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Supreme Court to Review FDA’s Decision on Mifepristone Safety in Virtual Appointments

Supreme Court to Review FDA's Decision on Mifepristone Safety in Virtual Appointments

(CTN News) – In March, the Supreme Court will hear a case involving mifepristone, one of two medicines used in medication abortion.

A significant question in that case is whether the Food and Medicine Administration was accurate when it determined that the medicine was safe to prescribe to patients via virtual appointment.

Research published Thursday in Nature Medicine supports the FDA’s opinion that pharmacological abortion is safe and effective.

Researchers reviewed the electronic medical data of almost 6,000 patients from three abortion providers using telemedicine. They also performed an opt-in survey with 1,600 patients.

Some abortion patients communicated with a provider via video, while others utilised a secure chat network comparable to texting.

If patients were fewer than 10 weeks pregnant and otherwise eligible, the clinicians recommended two medications: mifepristone, which inhibits the pregnancy hormone progesterone, and misoprostol, which produces uterine contractions. Patients received both medications via mail-order pharmacy.

The study’s lead author, Ushma Upadhyay from the University of California – San Francisco, notes that a clinical follow-up was conducted 3-7 days later. “The provider checked in with the patient.”

‘Have you received your medications? Did you take your medications?’ They inquired about symptoms. Then, there was a clinical follow-up four weeks after the initial intake.

The researchers discovered that the medicine was effective, as it stopped pregnancy in 97.7% of patients without requiring more follow-up therapy.

It was also discovered to be safe; no major adverse outcomes followed 99.7% of abortions. The safety and efficacy were identical whether patients communicated via video or secure chat with a clinician.

“These results shouldn’t be surprising,” Upadhyay says. “It’s consistent with the over 100 studies on mifepristone that have affirmed the safety and effectiveness of this medication.”

The findings are also consistent with worldwide research on telehealth abortion and studies of pharmaceutical abortion administered in a clinic during an in-person session, she adds.

Rishi Desai, a pharmaceutical safety expert from Harvard Medical School, was not involved in the study. He adds that the study was “well-conducted,” especially given the difficulty of tracking patients who only communicate with clinicians remotely.

“I would say that this study provides reassuring data regarding safety of the medications, and this is very much in line with what we have seen in many previous studies,” he said. “So it’s good to see that safety findings hold up in this setting as well.”

Overview of the legal challenges surrounding mifepristone, including the 2022 lawsuit against the FDA and the upcoming Supreme Court hearing on March 26.

Still, whether mifepristone is safe and whether the FDA has adequately regulated how it is supplied is a legal issue.

An anti-abortion rights group sued the FDA in 2022, claiming that mifepristone is unsafe and was unlawfully approved in 2000. Judge Matthew Kacsmaryk, a district court judge appointed to the federal bench by President Trump, decided that mifepristone should be taken off the market worldwide.

Although his ruling did not go into effect while appeals were underway, the appeals court ruled against the FDA in part, notably limiting telemedicine abortion access. That is also currently on hold.

The Supreme Court will hear arguments in the matter on March 26. The ruling might have an impact on access to medication abortion across the country and establish a new precedent for challenges to the FDA’s jurisdiction.

Recently, there has been a surge in mifepristone research headlines. A report citing safety issues concerning mifepristone was recently retracted. This study, published on Thursday, supports the FDA‘s position that the drug can be safely prescribed remotely.

Upadhyay claims she has been working on this research for years and that the timing of its publication, weeks before the Supreme Court arguments, is coincidental.

“I don’t know if they can enter new evidence into the case at this point,” she said. “But I do hope it impacts the perception of how safe this medication is.”

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Google’s Search Dominance Is Unwinding, But Still Accounting 48% Search Revenue

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Google is so closely associated with its key product that its name is a verb that signifies “search.” However, Google’s dominance in that sector is dwindling.

According to eMarketer, Google will lose control of the US search industry for the first time in decades next year.

Google will remain the dominant search player, accounting for 48% of American search advertising revenue. And, remarkably, Google is still increasing its sales in the field, despite being the dominating player in search since the early days of the George W. Bush administration. However, Amazon is growing at a quicker rate.

google

Google’s Search Dominance Is Unwinding

Amazon will hold over a quarter of US search ad dollars next year, rising to 27% by 2026, while Google will fall even more, according to eMarketer.

The Wall Street Journal was first to report on the forecast.

Lest you think you’ll have to switch to Bing or Yahoo, this isn’t the end of Google or anything really near.

