Congress created the Space Force four years ago in recognition of the growing importance of space — not only as a warfighting domain but as an enabler of our economic power and influence. Since its formation, the U.S. Space Force — and Air Force Space Command before it — has worked hard to counteract the growing threats in space, especially in this era of great power competition from Russia and China.

Assured access to space — through having multiple ways to achieve different orbits and lift different types of satellites — is a key component of our strategy, one that occupied a great deal of my time when I served as secretary of the Air Force. We were searching for the right balance between speed, innovation, mission assurance, competition and cost. That’s no easy deal.

Most importantly, we could not afford to lose a billion-dollar satellite dedicated to surveillance, missile warning or other missions critical to the national security of the U.S.

Before Congress created the Space Force, in 2015, I — acting as the secretary of the Air Force — opened up (through a rigorous certification process) the National Security Space Launch business to an additional vendor (for a total of two), both of whom were able to convince our experts that they could reliably lift our most precious space assets into orbit safely. This move saved the government $7 billion over time and has worked well to ensure assured access to space.

Unfortunately, however, the Space Force is now considering opening our most difficult and precious category of launch to a third vendor. Although I’m all for competition — and I applaud the Space Force for opening the more risk-tolerant launch categories to many new space firms — I’m flatly against lowering the standards of the certification process for high-risk launches. And I’m also against allowing a vendor who has not yet successfully launched to compete on the basis of a paper proposal alone. Such a move would endanger the very assured access to space for our most critical and expensive satellites.

The Space Force specified that adding an additional provider to service the second lane’s missions could increase costs by over $5 billion while decreasing the incentive for contractors to provide price-competitive bids. These realities have not changed over the last six months, so neither should Space System Command’s procurement strategy.

In advance of a May hearing on the fiscal 2024 U.S. Space Force budget request, the U.S. Air Force’s assistant secretary for space acquisition and integration, Frank Calvelli, and the Space Force’s vice chief of space operations, Gen. David Thompson, stated that using “two fully certified launch service providers in one lane while allowing emerging providers to compete, when ready, for the [Department of Defense’s] more risk-tolerant missions in another lane” will “provide Assured Access to Space” and protect “capacity for the DoD’s less risk-tolerant missions.”

U.S. Air Force Secretary Frank Kendall agreed in congressional testimony, remarking that the Air Force’s NSSL strategy “allows us to bring new entrants in early, fluidly, but it also gives us assured access for the higher risk missions.”

While America is still the world’s leading space superpower, China and Russia are now years ahead of the rest of the globe in developing the technology needed to weaken, destroy or interfere with our space systems. We can’t let that happen, nor should we rush to allow an unproven third entrant attempt to launch our most exquisite space assets.

With the Air Force, Air Force Research Laboratory, Defense Innovation Unit and the Space Force’s 2022 State of the Space Industrial Base report stating that China’s space trajectory is more positive than the U.S., now is not the time to lower standards and take unnecessary risks with America’s premier space launch program. Rather, now is the time to prioritize reliability where it counts the most.

Deborah Lee James is a former secretary of the U.S. Air Force. She serves as chair of the Defense Business Board and is affiliated with several organizations and businesses.

Scranton, PA, August 22, 2023 — Munley Law is pleased to announce that truck accident lawyer Marion Munley was sworn in as the Treasurer for the American Association for Justice (AAJ). The American Association of Justice is a 20,000-member organization of plaintiff attorneys dedicated to protecting the rights of trial by jury. The mission of the AAJ […]

- August 22, 2023 —

Scranton, PA, August 22, 2023 — Munley Law is pleased to announce that truck accident lawyer Marion Munley was sworn in as the Treasurer for the American Association for Justice (AAJ).

The American Association of Justice is a 20,000-member organization of plaintiff attorneys

dedicated to protecting the rights of trial by jury. The mission of the AAJ is to promote justice and fairness for injured victims, safeguard victims’ rights, and strengthen the civil justice system through education and disclosure of information critical to public safety and health.

Marion has held several positions in the AAJ over the years. She was elected as the AAJ Parliamentarian in 2022 and has served on the Board of Governors and its Executive Committee. In 2018, she was the first woman to become the Chair of the AAJ Trucking Litigations Group and received the organization’s Robert W. Munley Champion of Justice Award in 2020.

Marion is widely recognized as one of the most prominent and widely respected personal injury lawyers in the Commonwealth of Pennsylvania. She has won many multimillion-dollar settlements and verdicts for injury clients throughout the United States, including one of the largest truck accident settlements in Pennsylvania. She is triple board certified by the National Board of Trial Advocacy in Civil Trial Law, Civil Practice Advocacy, and Truck Accident Law. She is the second woman in Pennsylvania to become board certified as a Civil Trial Advocate.

She has been listed in the Best Lawyers in America since 2013 and was named the 2023 “Lawyer of the Year” for Medical Malpractice in Northeastern Pennsylvania. She was recently named a 2023 Lawdragon 500 Leading Plaintiff Consumer Lawyer and is among the Top 10 Pennsylvania Super Lawyers for 2023.

About Munley Law

Founded in 1959, Munley Law is a national leader in personal injury law. Their attorneys have been listed in Best Lawyers in America, Pennsylvania Super Lawyers, U.S. News, and World Report’s Best Law Firms, and have earned Board Certification from the National Board of Trial Advocacy. Visit munley.com.

Source: https://thenewsfront.com/munley-law-partner-marion-munley-sworn-in-as-treasurer-for-the-american-association-for-justice/

About Us: Munley Law Personal Injury Attorneys has grown into one of the nation’s leading personal injury law firms, helping people from all over the country who have been injured by negligence and wrongdoing.

