21 years after 9/11, secondary barriers for cockpits still not mandatory

 Twenty-one years after the Sept. 11, 2001 attacks, the same aircraft flaw persists that let terrorists storm the cockpits of four jetliners, murder the pilots and turn the planes into weapons of mass destruction.

Commercial airplanes are still not required to install an added barrier that experts agree will help keep terrorists, hijackers and other attackers out of the cockpits.

“The threat and vulnerability remains that we can repeat a September 11th today,” Ellen Saracini, widow of Capt. Victor Saracini, a pilot of doomed United Flight 175, told The Post. He was 51, a father of two girls.

The hijackers sent by Al Qaeda leader Osama bin Laden brought down four planes on 9/11, two crashing into the World Trade Center, one into the Pentagon and one onto a field in Shanksville, Pa, after brave passengers fought to wrest control before it could reach the White House or US Capitol. 

Ellen Saracini, the widow of Victor Saracini, the pilot of United Flight 175.

Bucks County Herald

The terrorists did their homework.

“The best time to storm the cockpit would be about 10 to 15 minutes after takeoff, when the cockpit doors typically opened for the first time,” the 9/11 Commission found.

Other than knives they used to kill, 9/11 ringleader Mohamad Atta “did not believe they would need any other weapons. He was confident the cockpit doors would be opened and did not consider breaking them down,” the report said.

Saracini was 51 when he was killed on 9/11.

PA Images via Getty Images

While cockpit doors are required to stay closed and locked during flight, pilots step outside to use the restroom, let flight attendants bring in food, or switch crews for rest purposes.

After 9/11, Congress mandated airlines to fortify cockpit doors, making them virtually impenetrable.

But that protection is lost when the doors open.  “The flight deck is vulnerable,” the Federal Aviation Commission warned in a 2015 advisory.

The solution? Flight attendants are expected to wheel a food or beverage cart in front of the cockpit door and stand by until the door shuts.

“It’s an absurd practice to have flight attendants use their own bodies as the barrier between the cockpit and the cabin,” Sara Nelson, international president of the Association of Flight Attendants, testified to Congress last December.

Since 9/11, the Air Line Pilots Association has called for the mandatory installation of “secondary barriers” — lightweight wire mesh gates several feet outside the cockpit that lock in place before the cockpit door opens and lift after the door shuts.

Osama bin Laden, left, and the other conspirators behind 9/11 did their homework on how to penetrate the cockpit.

REUTERS

A video produced by airline employees and shared with Saracini shows the cockpit, without a secondary barrier, can be stormed in three seconds or less by one or more intruders waiting to pounce — even with a food cart in the way. FAA tests have confirmed the findings.

Two airlines, United and Northwest, which merged with Delta in 2008, have voluntarily installed lightweight wire barriers, costing about $5,000 each, on “hundreds” of aircraft, the pilots union says.

Roughly 5,800 jetliners operate in the US.

“The threats are increasing quicker than we can do the protections,” said former FAA agent Brian Sullivan.

David McGlynn

Meanwhile, legislation to mandate secondary barriers fell into a “bureaucratic black hole,” the pilots say.

In 2018 – 17 years after 9/11 — Congress finally approved a measure to require secondary barriers, but on newly built planes only, not existing aircraft.

The FAA was supposed to adopt the limited requirement in 2019, but skipped the deadline. It took the FAA until this past July 27 – another three years – to propose the requirement of secondary barriers on new planes. But after a 60-day public comment period and possibly months more to put out the final rule, it will not take effect for two more years – in 2025.

Saracini charges the agency has bowed to airline industry pressure.

“The airlines don’t want it, and the FAA doesn’t push for it,” she said. “They thwart the will of Congress. They don’t care. There’s no regulatory agency that is making the FAA do this.”

The FAA declined to comment, but officials said they must follow the “Administrative Procedures Act,” which governs how federal agencies develop and issue regulations, a slow and tedious process.

Meanwhile, thousands of planes currently fly unprotected.

In March 2021, several Congress members, including Rep. Josh Gottheimer (D-NJ), introduced the Saracini Enhanced Aviation Safety Act to require secondary cockpit barriers on all existing passenger aircraft, not just new ones. The bill is languishing in committee.

The barriers remain the only 9/11 Commission Report recommendation still not carried out.

