Wednesday, September 15, 2021
Should you get a third shot? Read and listen to the latest, then decide.
Pfizer Inc. said that data from the U.S. and Israel suggest that the efficacy of its Covid-19 vaccine wanes over time and that a booster dose was safe and effective at warding off the virus and new variants.
The company detailed the data in a presentation it will deliver to a meeting of outside advisers to the Food and Drug Administration on Friday. The panel is expected to make recommendations for whether more Americans should receive booster shots.
“Real-world data from Israel and the United States suggest that rates of breakthrough infections are rising faster in individuals who were vaccinated earlier,” Pfizer said in its presentation, which was posted on the FDA website. The drug giant is partnering with Germany’s BioNTech SE to make the shots.
Pfizer (PFE) Says Covid-19 Vaccine Efficacy Erodes Over Time - Bloomberg
Thursday, September 2, 2021
Telehealth’s Limits: Battle Over State Lines and Licensing Threatens Patients’ Options | California Healthline
Perhaps you live in a city that borders on two-state jurisdictions, such as Minneapolis-St Paul, Washington DC-Maryland-Virginia,
If you live in one state, does it matter that the doctor treating you online is in another? Surprisingly, the answer is yes, and the ability to conduct certain virtual appointments may be nearing an end.
This story also ran on Time. It can be republished for free.
Televisits for medical care took off during the worst days of the pandemic, quickly becoming commonplace. Most states and the Centers for Medicare & Medicaid Services temporarily waived rules requiring licensed clinicians to hold a valid license in the state where their patient is located. Those restrictions don’t keep patients from visiting doctors’ offices in other states, but problems could arise if those same patients used telemedicine. State medical boards don’t want to cede authority, saying their power to license and discipline medical professionals boosts patient safety. Licensing is also a source of state revenue.
Providers have long been split on whether to change cross-state licensing rules. Different state requirements — along with fees — make it cumbersome and expensive for doctors, nurses, and other clinicians to get licenses in multiple states, leading to calls for more flexibility. Even so, those efforts have faced pushback from within the profession, with opposition from other clinicians who fear the added competition that could come from telehealth could lead to losing patients or jobs.
Now states are rolling back many of those pandemic workarounds. Many states have agreed to interstate medical licensing compacts for physicians, nurses, and some other health care providers
During the past 18 months, the public health emergency for the Covid19 pandemic created a national emergency causing an exponential rise in telehealth visits. Many states loosened their regulations regarding telehealth visits, including cross-state border visits. CMS (formerly Medicare) loosened it's a restriction only allowing telehealth visits from rural or underserved areas to general usage. The reasons for this had to do with social distancing and lockdown orders preventing traveling.
Even though the initial spike in telehealth visits has eased, utilization remains 38 times higher than before the pandemic, attracting not only patients but also venture capitalists seeking to join the hot business opportunity, according to a report from consulting firm McKinsey and Co. “As with most things in medicine, it’s a bottom-line issue. The reason telehealth has been blocked across state lines for many years is related fundamentally to physicians wanting to protect their own practices,” said Greenspun.
“The whole challenge is to ensure maximum access to health while assuring quality,” said Barak Richman, a Duke University law professor, who said laws and policies haven’t been updated to reflect new technological realities partly because state boards want to hang onto their authority.
Patients and their doctors are getting creative, with some consumers simply driving across state lines, then making a Zoom call from their vehicle.
“It’s not ideal, but some patients say they are willing to drive a mile or two and sit in a parking lot in a private space and continue to get my care,” said Dr. Shabana Khan, director of telepsychiatry at NYU Langone Health’s department of child and adolescent psychiatry and a member of the American Psychiatric Association’s Telepsychiatry Committee. She and other practitioners ask their patients about their locations, mainly for safety reasons, but also to check that they are in-state.
Allowing a change that doesn’t put centralized authority in a patient’s home state would raise “serious enforcement issues as states do not have interstate policing authority and cannot investigate incidents that happen in another state,” said then-AMA President-elect Jack Resneck during a congressional hearing in March.
Telehealth’s Limits: Battle Over State Lines and Licensing Threatens Patients’ Options | California Healthline
Saturday, August 21, 2021
Wednesday, August 18, 2021
Thursday, July 8, 2021
Thursday, June 17, 2021
Perhaps a trip to your dentist will help your mood. Contrary to what you feel about going to see your dentist for that toothache, it may have a beneficial effect on your mood due to a finding from a limited study. In this study, it turns out laughing gas (Nitrous oxide) may be a treatment for depression that does not respond to other treatments for chronic depression.