Contact Info:
Organization: Munley Law® Personal Injury Lawyers – Philadelphia
Address: 1617 John F Kennedy Blvd #1690 Philadelphia Pennsylvania 19103 United States
Phone: (570) 983-3860
Website: https://munley.com

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Whether you’re a fan of them or not, autonomous or remotely piloted aircraft systems will likely become a key segment in aviation. But to eventually remove the pilot from the cockpit in some aircraft—or drastically reduce their role—it will be the FAA’s job to determine which systems are safe and reliable.

As part of that effort, the agency recently hosted a weeklong series of trials of Mountain View, California-based Reliable Robotics’ continuous autopilot solution. The testing and simulation regimen included three flights of the company’s modified Cessna 208 Caravan, which lasted several hours. The demonstrations should supply the FAA insight into the integration of remotely piloted aircraft in congested airspace.

“Collaborating with the FAA on demonstrations like this will help enable the future of mobility and the evolution of our airspace to accommodate new aircraft systems,” said Davis Hackenberg, vice president of government partnerships at Reliable. “Watching our system successfully operate in a live test environment is exciting, and we are proud to help pave the way for future integration of large uncrewed aircraft.”

The series of flight tests and simulations demonstrated Reliable’s ability to reroute the aircraft, change speeds on a dime, and fly under simulated weather conditions by updating flight plan routing. An onboard test pilot observed each flight. The system was also tested in simulated Class B airspace, typically defined as airspace surrounding the nation’s “busiest” airports.

Reliable shared aircraft telemetry from the company’s control center through third-party service provider OneSky, which transmitted the data to the FAA’s NextGen Integration and Evaluation Capability (NIEC) research lab. 

FAA air traffic controllers also participated in the testing, soaking up valuable insights to bring back to the NextGen program office as it develops its Urban Air Mobility (UAM) Concept of Operations 2.0. The living document is essentially a blueprint for future UAM services.

The demonstrations were part of the FAA’s UAM Airspace Management Demonstration (UAMD), which aims to showcase emerging urban and advanced air mobility (AAM) concepts to plot future operations. Trials were funded by the agency through Embry-Riddle Aeronautical University and took place at Reliable’s control center in Mountain View.

“The flight tests conducted by Reliable highlighted the ability for new aircraft systems to interact with third-party service providers and seamlessly integrate into future airspace environments, and provided critical data for future operations,” said Diana Liang, enterprise portfolio manager at the FAA.

The agency formally accepted Reliable’s Project-Specific Certification Plan (PSCP) for its continuous autopilot engagement system in June. That makes it one of a handful of firms that have made material progress toward type certification of a fully automated flight control system, though it will have a few more significant hoops to jump through before it gets there.

Reliable’s autopilot system automates all phases of flight, from taxi to takeoff and landing. It uses redundant hardware and software to automate flight control surfaces and engine controls, as well as redundant voice and data networks for secure air-to-ground connectivity, which enables remote aircraft command and radio management.

The solution includes electromechanically actuated brakes with autoland capability. It also integrates aircraft with airborne detection technology for traffic and terrain avoidance. A precision navigation system, meanwhile, uses sensor fusion techniques common in spacecraft design to bring together inputs from multiple sensors and create a single, unified model.

An advanced autopilot flight management system ties everything together with a simplified user interface, enabling remote supervision of all phases of flight in all operating conditions.

The system is designed and will be certified for a wide variety of aircraft and applications. But the company intends to start by retrofitting Cessna Caravans and launching automated air cargo operations in the U.S.

So far, Reliable conducted flight demonstrations in May for the Air Force through a contract to study the automation of large, multiengine jets. It also has a Phase III Small Business Innovation Research (SBIR) agreement to demonstrate the performance of remotely piloted aircraft for the department.

That campaign followed prior flights with NASA as part of the agency’s AAM National Campaign. These included detect-and-avoid encounter flights of Cessna 172 and Cessna 208 aircraft to help NASA validate the use of existing FAA primary surveillance radars.

Reliable is working to commercialize its technology for Part 23 cargo and Part 25 passenger aircraft. It’s currently going through the process defined in Part 21 and FAA Order 8110.4C for certifying new aircraft, engines, and propellers and is seeking Part 23 supplemental type certification. That means it will certify to well-known airworthiness requirements for normal category airplanes. This is similar to the process used currently for autothrottle and autoland STC development in piloted aircraft.

Notably, the company’s design certification plan will not require special conditions or exemptions. Its solution will not be treated as a new type design—instead, it will leverage existing regulations for normal and transport category aircraft, modifying them slightly.

Reliable is seeking approval for operations across the entire coterminous U.S. plus Alaska, with no exemptions, special conditions, or equivalent level of safety findings. Recently, it’s made a few key executive appointments to Boost its chances.

Hackenberg joined the company in May after nearly two decades with NASA. There, he served as AAM Mission Manager and spent many years leading a project to integrate unmanned aircraft systems (UAS) into the national airspace system, among other tasks.

Reliable also brought on Lee Moak and Steve Alterman as strategic advisors in December. Moak served on the Department of Transportation’s Advanced Aviation Advisory Committee and the Postal Service Board of Governors; Alterman led the Cargo Airline Association for four decades as president.

Another important addition was Scott O’Brien as vice president of legislative affairs in October. O’Brien was previously senior director of public policy and advocacy for the National Business Aviation Association and worked on legislative strategy for the organization’s AAM Roundtable.

Other appointments include a veteran engineer of Virgin Orbit, Lockheed Martin, and Paragon Labs as chief engineer, and the former leader of remotely piloted aircraft system integration efforts for General Atomics as vice president of UAS integration.

