Trump’s Coronavirus Cavalcade: October 7, 2020

Donald Trump leaves the hospital to wave to followers (photo: public domain)
In this edition of Donald Trump’s Coronavirus Cavalcade: • After little-to-no effort to assauge the coronavirus in the White House working environment other than testing (that clearly failed), staffers have been instructed to wear full PPE gear when closely interacting with Donald Trump reports the New York Times. Even so, there are conflicting accounts as to whether Trump is working from the White House residence or in the Oval Office. • The FDA has issued guidance recommending that participants in late-stage coronavirus vaccine clinical trials be followed for at least two months after the final injection to ensure safety and boost public trust in any approved vaccine. • Trump adviser Stephen Miller is the most recent high-level White House adviser to test positive for the coronavirus. Additionally, one of Trump’s military aides who carries the ‘nuclear football’ has tested positive as well. • Speaking of the ‘nuclear football,’ due to the medications Trump has received to treat coronavirus (including dexamethasone, which can cause mood swings and “frank psychotic manifestations”), the Bulletin of Atomic Scientists has issued a statement saying “we should not entrust nuclear launch authority to someone who is not fully lucid.” • After more than a dozen White House staffers have tested positive for coronavirus, Vice President Mike Pence’s team has finally agreed to allow plexiglass barriers between himself and Democratic vice-presidential candidate Kamala Harris at tonight’s veep debate in light of the rash of positive cases within the White House. • Donald Trump announced that he ordered Republicans to end negotiations for further coronavirus stimulus for Americans because some of the money would go to ‘Democrat’ states. Pssst, most of those states send the largest portion of tax dollars to the federal government. Oh, and blue state folks are Americans, too. 

FDA Withdraws Emergency Use Authorization Of Hydroxychloroquine For COVID-19

The first confirmed case of the omicron variant in the U.S. has been discovered in California.

The FDA has pulled the emergency authorizations for using hydroxychloroquine for treating COVID-19 due to concerns about effectiveness and safety. Donald Trump has spent the past couple of months heralding the drug as a miracle treatment for the novel coronavirus. Via Politico:

The Food and Drug Administration on Monday withdrew emergency use authorizations for two coronavirus treatments promoted by President Donald Trump despite concerns about their safety and effectiveness.

The agency revoked the authorizations for hydroxychloroquine and chloroquine after a request from Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority.

After reviewing new information from large clinical trials the agency now believes that the suggested dosing regimens “are unlikely to produce an antiviral effect,” FDA chief scientist Denise Hinton said in a letter announcing the decision.

Critics have accused the agency of caving to political pressure when it authorized use of hydroxychloroquine and chloroquine in hospitalized Covid-19 patients in late March despite thin evidence.

More recent randomized controlled trials have found the drugs do not benefit coronavirus patients, and doctors have reported that hydroxychloroquine can cause heart problems.

FDA To Authorize Emergency Use Of New Drug After ‘Optimistic’ Signs

The New York Times reports the F.D.A. is expected to authorize as early as Wednesday Gilead Sciences’ experimental anti-viral drug remdesivir for emergency use in treating patients with Covid-19. Dr. Anthony S. Fauci, the federal government’s leading infectious diseases scientist, told reporters a trial study overseen by the National Institutes of Health showed clear signs the drug could make a difference in speeding up the recovery of some patients.

Dr. Fauci said the federal trial indicated that the drug remdesivir could shorten the time to recovery by about a third. “Although a 31 percent improvement doesn’t seem like a knockout 100 percent, it is a very important proof of concept because what it has proven is that a drug can block this virus,” Dr. Fauci said. “This is very optimistic.”

In a statement, Gilead Sciences said it was “aware of positive data emerging from” the study by Dr. Fauci’s institute, known as NIAID. “We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing.”

Remdesivir is not yet licensed or approved in the United States or anywhere in the world “and has not yet been demonstrated to be safe or effective for the treatment of Covid-19,” according to Gilead.

Remdesivir has never been approved as a treatment for any disease. It was developed to fight Ebola, but results from a clinical trial in Africa were disappointing.

FDA Approves ‘Quick Result’ Coronavirus Test

The Washington Post reports the FDA has approved a new “rapid result” coronavirus test that can deliver results in 45 minutes.

The FDA granted “emergency use authorization” to Cepheid, a California company that makes a rapid molecular test for the coronavirus. Getting results in 45 minutes would be far quicker than the current situation in which tests typically are sent to central reference labs that can take days to deliver results.

The FDA authorization covers “patient care settings,” including doctors’ offices, but initially will be used primarily by hospitals and emergency departments, the company said.

The specimen can be collected either by a nasal swab or by a saline wash using a small catheter. Neither is particularly comfortable, but the advantage of the wash is that it doesn’t require swabs, which are in short supply.

Legal Age For Smoking Officially Raised To 21

(image via Luka Malic/Unsplash)
The Food and Drug Administration (FDA) has officially raised the legal age to buy tobacco products in the United States from 18 to 21, reports The Hill.

The move applies to all tobacco products, e-cigarettes and vaping cartridges, and comes after President Trump last week signed a $1.4 trillion spending package that included a measure raising the tobacco-buying age.

Initially, it was unclear when the age change would take effect. The FDA had six months to amend their policies after Trump signed the bill into law and then 90 days to put the change in place.

However, the FDA said in a message posted on its website that the change is now in effect.

