SER-109 achieved statistically significant and clinically meaningful improvements in key primary and secondary efficacy measures compared with placebo –
– SER-109 was well tolerated, with a safety profile comparable to placebo –
– Company expects to finalize Biologics License Application (BLA) filing in mid-2022
https://finance.yahoo.com/news/england-journal-medicine-publishes-data-220100006.html
"Ivermectin, For and Against" is a Rebel Wisdom broadcast that aired before World Ivermectin Day last July 24. Although certainly additional data have emerged since, this is still one of the most complete and balanced conversations regarding the controversy over use of this drug since the pandemic began.
Journalist David Fuller interviews three authorities who review both scientific evidence clarifying and technological censorship obscuring our knowledge and understanding about ivermectin in ongoing COVID crisis conversations. An extensive briefing document by Ed Prideaux accompanies the video, for us visual learners.
A prior Rebel Wisdom newsletter, "The Uncanny Valley," elaborates. The valley (more like a canyon) "exists because the mainstream refuses to platform 'heterodox' opinions for fear of giving 'fringe' perspectives too much prominence [or] a false equivalence with medical consensus." The result is that "conspiracy theories tend to grow in the gaps…filling the void of unanswered questions."
The practice of "nonplatforming" from social media "pushes people with 'fringe perspectives' to appear only on alternative channels [where their views will be aired, but] where their claims are rarely challenged," according to the newsletter.
But, scientifically speaking, such apartheid isn't how you find truth — or trust.
"Nonplatforming" is when tech outlets, fearing public health–based government pressure or censorship, appoint themselves as guardians of scientific accuracy and summarily remove from social media any comment (or commentator) who goes against an officially sanctioned message. Vaguely reminiscent of Kapo or even Zersetzung tactics, all commenters are encouraged to report, sometimes without explanation, any posts that might violate community "standards" or "guidelines."
I have held my breath after posting things to medical social media that, if not read carefully or not fully understood by whoever is doing such gatekeeping, might be considered subversively heterodox. I've also wondered whether those performing this function for these outlets actually have any medical or scientific expertise, or whether they are lay "screeners" of what might go against (their interpretation of) a prevailing public health message.
Recently, on a physician-only platform, a brief educational piece by the AMA about ivermectin (containing the sanctioned public health message) spurred a conversation in the comments about possible benefits of the drug in COVID. I posted that I had just noticed for the first time a more recent AMA story that did not reference ivermectin pejoratively, and that even provided a link to the recently initiated HHS-publicized ACTIV-6 study comparing fluvoxamine, fluticasone, and ivermectin in symptomatic early mild COVID.
A young physician reader asked for references to support that there could be some usefulness to ivermectin in combating COVID. Several respondents provided examples (such as this one). A polite back-and-forth ensued with no discernible violations of published "community guidelines," which even state "[this platform] acknowledges and respects the value of different opinions, and our policies reflect our impartiality." Really?
Someone mentioned me by name in a comment. Investigating, I found that the entire discussion had been removed, and it was no longer possible to even comment on the article. The guidelines advise that "if you can no longer see [it] on the network, your comment has been removed for violating one or more of our community standards." Since no prior comment had violated them, I can only assume that some subsequent comment did (maybe even the one about me? Yipes!), and that this eventuated removal of the entire thread. Or, alternatively, the original poster decided that the conversation was just too dangerous to allow its continuation. There's no way to know, as the platform reserves complete discretion.
This rankles me. There is plenty of evidence that ivermectin, like many other already approved drugs, has numerous actions that could be of benefit in combating specific aspects of COVID infection. The chief arguments made against its use are:
There has as yet been no large, randomized, double-blind clinical trial of its use in COVID (because no organization is willing to undertake such a study, given that ivermectin is long off patent);
Some findings of the small clinically driven studies seem "too good to be true"(this being asserted without any evidence or supportive study finding);
It is not pharmacologically possible, without adjuvants like ritonavir, to safely achieve plasma levels in humans necessary to prevent infection by the mechanism suggested in the first in vitro study, or to function as a 3CL protease inhibitor;
If people are free to take ivermectin, they might use this as an excuse to avoid vaccination (as has happened in some countries); and
Since ivermectin is principally used in the US as a veterinary medicine, it could be (and indeed has been) misused by the public (which explains the remarkably sophomoric FDA tweet, especially insulting to Southerners).
