Backers of abortion pills warily eye legal challenge

 Reproductive rights advocates are on edge over a lawsuit to revoke the decades-old Food and Drug Administration (FDA) approval of mifepristone, which, if successful, would end legal access to abortion pills nationwide.

Advocates and legal experts say the suit has no merit, but they fear conservative courts will think otherwise.

Abortion pills have become one of the next major fronts in the fight over reproductive health care in the wake of the Supreme Court’s decision overturning Roe v. Wade, and the lawsuit is seen by both sides as the start of the battle to come.

Mifepristone, a drug that blocks hormones necessary for pregnancy, was approved by the FDA in 2000. It is used with a second drug called misoprostol, which causes contractions and essentially induces a miscarriage.

Jenny Ma, senior counsel for the Center for Reproductive Rights, said she anticipates seeing challenges in the courts as well as laws coming out of state legislatures that would either ban medication abortion outright or institute restrictions so significant it may as well be a ban. 

“The anti-abortion activists are pushing the boundaries of what that [Dobbs] decision could lead to,” Ma said. “This does not end with the Dobbs decision, and that there will be so many more restrictions and laws and lawsuits that follow because of it.”

Katie Glenn, state policy director for Susan B. Anthony Pro-Life America, said limiting the availability of abortion pills is a major priority for her organization. They want states to crack down on the ability to order the drugs online and then have the pills shipped across state lines. 

“We see this as a huge danger to American women,” Glenn said. 

In 2020, medication abortion accounted for 54 percent of all pregnancy terminations in the U.S. Since the Supreme Court’s decision overturning Roe v. Wade in June, women have increasingly turned to abortion pills if they need to terminate a pregnancy.

Health officials and major groups such as the American Medical Association and the American College of Obstetricians and Gynecologists say mifepristone is safe and effective.

Mifepristone has been used by more than 3 million women in the United States since FDA approval, the groups said in a June letter to the Biden administration, “and robust evidence exists regarding the safety of mifepristone for medication induced abortion.”

The lawsuit was filed two weeks ago in Amarillo, Texas, by the Alliance Defending Freedom (ADF), a powerhouse conservative legal group that has helped draft and defend states’ anti-abortion laws, including in Mississippi in the case that led the Supreme Court to overturn Roe v. Wade. 

The lawsuit argues the FDA unlawfully fast-tracked the approval of mifepristone through a process intended for treatments of life-threatening illnesses. The group alleged the agency failed to protect the health, safety and welfare of girls and women and never studied the safety of the drugs under the labeled conditions of use.

This lawsuit “is the culmination of decades-long efforts by ADF’s clients to hold the FDA accountable for its irresponsible actions,” the group said. 

The FDA said it does not comment on litigation.

The ADF first filed a citizen petition in 2002 to challenge the FDA’s approval. It was rejected. The group filed another petition in 2016 when the FDA expanded availability of mifepristone and said it was safe to use through the first 10 weeks of pregnancy.

“The FDA never had the authority to approve these dangerous drugs for sale. We urge the court to listen to the doctors we represent who are seeking to protect girls and women from the documented dangers of chemical abortion drugs,” ADF senior counsel Julie Blake said in a statement.

The lawsuit asked for the court to immediately pause the FDA’s approval of the drug while the case proceeds, which would effectively make all medication abortions illegal.

Susan Wood, former assistant commissioner for women’s health at the FDA and current director of the Jacobs Institute of Women’s Health Services at George Washington University, said the ADF’s arguments aren’t valid.

She said the approval process that mifepristone went through more than 20 years ago was appropriate for the time. After approval, the agency put guardrails in place that some even saw as too strict.  

“If a court rules allowing these factually incorrect arguments to go forward … it would put FDA authority at risk, and I think in a fairly serious way,” Wood said.

But the lawsuit was strategically filed in district court in Amarillo, where Judge Matthew Kacsmaryk presides over all new cases. 

Prior to being appointed by former President Trump in 2017, Kacsmaryk was deputy general counsel at the First Liberty Institute, a Christian legal advocacy group.

In that role, he helped businesses fight against contraceptive mandates and represented an Oregon bakery that refused to bake a cake for a same-sex wedding.

Should Kacsmaryk prove to be sympathetic to the ADF’s arguments, the government would likely appeal. The case would go to the 5th Circuit Court of Appeals, which has jurisdiction over Texas, Louisiana and Mississippi.

Abortion has been banned in all three of those states.

https://thehill.com/policy/healthcare/3760312-advocates-warily-eye-legal-challenge-to-abortion-pills/

Merck could keep patent edge by shifting Keytruda cancer drug to simple shot

 U.S. drugmaker Merck & Co hopes to patent a new formulation of its $20 billion cancer immunotherapy Keytruda that can be injected under the skin, allowing it to protect its best-selling drug from competition expected as soon as 2028.

