Day: July 2, 2024

WASHINGTON — U.S. officials have approved another Alzheimer’s drug that can modestly slow the disease, providing a new option for patients in the early stages of the incurable, memory-destroying ailment. 

The Food and Drug Administration approved Eli Lilly’s Kisunla on Tuesday for mild or early cases of dementia caused by Alzheimer’s. It’s only the second drug that’s been convincingly shown to delay cognitive decline in patients, following last year’s approval of a similar drug from Japanese drugmaker Eisai. 

The delay seen with both drugs amounts to a matter of months — about seven months, in the case of Lilly’s drug. Patients and their families will have to weigh that benefit against the downsides, including regular IV infusions and potentially dangerous side effects like brain swelling. 

Physicians who treat Alzheimer’s say the approval is an important step after decades of failed experimental treatments. 

“I’m thrilled to have different options to help my patients,” said Dr. Suzanne Schindler, a neurologist at Washington University in St. Louis. “It’s been difficult as a dementia specialist — I diagnose my patients with Alzheimer’s and then every year I see them get worse and they progress until they die.” 

Both Kisunla and the Japanese drug, Leqembi, are laboratory-made antibodies, administered by IV, that target one contributor to Alzheimer’s: sticky amyloid plaque buildup in the brain. Questions remain about which patients should get the drugs and how long they might benefit. 

The new drug’s approval was expected after an outside panel of FDA advisers unanimously voted in favor of its benefits at a public meeting last month. That endorsement came despite several questions from FDA reviewers about how Lilly studied the drug, including allowing patients to discontinue treatment after their plaque reached very low levels. 

Costs will vary by patient, based on how long they take the drug, Lilly said. The company also said a year’s worth of therapy would cost $32,000 — more than the $26,500 price of a year’s worth of Leqembi. 

The FDA’s prescribing information tells doctors they can consider stopping the drug after confirming via brain scans that patients have minimal plaque. 

More than 6 million Americans have Alzheimer’s. Only those with early or mild disease will be eligible for the new drug, and an even smaller subset are likely to undergo the multistep process needed to get a prescription. 

The FDA approved Kisunla, known chemically as donanemab, based on results from an 18-month study in which patients given the treatment declined about 22% more slowly in terms of memory and cognitive ability than those who received a dummy infusion. 

The main safety issue was brain swelling and bleeding, a problem common to all plaque-targeting drugs. The rates reported in Lilly’s study, including 20% of patients with microbleeds, were slightly higher than those reported with competitor Leqembi. However, the two drugs were tested in slightly different types of patients, which experts say makes it difficult to compare the drugs’ safety. 

Kisunla is infused once a month compared to Leqembi’s twice-a-month regimen, which could make things easier for caregivers who bring their loved ones to a hospital or clinic for treatment.
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islamabad — A new study has revealed that recent floods in Pakistan have substantially weakened its societal resilience in coping with and recovering from such disasters as the threat from climate change continues to grow.

The London-headquartered independent global charity Lloyd’s Register Foundation said Tuesday the findings are part of the latest edition of their flagship World Risk Poll Resilience Index.

The study also highlighted that the number of Pakistanis who have experienced a disaster in the past five years has more than doubled since 2021, increasing from 11% to 27%.

“This increase has been driven primarily by the extensive floods that hit the country in 2022, affecting regions containing around 15% of the population,” the study said.

The report noted that community and society resilience scores declined sharply in the regions most affected by the floods, particularly in the southern Sindh province.

“These scores declined because people reported losing confidence in the support of the government, community and infrastructure — at a national level, those who said their government cared ‘not at all’ about them and their well-being rose from 60% in 2021 to almost three-quarters [72%] in 2023.”

Meanwhile, the country’s already low individual and household resilience levels failed to improve, with Pakistan ranking in the bottom 10 globally for both resilience scores, according to the report.

Nancy Hey, the director of evidence and insight at Lloyd’s Register Foundation, urged policymakers in Pakistan to prioritize rebuilding and strengthening the resilience of the most affected communities.

She said this would better prepare them to face natural hazards and other potential causes of disasters in the wake of the growing threat of climate change.