If there is any audience able to examine this evidence and come to a reasonable consensus, it is (in my opinion) the physician community. Why shouldn't we be allowed to attempt to bridge the "uncanny valley"? Is it just too unsafe for physicians to collaboratively discuss any topic that might eventually undermine a current public health message?
Of course there is always a hazard, if such discussions are taken out of context or shared with less discerning audiences, as explored in my last post.
But dissemination is an unavoidable hazard of free speech.
Something attributed to Voltaire (but penned by Beatrice Hall) and paraphrased by many a judge, including former Harvard Medical Dean Dr Chief Justice Oliver Wendell Holmes, embodies the spirit of the US Constitution's First Amendment and resonates with me: "I disapprove of what you say, but I will defend to the death your right to say it."
Mentioning that ivermectin is not just a horse-deworming medicine is hardly tantamount to yelling "Fire!" in a crowded theater. What do you think? Please comment, or correspond on this or other topics at Medscapementor@gmail.com.
A semi-automated insulin delivery system improved glycemic control in young children with type 1 diabetes aged 1 to 7 years without increasing hypoglycemia.
"Hybrid closed-loop" systems — comprised of an insulin pump, a continuous glucose monitor (CGM), and software enabling communication that semi-automates insulin delivery based on glucose levels — have been shown to improve glucose control in older children and adults.
The technology, also known as an artificial pancreas, has been less studied in very young children even though it may uniquely benefit them, say the authors of the new study, led by Julia Ware, MD, of the Wellcome Trust–Medical Research Council Institute of Metabolic Science and the University of Cambridge, UK. The findings were published online January 19 in the New England Journal of Medicine.
"Very young children are extremely vulnerable to changes in their blood sugar levels. High levels in particular can have potentially lasting consequences to their brain development. On top of that, diabetes is very challenging to manage in this age group, creating a huge burden for families," she said in a University of Cambridge statement.
There is "high variability of insulin requirements, marked insulin sensitivity, and unpredictable eating and activity patterns," Ware and colleagues note.
"Caregiver fear of hypoglycemia, particularly overnight, is common and, coupled with young children's unawareness that hypoglycemia is occurring, contributes to children not meeting the recommended glycemic targets or having difficulty maintaining recommended glycemic control unless caregivers can provide constant monitoring. These issues often lead to...reduced quality of life for the whole family," they add.
The new multicenter, randomized, crossover trial was conducted at seven centers across Austria, Germany, Luxembourg, and the UK in 2019-2020.
The trial compared the safety and efficacy of hybrid closed-loop therapy with sensor-augmented pump therapy (that is, without the device communication, as a control). All 74 children used the CamAPS FX hybrid closed-loop system for 16 weeks, and then used the control treatment for 16 weeks. The children were a mean age of 5.6 years and had a baseline A1c of 7.3% (56.6 mmol/mol).
The hybrid closed-loop system consisted of components that are commercially available in Europe: the Sooil insulin pump (Dana Diabecare RS) and the Dexcom G6 CGM, along with an unlocked Samsung Galaxy 8 smartphone housing an app (CamAPS FX, CamDiab) that runs the Cambridge proprietary model predictive control algorithm.
The smartphone communicates wirelessly with both the pump and the CGM transmitter and automatically adjusts the pump's insulin delivery based on real-time sensor glucose readings. It also issues alarms if glucose levels fall below or rise above user-specified thresholds. This functionality was disabled during the study control periods.
Senior investigator Roman Hovorka, PhD, who developed the CamAPS FX app, explains in the University of Cambridge statement that the app "makes predictions about what it thinks is likely to happen next based on past experience. It learns how much insulin the child needs per day and how this changes at different times of the day."