An old idea, cockpit barriers came up even before 9/11,  said Mary Schiavo, who was inspector general of the US Transportation Department in the ’90s.

“The issue came up many times, but there was always such fierce resistance from the airline industry that proposals really never got anywhere,” she said.

The holdup? “Money,” she said.

After 9/11, Schiavo and fellow aviation lawyers sued the airlines for negligence — citing the lack of cockpit barriers, among other safety failures. The suits reaped more than $500 million in settlements for the families of those killed in the planes.

A 46-page FAA study said the secondary barriers on new planes would cost a one-time $9 million in engineering, $35,000 per aircraft to install, plus training and other minor expenses.

The FAA is finally acting, Schiavo believes, because it expects another terrorist attack on aircraft in the near future.

“If they’re putting this forward now, I suspect they have enough reason to do so. My guess is, they have new intelligence,” she said.

“So the threat is real, and it’s necessary,” she said of the barriers.

Brian Sullivan, a former FAA special agent, agreed, citing possible retaliation for six recent US drone strikes against Al-Shabaab, al Qaeda’s branch in East Africa, and one in Afghanistan that killed 9/11 mastermind Ayman al-Zawahiri. In other alerts, author Salman Rushdie’s stabbing in upstate New York, and Iranian plots to assassinate Mike Pompeo and John Bolton.

“The threats are increasing quicker than we can do the protections,” said Sullivan, who also noted several attempts in the past year to storm cockpits.

Last September, it took six or seven crew members to restrain a passenger who went berserk, yelling “Allah,” on a JetBlue flight from Boston to Puerto Rico when he saw the cockpit door being opened by a pilot. It took six or seven crew members to restrain him. In February, an American Airlines flight attendant en route from LA to Washington, D.C. bashed an “unruly passenger” on the head with a coffee pot while subduing him with other customers.

Saracini fears more passengers and crew will die, and says she won’t stop her safety campaign until every commercial plane has a secondary cockpit barrier. 

“I can’t look at another family member in the eye and say, ‘Sorry, I knew there was a vulnerability, and didn’t do anything about it.’”

https://nypost.com/2022/09/03/21-years-after-9-11-secondary-barriers-for-cockpits-still-not-mandatory/

Human body parts sold on Facebook leads to arrest

 East Pennsboro Township received a complaint about possible human body parts being sold from 200 block of N. Enola Road on June 14 .

Police were then lead to the house of Jeremy Pauley on July 8 where an investigation was conducted after police were able to receive a search warrant for his property.

In his residence, Pauley was confirmed to have three full skeletons, approximately 15-20 human skulls, and buckets containing fifteen gallons of human remains and organs such as livers, brains, kidneys, etc., according to the affidavit.

The documents state Pauley, was found to have purchased these human body parts via Facebook from a female in Arkansas named Candace Scott:

• One half head
• One whole head minus the skull cap
• Three brains with a skull cap
• One heart
• One liver
• One lung
• Two kidneys
• One full female pelvis
• One piece of skin with nipple
• Four hands

Pauley was able to purchase the items from Scott for $4,000.

An investigation by Arkansas FBI was able to determine that the remains were stolen from a mortuary in Arkansas.

That mortuary was connected with the University of Arkansas who had used the mortuary as a way for students in medical fields to study real human bodies.

A full statement from the University of Arkansas for Medical Sciences:

UAMS is extremely grateful to the many people who unselfishly donate their bodies to our anatomical gift program for use in medical education and research. Human bodies are an indispensable aid in the education of medical students, nurses and other health professions students. UAMS is extremely respectful of our donors when they are here in our care. We have a contract with Arkansas Central Mortuary Services to take the bodies for cremation after they are no longer being used by our students. An employee of the mortuary service is under investigation by federal authorities for taking some human remains from the mortuary that were donated to UAMS. We are saddened and appalled that this happened.

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Arkansas Central Mortuary Services

Authorities say that Pauley had admitted to purchasing two shipments of body parts from Scott, stating that he was a collector of "oddities" and that the human parts were purchased through legal means.

Police also say that they were able to determine that those human remains were then being sold by Pauley for monetary gain.

At this moment, human remains have been located in Enola, Arkansas, and Scranton after a shipment of remains from Pauley was intercepted by USPS Scranton Agents, FBI Scranton, and PSP.

