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Saturday, October 1, 2022

FDA drops push for medical device cybersecurity requirement

 The FDA user-fee agreements bill was recently reauthorized, but without the previously introduced medical device cybersecurity rules, SC Magazine reported Sept. 29.

The cybersecurity rules would have required developers to create processes for identifying and addressing security vulnerabilities and threats for products brought to market.

Greg Murphy, CEO and president of computer security service Ordr, told SC Magazine the removal of the cybersecurity provisions "illustrates why healthcare organizations can't wait for government regulations before acting." 

The bill passed in the House in June. It aimed to reauthorize user-fee agreements, target lower costs, support innovation and improve generic drug competition.

Next On Europe's Doomsday List: Collapse Of Cell Phone Networks

 It's not just heating that could be missing across Europe this winter: cell phones may be the next to go. That's because if power cuts or energy rationing knocks out parts of the mobile networks across the region, mobile phones could go dark around Europe this winter according to the latest doomsday reporting from Reuters.

While everyone knows by now that Europe's chances of rationing and power shortages have exploded ever since Moscow suspended gas supplies, in France, the situation is even worse as several nuclear power plants are shutting down for maintenance. And the cherry on top: telecom industry officials told Reuters they fear a severe winter will put Europe's telecoms infrastructure to the test, forcing companies and governments to try to mitigate the impact (i.e., more bailout demands).

The problem, as four telecoms executives put it, is that currently there are not enough back-up systems in many European countries to handle widespread power cuts, raising the prospect of mobile phone outages. Realizing that in just weeks Europe could be cell phone free, countries including France, Sweden and Germany, are scarmbling to ensure communications can continue even if power cuts end up exhausting back-up batteries installed on the thousands of cellular antennas spread across their territory.

Alas, like with everything else in Europe, it's too little, too late and Europe is facing a truly historic cell phone black out because while Europe has nearly half a million telecom towers, most of them have battery backups that last around 30 minutes to run the mobile antennas. After that they go dark.

One of the alternatives being discussed is pushing Europe back to communist era blackout regimes: In France, a plan put forward by electricity distributor Enedis, includes potential power cuts of up to two hours in a worst case scenario, two sources familiar with the matter said.

The general black-outs would affect only parts of the country on a rotating basis. Essential services such as hospitals, police and government will not be impacted, the sources said. And now, it appears that cell phones are considered essential too: the French Federation of Telecoms (FFT), a lobby group representing Orange, Bouygues Telecomand Altice's SFR, put the spotlight on Enedis for being unable to exempt antennas from the power cuts.

Enedis said it was able to isolate sections of the network to supply priority customers, such as hospitals, key industrial installations and the military and that it was up to local authorities to add telecoms operators infrastructure to the list of priority customers.

"Maybe we'll improve our knowledge on the matter by this winter, but it's not easy to isolate a mobile antenna (from the rest of the network)," said a French finance ministry official with knowledge of the talks.

Telcos in Sweden and Germany have also raised concerns over potential electricity shortages with their governments, several sources familiar with the matter said. Swedish telecom regulator PTS is working with telecom operators and other government agencies to find solutions, it said. That includes talks about what will happen if electricity is rationed. PTS is financing the purchase of transportable fuel stations and mobile base stations that connect to mobile phones to handle longer power outages, a PTS spokesperson said.

The Italian telecoms lobby was even more forceful, and told Reuters it wants the mobile network to be excluded from any power cut or energy saving stoppage and will raise this with Italy's new government. The power outages increase the probability of electronic components failing if subjected to abrupt interruptions, telecoms lobby chief Massimo Sarmi said in an interview.

Until a solution is reached, to save power, telecom companies are using software to optimise traffic flow, make towers "sleep" when not in use and switch off different spectrum bands, Reuters sources said. The telecom operators are also working with national governments to check if plans are in place to maintain critical services. In Germany, Deutsche Telekom has 33,000 mobile radio towers and its mobile emergency power systems can only support a small number of them at the same time, a company spokesperson said.

https://www.zerohedge.com/technology/gone-30-minutes-next-europes-doomsday-list-collapse-cell-phone-networks

California City Holding 'Groceries For Guns' Drop-Off Event

 The California coastal community of San Luis Obispo has allocated $12,000 for a 'Guns for Groceries' drop-off event, in which Californians who drop off 'assault rifles' will receive a $200 grocery store gift card, while handguns, other rifles and shotguns will be worth $100 each.

