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Wednesday, January 18, 2023

Reversing abortion drug's approval would harm public interest, U.S. FDA says

 President Joe Biden's administration is urging a judge to reject a request by abortion opponents for a court order withdrawing federal approval for the drug used in medication abortions - which account for more than half of U.S. abortions - citing potential dangers to women seeking to end their pregnancies.

The U.S. Food and Drug Administration's filing to U.S. District Judge Matthew Kacsmaryk, made available online on Tuesday, came in a lawsuit in Texas by anti-abortion groups challenging the agency's approval of the drug mifepristone in 2000 for medication abortion.

"The public interest would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for twenty-two years," lawyers for the FDA said in the filing to Kacsmaryk, who is based in Amarillo.

Mifepristone is available under the brand name Mifeprex and as a generic. Used in conjunction with another drug, it is approved to terminate a pregnancy within the first 10 weeks of a pregnancy. The FDA on Jan. 3 said the government for the first time will allow mifepristone to be dispensed at retail pharmacies.

Medication abortion has drawn increasing attention since the U.S. Supreme Court last June overturned its landmark 1973 Roe v. Wade decision that had legalized abortion nationwide. Nearly all abortions, including medication abortions, are now banned in 12 states, and 16 states that permit some abortions also had laws restricting medication abortion as of November, according to the Guttmacher Institute, a research group that supports abortion rights.

"No abortion is safe, and chemical abortions are particularly dangerous," said Julie Blake, senior counsel at the conservative legal group Alliance Defending Freedom, which represents the plaintiffs in the lawsuit. "The FDA, by approving chemical abortion drugs for home use, puts a woman or girl's life at risk."

China's pessimistic Gen Z poses challenge for Xi post-COVID

 The first weekend after COVID-19 restrictions ended last month, dozens of young Chinese jostled in the dark at a heavy-metal concert in a tiny Shanghai music venue that reeked of sweat and hard liquor.\

It was the kind of freedom young Chinese had demanded in late November in protests against the zero-COVID policy that became the biggest outpouring of public anger in mainland China since President Xi Jinping took power a decade ago.

After three years of lockdowns, testing, economic hardship and isolation, many of China's Generation Z — the 280 million born between 1995 and 2010 — had found a new political voice, repudiating their stereotypes as either nationalist keyboard warriors or apolitical loafers.

Pacifying a generation faced with near-record youth unemployment and some of the slowest economic growth in nearly half a century presents a policymaking challenge for Xi, who is just beginning a precedent-breaking third term. Improving young people's livelihoods without abandoning the country's export-led growth model poses inherent conflicts for a government that prioritises social stability.

This generation is the most pessimistic of all age groups in China, surveys show. While the protests succeeded in hastening the end of COVID curbs, the hurdles Chinese youth face in achieving better living standards will be harder to overcome, some analysts say.

"As the road ahead for the youth gets narrower and tougher, their hopes for the future evaporate," said Wu Qiang, a former politics lecturer at Tsinghua University who is now an independent commentator in Beijing. Young people no longer had "blind confidence and adulation" towards China's leaders, he added.

Some Chinese youth who spoke to Reuters reflected the sense of frustration.

"If they didn't change the policy, then more people would protest, so they had to change," said 26-year-old Alex, who declined to give her last name for fear of retribution from the authorities, in an interview before the Shanghai concert.

China's COVID-19 reopening set to push 2023 oil demand to new high -IEA

 

The lifting of COVID-19 restrictions in China is set to boost global oil demand this year to a new record high, the International Energy Agency (IEA) said on Wednesday, while price cap sanctions on Russia could dent supply.

"Two wild cards dominate the 2023 oil market outlook: Russia and China," the Paris-based energy watchdog said in its monthly oil report.

"Russian supply slows under the full impact of sanctions (while) China will drive nearly half this global demand growth even as the shape and speed of its reopening remains uncertain."

Weak industrial activity and mild weather helped cut oil demand by nearly a million barrels per day in the OECD developed countries in the last quarter of 2022.

But despite possible but likely mild recessions in Europe and the United States, China's expected reopening is set to fuel rebounds in nearby Asian economies and see it take the lead from India as the world's leader in oil demand growth.

"The preeminent driver of 2023 GDP and oil demand growth will be the timing and pace of China's post-lockdown recovery," the IEA said.

