Day: September 28, 2023

Federal health advisers voted overwhelmingly against an experimental treatment for Lou Gehrig’s disease at a Wednesday meeting prompted by years of patient efforts seeking access to the unproven therapy.

The panel of Food and Drug Administration experts voted 17-1 that drugmaker Brainstorm’s stem cell-based treatment has not been shown effective for patients with the fatal, muscle-wasting disease known as ALS, or amyotrophic lateral sclerosis. One panel member abstained from voting.

While the FDA is not bound by the vote, it largely aligns with the agency’s own strikingly negative review released earlier this week, in which staff scientists described Brainstorm’s application as “scientifically incomplete” and “grossly deficient.”

“Creating false hope can be considered a moral injury and the use of statistical magic or manipulation to provide false hope is problematic,” said Lisa Lee, a bioethics and research integrity expert from Virginia Tech who voted against the treatment. The lone positive vote came from a panel member representing patients.

Wednesday’s public meeting was essentially a longshot attempt by Brainstorm and the ALS community to sway FDA’s thinking on the treatment, dubbed NurOwn.

Brainstorm’s single 200-patient study failed to show that NurOwn extended life, slowed disease or improved patient mobility. But the FDA agreed to convene the panel of outside advisers after ALS patients and advocates submitted a 30,000-signature petition seeking a public meeting.

In the last year, the FDA has approved two new drugs for ALS, after a nearly 20-year drought of new options. The approvals followed intense lobbying by advocacy groups.

FDA leaders have recently emphasized a new level of “regulatory flexibility” when reviewing experimental treatments for fatal, hard-to-treat conditions, including ALS, Alzheimer’s and muscular dystrophy.

But the agency appears unwilling to overlook the failed study results and missing information in Brainstorm’s submission, including key details on manufacturing and quality control needed to establish the product’s safety.

“It really is a disease that needs a safe and effective treatment and there are a lot of other prospects out there that we need to encourage. Approving one like this would get in the way of that,” said Dr. Kenneth Fischbeck of the National Institutes of Health.

ALS destroys nerve cells in the brain and spinal cord needed to walk, talk, swallow and — eventually — breathe. Most people die within three to five years of their first symptoms.

More than a dozen people spoke during a public comment session Wednesday, including ALS patients, their family members and physicians who implored FDA to grant approval. Several speakers presented before-and-after videos showing patients who participated in Brainstorm’s study walking, climbing stairs and performing other tasks that they attributed to NurOwn.

“When Matt is on NurOwn it helps him, when he’s off of it he gets worse,” said Mitze Klingenberg, speaking on behalf of her son, Matt Klingenberg, who was diagnosed with ALS in 2018.

The FDA is expected to issue a decision on the therapy by December 8.

Israel-based Brainstorm Cell Therapeutics’ stock price has lost more than 90% of its value over the last year, falling to 39 cents per share before being halted ahead of Wednesday’s FDA meeting.
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On the sidelines of the 78th United Nations General Assembly in New York last week, Taiwan’s Minister of Digital Affairs Audrey Tang delivered a speech at the Concordia Annual Summit on digital democracy and artificial intelligence. VOA spoke with Tang about how AI might help break through China’s censorship and the challenges and opportunities the technology brings to global democracy.

This interview has been edited for clarity and brevity.

VOA: You mentioned the concept of AI governance in your speech. In addition to being applied to democratic countries, can this concept also be applied to totalitarian countries?

Taiwan Minister of Digital Affairs Audrey Tang: From 2010 to 2012 and 2013, consultative democracy was also studied in some places in the CCP [Chinese Communist Party], but not at the central level. Later, including freedom of the press, assembly, association and expression, all aspects were restricted. If you look at the papers, there have been very few studies promoting consultative democracy through the internet in recent years. Conceptually and theoretically, if we look at the situation in 2000, it seemed possible. But if we look at the situation in recent years, there seems to be no research on this. Maybe the premise is freedom of the press, and people must fully understand what the truth is. Regardless of consultation or deliberation, this foundation is needed. If freedom of the press is deprived, it will not be easy to develop further.

VOA: What do you think of the potential and limitations of artificial intelligence in China?

Tang: Artificial intelligence technology can turn public information on the entire Internet into material. After the [open-source] model is successfully created, it can actually be saved on a USB flash drive. Anyone can run this model on a laptop or personal computer, which greatly challenges censorship. In the past, as long as a comprehensive totalitarian government guarded access to Google, Wikipedia or other websites, it would make it difficult for their people to get the truth. But now, as long as netizens can get the [open-source] language models on a flash drive … they will no longer need an internet connection, and they can always find out what happened and when exactly did it happen.

VOA: Former White House deputy national security adviser Matt Pottinger has proposed punching holes in China’s Great Firewall. Is that possible?

Tang: If the holes are temporary, they will be repaired once people find them. The language models I just mentioned don’t mean that there needs to be holes continuously, but that if there is a certain way to send information in, there is no need to connect to the outside anymore. The bad use is that if a Trojan horse is sent in, there is no need to control the computer anymore, and it can conduct network attacks by itself. This is a bad use. But there is another use, which is to send in the truth, and after that, it can even tell the users in the interactive Q&A format, including showing contemporaneous photos and videos from the time.

VOA: Does your upbringing and way of thinking help you with your current work?