For years Merck has relied on Keytruda to fuel its growth. The treatment, approved in 2014, harnesses the body's own immune system to fight cancers with dramatic results. Against advanced lung cancer, it has led to a five-year survival rate in about one-quarter of people compared to 5% of people historically.

But the key patents on Keytruda will begin to expire in 2028, opening the door to biosimilars - near copies of expensive biologic drugs whose complex molecules cultivated inside living cells make it impossible to manufacture exact copies.

Merck is testing in clinical trials two versions of the drug that can be injected subcutaneously, a quick alternative to infusions, the current delivery method in which patients receive an intravenous drip in a health office once every three or six weeks. The company reported early data from one of those trials last year.

While Merck has disclosed that it is developing subcutaneous versions of Keytruda, it has not previously said that it expects the new formulation to become the most widely used version of the drug after it is rolled out and an engine for growth toward the end of the decade.

If successful, Merck could begin marketing the new formulation within a few years, a top Merck executive told Reuters. It expects it to fuel Keytruda's growth as it gains approvals in earlier stage cancers. Keytruda now accounts for more than one-third of Merck’s sales.

"We believe that subcutaneous formulation has the potential to be novel, non-obvious and useful, which means we would get a new patent for it," Merck CFO Caroline Litchfield said in an interview, using the terminology for the criteria under U.S. law to determine what technologies merit a patent.

https://www.yahoo.com/now/merck-could-keep-patent-edge-111346733.html

TikTok trend of taping mouth shut for weight loss and better sleep could SUFFOCATE you

 Doctors are warning against the latest bogus TikTok health hack that involves taping your mouth shut before bed to lose weight.  

Videos on TikTok extolling the benefits of mouth taping have amassed hundreds of thousands of views. One such benefit, according to mouth tape manufacturer Somnifix, is that forcing yourself to breathe through the nose only promotes fat loss. 

Proponents also claim it improves airflow, relaxes the body, stops snoring and helps people stay asleep.

Dr Raj Dasgupta, a sleep specialist at the University of Southern California, said mouth taping at worst could lead to obstructed breathing and suffocation, explaining  that 'if you have obstructive sleep apnea, yes, this can be very dangerous'. 

Mouth taping is the latest TikTok trend to catch fire despite warnings from healthcare professionals.  

Doctors recently warned against a similar viral trend called 'vabbing,' which involves smearing vaginal fluid behind the ears and neck, which proponents claim increases the chance of attracting men, by spreading their pheromones. 

Dr Dasgupta told CNBC: 'There is limited evidence on the benefits of mouth taping and I would be very careful — and even talk to your health care provider before attempting it.'

Some mouth tape users report having more energy in the hours after waking as a result of their improved sleep quality. 

Experts fear that taking part in the trend can harm the 22million Americans who suffer from sleep apnea - a condition where breathing repeatedly stops and starts at night.

It can occur when the relaxation of a person's throat muscles while sleeping obstructs airways, or when the brain does not properly send signals to the body to continue breathing.

Experts warn that obstructing the mouth could make sleep apnea symptoms even worse. 

Doctors also advise against taping your mouth if your nasal passages are not completely clear. 

Dr Megan Acho, a pulmonologist and sleep specialist at the University of Michigan Health said: ‘Importantly, if you have nasal congestion or a deviated nasal septum, you could potentially limit airflow if you tape your mouth. 

'This is one reason why we would definitely recommend avoiding mouth taping in people with known nasal disease and in children.’

Mouth taping is not a new practice, but it has exploded in popularity on TikTok where millions of users have posted about their experiences. 

Some videos have as many as 500,000 likes and the tag ‘mouth taping’ has been viewed more than 43 million times.

While doctors may warn against taping the mouth - there are some real benefits. 

One influencer who tapes her mouth shut before bed rattled off a series of issues linked to mouth breathing such as cavities, gum disease, bad breath, brain fog, and sore throat.

Research also finds that breathing through the nose helps the body perform at its optimum level. 

People who mouth-breathe are not absorbing enough oxygen. Without sufficient oxygen, our sleep quality and energy levels plummet.

Nose breathing, which brings more oxygen into the body, also helps lower blood pressure. 

It is a crucial part of meditation because it activates the parasympathetic nervous system which dilates blood vessels and decreases the heart rate, reducing overall blood pressure.

Mouth taping also purports to help promote fat burning, a benefit of increased oxygen intake. 

Oxygen helps break down fat molecules which are metabolized to become energy to help the body function. Evidence is limited, though, as studies have been relatively small.