Laughing gas has been used to dull pain in dental offices and maternity units for more than a century, and researchers now think the gas, called nitrous oxide, may effectively treat depression when other therapies have failed.
That's according to the results of a small phase 2 clinical trial, published Wednesday in the journal Science Translational Medicine.
About one-third of individuals suffering from depression are at risk for treatment resistance. Whereas inhaled 50% nitrous oxide has early antidepressant effects on individuals with treatment-resistant major depression (TRMD), adverse effects can occur at this concentration. In this phase 2 clinical trial, Nagele et al. studied the effects of a single 1-hour treatment with 25% nitrous oxide on depression symptoms in those with TRMD, finding that this lower concentration had comparable efficacy to 50% nitrous oxide over several weeks but was associated with significantly fewer adverse effects. These results highlight that lower concentrations of nitrous oxide may be a useful treatment for TRMD.
Up to 30 percent of people diagnosed with major depressive disorder don't respond to typical treatments, leaving a significant proportion of patients in need of new treatment options.
"Magic" mushrooms containing the psychedelic compound, Psilocybin
A Phase 2 clinical trial, conducted by researchers in London, was the first randomized trial to compare therapeutic doses of psilocybin — the psychedelic compound found in so-called magic mushrooms — with daily medication. The results were released in The New England Journal of Medicine.
"This is huge because it's showing that psilocybin is at least as good — and probably better than the gold standard treatment for depression," said Roland Griffiths, director of the Center for Psychedelic and Consciousness Research at Johns Hopkins University, who was not involved in the study.
Research on how psychedelics can be used to treat mental health conditions is still in its early stages, and much more will be needed to determine whether psychedelics, including psilocybin, are an effective long-term treatment. It's also still unclear how treatment involving psychedelics would be used in the real world, as patients must be monitored for hours when they are given the drug.
In addition to psychedelic drugs, ketamine an anesthetic drug used for many years for minor procedures is now approved by the FDA for use as a nasal spray.
Spravata, an FDA approved nasal spray containing esketamine
Just what can the drugs do? A single treatment with psilocybin has been shown to relieve crippling anxiety in people with terminal cancer. The drug has also been shown to be an effective therapy for substance use disorders. MDMA can provide valuable help to people suffering from post-traumatic stress disorder (PTSD).
And there’s more. Preliminary evidence suggests that psychedelic drugs can be effective for eating disorders, obsessive-compulsive disorder, and major depression — including cases that don't respond to conventional antidepressants.
The drugs may also be good for helping smokers kick the habit, a process that's often notoriously difficult via conventional means.
Wednesday, May 26, 2021
Digital Health Passes in the Age of COVID-19: Are “Vaccine Passports” Lawful and Ethical? | Law and Medicine | JAMA | JAMA Network
As the rate of Covid 19 decreases behold thresholds social distancing will be discontinued as well as masking. Some venues may require masking and vaccination to enter. Some are planning to use a vaccine passport to screen entrants to large venues. Questions arise as to the legality of this being required.
With the use of smartphone apps or even a printed vaccination. card, much like the yellow one we used as children, it will be easy to carry your vaccine passport where ever you go.
Smartphone app developers are already in the process of having these available on the Google Play Store
Once you activate your passport, a quick flash of your phone (QR code) will be your entry ticket to large sporting events or other large gatherings.
As COVID-19 vaccination rates in high-income countries increase, governments are proposing or implementing digital health passes (DHPs) (vaccine “passports” or “certificates”). Israel uses a “green pass” smartphone application permitting vaccinated individuals’ access to public venues (eg, gyms, hotels, entertainment).1 The European Union plans a “Digital Green Certificate” enabling free travel within the bloc (see eTable in the Supplement). New York is piloting an IBM “Excelsior Pass,” confirming vaccination or negative SARS-CoV-2 test status through confidential data transfers to fast-track business reopenings.2 This Viewpoint examines the benefits of DHPs, scientific challenges, and whether they are lawful and ethical.
Benefits of DHPs
Digital health passes offer health and economic benefits until herd immunity is achieved. By allowing a safe return to a more normal life, DHPs encourage people to be vaccinated. Digital health passes also allow a gradual reopening of the economy in key sectors such as food, retail, entertainment, and travel. Consumers are likely to rejoin recreational and commercial activities if they are confident doing so is safe. Digital health passes offer a less restrictive means to relax COVID-19 preventive measures such as quarantines, business closures, and stay-at-home orders.