Tang: I am nonbinary not only in terms of gender but also in terms of ideology. Many people have to make choices, such as the left and the right [politically]. For me, they all coexist. I don’t particularly feel I’m very close to or very far from half of the people because they are rightists or leftists. I don’t think that way. Everyone is at the same distance. If I can’t understand the ideas of a certain side, I will feel I’m not plural enough, and I should be in touch with them more.
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Environmental experts are ringing alarm bells, saying decades-long climate and environmental changes in Sudan have exacerbated social and political instability, fueling the monthslong conflict in the country centered around access to land, water and other vital resources.

The current conflict in Sudan, rooted in global geopolitics and the historical legacy of the previous leadership of now-deposed authoritarian leader Omar al-Bashir, is increasingly being attributed to climate change.

In a May report, Practical Action, a Britain-based international development organization, highlighted the impact of climate change in Sudan, which includes the encroachment of the desert southward and a stark reduction in rainfall.

Akinyi Walender, Practical Action Africa director, underscored the consequences of climate change in Sudan, including heightened drought, extreme rainfall variability, depletion of water sources and desertification spanning millions of hectares of land.

Speaking to VOA via WhatsApp, Walender said the conversion of migratory routes and pastureland into farmland has significantly disrupted “the natural balance” and accelerated desertification.

The United Nations says desertification is the persistent degradation of dryland ecosystems by climate change and mainly human activities — unsustainable farming, mining, overgrazing and clear-cutting of land.

The U.N. Convention to Combat Desertification says approximately 65% of Sudan’s land is affected by desertification.

Walender said climate change and conflict in Sudan are caught in a destructive cycle, potentially worsening the situation in the East African nation.

“The effects of war, such as the destruction of infrastructure, displacement of communities, and the use of airstrikes and heavy artillery, intensify the environmental damage in Sudan,” she said.

The International Organization for Migration, the U.N.’s migration agency, says nearly 7.1 million people are internally displaced within Sudan, 3.8 million being newly displaced due to the country’s monthslong conflict between the paramilitary Rapid Support Forces and the Sudanese Armed Force.

Awadalla Hamid, an environmental conservation manager at Practical Action in Sudan’s North Darfur State, said human activities have taken a toll on natural resources and ecosystems, intensifying environmental degradation.

Hamid said the displacement of communities in Sudan has led to further environmental damage.

“As people are forced to flee their homes, they often settle in temporary camps or new areas, leading to uncontrolled land-use changes, overexploitation of resources and increased pressure on fragile environments,” Hamid said. “The influx of displaced populations can also result in deforestation, soil erosion and pollution.”

The U.N. Environment Program says environmental destruction during conflicts has a direct impact on public health due to air and water pollution. The use of airstrikes and heavy artillery, while causing immediate destruction, also results in long-term environmental consequences, the U.N says.

Walender said addressing the environmental consequences of conflict requires a holistic approach —peacebuilding, conflict resolution and sustainable environmental practices.

Swar Adam, who fled violence in South Darfur and currently resides in Kosti, White Nile State, Sudan, told VOA his displacement has left him unable to tend to his livestock, which is his livelihood.

“It is very difficult at the moment to go and identify your cattle in such a situation,” Adam said. “I am not sure if they are now being fed on good grazing land or not. This is the situation I am in now.”

This story originated in VOA English to Africa’s South Sudan In Focus Program.
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India’s moon lander and rover, which made a historic landing on the south pole of the moon, have not “woken up” after being put in sleep mode earlier this month to survive the freezing lunar night temperatures.

Scientists at the Indian Space Research Organization have not succeeded in reestablishing communication with the Vikram lander and the Pragyan rover, which were part of India’s pioneering Chandrayaan-3 mission.

After the spacecraft soft-landed on the little-explored lunar south pole on Aug. 23 — five days after a Russian spacecraft on an identical mission crashed — the rover spent 10 days traveling more than 100 meters on the lunar surface gathering scientific data.

Tasked with “the pursuit of lunar secrets” by the ISRO, the spacecraft transmitted images and scientific data back to Earth and confirmed the presence of sulfur, iron, titanium and oxygen on the moon.

Before the sun set on the moon Sept. 2, ISRO scientists switched the rover to sleep mode to hibernate and protect the spacecraft’s sensitive components from the freezing lunar night conditions. The lander was switched to sleep mode on Sept. 4.

A lunar day and night each lasts a little over 14 Earth days. During the lunar night, the temperature on the moon can drop between minus 200 degrees Celsius and minus 250 degrees Celsius.

After switching the lander and rover to sleep mode, ISRO said in a statement that the rover had completed its first set of assignments — Chandrayaan-3 mission’s primary goal — and they were confident the spacecraft could survive the extreme lunar night.

The ISRO said that after the spacecraft reawakened Friday, the sun would shine on its solar panels, and its batteries would recharge. The agency also said that if the spacecraft did not reawaken it would “forever stay there as India’s lunar ambassador.”

In a Friday post on X, formerly known as Twitter, the ISRO scientists explained their attempts to reawaken the robotic explorers.

“Efforts have been made to establish communication with the Vikram lander and Pragyan rover to ascertain their wake-up condition. As of now, no signals have been received from them. Efforts to establish contact will continue,” ISRO said, raising doubts about whether communication with the spacecraft would be reestablished and the mission’s scientific exploration of the lunar surface would be resumed.

In its latest update on Chandrayaan-3, ISRO said it would continue attempting to make contact with the spacecraft at least until the lunar night begins Oct. 6.

The Chandrayaan-3 mission made India the fourth country in the world to land on the moon, and the first to reach the south pole region. The achievement, hailed as “a victory cry of a new India” by Prime Minister Narendra Modi, sparked a feeling of national pride among millions of Indians, who watched the touchdown of the spacecraft live on television. 
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