In a 2018 study conducted in Korea, 38 people were asked to do different deep breathing exercises.

Some were asked to perform diaphragmatic breathing - a process where a person slowly inhales and exhales to relax themselves.

Those who did it through the nose, sometimes called belly breathing, had a higher resting metabolic rate than others.

This can help a person lose weight, cut fat and reduce their risk of heart disease, diabetes and other conditions. 

Evidence that the practice works is mostly anecdotal, though.

https://www.dailymail.co.uk/health/article-11492467/Dangerous-trend-TikTok-taping-mouth-shut-weight-loss-better-sleep-SUFFOCATE-you.html

Biden administration pledges to spend billions to eradicate AIDS by 2030

 The Biden administration has pledged to eradicate HIV/AIDS by the year 2030 in the US and worldwide.

Medical advances mean rich countries have now suppressed the virus and most patients with the disease can lead a normal life. But in poorer countries the disease is still deadly, and among the top five causes of death in Africa every year.

In the US about 30,000 people catch HIV every year, while globally there are 1.5million infections annually — mostly in sub-Saharan Africa.

In the US, the Biden administration has already ironed out plans to invest $10billion on supplying Pre-exposure Prophylaxis (PrEP) to underinsured or uninsured Americans.

The drug slashes the risk of someone catching the virus by 99 percent, and works by preventing it from replicating. But it is not prescribed for people who already have HIV.

Plans are also in place for $850million in funding for HIV care and prevention programs.

The proposals were included in the 2023 Federal budget, which is yet to be passed by Congress.

The Biden administration pledged to eradicate HIV in the US in 2019.

It defined this as cutting new HIV infections nationwide by more than 90 percent, or to below 3,000 a year.

The White House unveiled the new five-year strategy on world AIDS awareness day on Thursday.

US Secretary of State Anthony Blinkinken said: 'Our work is not done. HIV remains a serious threat to global health security and economic development.

'Our progress can be easily derailed if we lose our focus or conviction, or fail to address the inequities, many fueled by stigma and discrimination and punitive laws, that stand in our way.'

The plan focuses on five pillars to combat HIV infections worldwide.

They included investment to expand HIV testing in Africa, and set up more factories to manufacture drugs for HIV patients on the continent.

Officials are also planning to establish clear targets with regional and local leaders for reducing HIV transmission.

Some $7.4billion was requested for these efforts in the 2023 budget alone, with them costing $7billion last year.

HIV emerged in the 1970s and 1980s mostly among gay or bisexual men as an epidemic in the community.

The disease attacks the immune system, eventually leading to the body being overwhelmed by conditions normally kept in check — or acquired immune deficiency syndrome (AIDS).

In the US, the AIDS virus was first identified in June 1981 — after sparking an epidemic that killed more than 100,000 people, mostly gay men.

Since then billions in funding has been poured into researching treatments and cures for the disease.

This has led to the development of PrEP — protecting people from infection —, and antiretrovirals which work to suppress the virus in patients.

In February this year trials began on an HIV vaccine, which uses the same mRNA technology as Pfizer and Moderna's Covid jabs.

The new plan was unveiled for the United States President's Emergency Plan for AIDS Relief (PEPFAR), which leads US efforts to end the HIV epidemic globally.

The agency works in 50 countries in Africa and the Americas including Nigeria, South Africa, Democratic Republic of Congo and Haiti.

In a release, the agency said it would boost its 'collaboration and partnerships' with other global and local organizations working towards the same goal.

It plans to strengthen ties with the Africa CDC, WHO AFRO and the Pan American Health Organization (PAHO) among others.

PEPFAR also said in the release that it had supported antiretroviral treatment for 10-fold more people this year compared to 2021.

Some 20million people globally got the treatment as of September, it said, compared to less than two million in 2020.

The program also supported HIV tests for 64.7million people, and had helped prevent 5.5million babies being born with HIV.

It estimated that the efforts had saved 25million lives. 

For the US, latest data shows there were 30,000 new HIV diagnoses in 2020, which was down 12 per cent on the previous year and the lowest annual figure since 2015.

It is likely that Covid lockdowns, restrictions and stay-at-home orders contributed to this drop in transmission. 

Data is yet to be released for 2021, but transmission of other STIs — such as gonorrhea and chlamydia — rose this year. 

More than seven in ten new cases were among gay or bisexual men in 2019, and last year half of all cases were detected in the southern US. 

The Administration aims to cut new infections to 9,588 by 2025 — down 70 percent — and to 3,000 by 2030 — down 90 percent. 

About 1.2million Americans are living with HIV, while globally there are 38.4million living with the disease. 