Pauley was arrested and released on a $50,000 bond on August 18 on the charges of abuse of a corpse, receiving stolen property, and dealing in proceeds of unlawful activities.

https://kfoxtv.com/news/nation-world/human-body-parts-sold-on-facebook-leads-to-arrest-of-enola-man

For Some Patients, Long Covid Symptoms Mask Something Else

 IT WAS OVERUSE of acetaminophen that finally led to Nic Petermann’s cancer diagnosis. For months, the then 26-year-old had been contending with exhaustion, night sweats, recurring fevers, and abdominal pain so debilitating that she regularly woke up in the middle of the night to take soothing baths. Her persistent flu-like symptoms, she’d read online, were probably just the lingering effects of a Covid infection she’d had in January 2021; the pain was the odd symptom out, but an ultrasound had turned up nothing.

Come June, the pain was too much to bear—Petermann called a telehealth hotline and was immediately referred to the hospital after the staff heard how much acetaminophen she had been taking. After extensive testing, Petermann finally had an answer: All her symptoms, including those that seemed to be long Covid, were due to Stage IV Hodgkin’s lymphoma. She started chemotherapy the next day.

Today, Petermann is in remission, though she still deals with the long-term consequences of the aggressive, monthslong chemo. If she hadn’t assumed most of her symptoms were due to long Covid, she says, she may have received proper treatment and a diagnosis much earlier. “When I went to get my pain symptoms checked out, I didn’t mention the flu-like symptoms, because I just thought that was something that I would have to deal with,” she says.

Most people with Petermann’s symptoms won’t end up in her position. Long Covid is common—estimates of its prevalence vary widely, but even the most conservative studies imply that millions of people are dealing with long-lasting symptoms of their infections. Hodgkin’s lymphoma, on the other hand, is rare. But with dozens of possible symptoms, long Covid can be easily confused with countless other conditions, including cardiovascular diseases such as hypertension and diabetes, autoimmune diseases like lupus and multiple sclerosis, and cancer. Add the fact that Covid can make preexisting conditions worse, and determining whether or not someone has long Covid becomes a daunting task.

Parsing these vast sets of alternatives has become the responsibility of clinicians on the vanguard of long Covid care, from the primary care physicians whom patients first seek out to the experts who staff long Covid clinics. For each patient they must perform a careful differential diagnosis, a medical term for the process of considering every possible cause of a patient’s set of symptoms.

Accurate differential diagnosis is essential not just for getting patients care, but also for furthering medical understanding of a still-obscure condition. “We need to be cautious not to turn long Covid into a catch-all diagnosis,” says Linda Geng, codirector of the Stanford Post-Acute Covid-19 Syndrome Clinic.

In the absence of any objective tests, however, long Covid remains a “diagnosis of exclusion”—one that is made only after other reasonable possibilities have been exhausted. Recent data suggest that many patients will emerge from this process with a diagnosis not of long Covid, but of something else. A July paper in Nature that analyzed the medical records of over 2 million patients in the UK found that, while 5.4 percent of those with a previous Covid infection had at least one long Covid symptom recorded in their charts, 4.5 percent without evidence of infection also had at least one symptom.

In other words, long Covid symptoms are meaningfully common in people who have never contracted Covid—so even those who have had the illness might be experiencing persistent symptoms for unrelated reasons, says Shamil Haroon, associate clinical professor of public health at the University of Birmingham and the Nature study’s senior author. (Haroon notes that these numbers are likely vast underestimates—many doctors only write patient symptoms in the free text portion of patient charts, which the study did not examine.)

Similarly, an August paper published in The Lancet found that 21 percent of recent Covid patients in the Netherlands reported at least one symptom that worsened after their Covid infection, whereas 9 percent with no evidence of infection had similar symptoms.

These high-level statistics are borne out by the experiences of long Covid specialists. By the time someone makes it to their clinics, they’ve usually already been through testing elsewhere—typically with their primary care provider—and the most obvious alternatives have been considered and rejected. And yet many patients leave these clinics with a diagnosis they did not expect. Fernando Carnavali, site coordinator of the Center for Post-Covid Care at Mount Sinai West in New York, described the situation as “not uncommon.” Nisha Viswanathan, director of the UCLA Health Long Covid Program, estimates that a quarter of the patients she sees end up diagnosed with something other than long Covid.