Meanwhile the main growth in oil supply is set to come from the United States as output from the OPEC+ producer group will decline by 870,000 barrels per day (bpd), led by Russia.

Russian oil output was dented by only 200,000 barrels per day (bpd) in December after the European Union banned imports of its seaborne crude and a coalition of countries imposed a price cap on its crude, the IEA said.

That was around double what the IEA had predicted in its last report and the agency originally foresaw 3 million bpd being shut in after Moscow's invasion of Ukraine.

Russia's oil exports increased by just under 5% last year, the IEA said on Wednesday, though prices were far lower.

https://www.marketscreener.com/news/latest/China-s-COVID-19-reopening-set-to-push-2023-oil-demand-to-new-high-IEA--42755800/

How Ozone-Depleting Gases (Almost) Disappeared

 According to an expert assessment released last week, the hole in the ozone layer is expected to close completely over the upcoming decades.

As Statista's Katharina Buchholz reports, the layer in the world’s stratosphere containing a high concentration of ozone had ruptured every year since the 1980s due to harmful chemicals being released into the air and depleting the atmosphere’s naturally occurring ozone. Striking a hopeful note for the successes possible in environmental and climate conservation, the phase-out of substances like CFCs are expected to reverse the damage done.

Infographic: How Ozone-Depleting Gases (Almost) Disappeared | Statista

Tuesday, January 17, 2023

FBI Decided Not To Monitor Biden Document Search

After President Biden's lawyers found classified documents at an office he used at a DC think tank, His Justice Department considered, and then declined, a plan to have FBI agents monitor a search for classified documents at his residences, in order to 'avoid complicating later stages of the investigation,' and because Biden's attorneys 'had quickly turned over a first batch and were cooperating,' the Wall Street Journal reports, citing people familiar with the matter.

Instead, the DOJ decided that it would be just fine for Biden's lawyers to conduct the additional searches by themselves, and would agree to immediately notify the Justice Department if they found any other potentially classified records - after which law-enforcement authorities would take them.

The arrangement meant that FBI agents wouldn't bear witness to things such as the volume, or contents, of whatever might turn up. This is, of course, the same FBI that participated in a plan (and fabricated evidence) in a plot to frame former President Trump as a Russian asset, and then ran cover for the Bidens during the 2020 US election - telling social media companies that Hunter Biden's laptop, or anything like it, was likely Russian disinformation.

In the week since news reports first surfaced about the documents, the incident has drawn parallels to the discovery of a much larger number of documents at former President Donald Trump’s Mar-a-Lago home in Florida, which federal agents obtained a warrant to search in August after more than a year of negotiations between Mr. Trump’s lawyers, the National Archives and the Justice Department and after Mr. Trump’s lawyers said all documents had been returned. -WSJ

After the initial finding at the Penn-Biden Center in early November (and not disclosed until last week), classified materials were discovered on three separate occasions in Biden’s Wilmington house in December and January, in the garage and a room adjacent to it, White House lawyer Richard Sauber said last week.

According to Sauber, the documents were "inadvertently placed" at the locations.

Trump supporters have accused the DOJ of a double standard in the handling of the Biden situation vs. Trump's. And of course, as President, Trump's ability to declassify the documents obtained in the raid remains a constitutional grey area. 

Biden's supporters have pointed to the president's cooperation, however the DOJ's willingness to let Biden's lawyers conduct unsupervised searches is obviously fraught with concern.

According to the White House, it's no big deal.

The Renewable Energy Problem That No One Talks About

 by Peter Castle via The Epoch Times,

An obvious barrier to adopting wind and solar power for electricity supply is their intermittency - when the wind isn’t blowing, and the sun isn’t shining, substitute sources are required. This issue is given much attention by conservative media, as it should.

Yet one of the less well-known roadblocks for these renewable technologies is frequency control, even though it becomes a critical concern much sooner.

Since the 1890s, electricity networks and devices all around the globe have used alternating current (AC) systems, which means that the flow of electricity in the system is repeatedly changing direction.

In Australia, it alternates 50 times a second, that is, at a frequency of 50 Hertz (in the USA, it is 60 Hertz).

Supplying electricity at a consistent frequency is very important because appliances and electronics on the network are designed for a specific frequency/voltage input. Therefore, they can be damaged by the wrong electricity supply.