Are DHPs Lawful?
Governments have the power to validate and monitor vaccination status while requiring proof of vaccination for access to certain privileges. International law poses few restrictions on DHPs. The International Health Regulations, signed by 196 countries, grant wide discretion to exercise evidence-based public health powers. Article 31 of these regulations specifically allows governments to require “proof of vaccination or other prophylaxis,” while Annex 7 authorizes yellow fever vaccination certificates for international travel.
In the US, individual states hold primary public health powers. States already condition school entry on proof of vaccination. During the COVID-19 pandemic, states and localities have also required masks and social distancing in certain venues. They similarly could authorize or require DHPs, authenticating vaccination status either through public or private digital platforms.
The president has broad power to require vaccination for entry to airports and federal buildings and land, just as President Biden did for masks. However, a federal DHP system would likely require congressional action, and a clear necessity to prevent the interstate spread of infectious diseases. Congress could also allocate funding for state DHPs, even conditioning further COVID-19 relief spending on state adoption of DHPs.
Government DHPs must navigate constitutional and civil rights constraints. While the Supreme Court grants public health agencies wide discretion, it is more protective of First Amendment freedoms, including religion, speech, and assembly. The Court has struck down COVID-19 public gathering restrictions as applied to houses of worship. The Court would likely subject government-run DHPs to high-level scrutiny if they prevented unvaccinated individuals from attending religious services or infringed other constitutionally protected rights.
The private sector has a particular interest in ensuring that employees and customers are vaccinated because it facilitates a return to social and commercial activities. Businesses could rely on government-run or proprietary DHPs. The Equal Employment Opportunity Commission (EEOC) issued guidance on SARS-CoV-2 vaccinations, which applies to any vaccine “approved or authorized by the Food and Drug Administration,” suggesting that employers could require vaccinations even under an Emergency Use Authorization.
The EEOC allows employers to require SARS-CoV-2 vaccination to return to the workplace, thus ensuring employees do “not pose a direct threat to health or safety.”5 Employers also can use DHPs for proof of vaccination. Businesses can require employees to “provide proof they have received a COVID-19 vaccination.” Requiring a proof of vaccination, moreover, does not violate the Americans With Disabilities Act or the Genetic Information Nondiscrimination Act. However, employers should caution employees “not to provide any medical information as part of the proof.”
Digital health passes also would be unlikely to violate privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA). Employers typically are not “covered entities” under HIPAA. Digital health passes could actually be advantageous because they provide proof of vaccination without sharing any other medical information.
Although employers may require proof of vaccination, they must abide by civil rights law. Thus, employers, whenever possible, should afford persons with disabilities “reasonable accommodations,” such as through telework. Similarly, employers should provide reasonable accommodations to individuals who hold a “sincere religious belief, practice, or observance.” Some states are considering prohibiting private-sector use of DHPs, but courts may decide whether they have the legal authority to do so.
Ethics and Equity
As long as there is supply scarcity, DHPs would unfairly exclude individuals who cannot access vaccines. Yet once everyone can gain access to vaccines, there is a strong ethical justification for DHPs designed to create safer environments to work, shop, recreate, and travel, as they represent a less restrictive alternative to current public health measures.6 Unvaccinated individuals have no right to impose risks on others, thus impeding a return to normal activities. Digital health passes therefore must be fully and equally available to all members of society, including the most disadvantaged people. Individuals who cannot be vaccinated for medical reasons also should not be excluded from DHP privileges. Consideration should also be given to granting exemptions for genuine religious or conscientious objections.
Health disparities based on race have been a persistent challenge. Black and Hispanic individuals in the US have had a significantly lower uptake of SARS-CoV-2 vaccines compared with the overall population.7 Racial minorities’ historic distrust of the health system should not disqualify them from economic and social opportunities. Governments should amply fund community-based outreach to encourage vaccine uptake.
Governments or airlines could soon introduce “vaccine passports” to facilitate international travel. Yet requiring proof of vaccination as a condition of travel would unfairly burden most low- and middle-income countries, which may lack adequate doses to fully vaccinate their populations for several years. Approximately 70 countries have not even begun vaccination campaigns, including most sub-Saharan African nations. COVAX, the global vaccine facility, aims to vaccinate only 20% of lower-income populations by 2022. Compounding the unfairness, high-income countries have contributed to supply scarcity by signing advance purchase agreements with vaccine companies. High-income countries could help ameliorate inequities through funding and donating vaccine doses to COVAX while building manufacturing capacities in low- and middle-income countries, including technology transfer.8
Digital health passes could become an important vehicle for a rapid return to commerce, recreation, and travel. To ensure their success, they must be scientifically well-grounded and the least restrictive alternative. Above all, DHPs must be administered equitably, ensuring that everyone has a fair chance to return to a normal life.