Reliable recently provided input on the House FAA Reauthorization Bill, lauding the legislation for giving the FAA more authority and resources to advance certification of autonomous flight systems. The bill calls for the creation of an FAA Office of Innovation that will work directly with agency leadership to support innovation, as well as incentives for broader ADS-B usage to prevent midair collisions.

We will see if these provisions remain in the legislation by September 30, the deadline for FAA reauthorization. But if they do, Reliable’s credibility will be on the rise.

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Last week, I wrote what was basically a lament and jeremiad about the longstanding failure of state medical boards to discipline quacks and antivax doctors. It is, as I discussed, a failure that dates back to before the pandemic, which is why I described how the pandemic had exposed the toothlessness of most state medical boards. My observation was based on a exact story published in The Washington Post by Lena Sun, Lauren Weber, and Hayden Godfrey that described how few physicians spreading misinformation about COVID-19 and vaccines had suffered anything in the way of discipline or penalties, much less actually had their medical licenses revoked, despite the unfortunately huge numbers of physicians who have made a name for themselves on social media for spreading fear, uncertainty, and doubt about public health interventions, treatments, and vaccines for COVID-19, with many of them selling quackery such as “spike protein detox” instead. As you might expect, I pointed out that this has been a longstanding problem with state medical boards, which are often understaffed and underfunded, incentivizing them to deal with easy, imminent threats, like doctors with substance abuse disorder, rather than cases where they have to adjudicate a standard of care an possibly devote large amounts of their limited resources to take on well-funded quacks like Stanislaw Burzynski and Rashid Buttar.

Given that I had just written about the syllabu of holding misbehaving physicians accountable for the harm that they do, naturally it caught my attention when I saw this Tweet on Friday from journalist Anna Merlan citing an email blast from the what is in my opinion a quack medical group, the Front Line COVID-19 Critical Care Alliance (FLCCC Alliance) about a decision apparently made by the American Board of Internal Medicine (ABIM) this week:

Curious, I went to the FLCCC Alliance website and Substack, where I was greeted with headlines like Two Leading COVID-19 Doctors are Facing Accusations of Spreading Misinformation by American Board of Internal Medicine (ABIM) Committee and FLCCC Doctors Plan to Fight Board Decision. It didn’t take long for allies of Drs. Pierre Kory and Paul Malik to weigh in, in particular Sen. Ron Johnson:

Many of you will recognize the video as a brief “greatest hits” of COVID-19 misinformation, complete with the bogus “Pfizer whistleblower” conspiracy theory and a bit at the end about “looking at the evidence for myself.” Regular readers of SBM and my not-so-secret-other-blog know my opinion of FLCCC, namely that they’re a bunch of rank quacks who made their name selling ivermectin as a “cure” for COVID-19. Unfortunately, there are a lot of ideological useful idiots in positions of power who have portrayed the FLCCC as a group of “brave maverick doctors”—”truth tellers”—and tried to alter the law to shield them from the consequences of the misinformation they spread and the quackery they practice, even as they were part of a network creating a global market for health fraud selling ineffective repurposed drugs like hydroxychloroquine and ivermectin to treat COVID-19.

Indeed, in retrospect, I had noticed a rare email from ABIM sent to my work address earlier in the week, which made me wonder if something was up. Here’s a rather generous excerpt, given that it’s an email blast:

Second, I wanted to provide an update on our work around addressing medical misinformation. I’m sharing a piece just published in JAMA that I coauthored with Dean Schillinger, MD, Professor of Medicine in Residence at the University of California San Francisco, titled “Health Communication Science in the Balance.”

In it, we explore how and why the NIH abruptly “paused” a new $154 million research program called Advancing Health Science Communication and Practice—which was 20 months in the making—with only a vague explanation that they needed to “reconsider the scope and aims in the context of the changing legal and regulatory landscape related to communication platforms.”

It should be noted that this announcement was made June 6, 2023, just weeks ahead of a judicial order issued on July 4 in the Missouri v. Biden legal case that prohibits governmental agencies from talking with social media companies. Judge Terry A. Doughty’s order has been stayed temporarily by the Appellate Court, but it appears to have already had an impact on federal officials.

At a time when trust in the medical profession is at an all-time low, we know patients seek guidance about their health from a wide variety of other sources, including social media platforms. It is a tremendous disservice to patients everywhere when agencies like the CDC cannot even have a conversation with social media companies about how to ensure that evidence-based medical information is easily identifiable and distinguishable from snake oil.

It also hampers our collective ability across all sectors of health care to collaborate on initiatives that may help mitigate misinformation and elevate expert voices. I wrote about one such potential private-public partnership model in a piece in the Annals of Internal Medicine that you may have seen, called Addressing Viral Medical Rumors and False or Misleading Information.

In closing, I’d also like to share a exact article in the Washington Post, where reporters Lena Sun, Lauren Weber (of the Post’s misinformation team) and Hayden Godfrey undertook a comprehensive investigation of disciplinary actions taken by medical boards across all 50 states, concluding that “doctors who jeopardized patients’ lives by pushing medical misinformation during the pandemic and its aftermath have faced few repercussions.”

It’s truly a remarkable piece of journalism, and while it speaks specifically to the challenges that state medical boards are confronted with in our current environment, I’m sure we can all see aspects of ourselves and the organizations we serve in this story. It shouldn’t surprise any of us if this isn’t the last story we see like this.

First of all, the fact that political pushback seems to have shelved the $154 million research program called Advancing Health Science Communication and Practice shows just how powerful the forces promoting misinformation and resisting any effort to counter it have become. In its article listed above, the ABIM asks, “What does the ‘current regulatory and legal landscape around communication platforms’ refer to, and why does it matter?” I assume that these are rhetorical questions, as it is pretty obvious to me what they refer to and mean—and why they, unfortunately, do matter. Basically, to me it sounds as though the NIH caved to political pressure from Republicans like Sen. Ron Johnson.

