Author: MIL-OSI Publisher

Source: The Conversation – USA (3) – By C. Michael White, Distinguished Professor of Pharmacy Practice, University of Connecticut

A “black box” warning on a health product sounds pretty scary – maybe even more so when it’s suddenly being taken off the packaging.

Americans were reminded of this type of public health messaging on Nov. 10, 2025, when the Food and Drug Administration announced it is removing the “black box” warning from hormone replacement therapy for menopause.

But what are these warnings, anyway? What’s their history, and how do they affect a drug’s use?

I am a clinical pharmacologist and pharmacist studying drug prescribing, safety and effectiveness for over 25 years.

Black box warnings – or as the FDA officially calls them, boxed warnings – are a tool for alerting pharmacists and clinicians that the medication may have serious risks. These health care professionals are then expected to communicate those risks to consumers.

An official source of drug information

Black box warnings for particular medications appear on the product package inserts that the FDA requires pharmaceutical companies to create for each prescription drug.

Product package inserts provide official information about the drug to health care professionals. These pamphlets are attached to bulk containers of drugs purchased by pharmacies so that the pharmacist has the most updated official information on the product. The package inserts are also published in textbooks such as the Physician’s Desk Reference and on websites maintained by drug manufacturers.

The requirement for product package inserts came out of a consumer protection law passed in 1966, called the Fair Packaging and Labeling Act, which aimed to prevent unfair or deceptive packaging in products used by consumers.

The package insert carries a set of official information about the drug, provided by the manufacturer and regulated by the FDA. The insert must include who the drug is approved for, proper dosing and administration, and a description of the key clinical trial results that showed it was effective and safe.

It must also disclose any health risks that the drug poses – such as a boxed warning.

Flagging safety risks

The FDA has two categories for the health risks that medications could pose: precautions and warnings. Both are listed on the package insert.

Precautions warn clinicians of possible harm that could result in minor or moderate injury to patients. Warnings, on the other hand, alert them to the potential risk of dangerous adverse events that could result in serious injury or death. The most serious warnings for a drug are called boxed warnings. The text of those warnings is enclosed by a black box on the insert so they will not be missed by clinicians.

According to a 2022 study, more than 400 medications currently carry black box warnings.

Antidepressants are one example. While such drugs can lessen the severity of depression symptoms, researchers have found that during the first few weeks of taking them, patients have an increased risk of suicide – particularly children and young adults. The FDA first issued a black box warning about the drugs’ use in children and adolescents in 2004 and expanded the warning to young adults in 2007.

Another example is clozapine, a drug used to suppress delusions experienced by people with schizophrenia. Although the drug is very effective, the FDA first gave it a black box warning when it was reintroduced to the market in 1989 because it can stop the production of white blood cells, potentially leading to life-threatening infections.

Hormone replacement therapy for menopause got its black box warning in 2003 after a clinical trial called the Women’s Health Initiative pointed to an increased risk of breast cancer without a reduced risk of heart disease in women who used it.

In subsequent years, reanalyses of the Women’s Health Initiative results, as well as data from other studies, have shown that the therapy is safe in women ages 50 to 60. Newer, safer formulations of estrogen and progestin have also emerged. These factors prompted the FDA to remove the warnings in November 2025, saying the therapy doesn’t pose significant risks.

Medical and legal realities

Black box warnings can influence clinicians’ choice of whether or not to prescribe a particular drug. For example, since other drugs for schizophrenia do not carry the serious risks that clozapine does, clinicians usually reserve that medicine for people who could not use those other drugs.

The black box warnings can also play a role in malpractice cases. In some states, package inserts and any warnings they contain can be used to establish a standard of care, leaving clinicians who deviate from them liable for damages. In other states, the warnings they list can be used to support findings of negligence.

For instance, the black box warning on the insert of the drug thalidomide states it can cause birth defects. It instructs clinicians to obtain a
a negative pregnancy test before use and ensure the patient is not able to get pregnant or is taking precautions to avoid pregnancy before prescribing. Failure to do so could make the clinician liable if the person taking the drug bears a child with birth defects.

Product package inserts are living documents. As new information becomes available, the FDA may find a medication’s risk is untenable and request the drug be removed from the market. Or it may decide to remove the boxed warning from the drug if new data shows the drug is less dangerous than previously thought.

C. Michael White does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

– ref. What’s a ‘black box’ warning? A pharmacologist explains how these labels protect patients – https://theconversation.com/whats-a-black-box-warning-a-pharmacologist-explains-how-these-labels-protect-patients-269470

Source: The Conversation – USA – By R. Lincoln Hines, Assistant Professor of International Affairs, Georgia Institute of Technology

China’s Shenzhou-20 spacecraft took a hit from a piece of space debris floating through orbit, causing Chinese officials to delay the spacecraft’s return from its Tiangong space station in early November 2025.