Scientific and Technical Challenges
Digital health passes involve considerable scientific and technical challenges, including variable effectiveness by vaccine type, effectiveness in preventing transmission, the durability of immunity, and the emergence of variant strains. Currently, the overall efficacy of 6 SARS-CoV-2 vaccines, mRNA-1273 (Moderna/NIAID), BNT162b2 (Pfizer-BioNTech), Ad26.COV2.S (Janssen/Johnson & Johnson), ChAdOx1 nCoV-19 (University of Oxford/AstraZeneca), Gam-COVID-Vac/Sputnik V (Gamaleya Research Institute of Epidemiology and Microbiology), and BBIBP-CorV (Sinopharm/Beijing Institute of Biological Products), authorized for use in select countries, ranges from 65.5% to 94.6% in preventing symptomatic COVID-19 based on published clinical trial data. Each vaccine could have variable effectiveness against currently circulating and future SARS-CoV-2 variants. Considerable variability in vaccine effectiveness in preventing symptomatic disease could affect the usefulness of DHPs. If DHPs were limited to only certain vaccine products, it would also exacerbate inequities based on access to particular vaccines.
The duration of protection afforded by SARS-CoV-2 vaccines is uncertain. Coronavirus infections, such as from the 2002-2004 SARS-CoV-1 outbreak, generally afford limited protection for 1 to 2 years.3 Reinfection with SARS-CoV-2 has occurred, albeit rarely. Yet there is limited evidence of vaccine-induced immunity beyond limited follow-up of clinical trial participants. Waning vaccine immunity will be better understood with follow-up of clinical trial participants, along with observational studies. Digital health passes should include dates of series completion to determine expiration once longevity of vaccine protection is better defined.
Digital Health Passes in the Age of COVID-19: Are “Vaccine Passports” Lawful and Ethical? | Law and Medicine | JAMA | JAMA Network
at May 26, 2021
Friday, May 14, 2021
Vaccination has made a tremendous difference decreasing serioius illness and hospitalization.
The Good News
The Cleveland Clinic on Tuesday released a study showing that 99.75% of patients hospitalized with COVID-19 between Jan. 1 and April 13 were not fully vaccinated, according to data provided to Axios.
Why it matters: Real-world evidence continues to show coronavirus vaccines are effective at keeping people from dying and out of hospitals. The Pfizer-BioNTech and Moderna vaccines have been found to be 95% and 94% effective, respectively, at preventing symptomatic infections.
Details: The study also looked at 47,000 Cleveland Clinic employees who had received one shot, both shots or no shots at all.
The Cleveland Clinic found that 99.7% of its employees who were infected with the coronavirus were not vaccinated, and 0.3% of infections occurred in those who were fully vaccinated.
The study found that in this group, mRNA vaccines were more than 96% effective in protecting against coronavirus infections.
Vaccines are complicated. Here’s what you need to know about how they work to prevent deadly diseases; the different kinds of vaccines; and why herd immunity matters.
3. Fauci: U.S. could achieve herd immunity by fall if vaccine rollout goes to plan
The Bad News
Despite the paradigm shift in vaccine manufacturing which involved an entirely new process using messenger RNA, several things diminished the rollout of the covid19 vaccine.
A coincidental major national election intensified disagreements between political parties who are already deeply divided on most things. An "infodemic" of misinformation and disinformation has helped cripple the response to the novel coronavirus.
Why it matters: High-powered social media accelerates the spread of lies and political polarization that motivates people to believe them. Unless the public health sphere can effectively counter misinformation, not even an effective vaccine may be enough to end the pandemic.
How to protect yourself in the infodemic?
Driving the news: This month the WHO is running the first "infodemiology" conference, to study the infodemic of misinformation and disinformation around the coronavirus.
What they're saying: While fake news is anything but new, the difference is the infodemic "can kill people if they don't understand what precautions to take," says Phil Howard, director of the Oxford Internet Institute and author of the new book "Lie Machines."
Beyond its effect on individuals, the infodemic erodes trust in government and science at the moment when that trust is most needed.