Be that as it may, I did wonder from the ABIM email blast whether something was up or not, given how seldom I’ve received these emails, and apparently I was correct. The ABIM has apparently decided to take its first concrete action against FLCCC members Dr. Paul Marik and Dr. Pierre Kory. But what does this all mean? Let’s start with Merlan’s VICE article published a month and a half ago, Fringe COVID Doctors Say They’re Under Attack by Medical Certification Board.

The grifters’ “persecution” narrative

If there’s one thing that cranks, quacks, and grifters have long known, it’s that somehow being able to portray oneself as a “victim,” as “persecuted,” is the most effective way to rally followers and promote the grift, and FLCCC is no different. As Merlan reported:

In the ongoing saga of the ivermectin guys, who claim they alone hold the extremely dubious cure for COVID, it’s necessary to have an antagonist—someone they can say is threatening them for exposing the truth. Recently, it’s been the American Board of Internal Medicine, or ABIM.

Two prominent vaccine skeptics and promoters of unproven COVID treatments, Drs. Pierre Kory and Peter McCullough, said on Twitter that the board is threatening them for their work. This narrative has speedily picked up speed across the right-wing ecosystem, with one right-wing website claiming the board is going to “revoke their medical licenses,” which is not something the ABIM can do. The whole thing is a useful view into how mainstream medical bodies are struggling to deal with their still-certified but increasingly out-there colleagues. And it’s a very instructive example of how fringe medicine promoters—and their allies in Congress—immediately spin their tangles with the medical establishment into more fame and attention.

This strategy works even better if it’s coupled with pugnaciousness and a vow to “fight” the “oppressor”:

It was basically, the “Debate me, bro!” tactic so beloved of cranks, quacks, and conspiracy theorists disingenuously employed. I say “disingenuously” because no doubt Drs. Kory and McCullough know that the ABIM probably couldn’t do this even if it wanted to, because it would be arguing an individual case in public. Just remember that this wasn’t a serious proposal. It was all performative, as the clip from the movie Braveheart included by Dr. McCullough in his quote-Tweeted Tweet above shows:

I suppose I should be grateful that Dr. McCullough refrained from using the clip of Mel Gibson’s rendition of William Wallace’s inspirational speech to his troops before battle with the English or maybe even of Wallace’s execution, when, instead of taking the quick and merciful death promised him if he were just to ask for “mercy,”  he cries out “Freedom!” as he is being tortured and disemboweled. (I was half-tempted to issue a spoiler alert, but then realized that the movie is 28 years old. Deal with it.) Basically, the martyr complex is an essential element to all good quack grifts. (Burzynski was a master of it, for example.) It doesn’t matter that, in countering charges that they are spreading misinformation, they spread misinformation:

The current situation began when McCullough, a cardiologist formerly employed by Baylor Hospital who’s become a vocal vaccine skeptic, and Kory, a co-founder of the ivermectin-promoting Frontline Covid-19 Critical Care Alliance, or FLCCC, both said that they’d received threatening letters from the ABIM, saying it was considering disciplinary sanctions against the two men from promoting misinformation. This immediately became a fairly big deal on the COVID-skeptical and ivermectin-promoting right, and the publication American Greatness immediately claimed that the body was threatening to “revoke the medical licenses” of both men.

That is, as a point of order, both wrong and very dumb: The ABIM is a certification body, not a licensing one. The ABIM certifies doctors who specialize in internal medicine and other subspecialties; that certification proves they completed a residency in their specialty and also passed a specialized exam.

This is a common misunderstanding among the public about the difference between medical licensure and board certification. In order to practice medicine, you do have to be licensed by the state in which you practice. However, you can get a medical license after just medical school and one year of internship. In general, however, to practice you also have to have completed an accredited residency in a medical specialty. Board certification involves the board for that medical specialty “certifying” that you have (1) successfully completed an accredited residency in the specialty and (2) completed a test that demonstrates a basic level of knowledge and competency in the specialty. For my specialty, the American Board of Surgery (ABS) required passing a written qualifying examination, after which I then had to pass an oral certifying examination. After that, I had to recertify every ten years by passing a written examination. It is true that the ABS has, since my last recertification, created a new track that doesn’t involve taking a test on all of general surgery, the way I did twice before after my initial board certification but rather involves self-learning, documentation of continuing medical education, case logs, and smaller, specialty-focused tests every three years. (That is the track to which I will switch when my current ten-year board certification expires in a few years.) In the medical specialties overseen by ABIM, the process of maintaining board certification can be much more involved, including submitting patient evaluations, which has led to a fair amount of resistance and pushback from physicians chafing under the requirements.

It is not my intention to comment on the process itself beyond this, but rather to explain what board certification is. Also, most hospitals will not provide privileges to a physician who is not board-certified by an accepted, recognized board, nor will insurance companies reimburse for services provided by such doctors. Of course, the wag in me can’t help but wonder why Drs. Kory and Marik are so upset given that they both appear to have abandoned traditional medical practice in which they might want to have hospital privileges and bill insurance companies and Medicare for their services in favor of the model preferred by “brave maverick doctors” who don’t practice according to science-based guidelines or scientific consensus: Cash on the barrelhead fee-for-service, no insurance accepted. As far as their livelihood goes, even if the ABIM does revoke their board certifications, the action is unlikely to have much, if any, financial impact on them. They even admit it in their response:

The loss of ABIM certification will not impact Dr. Kory or Dr. Marik’s ability to practice medicine or conduct scientific research or educational work. Some hospitals and healthcare providers require ABIM certification for employment, however the certification is not required by state medical boards or for a medical license anywhere in the U.S.

