What We Know:
- Aducanumab, also known as Aduhelm, is the first drug approved by U.S. regulators targeted at Alzheimer’s in 20 years. Over six million Americans live with Alzheimer’s, which is the most common form of dementia, and it is predicted that the number will be closer to 13 million by 2050.
- Aduhelm focuses on the brain’s deterioration of those with the disease and not just the symptoms that come along with it. It is a “monoclonal antibody administered via a monthly infusion” and targets the amyloid protein that accumulates in patients’ brains and is said to cause progressive dementia.
Harry Johns, CEO of the Alzheimer’s Association, stated, “this approval allows people living with Alzheimer’s more time to live better. For families it means being able to hold on to their loved ones longer. It is about reinvigorating scientists and companies in the fight against this scourge of a disease. It is about hope.”
- Biogen halted production of the drug in May 2019 due to reports of it not being beneficial to those with Alzheimer’s. After months of further research and the backing of the FDA, the company re-started production on the highly anticipated drug. However, a group of experts has stated the FDA refused to endorse the drug due to a lack of “convincing data” and a high price tag.
- The push for Aduhelm came from advocacy groups and those living with the life-threatening disease. Jenny Knap, 69 with mild cognitive impairment, has been receiving the drug for about a year as part of the clinical trial, and stated: “I can’t say if I noticed it on a daily basis, but I do think overall, I’m doing much better in terms of looking for where my glasses are…things like that.”
- According to POLITICO, since the approval went through the FDA’s accelerated approval process, Biogen has to conduct a new clinical trial. If the company doesn’t finish by the given deadline, then the FDA can discontinue the drug. Despite the agency acknowledging that they still have to work to do and that the benefits outweigh the harms, some medical professionals still aren’t convinced.
David Knopman, a clinical neurologist at the Mayo Clinic, stated: “I’m worried about the inconclusiveness of the current data and the possibility that the effect the drug showed in those two trials was no better than no treatment.”
Biogen is said to bring in billions of dollars with the production of Aduhelm. The company promises the drug will be financially accessible to those who need it, despite the wholesale cost being about $4,312 per infusion, making the annual cost around $56,000 for a high dose.
Keystone XL Pipeline Project Cancelled
Developer TC Energy terminated the project Wednesday after failing to persuade President Biden to reverse his permit cancellation from January.
What We Know:
- Former President Donald Trump gave the project a green light after stagnation from the Obama administration. Construction began last year on the 1,200-mile pipeline that would have moved 35 million gallons of crude oil daily. The pipeline would have connected Nebraska to other pipelines on the Gulf Coast.
- Biden canceled the border-crossing permit on his first day in the White House, which has been considered a win for activists. Concerns that burning oil sands crude could make climate change effects worse or harder to reverse were a major part of the decision.
- TC Energy warned that this decision would lead to the layoff of thousands of union workers. Attorney generals from 21 states went on to sue to overturn Biden’s decision as the pipeline would have created thousands of construction jobs. Robin Rorick, Vice President of midstream and industry operations at the American Petroleum Institute, stated, “This is a blow to U.S. energy security and a blow to the thousands of good-paying union jobs this project would have supported.”
- The Canadian government had invested more than $1 billion into the project. Prime Minister Justin Trudeau objected to Biden’s decision which has caused tension between the U.S. and Canada. Alberta officials reached an agreement with TC Energy to exit the deal and they plan to try and recoup the investment.
- Activists are counting this as a major win in their fight for environmental justice. A lot of credit is being given to indigenous communities that have engaged in this fight for years. “We stood hand-in-hand to protect the next seven generations of life, the water, and our communities from this dirty tar pipeline,” the Indigenous Environmental Network said in a statement.
Biden’s decision to revoke the permit aligns with the environmental initiatives of his administration. David Turnbull, Strategic Communications Direction at Oil Change International, said, “The cancellation of Keystone XL is a reminder that this project was never needed and never in public interest, and that it is time for the fossil fuel era to rapidly come to a close.”
France, Belgium Ease Virus Curbs
On Wednesday, France and Belgium announced they would begin easing their COVID-19 restrictions; the countries would do this by allowing cafes and restaurants to serve indoors, dropping overnight curfews, and more.