A study by the Reuters Institute found 39% of English-language misinformation assessed between January and March included false claims about the actions or policies of authorities.
The infodemic has spread nearly as widely as the pandemic itself in the U.S.
As early as March, about half of surveyed Americans reported they had encountered at least some completely made-up news about the pandemic.
38% of Americans surveyed by Pew in June said that compared to the first couple of weeks of the pandemic, they found it harder to identify what was true and what was false about the virus.
In that same survey, roughly a third of Americans exposed to a conspiracy theory that the COVID-19 outbreak was intentionally unleashed by people in power said that they saw some truth in it.
How it works: Misinformation and disinformation have always been a destabilizing feature of infectious disease outbreaks. But several factors have made the situation worse with COVID-19.
An evolving outbreak: COVID-19 is new, and as scientists have learned more about the virus, they've had to change recommendations. That's how science works, but "if you're distrustful of authorities, an expert taking a position different than it was three days ago just confirms your bias," says Joe Smyser, CEO of the Public Good Projects.
Social media: While experts give some credit to companies like Facebook and Twitter for their efforts to stem the spread of coronavirus misinformation, the reality is that platforms built on engagement will often end up as conduits of conspiracy content, which Howard notes tends to be unusually "sticky." A review by the Reuters Institute of 225 pieces of misinformation spread by political figures and celebrities made up only 20% of the sample but accounted for 69% of engagement.
Disinformation warfare: In June, the European Commission issued a joint communication blaming Russia and China for "targeted influence operations and disinformation campaigns around COVID-19 in the EU." And those campaigns are effective — in a recent study, Howard found disinformation from Russian and Chinese state sources often reached a bigger audience on social media in Europe than reporting by major domestic outlets.
Political and media polarization: "In our hyper-polarized and politicized climate, many folks just inherently mistrust advice or evidence that comes from an opposing political party," notes Alison Buttenheim of the University of Pennsylvania School of Nursing. Conservatives are particularly vulnerable — an April study found Americans who relied on conservative media were more likely to believe conspiracy theories and rumors about the coronavirus.
Public health experts must take an active role in combating the infodemic, says Timothy Caulfield, research director of the University of Alberta's Health Law Institute.
One example is the "Nerdy Girls," an all-female team of experts who spread accurate information about the pandemic on social media in a way that aims to "engender trust," says Buttenheim, one of the group's members.
(Who are the Nerdy Girls ?) Those Nerdy Girls, a volunteer team of female PhDs, MDs, and DOs curating COVID-19 content for the greater good. We love facts. For educational purposes; nothing here substitutes for advice from your healthcare provider. Stay safe, stay sane.
Individuals can do their part by practicing information distancing as well as social distancing. "If you can just nudge people to pause before they share on social media, you can actually decrease the spread of misinformation," says Caulfield.
Study: 99.75% of hospitalized COVID-19 patients weren't vaccinated - Axios: The study found that 0.3% of infections occurred in people who were fully vaccinated.
at May 14, 2021
Wednesday, May 12, 2021
At the beach, Pacific Beach, San Diego
As usual, especially along either the left or right coast or the river or lake, young people head to the beach to picnic swim, surf, sunbathe, or just plain relax this summer vaccination will be offered to young people. Now that the FDA has approved Covid 19 vaccination for 12-15 year olds.
The F.D.A.’s authorization of Pfizer’s Covid shot for 12- to 15-year-olds is a milestone in battling the coronavirus, but actually getting them vaccinated involves new challenges.
Even more incentives could include a free joint (with parental permission). Let's face it almost all kids have tried marijuana or want to try it. Marijuan is no. longer consiered a 'gateway drug"The scientific risk of a joint is far less than contracting covid, or at least equal. (my own personal opinion) and not to be taken as medical advice. Public health concerns should outweigh other issues.
Any parent knows this age group is particularly independent, contrary and unlikely to go to a public health vaccination site. In addition this group does not drive, in the no mans land of pubescence and adulthood. Peer pressure and conformance with their peers is an overriding feature of this age group. Wanting to belong is almost the only personal objective of teenagers.
Other possible venues for vaccination are music festivals, pop concerts, sporting events. Go to where they are decreases the likelihood young people will avoid the 'shot'.
Colorado River, a favorite place on the California Arizona Border
To Vaccinate Younger Teens, States and Cities Look to Schools, Camps, Even Beaches - The New York Times
at May 12, 2021