“For residents of Pakistan, catastrophic flooding is largely responsible for the doubling in disaster experience since 2021. This may have led to a ‘reality check’ for residents in terms of how prepared they feel for such events, with community and societal resilience particularly negatively affected,” Hey said.

In 2022, Pakistan’s southern and southwestern regions experienced devastating floods triggered by climate change-induced unusually heavy monsoon rains, killing more than 1,700 people, affecting 33 million others, and submerging approximately one-third of Pakistan.

The South Asian nation of about 245 million contributes less than 1% to global carbon emissions but bears the brunt of climate change.

The country’s weather patterns have changed dramatically in recent years, and it officially “ranks fifth among the countries most affected by global warming.”

April was recorded as the wettest month in Pakistan since 1961, with more than double the usual monthly rainfall, killing scores of people and destroying property as well as farmland.

In May and June, Pakistan experienced relatively hotter heat waves, with temperatures in some districts rising to more than 52 degrees Celsius for days. The hot weather prompted authorities in May to temporarily shut down education for half of Pakistan’s schoolchildren to protect them from heatstroke and dehydration.

The United Nations has warned that an estimated 200,000 Pakistanis could be affected by the coming monsoon season and flash floods, as national weather forecasters project above-normal rainfall.

Prime Minister Shehbaz Sharif reviewed preparations for the monsoon season at a special meeting Tuesday and formed “a high-level committee” to handle potential emergencies, his office said in a statement.

National Disaster Management Authority officials told the meeting that all relevant institutions and Pakistani troops remain on “high alert” in vulnerable districts. They were quoted as saying that “adequate stocks” of boats, tents, drainage pumps, medicines and other essential items were available for people in areas prone to rain-related disasters.”
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WASHINGTON — The U.S. Supreme Court took up an e-cigarette case Tuesday, weighing whether the Food and Drug Administration wrongly blocked the marketing of sweet, flavored products amid a surge in vaping by young people.

Vaping companies argue the FDA unfairly denied more than a million applications to market fruit or candy flavored versions of nicotine-laced liquid that’s heated by the e-cigarette to create an inhalable aerosol.

The case comes as the FDA undertakes a sweeping review after years of regulatory delays intended to bring scientific scrutiny to the multibillion-dollar vaping market, which includes thousands of flavored vapes that are technically illegal but are widely available in convenience stores, gas stations and vape shops. The FDA recently approved its first menthol-flavored electronic cigarettes for adult smokers.

The agency says the sweet, flavored e-liquids pose a “serious, well-documented risk” of enticing more young people to pick up a nicotine habit. In 2020, nearly 20% of high school students and almost 5% of middle school students used e-cigarettes, and almost all of those kids used flavored products, the agency said in court documents.

The agency says companies were blocked because they couldn’t show the possible benefits for adult smokers outweighed the risk of underage use. The companies say they had prepared detailed plans to avoid appealing to young people.

The companies scored a victory when the U.S. 5th Circuit Court of Appeals sided with vaping companies and tossed out orders denying the marketing of e-liquids with names like “Jimmy The Juice Man in Peachy Strawberry.”

The 5th Circuit found the agency was unfair because it required the companies, without warning, to present studies showing that flavored products would help with smoking cessation.

The FDA appealed that finding to the Supreme Court. The justices are expecting to hear the case in the fall.

Other appeals courts have sided with the FDA, which regulates new tobacco products under a 2009 law aimed at curbing youth tobacco use.

Vaping companies have long claimed their products can help blunt the toll of smoking, which is blamed for 480,000 U.S. deaths annually due to cancer, lung disease and heart disease.

Youth vaping has declined from all-time highs in recent years, but about 10% of high schoolers still reported e-cigarette use last year.
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UCLA molecular bioengineer Mireille Kamariza has developed a new tuberculosis test that tackles shortcomings of existing TB diagnostics. VOA’s Genia Dulot reports for this week’s episode of LogOn.
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The U.S. government’s representative to the Minerals Security Partnership, an alliance of mostly Western countries that aims to speed the development of energy mineral supply chains, said last month that a Chinese company was using “predatory” tactics to hold down the price of cobalt mined in the Democratic Republic of Congo. Henry Wilkins looks at what this means for Africa.
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