As a rule, networks would rather supply no electricity than bad electricity. Automated controls through the electricity system will disconnect the supply if the frequency or voltage is “off-spec.”

A technician monitors electricity levels in front of a giant screen showing the eastern German electricity transmission grid in the control centre at Neuenhagen bei Berlin, Germany, on Dec. 17, 2015. (Sean Gallup/Getty Images)

South Australians will not soon forget when this happened to the entire state network in 2016. The state-wide blackout started late in the afternoon during some poor weather conditions, and thousands of people had to drive out of the city without any streetlights or traffic signals.

There were a range of contributing causes, including gusty winds taking down some transmission lines and a lightning strike on a power station.

After those physical causes, automated protection systems took over. Wind turbines disconnected themselves from the network. The system naturally started drawing more load from all remaining supplies, which maxed out the capacity of the interconnector to the rest of the East Coast network, which consequently disconnected.

From that point, the shutdowns cascaded throughout the whole network. This all happened in less than a second.

The potential for a cascading shutdown can never be entirely eliminated; automated protection systems must make decisions at a speed that prevents any human involvement.

Nevertheless, the vulnerability of the whole system can vary, and increasing intermittent renewables contribute to decreasing the system’s stability.

Traditional vs Renewable Generators

Traditional generators use turbines—steam turbines, open-cycle turbines, and water turbines (hydroelectricity). This equipment is called “synchronous” because the frequency of the electricity they produce is directly linked to the speed that the shafts of the turbines rotate.

Because these machines are large and heavy, it takes time and energy to speed them up or slow them down, which means that the frequency of the electricity cannot change too quickly. This is called “inertia.”

As you may imagine, solar panels, having no moving parts, do not provide inertia. They match whatever frequency is already in the system; they do not help stabilise it.

Wind turbines, though they do have large spinning components, change speed all the time merely due to wind conditions. Hence they are not designed to synchronise with the AC network. So they do not provide inertia either.

If a system does not have inertia, then instead of gently responding to a change in load, the frequency can flail about like a cyclist getting speed wobbles (any engine can have the same problem if it doesn’t have a sufficiently heavy flywheel).

After the 2016 blackout, energy security gained its rightful place as the highest priority for a few glorious and brief weeks.

A package of actions was taken by the South Australian government over the next couple of years, including the installation of a large-scale battery (following a promise by Elon Musk to construct it within 100 days or provide it for free), the building of a new diesel power station, and providing incentives for new natural gas exploration and production.

Additionally, two synchronous condensers were installed. Synchronous condensers are large, heavy rotating shafts, similar to what is contained in a turbine, but they don’t produce electricity—they just help to stabilise the frequency of the network.

In the subsequent years, each of these responses was vindicated. The diesel generator has been used at several critical times. It was also found that the primary value of the large-scale battery was to stabilise the network.

Though it stores comparatively little energy, the battery responds rapidly to faults originating anywhere in the east coast network, even in Queensland. It has since been programmed to provide “virtual inertia.”

Technology for 100 Percent Renewable Network Is Not Here Yet

Advances in technology and network management have meant that renewables can provide more significant and larger portions of supply without unacceptably destabilising the network frequency.

Nevertheless, it remains true that almost no system can ever afford to operate on 100 percent renewables without keeping at least a few traditional rotating generators online.

Wind and solar generators are often switched off or “curtailed,” even when there are still some gas or coal generators active. The network operator cannot afford to turn off the synchronous generators without losing frequency control.

In the Northern Territory, which has a stand-alone electricity network, about 60 MW of solar farms have been constructed and yet have never once been switched on because the system cannot accommodate them.

Though the 2016 blackout triggered a suite of improvements to South Australia’s network, energy security still falls dangerously far down the list of priorities for Australian governments.

Important actions that support energy security, such as the construction of the Kurri Kurri peaking generator in New South Wales, often face opposition from the media and politicians.

Several times, Australia has come dangerously close to another cascading shutdown. Incidents have occurred in smaller networks but failed to gain national attention—such as the 2019 Alice Springs shutdown, in which the central-Australian network was shut down for several hours merely due to unanticipated cloud cover.

A recent example of a near-miss occurred in late November 2022. During a significant weather event, the main transmission line connecting South Australia to the rest of the east coast was broken near Tailem Bend.

South Australia’s electricity network became an island. For system stability, several rotating generators had to remain online. Yet the amount of solar energy the state can generate during the day can exceed demand. The network operator needed to curtail more solar generation than they have direct control over.