In addition to stranding the three Chinese astronauts – called taikonauts – who were set to return to Earth, this incident highlights the increasing risks posed to China and the broader international community by the growing amount of space debris.

I study China’s space program. My research suggests that national pride plays an important role in China’s growing space ambitions. As China continues to invest in expensive space capabilities, it will also likely become increasingly sensitive to losing them. The rise in space debris may create incentives for Chinese officials to cooperate with the United States on measures that reduce the risk of collisions.

Space debris – a growing issue

Space debris is creating growing problems for space operations. It includes any artificial objects in orbit not operating as satellites or spacecraft. It ranges in size from a fleck of paint to large rocket bodies roughly the size of a school bus.

In the most commonly used orbit – low Earth orbit – this debris can move at speeds of roughly 18,000 mph, almost seven times the speed of a bullet. At such high speeds, even tiny pieces of space debris can be highly destructive, to the point that this debris might continue to multiply until one day it makes certain critical orbits unusable. When space debris collides with other objects and fragments, they can break into smaller pieces, generating even more debris.

It’s somewhat ironic that China’s spacecraft took a hit from space junk. The country is responsible for creating the majority of space debris. In 2007, China blew up a defunct Fengyun-1c weather satellite to test an anti-satellite weapon. It generated the most space debris in history – over 3,000 pieces are still orbiting today.

On several occasions, the International Space Station has had to maneuver to narrowly avoid being struck by debris from this test, including as recently as 2021.

Anti-satellite weapons

Why would China, or any other country, want to develop an anti-satellite weapon? Satellites provide significant benefits to militaries. They help with reconnaissance and intelligence, allow for the precise targeting and guidance of long-range munitions, support communication over large distances and supply weather data, to name just a few uses.

These advantages were showcased during the first Gulf War, often called the “first space war.” The United States used space technologies to quickly and decisively defeat the Iraqi military within weeks, and with far fewer casualties than expected. The Gulf War had a profound impact on Chinese military thinking, with analysts in the People’s Liberation Army recognizing the importance of space technologies in modern warfare.

Whereas the United States has been and remains highly dependent on space capabilities, China has historically been less dependent on them. This means that China has traditionally had far less to lose from striking satellites in orbit and comparatively more to gain from disabling an adversary’s satellites.

Since the 1990s, China has invested in technologies that can jam, disable or outright destroy another country’s satellites. This effort has been driven by a desire to counter what it sees as a key vulnerability of the U.S. military – its heavy reliance on space capabilities.

Yet much has changed since China’s first anti-satellite test in 2007.

China has gradually narrowed the gap with the United States in space capabilities and is now one of the most powerful spacefaring nations on Earth. As a result, China now has more at stake if it were to lose access to space.

Space debris is becoming a serious threat to Chinese interests in space. In 2022, for example, reports emerged that debris from Russia’s 2021 ASAT test came dangerously close to a Chinese satellite. Similarly, in 2021 China filed a claim at the United Nations that China’s Tiangong space station had to perform avoidance maneuvers due to “close encounters” with Starlink satellites. And now, in November 2025, China’s Shenzhou-20 spacecraft has actually been struck by space debris.

Recognizing the problem

It is too early to gauge how seriously Chinese officials view the threat of space debris. However, the high-profile nature of this recent incident may alert China’s public and officials to the risks posed by space debris.

China’s space station, its astronauts and its satellites are important to the Chinese Communist Party. If space debris permanently destroyed parts or all of China’s space station, or even killed a Chinese astronaut, it would likely lead to significant public outcry.

China’s space station is a project over three decades in the making and is the crown jewel of its space program. The Tiangong is set to become the only space station in orbit if the United States proceeds with its plans to deorbit the ISS in 2030.

Just as an owner of an expensive Lamborghini may become increasingly worried about dangerous road conditions that may damage their prized possession, Chinese officials may become anxious about China’s ability to operate its space station should space junk continue to clutter low Earth orbit.

Even if space debris does not damage China’s space station, it still poses a risk to Chinese satellites. And low Earth orbit is likely to become only more crowded, as SpaceX has announced plans to add up to 40,000 Starlink satellites in orbit, and China plans to add tens of thousands more satellites in low Earth orbit through its Guowang and Qianfan satellite megaconstellations.

China’s growing vulnerability to space debris creates an area of mutual concern where the United States and China may be able to work together to avoid future accidents.