The event is scheduled for Saturday, Oct. 1 from 9am - 1pm.

The event is designed to clear the streets of unwanted guns that are not in use and inherited firearms that residents would like to discard but don’t know where or how to do so.

Gun enthusiasts initially perceived the event as a gun grab until San Luis Obispo Police Captain Fred Mickel explained the program is not targeting responsible gun owners. -Epoch Times

The event comes at state Attorney General Rob Bonta comes under fire for asking major credit card companies to slap codes on purchases from gun stores in order to track who's buying what.

Fortunately for gun owners who wish to remain anonymous, the Guns for Groceries event is no-questions asked, and drivers will remain anonymous when they drive up to drop off the guns (no word on whether they - or some other agency - will run plates, of course).

Firearms turned in must be unloaded and packed in the trunks of vehicles upon arrival. Ammo will not be accepted, according to Captain Mickel - who has run similar programs in Petaluma, Sacramento, and Los Angeles County, and told the Epoch Times that there is no political agenda underlying the program.

The collected guns will be destroyed (totally).

https://www.zerohedge.com/political/california-city-holding-groceries-guns-drop-event

Fed Begins to Split on the Need for Speed to Peak Rates

 Federal Reserve officials are starting to stake out different views on how fast to raise interest rates as they balance hot inflation against rising stress in financial markets.

With Fed target range now at 3% to 3.25% and only a few moves from reaching their forecast peak, officials are starting to speak differently about the urgency with which they need to get there.

Hawks like Cleveland Fed chief Loretta Mester say they must keep raising rates aggressively to win the battle against inflation even if that causes a recession. Vice Chair Lael Brainard has offered a slightly softer assessment while continuing to stress the need to tighten policy.

Brainard’s speech Friday -- the first from Fed board leadership since officials met last week -- said policy will need be restrictive for some time and avoid the risk of prematurely pulling back.

But she injected a note of caution about how fast they need to go, while discussing a number of ways in which the global rate-hiking cycle could spill over on the US economy.

Her San Francisco colleague Mary Daly also highlighted the cost of doing too much -- as well as too little -- to cool prices.

Their comments injected a slight variation into what has been a uniformed stream of insistence from regional Fed presidents declaring unflinching resolve to crush inflation. 

The potential costs to the economy of are already being telegraphed in the form of falling asset prices. The S&P 500 declined 9.3% in September in the steepest monthly decline since March 2020 as Covid-19 spread.

US Equities Sink

S&P 500 falls to lowest level since November 2020 on Sept. 30

Source: Bloomberg

Bank of America Corp. says credit stress is at a “borderline critical level” beyond which dysfunction begins. That’s something the Fed wants to avoid because market breakdowns are difficult to control and can accelerate downturns.

The divisions among officials showed up in their forecasts released Sept. 21 that showed 8 officials estimating they would finish the year with rates in a 4% to 4.25% range while nine were a quarter point higher.

One of the dividing lines, said Derek Tang, an economist at LH Meyer in Washington, is differing views on longer-run inflation expectations, with those taking more comfort in the stability of those gauges now saying the committee can take a step-by-step approach in getting to peak rates. Policymakers see that at 4.6% next year, according to their median estimate.

Brainard cautioned that it will take time for the full extent of tightening to bite down broadly across the economy, another way of arguing for some patience starting now.

“Uncertainty is currently high, and there are a range of estimates around the appropriate destination of the target range for the cycle,” she told a conference hosted at the New York Fed on financial stability. “Proceeding deliberately and in a data-dependent manner will enable us to learn how economic activity and inflation are adjusting to the cumulative tightening.” 

That contrasts sharply with Fed hawks. In fact, Mester has argued aggressively against down-shifting into more deliberative policy, as officials have done in past tightening cycles when high uncertainty lead the central bank to inch rates up a quarter-point at a time. 