Of course it doesn’t! Neither of these doctors is practicing in an environment where board certification is even required! However, the narrative of the poor victim persecuted by big government, big tech, big pharma, and big medicine must be maintained, hence the outrage from FLCCC Alliance and Drs. Kory and Marik. Also, I’m pretty sure that there is also likely an element of pride involved, in which the likelihood of soon having something as important as their board certification revoked injures their massive egos.

In addition, Sen. Ron Johnson was at it again after the initial letter in June, publishing an open letter to the ABIM containing another “Debate me, bro!” challenge to the ABIM, even inviting ABIM representatives to one of his COVID-19 “roundtables”:

Unfortunately, the federal health agencies, public health experts and vaccine manufacturers did not accept my invitation to either event.   Rather than engage in a public dialogue in which information and perspectives can be openly exchanged and debated, the individuals and organizations responsible for our pandemic response continue to attack and discredit those with a different perspective by using the vague pejorative of “spreading misinformation”.

It is well last time for the public to hear from many sides regarding COVID-19 in a public forum.  The purpose of this letter is to invite you, members of your Credentials and Certification Committee, and any other medical expert of your choosing to come to Washington and engage in an open and honest interchange regarding all aspects of COVID-19, without the threat of reprisal by the ABIM or any other organization.  I request your participation in a public forum on one of the following dates: July 26, July 27, July 29, August 2 or August 3.

It is also telling that Dr. McCullough didn’t announce the ABIM letter himself first, but rather appears to have just forwarded it to Sen. Johnson, who used it as a tool to promote his misinformation-packed COVID-19 roundtable events.

Also, from the wording of the letter quoted by the FLCCC Alliance, the ABIM hasn’t even actually officially revoked Dr. Marik and Kory’s board certifications yet. Before concluding that, in “accordance with ABIM bylaws, Dr. Marik and Dr. Kory will appeal the committee’s recommendation,” FLCCC rants:

The ABIM Credentials and Certification Committee has recommended that FLCCC co-founders, Paul Marik, MD and Pierre Kory, MD, MPA should have their ABIM certifications revoked for spreading what the committee considers “false or inaccurate medical information.” The committee concluded that the published peer-reviewed, clinical, and observational data that create the foundation of FLCCC protocols, educational materials and public statements are not “consensus driven scientific evidence.” In reaching their recommendation, the committee cites NIH and CDC guidelines as well as several studies that have been largely disproven or questioned for their glaring flaws, conflicts of interest or poor design. Additionally, the committee cites a National Public Radio story that was later corrected for falsely reporting that overdosing of ivermectin was causing a surge in emergency room admittance.

“What ABIM is doing is basically telling doctors that we need to take our orders from bureaucrats in Washington and certain medical journals instead of making treatment decisions based on our training and expertise,” said Pierre Kory, MD, MPA, president and chief medical officer of the FLCCC. “Threatening doctors the way the ABIM is doing, simply degrades the practice of medicine to be something that is done out of fear rather than to heal our patients in the best way we know how.”

And:

“The ABIM is doing this to us and other doctors who didn’t follow what the committee is calling ‘consensus’ as a way to scare others into silence,” said Paul Marik, MD, chairman and chief scientific officer of the FLCCC. “Following the ABIM’s ‘consensus’ will only deprive patients of important treatments that have saved lives all over the world.”

The ABIM committee continues to spread the myth that ivermectin is dangerous without critically examining the scientific and clinical evidence. In its statement the committee cites false claims that ivermectin could be “fatal” while never mentioning the 99 controlled trials – 46 of them randomized controlled trials – that showed ivermectin is highly effective in treating COVID-19 with little to no reported side effects. These trials include over a hundred and thirty thousand patients successfully treated with no severe side effects, consistent with the WHO’s finding that ivermectin ranks higher in safety than Tylenol or aspirin.

Ivermectin is indeed safe and effective when used to treat roundworm infections. The problem, of course, is that it doesn’t work for COVID-19, those “randomized controlled trials,” many of them fraudulent, not withstanding. It was always predictable that ivermectin would be highly unlikely to work as a treatment for COVID-19 just on pharmacology. As I like to point out, the concentration of ivermectin that inhibited the replication of SARS-CoV-2, the coronavirus that causes COVID-19, in cell culture was 50- to 100-fold higher than what can be safely achieved in the human bloodstream using “safe” ivermectin dosing. There’s a reason that I’ve referred to ivermectin as the “acupuncture of COVID-19 treatments” and pointed to it as an example of why science-based medicine is important not just for low plausibility alternative medicine treatments but for low plausibility treatments of all kinds—like ivermectin for COVID-19.

Also, what the FLCCC Alliance conveniently fails to mention is that the promotion of ivermectin as a cure-all for COVID-19 has indeed led people to use veterinarian formulations designed for large animals like horses and cows. As I like to point out, equine ivermectin comes packaged in syringes with “1.87% ivermectin paste. 6.08 g syringe treats up to 1,250 lbs. Safe for horses of all ages, pregnant mares, breeding stallions.” Another formulation comes as a 1% solution to be given 1 ml/110 lbs of weight. Basically, in horses the dose of ivermectin can be up to 1.200 mg, while the human dose recommended is only around 3 mg. When ivermectin promoters state that ivermectin is “very safe” in humans, they are correct, but only at the dose recommended for humans. As with many drugs, toxicity increases with increasing dose, and when you take far more than the recommended dose your risk of serious side effects increases. Fortunately, most of these side effects have been mild, but even mild side effects are too much to risk for a drug that doesn’t work. Worse, promotion of ivermectin for COVID-19 has, predictably, expanded to its being touted for cancer and even autism. The FLCCC will, of course, claim that they have never promoted ivermectin for such purposes, but their ally Tess Lawrie has. Promoting a drug—any drug—as a near-miraculous cure for one life-threatening disease will almost always lead other quacks to promote it for other conditions and diseases.