Risk-reduction measures could include the two countries notifying each other about potential collisions. China and the United States could also open discussions around how to safely operate satellites or remove them from orbit when they’re no longer useful.

It remains to be seen what lessons Chinese decision-makers draw from this recent episode. But the problem of space debris is not going away.

R. Lincoln Hines does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

– ref. Space debris struck a Chinese spacecraft – how the incident could be a wake-up call for international collaboration – https://theconversation.com/space-debris-struck-a-chinese-spacecraft-how-the-incident-could-be-a-wake-up-call-for-international-collaboration-269268

Source: The Conversation – USA – By Christopher Carr, Assistant Professor of Aerospace Engineering, Georgia Institute of Technology

Envision a time when hundreds of spacecraft are exploring the solar system and beyond. That’s the future that NASA’s ESCAPADE, or escape and plasma acceleration and dynamics explorers, mission will help unleash: one where small, low-cost spacecraft enable researchers to learn rapidly, iterate, and advance technology and science.

The ESCAPADE mission will launch in mid-November 2025 on a Blue Origin New Glenn rocket, sending two small orbiters to Mars to study its atmosphere. As aerospace engineers, we’re excited about this mission because not only will it do great science while advancing the deep space capabilities of small spacecraft, but it also will travel to the red planet on an innovative new trajectory.

The ESCAPADE mission is actually two spacecraft instead of one. Two identical spacecraft will take simultaneous measurements, resulting in better science. These spacecraft are smaller than those used in the past, each about the size of a copy machine, partly enabled by an ongoing miniaturization trend in the space industry. Doing more with less is very important for space exploration, because it typically takes most of the mass of a spacecraft simply to transport it where you want it to go.

Having two spacecraft also acts as an insurance policy in case one of them doesn’t work as planned. Even if one completely fails, researchers can still do science with a single working spacecraft. This redundancy enables each spacecraft to be built more affordably than in the past, because the copies allow for more acceptance of risk.

Studying Mars’ history

Long before the ESCAPADE twin spacecraft Blue and Gold were ready to go to space – billions of years ago, to be more precise – Mars had a much thicker atmosphere than it does now. This atmosphere would have enabled liquids to flow on its surface, creating the channels and gullies that scientists can still observe today.

But where did the bulk of this atmosphere go? Its loss turned Mars into the cold and dry world it is today, with a surface air pressure less than 1% of Earth’s.

Mars also once had a magnetic field, like Earth’s, that helped to shield its atmosphere. That atmosphere and magnetic field would have been critical to any life that might have existed on early Mars.

ESCAPADE will measure remnants of this magnetic field that have been preserved by ancient rock and study the flow and energy of Mars’ atmosphere and how it interacts with the solar wind, the stream of particles that the sun emits along with light. These measurements will help to reveal where the atmosphere went and how quickly Mars is still losing it today.

Weathering space on a budget

Space is not a friendly place. Most of it is a vacuum – that is, mostly empty, without the gas molecules that create pressure and allow you to breathe or transfer heat. These molecules keep things from getting too hot or too cold. In space, with no pressure, a spacecraft can easily get too hot or too cold, depending on whether it is in sunlight or in shadow.

In addition, the Sun and other, farther astronomical objects emit radiation that living things do not experience on Earth. Earth’s magnetic field protects you from the worst of this radiation. So when humans or our robotic representatives leave the Earth, our spacecraft must survive in this extreme environment not present on Earth.

ESCAPADE will overcome these challenges with a shoestring budget totaling US$80 million. That is a lot of money, but for a mission to another planet it is inexpensive. It has kept costs low by leveraging commercial technologies for deep space exploration, which is now possible because of prior investments in fundamental research.

For example, the GRAIL mission, launched in 2011, previously used two spacecraft, Ebb and Flow, to map the Moon’s gravity fields. ESCAPADE takes this concept to another world, Mars, and costs a fraction as much as GRAIL.

Led by Rob Lillis of UC Berkeley’s Space Sciences Laboratory, this collaboration between spacecraft builders Rocket Lab, trajectory specialists Advanced Space LLC and launch provider Blue Origin – all commercial partners funded by NASA – aims to show that deep space exploration is now faster, more agile and more affordable than ever before.

How will ESCAPADE get to Mars?

ESCAPADE will also use a new trajectory to get to Mars. Imagine being an archer in the Olympics. To hit a bull’s-eye, you have to shoot an arrow through a 15-inch – 40-centimeter – circle from a distance of 300 feet, or 90 meters. Now imagine the bull’s-eye represents Mars. To hit it from Earth, you would have to shoot an arrow through the same 15-inch bull’s-eye at a distance of over 13 miles, or 22 kilometers. You would also have to shoot the arrow in a curved path so that it goes around the Sun.