At a time when inflation is too high, and the direction of inflation expectations is hard forecast, overshooting is better than undershooting, Mester says.

“Some results in the literature suggest that when policymakers confront more uncertainty either in their data or in their models, they should be more cautious in acting, that is, be more inertial in their responses,” she said in a Sept. 26 speech. “Subsequent research has shown that this is not generally true.”

“It can be better for policymakers to act more aggressively because aggressive and pre-emptive action can prevent the worst-case outcomes from actually coming about,” she added.

The debate about how quickly to get to peak rates is not a discussion about reversing course: Not a single official is talking about easing rapidly once they get there. Labor markets are strong with forecasters estimating another 250,000 jobs added in September, while the latest inflation report was discouraging.

Commerce Department data Friday showed the central bank’s preferred gauge rose 6.2% in the 12 months through August, down from 6.4% in July, but defying forecasters’ expectations for a greater moderation to 6%. 

US PCE Price Index Jumps More Than Forecast

Fed's preferred gauge rose 6.2% from year earlier; target is 2%

Source: Commerce Department

What ultimately determines the pace might be just whether markets remain orderly or not.

“They have made the decision they are going to tighten more rather than less, which certainly suggests the risks are that they will over-tighten. How are we going to see it? You are going to see it in financial conditions and market functioning,” said Julia Coronado, founding parter at MacroPolicy Perspectives.

“I think they still underweight” the risk of chaotic market breakdowns, she added. “When you say we are hellbent on being the fastest car on the road, that encourages a lot of positioning that is one way.”

https://www.bloomberg.com/news/articles/2022-10-01/fed-officials-begin-to-split-on-the-need-for-speed-to-peak-rates

Hydroponic crops qualify for organic certification, appellate court rules

 The court ruling allowing the USDA to grant organic certification to hydroponic crops will stand, the U.S. 9th Circuit Court of Appeals ruled on Thursday.

This latest decision is potentially the final chapter of the battle about whether organic crops must be planted in soil. The Center for Food Safety and other plaintiffs filed a lawsuit in 2020 following the USDA’s inaction on a petition urging the department to exclude hydroponically grown produce from organic certification.

The plaintiffs have argued for years that the 1990 Organic Foods Production Act, which established the organic program, mandates that its crops must “foster soil fertility.” Since hydroponic farming is done without soil, they have said it cannot meet the standards of the federal law and therefore crops grown that way should not be allowed to gain certification.

Last March, a federal judge upheld the USDA’s decision to allow hydroponic crops to be certified organic and dismissed the lawsuit. The judge ruled the USDA reasonably interpreted the law, which has no inherent prohibition for crops grown without soil. The plaintiffs appealed to the higher court.

The three-judge appellate panel agreed the text of the law does not expressly ban hydroponic crops from receiving organic certification. The USDA has a well-reasoned argument as to why hydroponic crops receive the certification, the opinion reads, so the court let the ruling stand.

The issue of whether hydroponic crops can be organic has been contentious since the organic program started. The National Organic Standards Board, which makes policy recommendations to the USDA, voted 8-to-7 against a ban on hydroponic certification in late 2017. The USDA followed those recommendations with new policy clarifications about hydroponic organic certification in early 2018.

Groups and individual farmers continued the fight with the petition and court case.

In an email, the Center for Food Safety said, “We are deeply disappointed by the Court’s decision, and are currently reviewing the decision and analyzing potential next steps.”

In the years since this battle began, several large indoor farming operations have grown with an eye on disrupting the produce industry.

Indoor farming companies Upward Farms and Soli Organic both have received USDA Organic Certification for their crops, but neither of them uses hydroponics. Many companies in this space that do hydroponic growth are not currently organic certified, but say on their websites that their practices are more stringent than organic.

https://www.fooddive.com/news/hydroponic-organic-certification-court-ruling/632526/

Methuselah’s Zoo: What Nature Can Teach Us about Living Longer, Healthier Lives

 Steven Austad is a Distinguished Professor of Biology at University of Alabama at Birmingham. His background involves close interactions with many animal species both in captivity and natural environments. Before becoming a scientist, he trained wild animals for the movie industry.