Google is the fourth-most valued public firm in the world. Its market worth is $2.1 trillion, trailing just Apple, Microsoft, and the AI chip darling Nvidia. It also maintains its dominance in other industries, such as display advertisements, where it dominates alongside Facebook’s parent firm Meta, and video ads on YouTube.

To put those “other” firms in context, each is worth more than Delta Air Lines’ total market value. So, yeah, Google is not going anywhere.

Nonetheless, Google faces numerous dangers to its operations, particularly from antitrust regulators.

On Monday, a federal judge in San Francisco ruled that Google must open up its Google Play Store to competitors, dealing a significant blow to the firm in its long-running battle with Fortnite creator Epic Games. Google announced that it would appeal the verdict.

In August, a federal judge ruled that Google has an illegal monopoly on search. That verdict could lead to the dissolution of the company’s search operation. Another antitrust lawsuit filed last month accuses Google of abusing its dominance in the online advertising business.

Meanwhile, European regulators have compelled Google to follow tough new standards, which have resulted in multiple $1 billion-plus fines.

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Pixa Bay

Google’s Search Dominance Is Unwinding

On top of that, the marketplace is becoming more difficult on its own.

TikTok, the fastest-growing social network, is expanding into the search market. And Amazon has accomplished something few other digital titans have done to date: it has established a habit.

When you want to buy anything, you usually go to Amazon, not Google. Amazon then buys adverts to push companies’ products to the top of your search results, increasing sales and earning Amazon a greater portion of the revenue. According to eMarketer, it is expected to generate $27.8 billion in search revenue in the United States next year, trailing only Google’s $62.9 billion total.

And then there’s AI, the technology that (supposedly) will change everything.

Why search in stilted language for “kendall jenner why bad bunny breakup” or “police moving violation driver rights no stop sign” when you can just ask OpenAI’s ChatGPT, “What’s going on with Kendall Jenner and Bad Bunny?” in “I need help fighting a moving violation involving a stop sign that wasn’t visible.” Google is working on exactly this technology with its Gemini product, but its success is far from guaranteed, especially with Apple collaborating with OpenAI and other businesses rapidly joining the market.

A Google spokeswoman referred to a blog post from last week in which the company unveiled ads in its AI overviews (the AI-generated text that appears at the top of search results). It’s Google’s way of expressing its ability to profit on a changing marketplace while retaining its business, even as its consumers steadily transition to ask-and-answer AI and away from search.

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Google has long used a single catchphrase to defend itself against opponents who claim it is a monopoly abusing its power: competition is only a click away. Until recently, that seemed comically obtuse. Really? We are going to switch to Bing? Or Duck Duck Go? Give me a break.

But today, it feels more like reality.

Google is in no danger of disappearing. However, every highly dominating company faces some type of reckoning over time. GE, a Dow mainstay for more than a century, was broken up last year and is now a shell of its previous dominance. Sears declared bankruptcy in 2022 and is virtually out of business. US Steel, long the foundation of American manufacturing, is attempting to sell itself to a Japanese corporation.

Could we remember Google in the same way that we remember Yahoo or Ask Jeeves in decades? These next few years could be significant.

SOURCE | CNN

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The Supreme Court Turns Down Biden’s Government Appeal in a Texas Emergency Abortion Matter.

Supreme Court

(VOR News) – A ruling that prohibits emergency abortions that contravene the Supreme Court law in the state of Texas, which has one of the most stringent abortion restrictions in the country, has been upheld by the Supreme Court of the United States. The United States Supreme Court upheld this decision.

The justices did not provide any specifics regarding the underlying reasons for their decision to uphold an order from a lower court that declared hospitals cannot be legally obligated to administer abortions if doing so would violate the law in the state of Texas.

Institutions are not required to perform abortions, as stipulated in the decree. The common populace did not investigate any opposing viewpoints. The decision was made just weeks before a presidential election that brought abortion to the forefront of the political agenda.

This decision follows the 2022 Supreme Court ruling that ended abortion nationwide.

In response to a request from the administration of Vice President Joe Biden to overturn the lower court’s decision, the justices expressed their disapproval.

The government contends that hospitals are obligated to perform abortions in compliance with federal legislation when the health or life of an expectant patient is in an exceedingly precarious condition.

This is the case in regions where the procedure is prohibited. The difficulty hospitals in Texas and other states are experiencing in determining whether or not routine care could be in violation of stringent state laws that prohibit abortion has resulted in an increase in the number of complaints concerning pregnant women who are experiencing medical distress being turned away from emergency rooms.