In response, the market operator began phoning behind-the-meter solar power providers and using social media to ask commercial and residential solar panel owners to switch off their panels. Thanks to these phone calls, they managed to turn off about half of South Australia’s solar power and thus prevent another shutdown.

The system was highly vulnerable, yet the whole event barely made the evening news.

Despite the lack of traction from that news story, the media loudly celebrated a fairly meaningless milestone a month later when the state’s renewables generation was 100 percent of demand for 10 days, which would have been impossible without exporting most of the generation to neighbouring states.

It seems that until the lights actually turn out, the decision maker will keep their gaze firmly fixed on the renewable mirage.

There are multiple reasons why renewables are not a simple panacea for electricity supply around the world:

  • the weather-dependence problem,

  • the energy storage problem,

  • the end-of-life replacement and recycling problem,

  • the land-area problem,

  • the materials-of-construction and scarcity problem.

Now you can add the frequency control problem to your list.

https://www.zerohedge.com/technology/renewable-energy-problem-no-one-talks-about

Making Cancer Treatment Smarter

 Sometimes, the results of clinical studies are counter-intuitive and offer a lesson in not making unfounded assumptions. I encountered an example of that when I read a study on the benefits of radiation therapy after surgery for breast cancer.

Radiotherapy after breast-conserving surgery for early breast cancer substantially reduced the risk of disease recurrence, but — and here’s the surprising part — the benefit did not translate to an improvement in overall survival after 30-year follow-up.

The study was the epic 30-year Scottish breast conservation trial. From 1985 to 1991, it enrolled 585 patients 70 years old and younger with primary breast tumors. After local excision of the tumor and an axillary lymph node biopsy or clearance, all patients received systemic therapy with oral or intravenous drugs appropriate to the estrogen receptor status of their tumor. (Different drugs are indicated depending on the genetics of the tumor.)

The patients were then randomized to either adjuvant radiotherapy or to no radiotherapy, which was the fundamental variable in the study — and local recurrence (that is, the development of a new tumor in the same breast) and overall survival were followed.

In the initial analysis of the trial at six years, the local recurrence rate was 5.8 percent in the radiotherapy arm and 24.5 percent in the no-radiotherapy arm, with no difference in overall survival.

At 10 years, local recurrence rates were 8.8 percent with radiotherapy versus 31 percent with no radiotherapy; at 20 years, rates were 15.2 percent and 37.6 percent, respectively; and at 30 years, rates were 27.8 percent and 42.7 percent.

Thus, adding radiotherapy to surgery and drug treatment lowered the incidence of local recurrence of tumors, which is not surprising. Perhaps unexpected, however, was the finding that by the 30-year mark, there was no significant difference in overall survival between patients who received radiotherapy and those who did not. Overall survival rates were 72.5 percent and 70.8 percent, respectively, at 10 years; 48.6 percent and 48.4 percent at 20 years; and 23.7 percent and 27.5 percent — in other words, statistically indistinguishable.

If radiotherapy lowers the incidence of recurrence of cancer in the affected breast and, therefore, presumably the possibility of resulting metastasis and mortality, why is long-term survival not also enhanced?

To answer that question, I consulted Dr. Joel Tepper, an eminent academic radiation oncologist.  He explained that there are two reasons.

“The first, and probably the most important, is that local recurrences can be well treated with a mastectomy in most patients, especially if the patients are carefully followed.  The second is that (especially with older techniques) there is likely some mortality from the extra treatment, specifically late cardiac injury with the older techniques that were used for left-sided breast cancer.  If they analyzed right vs. left, they might see a survival advantage in the right-sided tumors with RT. This has been looked at in some other reports.”

That second point is interesting, because it suggests that the study revealed side effects of the radiotherapy that wiped out what could have been an overall survival advantage from the treatment.

Tepper’s explanation is a reminder that we perform these kinds of studies of various treatment regimens to find out how effective they are and how they might be improved. Medicine, like the science that underlies it, is seldom transformed by “Eureka” breakthroughs; instead, it is most often a process of systematically accumulating knowledge and making incremental improvements.

Dr. Henry Miller, a physician and molecular biologist, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. He was the founding director of the FDA's Office of Biotechnology. 

https://dcjournal.com/making-cancer-treatment-smarter/