This can be a matter of urgency. “You wouldn’t want to miss shortness of breath being caused by a sudden blood clot in the lungs, or chest pain being caused by a heart attack,” says Jason Maley, director of the Beth Israel Deaconess Medical Center Critical Illness and Covid-19 Survivorship Program. More often, though, differential diagnosis is a long, sometimes discouraging, process that involves interrogating multiple explanations for each symptom. Patients might come in with half a dozen or more distinct complaints. Different clusters of those complaints suggest different potential explanations, creating a combinatorial explosion of diagnostic possibilities. “The differential diagnosis is immense,” Carnavali says. “That is the challenge.”

That’s not to say it’s impossible. Doctors at specialty clinics have seen enough long Covid patients that they can identify some characteristic patterns. Michael Brode, medical director of UT Health Austin’s Post-Covid-19 Program, says that almost all of the long Covid patients he has seen start developing their symptoms within six weeks of their infection; if there’s a longer delay, he suspects something else.

Symptoms that group together can help point doctors toward what that something else might be. Most of the long Covid patients Brode sees who exhibit fatigue and the sluggish thinking known as “brain fog” are also dealing with post-exertional malaise—extreme exhaustion after physical, mental, or emotional effort. So when a man came into his clinic with the first two symptoms but not the third, Brode suspected that something else might be going on. He eventually discovered that the patient was dealing with a large, benign brain tumor.

A benign brain tumor may not seem like good news. Unlike long Covid, though, it is curable. Clinicians don’t have many tools for alleviating long Covid beyond lifestyle changes and rehabilitation exercises; while these can make an enormous difference, they don’t necessarily offer the same succor as a pill or a surgery. Even Petermann, who received a cancer diagnosis, described “the relief of actually knowing what it was and knowing there was going to be a treatment.”

Yet a long Covid diagnosis can also be a form of solace—and validation. “People often come to my clinic and are just relieved for me to explain why I think their symptoms fit with what we’ve seen with long Covid,” Maley says.

Going through a diagnostic process based on excluding other problems can be frustrating, with the patients receiving endless “normal” test results despite feeling that something is wrong. “Normal doesn’t mean everything they’re going through is normal,” Brode says he tells his patients. “It just means it’s not something else.” Patients have come to him describing symptoms so unusual that they expect he won’t believe them—an internal vibrating sensation, for example—and Brode is able to tell them that not only are their symptoms real, but he has seen them in a number of other long Covid patients.

Not all patients have access to this kind of expertise. Most US states have only a few long Covid clinics; some have none at all. Some patients don’t have a primary care doctor; as a result, long Covid clinicians have had to take on the role of filling gaps in the nation’s medical system. (Carnavali recalls one patient whom he diagnosed not with long Covid, but with uncontrolled diabetes so severe that the person needed immediate treatment.) These clinics, however, were not designed to carry the full weight of chronic illness care in a broken health care system. “This is all very much indicative of a system that had never anticipated these kinds of care needs,” Viswanathan says.

And their care also doesn’t reach patients who, like Petermann, delay testing because they’ve already chalked their symptoms up to long Covid. As doctors see more suspected long Covid cases, they will become increasingly skilled at its differential diagnosis—but patients will have to seek out that expertise.

As a UK resident, Petermann could take advantage of her country’s socialized health care system. Even so, it took many months for her to get her cancer diagnosis. If she could do it all over again, she says, she would have asked doctors about all her symptoms—not just her pain—and asked them to consider other possibilities when scans didn’t turn up anything. “If you know something’s wrong,” she says, “push for answers.”

https://www.wired.com/story/for-some-patients-long-covid-symptoms-mask-something-else/

Aerospace Medicine: The Next Big Health Frontier?

 While scientists have been gathering data for several decades, the implications of extended trips to space are largely unknown.

In 2019, NASA published a study titled, "The NASA Twins Study: A multidimensional analysis of a year-long human spaceflight." This study is the only piece of literature that documents the biological and physiological alterations that occur in humans in spaceflight longer than 6 months. In this study, two identical twin astronauts were the subjects of over 300 different samples in order to generate preflight, inflight, and post-flight space data. One of the twins was sent to the ISS for 12 months, while the other twin stayed on Earth during this time period; both astronauts were 50 years old at the time.