"It then uses this [information] to adjust insulin levels to help achieve ideal blood sugar levels. Other than at mealtimes, it is fully automated, so parents do not need to continually monitor their child's blood sugar levels."
Indeed, the time spent in target glucose range (70-180 mg/dL) during the 16-week closed-loop period was 8.7 percentage points higher than during the control period (P < .001).
That difference translates to "a clinically meaningful 125 minutes per day," and represented around three quarters of their day (71.6%) in the target range, the investigators point out.
The mean adjusted difference in time spent above 180 mg/dL was 8.5 percentage points lower with the closed-loop, also a significant difference (P < .001). Time spent below 70 mg/dL did not differ significantly between the two interventions (P = .74).
At the end of the study periods, the mean adjusted between-treatment difference in A1c was –0.4 percentage points, significantly lower following the closed-loop compared with the control period (P < .001).
That percentage point difference (equivalent to 3.9 mmol/mol) "is important in a population of patients who had tight glycemic control at baseline. This result was observed without an increase in the time spent in a hypoglycemic state," Ware and colleagues note.
Median glucose sensor use was 99% during the closed-loop and 96% during the control periods. During the closed-loop periods, the system was in closed-loop mode 95% of the time.
This finding supports longer-term usability in this age group and compares well with use in older children, they say.
One serious hypoglycemic episode, attributed to parental error rather than system malfunction, occurred during the closed-loop period. There were no episodes of diabetic ketoacidosis. Rates of other adverse events didn't differ between the two periods.
"CamAPS FX led to improvements in several measures, including hyperglycemia and average blood sugar levels, without increasing the risk of hypos. This is likely to have important benefits for those children who use it," Ware summarized.
Reductions in time spent in hyperglycemia without increasing hypoglycemia could minimize the risk for neurocognitive deficits that have been reported among young children with type 1 diabetes, the authors speculate.
In addition, they note that because 80% of overnight sensor readings were within target range and less than 3% were below 70 mg/dL, sleep quality could improve for both the children and their parents. This, in turn, "would confer associated quality-of-life benefits."
"Parents have described our artificial pancreas as 'life-changing' as it meant they were able to relax and spend less time worrying about their child's blood sugar levels, particularly at nighttime. They tell us it gives them more time to do what any 'normal' family can do, to play and do fun things with their children," observed Ware.
The CamAPS FX has been commercialized by CamDiab, a spin-out company set up by Hovorka. It is currently available through several NHS trusts across the UK, including Cambridge University Hospitals NHS Foundation Trust, and is expected to be more widely available soon.
The study was supported by the European Commission within the Horizon 2020 Framework Program, the NIHR Cambridge Biomedical Research Centre, and JDRF. Ware had no further disclosures. Hovorka has reported acting as consultant for Abbott Diabetes Care, BD, Dexcom, being a speaker for Novo Nordisk and Eli Lilly, and receiving royalty payments from B. Braun for software. He is director of CamDiab.
N Engl J Med. Published online January 19, 2022. Abstract
Starbucks is scrapping its COVID-19 vaccine requirement for U.S. workers after the Supreme Court blocked the Biden's administration's vaccine-or-test mandate for large employers last week.
"We respect the court’s ruling and will comply,” Starbucks Chief Operating Officer John Culver wrote in a memo sent to employees on Tuesday, The Associated Press reported.
Culver said in the memo that the Seattle company will continue to strongly encourage its employees to get their vaccines and booster shots, according to the AP.
This reversal comes after Starbucks announced earlier this month that it would enforce a vaccine-or-test mandate for the company's 220,000 U.S. employees. The original order required workers to be vaccinated by Feb. 9 or undergo weekly testing.
Culver said at the time that the "vaccine is the best option we have, by far, when it comes to staying safe and slowing the spread of COVID-19.”
The Supreme Court last week ruled 6-3 against the Biden administration's vaccine-or-test mandate for large employers, blocking it from taking effect while other legal challenges play out.
Researchers began testing a new COVID-19 vaccine patch this month that they hope will provide long-lasting protection against the virus.