Below, Steven shares 5 key insights from his new book, Methuselah’s Zoo: What Nature Can Teach Us about Living Longer, Healthier LivesListen to the audio version—read by Steven himself—in the Next Big Idea App.

Methuselah’s Zoo: What Nature Can Teach Us about Living Longer, Healthier Lives By Steven Austad

1. Living is inherently destructive.

Biologist Max Kleiber called it The Fire of Life—which is more than a metaphor. Our bodies consist of forty trillion cells, each of which is an energy factory. That energy is provided by chemical reactions identical to those of a highly regulated fire. The chemical bonds in food are torn apart with the help of oxygen to release the energy needed to perform all cellular functions. This is precisely the same chemistry that causes the chemical bonds in wood, paper, or gasoline to be torn apart with the help of oxygen to release energy in the form of fire.

Just as fire produces side effects—sparks, soot, smoke—our cellular energy factories also do, by way of chemical by-products. Some of these by-products are oxygen radicals, which are destructive to the cellular energy factories themselves. To give an idea of the scale of damage, the DNA in each of our cells is estimated to be damaged by internal fire at least ten thousand times per day. Ten thousand bits of DNA damage per day times forty trillion cells and we are talking about numbers more familiar to astronomers than biologists. How do we survive for months, much less decades, in the face of such destruction?

2. Longevity is about replacement and repair.

Living things can almost be defined by their ability to self-repair. Wounds heal, breaks mend, and parts that can’t be repaired must be replaced. Longevity is about our success in repairing or replacing damaged cells.

“The DNA in each of our cells is estimated to be damaged by internal fire at least ten thousand times per day.”

Almost all daily DNA damage is repaired by the hundred or so genes that are devoted solely to that single task. Of course, terminally damaged cells have to be replaced. We replace about one percent of our cells per day—so roughly 400 billion cells, which corresponds to about two thousand miles of new DNA produced per second.

The fact that humans can successfully repair or replace damaged DNA (not to mention repairing or replacing other cell components) at that scale for decade after decade is remarkable.

3. Other species do longevity better.

Evolution has had several billion years with several billion species to tinker with and improve repair and replacement processes. Why would we assume that humans do those things best? In fact, nature has provided many species with better repair or replacement processes than our own.

For example, virtually any of our cells could suffer enough random DNA damage to turn cancerous. Cancer originates as the result of multiple mutations (mutations are unrepaired DNA damage) within a single cell. Human repair and replacement processes are successful enough for us to survive decades without one or more of our cells growing into a serious cancer. In light of our prevalent DNA damage, we are pretty remarkable. But consider that an elephant has more than sixty times as many cells as a human, and each of those cells also has the potential to become cancerous, yet elephants live almost as long as we do. That means elephants must have around sixty times better cancer resistance, meaning better repair or replacement processes. What’s more, whales can have as many cells as thirty elephants, or eighteen hundred times as many as a human, yet some whales live twice as long as humans. What might we learn about cancer prevention from understanding whale cells?

“Consider that an elephant has more than sixty times as many cells as a human, and each of those cells also has the potential to become cancerous, yet elephants live almost as long as we do.”

Take the heart, as another example. The human heart beats about 70-80 times per minute, or roughly one hundred thousand times per day. The heart is a muscle and muscles wear out with age. Since people are living longer than ever before, deaths and disabilities from heart failure are increasing. Let’s say that a human heart can continue beating for about one hundred years, with diminishing quality. A hummingbird, by comparison, has a machine gun of a heart. It beats more than a thousand times per minute. Over the course of a twelve-year life (the longest on record), a hummingbird’s heart will beat about twice as many times as a hundred-year-old human heart. Not only that, but the hummingbird heart can’t afford to have its heart function deteriorate because any drop in the heart’s ability to deliver fuel and oxygen to flight muscles would compromise its ability to forage and flee danger. To add to the mystery, hummingbirds do this with blood glucose concentrations that would be diabetic in a human. Few things are more damaging to the human heart than uncontrolled diabetes. What might we learn about maintaining heart health if we understood hummingbird hearts?