The administration cited the Supreme Court’s ruling in a case that bore a striking resemblance to the one that was presented to it in Idaho at the beginning of the year. The justices took a limited decision in that case to allow the continuation of emergency abortions without interruption while a lawsuit was still being heard.

In contrast, Texas has been a vocal proponent of the injunction’s continued enforcement. Texas has argued that its circumstances are distinct from those of Idaho, as the state does have an exemption for situations that pose a significant hazard to the health of an expectant patient.

According to the state, the discrepancy is the result of this exemption. The state of Idaho had a provision that safeguarded a woman’s life when the issue was first broached; however, it did not include protection for her health.

Certified medical practitioners are not obligated to wait until a woman’s life is in imminent peril before they are legally permitted to perform an abortion, as determined by the state supreme court.

The state of Texas highlighted this to the Supreme Court.

Nevertheless, medical professionals have criticized the Texas statute as being perilously ambiguous, and a medical board has declined to provide a list of all the disorders that are eligible for an exception. Furthermore, the statute has been criticized for its hazardous ambiguity.

For an extended period, termination of pregnancies has been a standard procedure in medical treatment for individuals who have been experiencing significant issues. It is implemented in this manner to prevent catastrophic outcomes, such as sepsis, organ failure, and other severe scenarios.

Nevertheless, medical professionals and hospitals in Texas and other states with strict abortion laws have noted that it is uncertain whether or not these terminations could be in violation of abortion prohibitions that include the possibility of a prison sentence. This is the case in regions where abortion prohibitions are exceedingly restrictive.

Following the Supreme Court’s decision to overturn Roe v. Wade, which resulted in restrictions on the rights of women to have abortions in several Republican-ruled states, the Texas case was revisited in 2022.

As per the orders that were disclosed by the administration of Vice President Joe Biden, hospitals are still required to provide abortions in cases that are classified as dire emergency.

As stipulated in a piece of health care legislation, the majority of hospitals are obligated to provide medical assistance to patients who are experiencing medical distress. This is in accordance with the law.

The state of Texas maintained that hospitals should not be obligated to provide abortions throughout the litigation, as doing so would violate the state’s constitutional prohibition on abortions. In its January judgment, the 5th United States Circuit Court of Appeals concurred with the state and acknowledged that the administration had exceeded its authority.

SOURCE: AP

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Supreme Court Rejects Appeal From ‘Pharma Bro’ Martin Shkreli, To repay $6.4 Million

shkreli

Washington — The Supreme Court rejected Martin Shkreli’s appeal on Monday, after he was branded “Pharma Bro” for raising the price of a lifesaving prescription.

Martin appealed a decision to repay $64.6 million in profits he and his former company earned after monopolizing the pharmaceutical market and dramatically raising its price. His lawyers claimed the money went to his company rather than him personally.

The justices did not explain their reasoning, as is customary, and there were no notable dissents.

Prosecutors, conversely, claimed that the firm had promised to pay $40 million in a settlement and that because Martin orchestrated the plan, he should be held accountable for returning profits.

shkreli

Supreme Court Rejects Appeal From ‘Pharma Bro’ Martin Shkreli

Martin was also forced to forfeit the Wu-Tang Clan’s unreleased album “Once Upon a Time in Shaolin,” which has been dubbed the world’s rarest musical album. The multiplatinum hip-hop group auctioned off a single copy of the record in 2015, stipulating that it not be used commercially.

Shkreli was convicted of lying to investors and defrauding them of millions of dollars in two unsuccessful hedge funds he managed. Shkreli was the CEO of Turing Pharmaceuticals (later Vyera), which hiked the price of Daraprim from $13.50 to $750 per pill after acquiring exclusive rights to the decades-old medicine in 2015. It cures a rare parasite condition that affects pregnant women, cancer patients, and HIV patients.

shkreli

He defended the choice as an example of capitalism in action, claiming that insurance and other programs ensured that those in need of Daraprim would eventually receive it. However, the move prompted criticism, from the medical community to Congress.

shkreli

Supreme Court Rejects Appeal From ‘Pharma Bro’ Martin Shkreli

Attorney Thomas Huff said the Supreme Court’s Monday ruling was upsetting, but the high court could still overturn a lower court judgment that allowed the $64 million penalty order even though Shkreli had not personally received the money.

“If and when the Supreme Court does so, Mr. Shkreli will have a strong argument for modifying the order accordingly,” he told reporters.

Shkreli was freed from prison in 2022 after serving most of his seven-year sentence.

SOURCE | AP

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