Scientists observed the following changes:

• Cardiovascular fluids shift to the upper body and head during flight, with an increased cardiac output, stroke volume, and carotid intima-media thickness, but a decrease in mean arterial pressure and blood volume
• There was evidence of increased inflammation, indicated by an increase in cytokine and chemokine release, as well as an inconsistent increase of biomarkers of oxidative stress in the vasculature; in addition, the adaptive, innate, and natural killer cell-mediated immune response were altered
• Overall body mass was reduced by 7%, and there was a reduction in urine volume
• Markers of bone resorption and formation were increased by 50-60% during the first 6 months of flight, but then decreased during the last 6 months until immediately before landing
• There was evidence of retinal edema formation, signified by increased choroidal thickness and increased severity of choroidal folds; this finding is consistent with previous studies, which have since coined the term space-flight associated neuro-ocular syndrome, or SANS for short
• Microbiome alterations occurred, but not to a level of significance or concern; alterations in DNA methylation and telomere length were also observed
• Cognitive efficiency, measured by cognitive speed and accuracy through a computerized cognitive test, were unchanged during flight, but were significantly decreased post-flight

While the exact etiology of these physical and biological changes haven't been confirmed, several hypotheses exist. For example, the combined effect of weightlessness, cosmic radiation, and isolation are thought to cause some of these changes. A plethora of other physiological changes or health-related situations that can be impacted by space flight were not considered in this study -- from intracranial pressure to mental health to trauma, and countless others -- but are currently being explored elsewhere. Several organizations and institutions around the world are collaborating to learn more about the short- and long-term health impacts of space flight in the hopes of properly preparing our species for extended trips outside of lower earth orbit.

Uncharted Territory: Many Questions Remain

Researchers have barely scratched the surface of health and healthcare in space, especially after prolonged space exploration. As a pharmacology student, one area I am especially intrigued by is the logistical and operational challenges faced when approaching safe medication use and storage in space. Medication dosing may need to be adjusted as a result of the pharmacokinetic and pharmacodynamic changes that occur in humans due to the myriad of physiological alterations we have witnessed in studies thus far. In addition, the stability and shelf-life of medications are altered while in space, likely due to accelerated degradation from cosmic radiation exposure.

There are countless health-related avenues to consider when thinking about future missions to space. While every aerospace medicine colleague and mentor I have met through conferences and organizations so far have been bright, welcoming, and encouraging, the need for more healthcare professionals and scientists investigating this area is essential. Especially for any medical students or early-career professionals with a dual passion for healthcare and space, I implore you to consider exploring this field. The time to get involved is now: aerospace medicine could very well be the next big thing in healthcare.

https://www.medpagetoday.com/opinion/second-opinions/100536

FDA still skeptical of ALS drug ahead of high-stakes meeting

 U.S. Federal health regulators remain unconvinced about the benefits of a closely watched experimental drug for the debilitating illness known as Lou Gehrig's disease, even as they prepare to give its drugmaker a rare second opportunity to make a public case for the treatment.

Amylyx Pharmaceuticals' experimental drug has become a rallying cause for patients with the deadly neurodegenerative disease, their families and members of Congress who are pushing the FDA to approve the drug.

But regulators said Friday that the drugmaker's new analyses are not "sufficiently independent or persuasive" to establish effectiveness. The agency posted its review ahead of a Wednesday meeting of its outside advisers, who will vote on whether to recommend approval.

In March, the same panel of neurological experts voted 6-4 that the company's data failed to show a convincing benefit for ALS, or amyotrophic lateral sclerosis. It's extremely rare for the FDA to call a second review meeting after its advisers have already voted.

The FDA will ask the panel to review several new statistical analyses, which the company says strengthen the case that its drug prolongs life and delays hospitalization and other severe complications. The FDA says the experts can take into account "the unmet need in ALS," the disease's seriousness and other factors specific to the terminal diseases.

Elsewhere in its review the FDA detailed the flexibility it can apply to drug approval decisions, particularly for deadly diseases, which suggests "there is a chance that the FDA is still looking for a way to approve the product," SVB analyst Marc Goodman wrote in a note to investors. He gives Amylyx a 50% chance of approval.