Nearly 13,000 people die from AIDS in the US every year, while worldwide there are about 650,000 fatalities annually.

https://www.dailymail.co.uk/health/article-11495301/Biden-administration-pledges-eradicate-AIDS-2030-spend-extra-7-4bn-year.html

El Salvador deploys 10,000 troops to gang-run capital suburb

 El Salvador's President Nayib Bukele announced Saturday the deployment of 10,000 security forces to a suburb of San Salvador known to be a stronghold for gangs.

The move is the latest escalation in a crusade against gang violence that began in March, which human rights groups say has been marred by unjustified detentions.

"Soyapango is totally surrounded," the president wrote on Twitter early Saturday, referring to the municipality in the eastern part of the capital region known to be a stronghold of the Mara Salvatrucha and Barrio 18 gangs.

"8,500 soldiers and 1,500 agents have surrounded the city, while extraction teams from the police and the army are tasked with extricating all the gang members still there one by one."

Government representatives declined to comment on the deployment.

Images released by the government showed troops carrying heavy weapons, helmets and bulletproof vests, traveling in war vehicles. The municipality has a population of about 300,000 and was previously considered impregnable for law enforcement.

Since he began his plan to combat gangs, Bukele has ordered the arrest of more than 50,000 alleged gang members, whom he describes as terrorists and has denied basic procedural rights to.

The plan aims to reduce the Central American country's homicide rate to less than two a day, after dozens of Salvadorans were killed in a single weekend in March.

https://www.yahoo.com/now/el-salvador-deploys-10-000-161318978.html

Honduras to suspend some constitutional rights to fight gang violence

 The government of Honduras announced on Saturday that it will suspend some constitutional rights in areas of two main cities controlled by criminal groups.

The rights would be suspended under a national security emergency that would last for 30 days and be implemented on Tuesday in some of the poorest areas of the capital, Tegucigalpa, and the northern city of San Pedro Sula.

"The partial state of exception will enter into force on Tuesday, December 6 at 6pm for thirty days, to promote the gradual activity of economic development, investment, commerce and in public spaces," the country's security secretariat said in a statement.

The cities have been struggling with a so-called "war tax", in which gangs offer protection or say that those who pay up will not be killed. The gangs have torched buses and killed drivers who did not pay the fee, prompting businesses and people to pay out of fear.

The measure, which is expected to be endorsed by the council of ministers, is part of President Xiomara Castro's plan to deal with violent gangs.

The plan follows pressure from businessmen, truck, bus and taxi drivers, residents and non-governmental organizations (NGOs) who say extortion - largely by the Mara Salvatrucha MS-13 and Mara Barrio 18 gangs - has worsened in recent months.

This extortion generates annual profits equivalent to $737 million for the gangs, nearly 3% of the country's gross domestic product, according to the Association for a More Just Society, a security-focused non-governmental organization.

https://www.yahoo.com/now/honduras-suspend-constitutional-rights-fight-225835088.html

Amgen says experimental obesity drug has promising durability

 Amgen Inc's experimental obesity drug demonstrated promising durability trends in an early trial, paving the way for a larger mid-stage study early next year, company officials said ahead of a data presentation on Saturday.

The small Phase I trial found that patients maintained their weight loss for 70 days after receiving the highest tested dose of the injected drug, currently known as AMG133.

Amgen shares have gained about 5% since the company said on Nov. 7 that 12 weeks of trial treatment at the highest monthly dose of AMG133 resulted in mean weight loss of 14.5%.

At 150 days after the last dose, maintained weight loss had dropped to 11.2% below original weight at the start of the trial, according to findings detailed at a meeting of World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease in Los Angeles.

Patients treated with AMG133 did have side effects including nausea and vomiting, but most cases were mild and resolved within a couple of days after the first dose, Amgen said.

The U.S. Centers for Disease Control and Prevention estimates that more that 40% of the U.S. population is obese, costing nearly $173 billion annually. It is a primary cause of type 2 diabetes and been linked to heart disease, certain cancers and other health complications such as more severe COVID-19.

The weight loss field has gained renewed medical and investor attention in recent months after diabetes drugs from Eli Lilly and Co and Novo Nordisk, known as semaglutide and tirzepatide, were proven to help obese patients lose weight.

Both of those drugs, which need to be injected every two weeks, are designed to activate GLP-1, a hormone that triggers the feeling of fullness in the body after eating.

Amgen's AMG133 also targets GLP-1, but has a dual mechanism which aims at the same time to block activity of a gene known as GIP.

The drug was developed from work at Amgen to identify genetic signals associated with lower fat mass and body weight, and also healthy metabolic profiles, explained Saptarsi Haldar, head of cardiovascular metabolic discovery at Amgen.

https://finance.yahoo.com/news/amgen-says-experimental-obesity-drug-233000858.html