What We Know:
- The two nations’ leaders made the announcements, respectively. France’s Emmanuel Macron took to Twitter for his declaration. In his tweet, he emphasized the French citizens’ longing to return to normalcy while also advising people to continue following precautions. French people may now enjoy outdoor dining and stay out past 11 P.M. Additionally, Macron intends on removing the overnight curfew by June 30.
Nous y sommes !
S’asseoir à la table d’un restaurant.
S’évader le temps d’un spectacle.
Vibrer à l’unisson dans des gradins.
Retourner à la salle …
Cette vie nous avait tant manqué !
Pour que cette reprise soit durable, continuons à respecter protocoles et gestes barrières.
— Emmanuel Macron (@EmmanuelMacron) June 9, 2021
- Belgium’s Prime Minister Alexander De Croo stated the country will now permit parties of up to four people to dine indoors. Indoor events can now function with no more than 200 people, or 75% capacity. Furthermore, their work-from-home mandate is still in effect, but employees may request to spend one day in the office. Employers may accept this request as long as larger offices maintain a daily capacity of 20% of workers.
- The vaccine rollout across Europe facilitated the newfound lenience. Across the continent, nations are encouraging their subjects to get vaccinated in an attempt to “strike a balance” between public health and reviving industries. Europe wants to renew tourism across the continent, as pandemic travel restrictions devastated the sector the most.
Parliament gives its final green light to the EU Digital Covid Certificate to facilitate travel within the EU and contribute to the economic recovery. Press release → https://t.co/Lx4eAAL4h0 pic.twitter.com/dKMyiwqYui
— European Parliament (@Europarl_EN) June 9, 2021
- To boost travel, the European Parliament voted on Wednesday to approve the Digital Covid Certificate. The new document will permit those who received the vaccine, tested negative, or recently recovered from COVID-19 to travel across the European Union (EU) countries.
Currently, Bulgaria, Croatia, the Czech Republic, Denmark, Germany, Greece, Lithuania, Poland, and Spain already issued millions of certificates to EU residents.
Judge Overturns California’s Assault Weapons Ban
US District Judge Roger Benitez deemed the 32-year-old California Assault Weapons Ban unconstitutional in a 94-page decision. The reasoning Benitez applied has come into question by experts.
What We Know:
- Benitez was nominated in 2004 by President Georgia W. Bush. Despite being overwhelmingly opposed by the American Bar Association, the Senate confirmed him on a 98-1 vote. The ruling stems from a 2019 lawsuit filed by James Miller and the San Diego County Gun Owners, who alleged that the 1989 ban violates their Second Amendment rights.
- In his decision, he likened the AR-15 to a Swiss Army Knife. He also claimed that studies prove that the harm of an assault rifle being used in a mass shooting is “infinitesimally rare.” He further affirmed that more people have died from the COVID-19 vaccine than mass shootings in California. None of these claims were accompanied by evidence.
- California has had more than a dozen mass shootings this year, and since 2017 more than 50 people have died from mass shootings in the state. The CDC has investigated 4,900 reports of post-vaccine deaths and has been unable to find a causal link.
- Benitez did cite an emergency room physician’s testimony and wrote that injuries from AR-15’s are no different from other legal firearms. Dr. Heather Sher, a radiologist who treated Parkland shooting victims, stated, “Handgun injuries to the liver are generally survivable […] An Ar-15 bullet wound to the middle of the liver would cause so much bleeding that the patient would likely never make it to the trauma center to receive our care.”
- He has made other rulings in the gun control debate, such as tossing out the 10 round magazine limit and the use of background checks for ammunition sales. A rule in Southern California has established that cases go to judges with prior experience with the issue, which is how this case ended up with Benitez in the first place.
- There is potential for this case to come before the Supreme Court, which is now overwhelmingly conservative due to the former administration. It could be used in the battle to overturn regulatory measures and rule that banning military-style weapons is unconstitutional.
The current ban will stay in place until the appeals court hands down the final ruling to the entire state. Benitez has enacted a 30-day stay so Attorney General Rob Bonta can file an appeal. Law Professor Jessica Levinson at Loyola Marymount University stated, “I think it’s incredibly problematic when a federal judge quotes things that are factually incorrect because it hurts the integrity of the branch.”
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