Free speech versus board certification

I will conclude by discussing how the FLCCC is also bemoaning the recommendation of the ABIM Credentials and Certification Committee to strip Drs. Kory and Marik of their board certifications as an attack on “free speech.” This is, of course, a lament that quacks throughout the decades that I’ve been writing about science-based medicine vs. quackery nearly always invoke whenever they are criticized or a medical authority tries to hold them accountable for their quackery. The FLCCC is no different. Consistent with the narrative of their conspiracy theories in which ivermectin is the “safe and effective” miracle cure for COVID-19 that “they” don’t want you to know about, there must be nefarious forces seeking to silence the FLCCC’s two heroic doctors who are only fighting for their patients. Seriously, I kid you not. You can buy merch on the FLCCC website with images of Drs. Marik and Kory like these:

Seriously, this is a bit too much, even for me, and I’ve seen so many brave maverick doctors portraying themselves as the heroes in an Ayn Rand novel.

It’s exactly the same narrative that Stanislaw Burzynski has employed for 45 years whenever the FDA or the Texas Medical Board made their feeble efforts to hold him accountable and that Dr. Rashid Buttar used back in 2008, when he called the North Carolina Medical Board a “rabid dog” for trying to “silence” him. It’s the same claim that quacks make about bills designed to strengthen state medical boards to act when physicians spread dangerous misinformation.

Unfortunately, it’s a very effective ploy. All too many of my colleagues chafe at any suggestion that they can be told how to practice medicine. Even though three years of a pandemic that’s killed over one million people in just the US alone has finally awakened regulatory agencies like state medical boards and professional societies to the the severity of the problem of doctors using their professional status to spread misinformation, unfortunately, we as a profession have a lot of members who either can’t or don’t want to see it as a problem and for whom the FLCCC’s defense resonates. I suspect that the reason now is similar to the reasons before the pandemic, involving our dislike of “being told what to do” and an attitude that any of us could fall victim to a bogus complaint to a state medical board or specialty board. (Ironically, I myself have experienced exactly that, when several years ago a patient of Stanislaw Burzynski reported me to my state medical board for my blog posts about her case.) I get it. I also get that a lot of my colleagues and I have to make medical decisions based on less than ideal evidence bases all the time (the “art” of medicine). Unfortunately, too many of us extrapolate that to justify what quacks do. Indeed, one mistake in framing that I see from the ABIM and state medical boards is to emphasize too strongly “spreading misinformation” as a reason for action, rather than the quackery. What physicians say will always draw a “free speech” defense. What they do—i.e., how they treat patients—is a lot less defensible and more strongly a basis for state medical boards and specialty boards to take action.

Professionalism, however, is essential to medicine, and one of the elements of professionalism is not to practice quackery or to recommend quackery, and, if there’s one thing I’ve observed, it’s that the practice and promotion of quackery almost always go hand-in-hand. In other words, physicians promoting medical misinformation (like the FLCCC) rarely just promote medical misinformation. They almost always practice what they preach, so to speak; i.e., practice quackery. After all, FLCCC doesn’t just recommend ivermectin, hydroxychloroquine, and its various and sundry “early treatment protocols” that don’t work, its members use them to treat COVID-19 patients—and are proud that they do so! It is true that the First Amendment gives physicians like Drs. Marik and Kory the freedom to say whatever they want about COVID-19 and its treatment, no matter how quacky, but it doesn’t mean that they can do so without consequences, which can be loss of board certification when their professional speech and actions wander too far outside of what can be justified with science. Revoking the licenses and board certifications of such physicians is quality control and consumer/patient protection, not “censorship.” These doctors are still free to say whatever they want, no matter what the ABIM does.

I only wish that state medical boards would do something that would really make a difference: Take away their medical licenses. Yes, I said it, and I meant it: Take away their medical licenses.

The Technology Development Board (TDB), operating under the Department of Science & Technology (DST), is thrilled to announce its strategic partnership with M/s Chemlife Innovations Pvt. Ltd., headquartered in Bengaluru, Karnataka. This collaboration marks a significant stride in advancing the project titled "Commercialization and Manufacturing of Bio-Trace Minerals used in Feed for Animals," a visionary endeavour that harmonizes seamlessly with TDB's commitment to fostering impactful scientific innovation.

Amid the present urgency for innovative solutions propelling sustainable progress, a crucial dimension of this collaboration aligns harmoniously with the National Livestock Mission—a cornerstone of India's strategic framework. Guided by the Prime Minister's vision, the mission aims to enhance livestock productivity, optimize feed and fodder resources and infuse technology into livestock management.

Aligned with this national roadmap, TDB and M/s Chemlife Innovations Pvt. Ltd. embark on a transformative journey, marking a pivotal milestone in the "Commercialization and Manufacturing of Bio-Trace Minerals used in Feed for Animals" project. TDB's unwavering support is evidenced by its commitment of ₹ 84 lakh, significantly contributing to the total project cost of ₹ 142.60 lakh.

Speaking on the occasion, Shri Rajesh Kr. Pathak, Secretary, TDB, said, "We're thrilled to support Chemlife Innovations Pvt. Ltd. in their pioneering endeavour. This project exemplifies technological innovation and sustainable manufacturing, aligning seamlessly with TDB's goals. As the project advances, it's poised to enhance animal nutrition, transform livestock and poultry & dairy production, and set new eco-friendly manufacturing benchmarks. This collaboration aligns with the National Livestock Mission's objectives, addressing vital aspects of animal nutrition through innovative bio-trace minerals in animal feed."