Not only that, but Mars won’t be at the bull’s-eye at the time you shoot the arrow. You must shoot for the spot that Mars will be in 10 months from now. This is the problem that the ESCAPADE mission designers faced. What is amazing is that the physical laws and forces of nature are so predictable that this was not even the hardest problem to solve for the ESCAPADE mission.

It takes energy to get from one place to another. To go from Earth to Mars, a spacecraft has to carry the energy it needs, in the form of rocket fuel, much like gasoline in a car. As a result, a high percentage of the total launch mass has to be fuel for the trip.

When going to Mars orbit from Earth orbit, as much as 80% to 85% of the spacecraft mass has to be propellant, which means not much mass is dedicated to the part of the spacecraft that does all the experiments. This issue makes it important to pack as much capability into the rest of the spacecraft as possible. For ESCAPADE, the propellant is only about 65% of the spacecraft’s mass.

ESCAPADE’s route is particularly fuel-efficient. First, Blue and Gold will go to the L2 Lagrange point, one of five places where gravitational forces of the Sun and Earth cancel out. Then, after about a year, during which they will collect data monitoring the Sun, they will fly by the Earth, using its gravitational field to get a boost. This way, they will arrive at Mars in about 10 more months.

This new approach has another advantage beyond needing to carry less fuel: Trips from Earth to Mars are typically favorable to save fuel about every 26 months due to the two planets’ relative positions. However, this new trajectory makes the departure time more flexible. Future cargo and human missions could use a similar trajectory to have more frequent and less time-constrained trips to Mars.

ESCAPADE will be a testament to a new era in spaceflight. For a new generation of scientists and engineers, ESCAPADE is not just a mission – it is a blueprint for a new collaborative era of exploration and discovery.

Christopher E. Carr is part of the science team for the Rocket Lab Mission to Venus (funding from Schmidt Sciences and NASA). More information is available at https://www.morningstarmissions.space/rocketlabmissiontovenus

Glenn Lightsey does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

– ref. Let’s go on an ESCAPADE – NASA’s small, low-cost orbiters will examine Mars’ atmosphere – https://theconversation.com/lets-go-on-an-escapade-nasas-small-low-cost-orbiters-will-examine-mars-atmosphere-269321

Source: The Conversation – USA – By Nicholas Jacobs, Goldfarb Family Distinguished Chair in American Government, Colby College; Institute for Humane Studies

Every few years, Democrats try to convince themselves they’ve found the one – a candidate who can finally speak fluent rural, who looks and sounds like the voters they’ve lost.

In 2024, that hope was pinned on Tim Walz, the flannel-wearing, “Midwestern nice” governor whose small-town roots were supposed to unlock the rural Midwest for a Harris–Walz victory.

It did not.

Now those expectations have migrated to New England, onto Graham Platner – the tattooed veteran and oyster farmer from Maine who swears from the stump, wears sweatshirts instead of suits, and, some believe, could be the party’s blue-collar savior against Sen. Susan Collins, the Republican incumbent running her sixth campaign for U.S. Senate.

I study rural politics and live in rural Maine. I’m skeptical whether Platner can reach the independents and rural moderates Democrats need. But I also see why people think he might: He’s speaking to grievances that are real, measurable and decades in the making.

Platner represents Democrats’ anxieties about class and geography – a projection of the authenticity they hope might reconcile their national brand with rural America. On paper, he’s the kind of figure they imagine can bridge the divide: a plainspoken Mainer.

But his story cuts both ways. He’s the grandson of a celebrated Manhattan architect, his father is a lawyer and his mother is a restaurateur whose business caters to summer tourists. He attended the elite Hotchkiss School.

It’s a life of silver spoons and salt air. That tension mirrors the Democratic party itself, led and funded by urban professionals who are increasingly aware of just how far they strayed from their working-class roots.

If Platner is to prevail, he must assemble a coalition that expands beyond what the party has become – concentrated in urban and coastal enclaves, financed nationally and culturally distant from much of rural America.

Yet Platner’s immediate hurdle isn’t rural Maine at all. It is the Democratic primary, and those voters do not live where his campaign imagery is set.

Opportunity zone

In 2024, nearly 6 in 10 registered Democrats in Maine lived south of the state capital Augusta. That part of the state would not constitute an urban metropolis anywhere else in the U.S., but it is a drastically different world than the one Platner is fighting for.