On Wednesday, researchers said the PepGNP-Covid19 vaccine is in an early-study phase, as the technology is much different than the Moderna or Pfizer-BioNTech coronavirus vaccines, Reuters reported.
Instead of producing an antibody response, the vaccine patch focuses on cellular immunity by targeting T-cells that could eliminate the coronavirus and prevent it from spreading in the body.
The vaccine works by putting a patch with microneedles on a person then taking it off.
"With this new vaccine that generates this cellular immunity we hope to have a longer period of protection ... we don't know yet, but it could be one year, two years, three years," professor Blaise Genton, head of the study, told Reuters.
The vaccine was developed by Emergex Vaccines Holding Ltd., and the trial will be conducted through Unisanté medical research center in Lausanne, Switzerland, along with a local hospital.
The trial includes 26 candidates who will receive two patches of the COVID-19 vaccine, with the second one being slightly stronger. The people will then be tracked for six months, Reuters noted.
The first trial for the vaccine began on Jan. 10. Emergex announced the development of the new vaccine back in November.
https://thehill.com/policy/healthcare/590435-researchers-testing-covid-19-vaccine-patch
People who experienced mild COVID-19 infections demonstrated attention and memory issues, but those problems appeared to be only temporary, according to a new study published on Wednesday.
Researchers from Oxford University studied 136 people, comprised of both individuals who had contracted COVID-19 and those who had not. When it came to looking at factors such as sleep patterns, fatigue and anxiety, the participants included in the study who previously had COVID-19 did not differ significantly from their control group counterparts.
All of them were asked to perform 12 different cognitive tasks, including ones on object memory, spatial span and motor control.
The findings of the study showed that “COVID-19 survivors showed a significant reduction in their ability to sustain attention on a demanding task up to 9 months after COVID-19 infection, along with mild, but significantly worse, episodic memory for up to 6 months” — the latter of which refers to recalling personal past events.
Researchers noted that the study had a few limitations, including its small sample size.
“We still do not understand the mechanisms that cause these cognitive deficits, but it is very encouraging to see that these attention and memory return largely to normal in most people we tested by 6-9 months after infection, who demonstrated good recovery over time,” Oxford University Professor Masud Husain, one of the researchers involved in the study, said in a statement.
The research could provide more clues into how COVID-19 affects people in the weeks and months after testing positive.
Health organizations have already detailed that people who have COVID-19 can develop “long COVID-19,” referred to as "post-COVID conditions" by the Centers for Disease Prevention and Control, which can include tiredness or fatigue, sleep problems, lightheadedness and difficulty breathing or shortness of breath.
Encompass Health Corporation ("Encompass Health" or the "Company") (NYSE: EHC), a national leader in integrated healthcare, offering facility-based and home-based patient care through its network of inpatient rehabilitation hospitals and home health and hospice agencies, today announced its intention to spin off its home health and hospice business to form an independent, publicly traded company (the "HH&H Business") and to rebrand the HH&H Business as Enhabit Home Health & Hospice.
The Encompass Health Board of Directors believes that the separation of its inpatient rehabilitation business and the HH&H Business into two independent, publicly traded companies will provide significant benefits to both businesses and their stakeholders, including improving the strategic and operational flexibility of each business, increasing the focus of each management team on its business strategy and operations, allowing each business to adopt a capital structure and investment policy best suited to its financial profile and business needs, and providing each company with its own equity currency to facilitate acquisitions and to better incentivize management.
The spin-off, which is expected to be tax-free to Encompass Health's shareholders, will result in Encompass Health's shareholders owning stock in both companies. The Company intends to consummate the spin-off in the first half of 2022, subject to various conditions, including the effectiveness of a Form 10 registration statement, regulatory approvals and receipt of a favorable IRS private letter ruling.
The establishment of Enhabit Home Health & Hospice will further strengthen Enhabit's focus on high-quality, cost-effective care delivered in the home setting. The rebranding is expected to begin in mid-April 2022 and to be largely completed by the consummation of the spin-off.