Driven by innovation and sustainability, M/s Chemlife Innovations Pvt. Ltd. envisions revolutionizing the manufacturing of bio-trace minerals for animal feed, particularly targeting the livestock and poultry/dairy sectors. Anchored by the ground breaking ‘Accelerated Natural Bio Transformation’ (ANBioT) technology, the project introduces a proprietary nutrient medium that facilitates chelation reactions under milder conditions, aligning seamlessly with principles of environmental sustainability.

Central to this endeavour is the ingenious use of pupa proteins, rich in hydroxy amino acids, offering an economical alternative to imported ligands like yeast hydrolysate and Methionine hydroxy analogue (MHA). This strategic shift not only enhances economic viability but also aligns with India's self-sufficiency goal.

The company's unwavering commitment to quality is substantiated by its attainment of Global Certification for Animal Feed Additive Quality and Feed Safety, alongside the esteemed FAMI-QS certification—a globally recognized benchmark. Third-party validation confirms the efficacy of their developed product 'MinBioZen,' showcasing compatibility and promising results.

Beyond the realm of innovation, this project contributes to the circular economy by repurposing silk worm pupae meal, thereby mitigating waste generated by the silk industry. The company’s membership in Pharmexcil augments export prospects, fostering economic growth. Leveraging locally available by-products from the silk industry enhances economic viability, aligning with import substitution objectives and potential foreign exchange savings.

Their comprehensive approach, fortified by global certifications, exemplifies their commitment to green chemistry principles and sustainable resource utilization. Innovative products like MinBioZen address the indispensable need for bio trace minerals—zinc, copper, manganese, iron, and selenium—in optimizing livestock health and growth. Aptly named MinBioZen, the product seamlessly integrates bioavailability and stability, symbolizing their dedication to innovation and environmental stewardship.

(With Inputs from PIB)

One of Pulaski County’s facilities to help those dealing with addiction transition back into society has cleared a key hurdle to continuing its mission.

Last Friday, Somerset Sober Living’s recovery homes for men received official certification by the Commonwealth of Kentucky.

The faith-based non-profit was recognized as complying with national best practices from the National Association of Recovery Residences (NARR), and are part of the Kentucky Housing Recovery Network. After a lengthy review of Somerset Sober Living’s policies and procedures as well as a state inspection, the certification was made official on August 4.

According to Somerset Sober Living board president Jonathan Hardy, it becomes the first of its kind locally to earn this certification to his knowledge.

“We’re the only certified sober living (facility) in the area at this point,” he said. “We’re the first to do it in the south-central Kentucky region. There are a few in Lexington and Louisville (that have).”

The approval follows the passage of Kentucky House Bill 248 in the 2023 state legislative session held earlier this year, which required minimum standards for operation of recovery residences in the state, with the requirement for them to be certified by an entity qualified to do so.

“We did that,” said Hardy. “We’ve been organized from those national standards from the get-go, but Frankfort actually has an affiliate now that can recognize us.

“We went through house inspections, they went through all of our forms and our best practices and our policies and made sure that we were in compliance with them,” he added. “... They came in and looked at the homes. They want to make sure it’s an environment conducive to (helping people stay sober). It looks like it’s a normal home. They don’t want it to look like a prison facility or a rehab facility, because it’s not. It’s supposed to be a normal home.”

The process took about four months, said Hardy.

Formed a little over four years ago, Somerset Sober Living operates two houses — one in the Oak Hill area, one in the Green Meadows subdivision — which they try to keep small: six men to a home, two to a room. Somerset Sober Living is only for men, and is a “transition point,” as Hardy put it, for those who have already been through a rehabilitation program for addiction.

“We’re an intermediate step,” said Hardy. “They detox somewhere else, usually a 30-day program, and when they come to us, they usually don’t have a job, they don’t have transportation. They may not have an ID or their birth certificate. We start from almost the ground up and they kind of have to rebuild their life. We have a lot of community resources to help them connect back in.”

Somerset Sober Living began when members of different local church communities came together to meet in the morning and pray. They felt “compelled that the recovery community was in need of assistance from the church,” noted Hardy, to help people transition out of rehab and get help with employment, transportation, and building new habits.

“Our mission statement, our vision is, Jesus changes everything,” said Hardy. “... We have mentors from the church that come alongside the guys. It’s a pretty structured program. (Residents) have to work full-time employment (minimum 31 hours). Mondays, we have a Bible study together. Tuesday through Thursday, they do intensive outpatient counseling with Gratitude Adjustment, a local counselor we work with. Fridays, we do an accountability meeting where we meet with the residents one-on-one and as a group and they set goals, and we talk about what progress they’re making and how we can help.”

There’s no set time limit on how long someone can stay there. The average is about six to nine months, but some have stayed a couple of years or more, said Hardy.

Board members like Hardy help out regularly — “We’ve got a really active board, about 10 members total,” he said — and he himself does accountability meetings. There’s a full-time recovery manager who takes care of the homes and makes sure the men are “on track,” noted Hardy, but board members pitch in to help with his duties on the weekends.

Being so structured, and so small, is key to making sure the recovery homes are more of a help than hindrance, both to the residents and others in the neighborhood.

“The problem that happens with a lot of operators is that they’ll just open something up and pack people into a home,” said Hardy. “The problem is, the neighborhood (residents say that) ‘There’s 20 cars in the house next door, I think there’s 15 people in there.’ All of a sudden, people start violating curfew and maybe owners aren’t really managing it. So you can quickly have something that’s supposed to be getting people drug-free become like a trap house kind of thing.

“(State legislators) saw this happen, really across the nation, but it happened in Kentucky as well,” he added, “in a lot of places where (the homes) just weren’t managed (well), not a lot of oversight with it.”