Red Cross Asks FDA To Lower Blood Donation Restrictions For Gay/Bi Men

France has lifted its ban on blood donations by gay and/or bisexual men which has been in place since the early days of the HIV/AIDS epidemic.

A young man donates blood (image via Depositphotos) The American Red Cross has issued a statement urging the Food and Drug Administration (FDA) to reduce the restrictions for gay and bisexual men to give blood. The Red Cross is asking the FDA to “consider reducing its deferral time for men who have sex with men (MSM) from twelve to three months.” Currently, gay and bisexual men are prohibited from donating blood if they have had sexual contact with another man within the past 12 months. That policy, begun in December 2015, replaced a decades-old regulation banning MSM and transgender women from donating blood at all. The Red Cross calls its suggested revision of current policy a “scientifically-based interim step” while further options are evaluated. The statement notes a 3-month policy would be consistent with other leading countries like Great Britain and Canada. The health organization also recommends “expanded use of new technologies to work toward the elimination of donor eligibility questions that would no longer be necessary.” Underscoring a commitment to “ensure that every blood recipient receives safe, lifesaving blood,” the statement declares that donating blood “should not be determined by methods that are based upon sexual orientation.” “We are committed to working toward achieving this goal,” adds the Red Cross. In a statement to NewNowNext, the FDA characterized the current 12-month ban as “a behavior-based policy, not one based upon sexual orientation.” The FDA’s statement goes on to note that the 2015 policy change was prompted, in part, by reviewing studies in blood donors which “showed that a history of male-to-male sexual contact was associated with a 62-fold increased risk for being HIV positive, whereas the increase in risk for a history of multiple sexual partners of the opposite sex in the last year was 2.3-fold.” The FDA added, “While acknowledging at the time that the change to a 12-month deferral was less than hoped for by some, the FDA considered this to be a first step in the process of evaluating and progressing its blood donor deferral policies for all donors.” I’ve been asked in the past what would happen if a gay man who is undetectable were to donate blood? I’m not a doctor, but some thoughts: The first thing that comes to mind is when you donate you’re asked if you’ve had sex with a man in the past 12 months. If you say yes, they won’t let you donate. If you fib, the blood will be tested and could be found to have HIV antibodies. You might be contacted by health officials to inquire if you were aware you’re positive. “Undetectable” is generally defined as less than 40 copies per ml, while under 200 copies per ml is considered “viral suppression.” According to the CDC, “a person with HIV who takes HIV medicine as prescribed and gets and stays virally suppressed or undetectable can stay healthy and has effectively no risk of sexually transmitting HIV to HIV-negative partners.” During sex, only small amounts of blood and semen are exchanged which is why U=U. But in blood transfusions, a lot of blood is being transferred. So I would imagine it’s possible some amount of virus – however tiny –  could be transferred. The issue I have with the FDA’s blood policy is sexually active HIV-negative gay men can’t donate, but a woman who might have unprotected sex with several partners can. It’s about the stigma attached that the current policy furthers. Plus, all donated blood is tested for a multitude of possible issues. So, I don’t see why a sexually active gay man who is HIV negative couldn’t be allowed to donate. For more information about the current blood donation policy in the U.S., check out this Q&A on the FDA’s official site. (source: Red Cross, NewNowNext)

News Round-Up: January 9, 2019

Some news items you might have missed:

• I’m not sure if I should caption this photo (above) from InstaHunk Joel Green in Bali “Strike a pose” (Joel) or “What are you looking at?”(his scene partner).

• Just as Colorado has sworn in Jared Polis as the first openly gay governor of a state, the Denver city council voted unanimously on Monday to ban so-called ‘conversion therapy’ for minors.

• Actor Timothée Chalamet has added to his growing reputation as an LGBTQ fan favorite by giving $1,000 to New York’s LGBT Community Center live on the Golden Globes red carpet.

• Thanks to the Trump shutdown, the FDA has stopped most food safety inspections. Feel safer?

• The Coast Guard Support Program has issued a five-page tip sheet on how to financially cope with a long U.S. government shutdown. The suggestions include: consider holding a garage sale, babysitting, dog-walking or serving as a “mystery shopper.”

• North Carolina just lost more revenue thanks to its anti-LGBTQ laws. Netflix has nixed the idea of shooting a new series, titled OBX, in the state. The production is expected to spend $60 million in whatever state Netflix eventually chooses.

• It may be hump day, but chill a bit with the latest single from VanJess, “Another Lover.”

I like the ebb and flow of the song, as well as the video’s visual change-ups from choreography to minimalist trance vibe.

FDA To Adjust Blood Donation Policy For Gay/Bisexual Men

According to the Associated Press, the Food and Drug Administration has decided to change it’s decades-old policy for banning blood donations from gay or bisexual men.

The new policy will allow gay/bisexual men to donate as long as they haven’t had sex with a man in the past 365 days. This would be more in line with other countries like the United Kingdom and Australia.

Activists say the change is definitely a step in the right direction, but still falls short.

From the Human Rights Campaign:

“This new policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply,” said David Stacy, HRC’s Government Affairs Director.

“While it’s a step in the right direction toward an ideal policy that reflects the best scientific research, it still falls far short of a fully acceptable solution because it continues to stigmatize gay and bisexual men. It simply cannot be justified in light of current scientific research and updated blood screening technology.

“We are committed to working towards an eventual outcome that both minimizes risk to the blood supply and treats gay and bisexual men with the respect they deserve.”