ALS destroys nerve cells needed to walk, talk, swallow and -- eventually -- breathe. There is no cure and most people die within three to five years.

The FDA's review reflects some of the biggest questions facing the agency, including: How strict should it be in enforcing approval standards for drugs against rare, fatal diseases? And how much weight, if any, should be given to outside appeals from patients, advocates and their political allies?

Typically, FDA approval requires two large studies or one study with a "very persuasive" effect on survival.

Amylyx's data comes from one small, mid-stage trial that showed some benefit in slowing the disease, but which was marred by missing data, implementation errors and other problems, according to FDA reviewers.

Amylyx says follow-up data gathered after the study concluded shows the drug extended life. When the company followed patients who continued taking the drug, they survived about 10 months longer than patients who never took the drug, according to a new company analysis.

But FDA said Friday the new approach "suffers from the same interpretability challenges" as Amylyx's initial study and that the new analysis "is not independent data."

The FDA does not publicly explain its rationale for holding meetings. But some outside analysts believe the agency is hoping that more external input will strengthen its hand when it renders its final decision, expected by the end of the month.

Amylyx's drug is a combination of two older drug ingredients: a prescription medication for liver disorders and a dietary supplement associated with traditional Chinese medicine. The Cambridge, Massachusetts, company has patented the combination and says the chemicals work together to shield cells from premature death. Its co-founders first hit upon the combination as Brown University students.

Some ALS patients already take both pills. FDA approval would likely compel insurers to cover the treatment.

The FDA will hear again from patients and advocacy groups, such as I AM ALS, which has lobbied the FDA and Congress for more than two years to make the drug available. The group's founder, Brian Wallach, said ALS patients, physicians and researchers believe that the company's data warrants approval.

"Patients do their homework-- we know this isn't going to cure us," said Wallach, who was diagnosed with ALS in 2017 and spoke through an interpreter. "But we also know it might keep us here until the next drug comes along and that one might be a cure."

Wallach currently takes the part of Amylyx's treatment that is available as a dietary supplement.

Despite the negative FDA review, there are several outside developments that could tip the FDA toward approval.

In June, Canadian regulators approved the drug for ALS patients, the first country to do so. That decision puts FDA regulators in a "precarious position," says bioethicist Holly Fernandez-Lynch.

"They typically like to be out ahead when making approval decisions," said Fernandez-Lynch, who teaches at the University of Pennsylvania. "They like to make the argument that they are not a barrier to patients accessing things that might help them."

https://www.ctvnews.ca/health/u-s-fda-still-skeptical-of-als-drug-ahead-of-high-stakes-meeting-1.6054600

Medical association to create 1st guidelines for diagnosing, treating ADHD

 The American Professional Society of ADHD and Related Disorders plans to develop the nation's first guidelines for diagnosing and treating attention-deficit hyperactivity disorder in adults, The Wall Street Journal reported Sept. 1. 

There are guidelines for diagnosing and treating the condition in children and adolescents, but none exist for adults. The decision to develop the guidance largely stems from specialists' concerns that telehealth startups Cerebral and Done have overprescribed stimulants throughout the pandemic. In March, the Journal reported that some Cerebral clinicians said they felt pressure to prescribe stimulants, such as Adderall, to patients after a 30-minute evaluation, which they said was not enough time to properly diagnose ADHD. 

Large pharmacy retailers including CVS Health and Rite Aid have stopped filling Adderall and other controlled-substance prescriptions for Cerebral and Done. Both companies have previously denied pressuring clinicians to prescribe stimulants. In May, Cerebral said it would stop prescribing most controlled substances.

The group working on the new ADHD guidelines told the Journal that research shows many in-person clinicians also don't complete steps necessary for a high-quality evaluation, such as taking blood-pressure readings. 

"We want to make sure that all ADHD medications are prescribed appropriately and that everyone has access to high-quality evaluations," Ann Childress, MD, president of the American Professional Society of ADHD and Related Disorders, told the news outlet. 

The guidelines are expected to be released next year and are likely to include steps that would require more than 30 minutes to complete, including obtaining detailed personal and family medical histories. 

https://www.beckershospitalreview.com/public-health/medical-association-to-create-1st-guidelines-for-diagnosing-treating-adhd.html