(Reuters) – The U.S. Food and Drug Administration on Monday revoked the emergency use authorization for malaria drug hydroxychloroquine as a treatment for COVID-19, the use of which has been championed by U.S. President Donald Trump.
The FDA said based on new evidence, it was no longer reasonable to believe that oral formulations of hydroxychloroquine and the related drug chloroquine may be effective in treating the respiratory illness caused by the novel coronavirus.
The move comes after several studies of the drug suggested it was not effective, including a widely anticipated trial earlier this month showed it failed to prevent infection in people who have been exposed to the virus.
In March, Trump said hydroxychloroquine used in combination with the antibiotic azithromycin had “a real chance to be one of the biggest game changers in the history of medicine”, with little evidence to back up that claim.
He later said he took the drugs preventively after two people who worked at the White House were diagnosed with COVID-19.
Reporting by Manas Mishra in Bengaluru; Editing by Shinjini Ganguli
Former Government Officials Say Cannabis Rescheduling Would ‘Supersize’ The Industry
Former DEA chiefs and retired White House drug czars are expressing concerns over the possible cannabis rescheduling. In a letter addressed to U.S. Attorney General Merrick…
Former DEA chiefs and retired White House drug czars are expressing concerns over the possible cannabis rescheduling. In a letter addressed to U.S. Attorney General Merrick Garland and DEA administrator Anne Milgram, the 11 ex-officials argued that reclassifying marijuana would “supersize” the industry through tax relief and normalization, reported Marijuana Moment.
The news comes some six weeks after Health and Human Services (HHS) Secretary Xavier Becerra confirmed his agency had responded to President Biden’s directive to provide cannabis rescheduling recommendations to the DEA. Becerra wrote to Milgram calling for marijuana to be reclassified as a Schedule III drug under the Controlled Substances Act (CSA).
Now, former DEA administrators and directors of the White House Office of National Drug Control Policy are basically recommending the DEA disregard the HHS’s recommendation.
“Schedule I drugs are those with no accepted medical use. The FDA has not approved marijuana for medical use because no double-blind, published studies show safety and efficacy for raw marijuana; thus, it must remain a Schedule I drug,” wrote six former DEA heads and five White House drug czars.
It is important to note that even though the FDA has not approved marijuana for medical use as yet, it did approve one CBD-based medication called Epidiolex, which is helping control seizures for numerous children suffering from rare forms of epilepsy. What’s more, the Schedule 1 status of cannabis was one of the main reasons why there have not been sufficient clinical trials and research on marijuana’s therapeutic effects and benefits.
‘Supersizing’ The Cannabis Industry
Even though former government officials recognized that cannabis rescheduling as Schedule III does not legalize it nor allow it to be recommended by physicians, they say their main concern is that it would “supersize” the industry.
“Moving marijuana to Schedule III would supersize the cannabis industry in the United States by allowing them to evade IRS Section 280E and deduct business expenses. Not only would this mean that marijuana corporations would be able to deduct expenses for advertisements appealing to youth and the sale of kid-friendly marijuana gummies, but it would also dramatically increase the industry’s commercialization ability,” they wrote.
IRS code 280E stipulates that no deductions or credit be allowed to companies running businesses that sell Schedule I or II controlled substances. Therefore, until cannabis is removed from its outdated classification as a Schedule I drug, no tax deductions or credits will be available to legal cannabis operators.
Signatories to the letter, including Michele Leonhart, Robert C. Bonner, Peter B. Bensinger, R. Gil Kerlikowske, General Barry R. McCaffrey USA (Ret.), William J. Bennett, Karen Tandy, John C. Lawn, John R. Bartels Jr., John P. Walters, and Robert Martinez also raised concerns about criminal penalties.
“Rescheduling marijuana, and thus reducing criminal penalties for marijuana trafficking, removes a key tool federal agents have to prosecute cartels,” they said.
However, Shane Pennington, an attorney who specializes in federal drug policy and litigation against DEA, told the outlet that penalties for various substances are not directly connected to the scheduling status under the CSA. “Unlike other substances where you change the schedule and the criminal penalties change accordingly, for certain substances—marijuana chiefly among them—that is not the case,” Pennington said.
The former officials are not the only ones concerned about HHS’ cannabis rescheduling recommendations. Republican senators recently presented a bill to block cannabis legalization without congressional approval.
The post Former Government Officials Say Cannabis Rescheduling Would ‘Supersize’ The Industry appeared first on The Dales Report.irs white house hhs fda clinical trials medication
Five tips for a sustainable Halloween
Halloween is a sustainability nightmare – but it doesn’t have to be.