The party’s gravitational center sits in Cumberland and York counties: Greater Portland and the southern coastal strip. That electorate is more educated, affluent and urban than the state as a whole, clustered in Portland’s walkable neighborhoods, college towns such as Brunswick and artsy coastal communities that swell with summer tourists.

Southern Maine – closer in feel to Boston’s suburbs than to the paper mills and potato fields up north – is where Democrats are already strong. Collins’ vulnerability lies instead among independents in small cities and towns, in deindustrialized and rural counties drifting rightward for two decades.

The 2020 U.S. Senate race – one that nearly every analyst, myself included, thought Collins was doomed to lose to Democrat Sara Gideon – makes that reality clear.

Collins outperformed Donald Trump in every county. She built commanding margins in rural Maine, offsetting Democratic gains in Portland and the southern coast. Her real breakthrough came in the kinds of small towns where Trump lost and she won or closed the margin: Ellsworth, Brewer, Machias, Gardiner and Winterport.

Those former mill towns and service hubs once anchored the Maine Democratic Party. They’re home to exactly the kinds of voters who, in principle, might give someone like Platner a hearing: not deeply ideological, modestly skeptical of both parties and wary of national polarization.

But they are also the voters least represented in the Democratic primary electorate or the donor class fueling Platner’s campaign.

Doing it as a Democrat

According to the most recent Federal Election Commission figures, only about 12% of Platner’s haul has even come from inside Maine. The nationalization of campaign finance is becoming more common for U.S. Senate candidates.

But there are two differences worth noting.

Platner’s in-state share is higher and more geographically diffuse than Gideon’s 2020 campaign. Then, in what became Maine’s most expensive Senate race, just 4% of Gideon’s war chest was homegrown. Most of that Maine money was heavily concentrated in Portland and the southern coastal corridor.

While 64% of Gideon’s Maine total fundraising amount came from the three southernmost counties, 88% of Platner’s current in-state funding is from outside the urban-suburban core of southern Maine.

That divergence matters. It suggests that while Platner’s campaign is still fueled by national money, its local base – however small – extends beyond the usual Portland orbit.

And there is a reason Platner’s message has not been dead on arrival.

The economic populism he’s advancing speaks directly to the material frustrations many rural residents express – frustration with corporate consolidation, rising costs and the feeling that prosperity never reaches their communities.

The 2024 Cooperative Election Study shows that rural independents and moderates often share progressive instincts on precisely these issues: Large majorities of rural, moderate/independent New Englanders support higher taxes on the wealthy and expanded health coverage. Platner is emphasizing those issues – corporate power, health costs, infrastructure, wages – where the urban–rural divide is narrowest.

Platner may be closing that gap. In an October 2025 survey, 58% of likely Democratic primary voters named him as their first choice for the 2026 Senate nomination. While that support has likely changed in the aftermath of two controversies – his chest tattoo that resembled a Nazi icon and recent posts on Reddit, including one in which he says rural people “actually are” “stupid” and “racist” – that poll’s most notable finding is the consistency of support across income and education levels.

Still, while his message may bridge income and education, the biggest obstacle facing Platner is the simplest one: He’s trying to do all of this as a Democrat.

Hearing, not speaking

Being anchored in metropolitan and professional networks far removed from rural life shapes not only what Democrats stand for but how they speak, focusing on moral and cultural commitments that resonate nationally but feel abstract in smaller, locally based communities.

That’s why even an economically resonant message struggles once it meets the national brand.

Rural independents and moderates often agree with Democrats on taxes, health care and wages. Those alignments fade when policy is framed through the institutions and moral language of a party many no longer see as compatible with rural ways of living.

It’s not clear yet how Platner will respond on issues that don’t poll well in rural Maine – environmental regulation, gun control or immigration – where loyalty to the national agenda has undone many would-be reformers before him.

And that schism is not because rural voters misunderstand their “self-interest” or because racial dog whistles have led them astray. It is hostility toward a party that, with rare exception, sees the future as something rural America must adapt to, not something it should help define.

That is the danger of treating biography as the solution to a decades-long realignment. Platner might be as close as Democrats have come in years to a candidate who can talk credibly to rural voters about power, place and policy. But he still has to do it while wearing the “scarlet D” – the weight of a party brand built over generations.

Whether he wins or loses, his campaign already points to a deeper question: Can Democrats do more than rent rural authenticity? Put more bluntly, the real test is not whether Platner can speak to rural Maine, it is whether his party can finally learn to hear it.

Nicholas Jacobs does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

– ref. Why rural Maine may back Democrat Graham Platner’s populism in the Senate campaign − but not his party – https://theconversation.com/why-rural-maine-may-back-democrat-graham-platners-populism-in-the-senate-campaign-but-not-his-party-269466