4. Size counts in the longevity game.

Large species typically live longer than small species. We know this intuitively. No one is surprised that a dog lives longer than a mouse, a horse longer than a dog, an elephant longer than a horse. This is a very general pattern in nature. Size and longevity are linked not only in mammals but the same pattern is found in birds, reptiles, salamanders, clams, and oysters—in just about everything. The reason is simple: the fire of life burns hotter and faster in smaller animals. A mouse’s cells burn energy fifteen times faster than a horse’s cells.

Smaller animals also live faster in many ways. They grow to adult size and begin reproducing faster. Their hearts beat faster. They breathe faster. Their muscles contract faster. Food churns through their guts faster. Their blood and skin cells are replaced faster. Their kidneys process waste faster. You get the idea. Physiological time runs faster for smaller animals.

“The fire of life burns hotter and faster in smaller animals.”

Given this general pattern, there are striking exceptions to the size-longevity rule. Humans are one exception because we live about four-and-a-half times longer than other mammals of our size. We must have considerably better mammalian repair and replacement processes, but still, other species do it better. When factoring in size, the longest-lived mammals are bats. One bat species lives ten times as long in the wild as a mammal its size should live even in the well-fed comfort of a lab or zoo.

Brandt’s bat is tiny, weighing as much as a 25-cent coin, yet can live more than forty years in the wild. For comparison, a four-times bigger mouse lives only up to one year in the wild, or three years in the safety of a laboratory. A bat small enough to be mistaken for a large butterfly manages to avoid predators, survive famine, flood, disease, heat waves, and cold snaps decade after decade. To survive nature’s challenges, Brandt’s bats need to maintain stamina. Human athletes requiring strength, agility, or endurance never maintain their highest performance level for forty years. We may have a lot to learn about preserving strength and agility from this bat. Plus, to navigate they echolocate, and therefore loss of high-frequency hearing would be a death blow to a bat. Human high-frequency hearing deteriorates significantly by our twenties and is practically gone by our forties. How do bats maintain that hearing?

5. Nature is full of surprises.

You can stumble on animals with remarkable repair abilities which are relevant to human health in the most unexpected of places. For instance, I stumbled on an animal that may hold a clue to Alzheimer’s disease prevention—even though it doesn’t have a brain! Oh, and it can live more than 500 years so it may have more than one thing to teach us about longevity and health. This animal, a clam called an ocean quahog, appears to contain chemicals that may be able to prevent Alzheimer’s plaques from forming.

Nature is smarter than we are and by paying attention to the ways in which evolution has produced healthy aging across the animal kingdom, we might discover new ways to enhance and extend our own health.

https://nextbigideaclub.com/magazine/methuselahs-zoo-nature-can-teach-us-living-longer-healthier-lives-bookbite/36190/

Alnylam Updates on Cardiomyopathy Therapy

 New Data Further Support Potential for Patisiran to be an Effective Treatment for Cardiomyopathy of ATTR Amyloidosis –

– Data from Exploratory Endpoints, Including Cardiac Biomarkers and Imaging, Suggest Favorable Impact of Patisiran on Measures of Cardiac Stress, Injury, Structure, and Function at Month 12 –

– Treatment with Patisiran Demonstrated Generally Consistent Benefit Across Prespecified Patient Subgroups on Functional Capacity as Measured by the 6 Minute Walk Test (6-MWT) and Health Status and Quality of Life, as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ-OS), Compared to Placebo at Month 12 –

– Patisiran Demonstrated Encouraging Safety and Tolerability Profile in Patients with ATTR Amyloidosis with Cardiomyopathy –

– Alnylam to Webcast Investor Event Today at 8:00 p.m. ET –

Alnylam Management and Mat Maurer, M.D., Arnold and Arlene Goldstein Professor of Cardiology at Columbia University, will discuss the APOLLO-B results via webcast on September 30, 2022, at 8:00 p.m. ET. The webcast will be available on the Investors section of the Company’s website at www.alnylam.com/events. An archived webcast will be available on the Company’s website approximately two hours after the event.

https://finance.yahoo.com/news/alnylam-presents-additional-results-apollo-180000519.html