Halloween is the spookiest time of the year. However, as you prepare to send shivers down the spines of your friends and family, you may not have given much thought to the environmental footprint that this holiday conceals.
In the UK alone, more than 8 million pumpkins are thrown away each year over Halloween. This amounts to about 18,000 tonnes of pumpkins going to waste that would have been eaten.
But that’s not the extent of it. Halloween has evolved into a commercial money-spinner, with store shelves brimming with plastic costumes, electronic and disposable decorations, and bags of plastic-wrapped sweets – most of which will eventually find their way into landfills after the festivities end.
If you’re looking to partake in the spooky festivities of Halloween, here are five tips to ensure you can give people a good fright without harming the environment.
1. What to do with your pumpkin
Pumpkin carving isn’t just a problem because of food waste, a huge amount of resources – including fuel for lorries and fertilisers – go into producing the mountain of pumpkins that are used over Halloween.
If you do plan on carving a pumpkin this year, make sure you throw it into a food waste bin. Pumpkins that end up in landfill emit methane as they decompose. Methane is a potent greenhouse gas that contributes to climate change.
A better approach may be to forgo the whole pumpkin thing altogether. Instead, consider investing in a reusable decoration (preferably one that’s not made from plastic) or crafting your own creepy creation out of something you already have in your home to put outside your door.
But if you still want to experience the fun of carving a pumpkin, then make sure it isn’t wasted by baking some pumpkin pie, roasting its seeds in the oven, or simply roasting segments of pumpkin as a savoury treat (even the skin is edible).
2. Cut down on buying new
The shops are filled to bursting with Halloween decorations. However, many of these decorations – from cackling witches to vampire bat lights – are electrical. Making these products uses up substantial resources, including endless amounts of copper wiring and some of the rarest materials on the planet, such as lanthanum, an element found in modern television sets, energy saving lamps and optical lenses.
When these decorations are thrown away, they contribute to the growing electrical waste crisis. In 2019, global electrical and electronic waste generation stood at around 54 million tonnes, amounting to around 7.5kg per person. This generation rate is expected to increase significantly in the future.
So consider if you really need to buy new. You may find you already have enough lying around to transform your home into a haunted house. Christmas lights, for example, could double up as a creepy addition to your Halloween decor.
You may also have some other old bits and pieces that you can remake into something suitably spooky. Old dolls can be given unsettling new attire crafted from fabric scraps (although they might be creepy enough by themselves). And bottles can be filled with water and a few drops of food dye to make a collection of witches’ brews.
3. Ditch single-use plastic
We all like being able to hand out some sweet treats to trick-or-treaters. But sweets are often individually wrapped in plastic. Many single-use plastics don’t get recycled and, because plastic doesn’t break down naturally, it can stay in the environment for hundreds of years.
Instead of plastic-wrapped treats, think about getting something in paper packaging. If you have the time, then maybe you could make some sweat treats yourself to hand out.
4. Make your own costume
Most of the Halloween costumes you can buy are made out of plastic. In fact, an investigation by Hubbub, an environmental charity, found that about 83% of the materials used to make the seasonal outfits available at 19 supermarkets and retailers in the UK were plastic.
These outfits not only contribute to the accumulation of plastic in landfills, they are also a source of harmful microplastics. These minuscule plastic particles have been found almost everywhere, including in water sources, marine life, human bodies, and now even in the clouds.
Even if you don’t throw away your costume, tiny plastic fibres are released from the fabric every time you wash it. These fibres ultimately find their way into the environment through the wastewater system.
So ditch the plastic wig and look at what you already own. Old clothes can be torn up to give the look of a horrifying zombie. And, although it may be an old standby, everyone has an old sheet somewhere that can be used as a ghost costume.
5. Less is more
Sustainability is all about leaving the world in a way that future generations can enjoy as good a quality of life as we do. A crucial element in making this future a reality is only using what we need instead of an excess.
So, when making choices about how to have a happy Halloween, think before you consume. Do you need to buy a load of prepackaged food? Or can you make your own pumpkin pie? Do you need to get in a car to go trick or treating? Or can you do it locally on foot?
By following these tips, you can have a fun, freaky – but also sustainable – Halloween.
Alice Brock receives funding from The South Coast Doctoral Training Partnership.uk
Memory in action: what the UK’s official COVID commemoration should look like
Memorialising a pandemic that is still underway is a challenge. Official commemoration needs to be about remembrance and preparedness.
