage To Bourbon!
Having put The Insider on pause for a few weeks to have some fun researching pandemics in earlier times (they were awful) and to improving my tennis game (it's pretty good), we now dive back into the blogging fray. Today, we get a running start.
At a press conference on 24 August, President Trump and FDA Commissioner Stephen Hahn trumpeted (pun very much intended) the FDA's Emergency Use Authorization (EUA) of blood plasma to treat COVID-19 patients. The Trump/Hahn announcement came less than a week after officials at the National Institutes of Health (NIH) had put a hold on releasing the EUA, saying randomized trials were needed before such an action could occur. The President disagreed, saying, “There are people in the FDA and actually in your larger department [HHS] that can see things being held up and wouldn't mind so much — its my opinion, a very strong opinion — and that's for political reasons. We are being very strong and we are being very forthright, and we have some incredible answers, and we're not going to be held up.”
In yet another example of Olympian Hyperbole, a disease to which Mr. Trump seems to be terminally infected, he also called the EUA a “truly historic announcement,” which puts it alongside something like the Emancipation Proclamation.
Like most of Trump's hyperbolic pronouncements, the blood plasma EUA created quite the controversy, especially when the FDA released the comments of one of its own scientists tasked with reviewing the appropriateness of the same blood plasma EUA. That scientist— displaying far less enthusiasm than Trump and Hahn, and whose name was redacted from a memo released by the agency — wrote that the data:
“…support the conclusion that [convalescent plasma] to treat hospitalized patients with COVID-19 meets the ‘may be effective' criteria for issuance of an EUA. Adequate and well-controlled randomized trials remain nonetheless necessary for a definitive demonstration of … efficacy and to determine the optimal product attributes and the appropriate patient populations for its use.”
After the 24 August press conference, it took about 1.5 nanoseconds for Joe Biden and many media pundits to accuse Trump and Hahn of politicizing the EUA to influence the coming election.
Which brings us to The Pledge.
On 8 September, wanting to get out of firing range, the CEOs of all the leading Western developers of COVID-19 vaccines vowed to only file for FDA approval after demonstrating safety and efficacy in their Phase 3 trials. Their Pledge and descriptions of all nine trials can be found here.
The Pledge also promises all the developers will share some, but not all, of their data to propel their vaccines to the finish line. However, although every CEO wants their vaccine to be the first approved, not one of them wants to get there only for the world to discover they've cut corners and now endanger humanity. These are people who want to go down in history for the right reason.
Mr. Trump will push, prod and kick these vaccine developers to get one of their efforts approved before 3 November. But I have a 95% confidence level none of them will buckle under that pressure. I sure hope I'm right.
In an example of the caution just described, last week AstraZenica announced it was putting its Phase 3 vaccine trial on hold, due to a suspected serious adverse reaction in a participant in the United Kingdom.
This is not an uncommon happening in vaccine development, but it does show how fraught with uncertainties these trials can be. It proves that AZ's data and safety monitoring group is doing its job, and that's what is supposed to happen. I previously wrote about all the leading COVID-19 vaccine candidates, as well as ChAdOx1, the one being tested by AstraZenica in partnership with the University of Oxford's Jenner Institute.
It is entirely possible we will experience more bumps in the road before one of the developers wins FDA approval.
AN IMPORTANT, NEW WCRI STUDY IS RELEASED
Low back pain (LBP) is something that has afflicted humanity since Homo Sapiens decided to stand straight and walk upright. And it's been the bane of claims adjusters since Otto von Bismarck, Germany's Iron Chancellor, created the first workers' compensation program in the 1880s.
Back injuries are the leading cause of all musculoskeletal claims, which are the leading cause of all workers' compensation claims, and have been since it seems forever. If you've ever looked at a workers' compensation loss run for any hospital in America, you'll know what I mean.
One of the myriad treatment modalities for these claims is physical therapy (PT). However, it's always been a bit of a crap shoot as to when to prescribe PT for a patient beset by a work injury resulting in low back pain.
Now, the Workers' Compensation Research Institute (WCRI) has produced a study that convincingly puts the matter to rest. The study's conclusion: the earlier PT is begun, the better.
The study, The Timing of Physical Therapy for Low Back Pain: Does It Matter in Workers' Compensation?, is based on a review of nearly 26,000 LBP-only claims with more than seven days of lost time from 27 states, with injuries from 1 October 2015, through 31 March 2017, and detailed medical transactions up through 31 March 2018.
One of the many reasons this study is important is that PT can sometimes be the last resort, not the first, in many cases being recommended only after opioids and other invasive procedures have been tried.
The WCRI study found:
Later timing of PT initiation is associated with longer temporary disability (TD) duration. On average, the number of TD weeks per claim was 58 percent longer for those with PT initiated more than 30 days post-injury and 24 percent longer for those with PT starting 15 to 30 days post-injury, compared with claims with PT within 3 days post-injury.
Workers whose PT treatment started more than 30 days post-injury were 46 and 47 percent more likely to receive opioid prescriptions and MRI, respectively, compared with those who had PT treatment initiated within 3 days of injury. The differences between PT after 30 days post-injury and PT within 3 days post-injury were 29 percent for pain management injections and 89 percent for low back surgeries.
The average payment for all medical services received during the first year of treatment was lower for workers with early PT compared with those with late PT. For example, the average medical cost per claim for workers who had PT more than 30 days post-injury was 24 percent higher than for those who had PT within 3 days post-injury.
Among claims with PT treatment starting more than 30 days post-injury, the percentage with attorney involvement was considerably higher (27 percent compared with 13–15 percent among those in the early PT groups) and workers received initial medical care much later (on average 18 days compared with 2–3 days in the early PT groups).
If you're a claims adjuster wary of incurring the cost of sending injured workers with resultant low back pain to PT, this study should make you press the “Reset” button in your mind.
AND, FINALLY, AN HOMAGE TO BOURBON (WHICH IS ALSO GOOD FOR LOW BACK PAIN)
In the constant sea of terrible, divisive, set-your-hair-on-fire news, we now row to a bipartisan safe harbor: Bourbon.
In the halls of Congress, bipartisanship seems to have gone the way of the Woolly Mammoth. But, reader, that is not the case in the case of Bourbon! That's because on 2 August 2007, Congress ratified a bill designating September as National Bourbon Heritage Month. More notable, however, is that it passed unanimously. Thus, history shows that amid the countless issues and places and opinions that divide us, nothing unites Americans like bourbon.
So, although I can't stand the stuff, as we all get sucked along the giant tube of political rigarmarole, you might want to consider the nationally endorsed benefits of America's Native Spirit. Things will still be dire, the President will continue his hyperbolic rants, many of your fellow Americans will continue to “choose liberty” over masks, but you? You'll hardly notice any of it.
Disclaimer: WorkersCompensation.com publishes independently generated writings from a variety of workers' compensation industry stakeholders. The opinions expressed are solely those of the author and do not necessarily reflect those of WorkersCompensation.com.