Whether an actual bereavement or a loss of experience, everyone has lost something to COVID. From early on in the pandemic, grassroots memorials sought to acknowledge this collective experience, including the national COVID memorial wall in London and the annual national day of reflection organised by the Marie Curie charity.
The pandemic has affected people in vastly different ways. How governments, institutions and the wider public have responded has varied enormously, too. It is also still ongoing, which complicates things further.
As immunologist Sheena Cruickshank put it recently, “it may feel like we should all be done with COVID-19, but sadly COVID-19 is not done with us”.
My research into memorial culture and modernism shows how the lack of a clear or coherent narrative for an event like a pandemic makes commemorating it that much harder. The official and cultural memory of the 1918 flu pandemic was subsumed into that of the first world war – and it remained largely unremembered, until COVID brought it back to public attention.
Remembrance and preparedness
From October to December 2022, the UK Commission on Covid Commemoration held a six-week period of public consultation. It conducted surveys, garnering 5,000 responses. It also met with affected groups, including bereaved families and long-COVID sufferers, as well as groups that are sceptical about the illness and lockdown strategies.
The report is, to my mind, admirably well considered, sensitive to the difficulties of the task. It firmly establishes why memorialising all deaths that have occurred during the pandemic – COVID-related or otherwise – is necessary. This chimes with previous research that has found that COVID-related grief is particularly difficult and that public commemoration is necessary for social cohesion.
The 11 members of the commission suggest a range of commemorations, which will now be considered for implementation by the British government. These include an annual day of reflection on the first Sunday in March, a new symbol to represent the pandemic, the establishment of a commemoration trust to organise and promote these initiatives, along with a commemoration website and an online book of remembrance.
The commissioners suggest creating ten green spaces across the country, each boasting a sculpture created by local artists. They recommend preserving those grassroots initiatives already in place, including the national COVID memorial wall.
Finally, they propose various educational initiatives. These include teaching the history of the pandemic in schools and college and collating oral histories from a wide range of groups, to, as the report puts it, “serve as a historical record of this period of our time and as an educational tool for future generations”. A postdoctoral fellowship programme is suggested, too, to enable future researchers to work with policy makers on national preparedness for natural hazards.
Most of these recommendations are fairly standard commemorative gestures. The decision to create disparate pockets of remembrance across the UK rather than one large-scale memorial is expected, as there is no consensus or agreed-upon version of the pandemic.
The choice of green spaces is usefully open-ended in terms of meaning. The memorial sculptures destined for each will, doubtless, be similarly open-ended, in keeping with the minimalist, abstract and predominantly secular tendencies in modern contemporary memorials in the UK.
The report also proposes council funding for local commemorative spaces in existing parks or green spaces, not unlike the many community-led first world war memorials.
The COVID symbol the commission suggests is a zinnia flower. Associated with remembrance, this floral design has similarities to the poppy which has long symbolised the first world war.
Large-scale commemorative gestures have already been seen in other nations. Most notably, Joe Biden’s first act as US president was, during his inaugural address, to lead a moment of silence to remember the then 400,000 Americans lost to the pandemic.
By contrast, the UK public has felt left down by its government’s response. The news, that former prime minister Boris Johnson reportedly said, in autumn 2020, that he would rather see “bodies pile high” than impose a third lockdown on the UK, has left a bitter taste.
Johnson’s subsequent clandestine evening trip, in April 2021, to the COVID memorial wall, as well as public scandals such as Partygate, have further angered the public. Bereaved family groups such as COVID-19 Bereaved Families for Justice are understandably anxious to see that their loved ones are remembered officially as names and not as numbers.
The commission is eager to distinguish itself from the contentious COVID-19 Inquiry. This report is a useful corrective to the inadequacies of the British government in commemorating the pandemic to date.
Some may wonder if it is too early to commemorate a pandemic that isn’t yet over. After 1914, nurses began to create memorials as soon as the first deaths happened. The British government established the Imperial War Museum in 1917, while the war was still ongoing. I have shown how necessary these commemorative gestures were. They ensured that the dead were not forgotten.
Whether the government will now do is yet to be seen. In its insistence both on remembrance and on preparedness – for the next pandemic that, experts agree, will happen – this report is a good first step.
Alice Kelly received a British Academy Rising Star Engagement Award from 2017-19 for a seminar series entitled "Cultures and Commemorations of War."deaths lockdown pandemic covid-19 uk
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