Somerset Sober Living is described by Hardy as “an extension of the church” and about half of its financial support comes through church donations, “so we’re definitely in need of financial help (from) people who believe in the mission as well.”

The goal is to make the Somerset Sober Living homes completely self-sufficient, and they have a capital campaign to generate funds for the purchase of a home outright, so as to drop operating expenses sufficiently to expand and offer more options to residents such as vocational training or even educational scholarships.

For more information, go to somersetsoberliving.org, where donations can be made online. Donations may also be made by sending a check to 402 Coomer Street, Suite 204, Somerset, Ky., 42503.

“We love to see lives changed and transformed by the good news that Jesus makes all things new,” said Hardy. “It’s no secret the opioid epidemic turned our region upside down, but the church has the prescription.”

ASHEVILLE – The North Carolina Department of Health and Human Services’ decision to grant Mission Hospital’s Certificate of Need application for an Arden freestanding emergency department has been reversed by an administrative law judge June 22.

This is the second freestanding emergency department Mission has proposed that has lost its preliminary appeal ― the certification for its Candler application was reversed in a March 17 decision. NCDHHS appealed both reversals to the North Carolina Court of Appeals. Buncombe County commissioners have an opportunity to supply their opinion about the controversial proposed emergency departments in a legal filing.

In most situations, health care providers in North Carolina must apply for a CON if they seek to expand their facilities, equipment, or initiate certain medical services, according to state guidance.

AdventHealth and UNC Pardee, which own hospitals in Henderson County, challenged NCDHHS’ preliminary decision to grant the CON for the Arden location. Only Advent appealed the Candler certification. The Citizen Times reached out to AdventHealth and Pardee for comment.

NCDHHS initially granted Mission’s application for both freestanding emergency rooms May 24, 2022, which were planned for the corner of Hendersonville Road and Airport Road, and in West Asheville near Candler. The department approved slightly more than $28 million in capital expenditure for the projects. For-profit HCA bought Mission in 2019 for $1.5 billion.

Administrative Law Judge David Sutton argued in his 88-page reversal that NCDHHS erred in granting the CON for the Arden location because the agency did not hold a public hearing prior to approving the application.

Arden Decision by Mitchell Black on Scribd

Mission Health spokesperson Nancy Lindell said in a July 28 statement to the Citizen Times that the public hearing requirement was “not included by the State in the application process as a precaution to prevent the spread of COVID.” She noted that there were other CONs approved across the state “during the more acute phases of the COVID public health emergency that did not have public hearings.”

Sutton noted that while this “failure” was enough to reverse the case, he made determinations on the other issues brought before him by the challengers, which ranged from claims about the freestanding emergency department entrenching Mission’s monopoly over acute care services to arguments that the freestanding emergency departments would impede access care for rural counties. The judge ultimately ruled for Mission on every single point beside the public hearing error.

Advent and Pardee will have a chance to relitigate those points before a panel of judges in the court of appeals. NCDHHS appealed the decision on the Arden freestanding emergency department July 21, and on the Candler location April 14.

An NCDHHS spokesperson said the department cannot comment on pending litigation.

Lindell added that applying for the certification for the freestanding emergency rooms was an effort to solve “rising ER demand.” She continued “by taking a patient to a closer, less busy ER, emergency medical service teams are able to get back on the road faster and serve more patients.”

Will freestanding emergency departments ease delays at Mission?

The Citizen Times recently reported that patients arriving at Mission Hospital in ambulances increasingly need to wait for extended periods before being accepted into the Emergency Department due to capacity issues. Mission Hospital workers and local emergency service leaders attributed the capacity issues to staffing challenges at the hospital, which restrict patient flow issues, leading to the backlog, and the long waits.

Emergency service experts noted that the freestanding emergency departments would have the capability to treat patients without severe illnesses or injuries. At the same time, they raised concerns about the freestanding emergency departments creating more or longer distance ambulance trips for an already-taxed EMS system.

The Buncombe County Board of Commissioners does not have jurisdiction over how HCA runs facilities within its boundaries, but the county interacts with HCA frequently through its EMS and 911 systems. Commissioners have previously expressed concern over HCA expanding its domain in the area.

More: Mission says $29M 'stand-alone' ER would cut wait times, but faces monopoly complaint

More: Mission/HCA to open Sweeten Creek Mental Health and Wellness Center in Asheville in Aug.

Board chairman Brownie Newman sent a letter to the leader of NCDHHS CON chief Michaela Mitchell supporting a provider other than Mission Health to own the 67-bed acute care hospital. The state initially granted AdventHealth a CON to build the hospital. HCA has appealed the decision.

Newman sent the letter June 8, 2022, on behalf of the entire board. “After the not-for-profit health care system was sold to for-profit HCA in 2019, residents have been increasingly vocal of their desire for improved access and patient choice,” the letter read.

Commissioners can supply their opinion in the appellate proceedings regarding the freestanding emergency departments through an amicus brief, according to the North Carolina rules of appellate procedure.

County leaders disagree over freestanding ERs

Opinions from members of the county government vary on freestanding emergency department ownership.

Newman told the Citizen Times July 27 that the commissioners have expressed concerns to HCA about the amount of time it takes patients to be accepted into the Emergency Department at Mission, and the consequences for the EMS system.

“We believe there is a significant need for improved staffing levels at Mission to address that concern,” Newman said.

Concerning the freestanding emergency departments, Newman added, “I would say at a high level, we support that there's a need for more capacity for those services in the community. But we've also had concerns about HCA’s monopolistic business pattern in terms of health care coverage in the region. We would like to see more capacity, but we would also like to see more diversity of providers in Buncombe County and Western North Carolina.”

He noted that the commission has not adopted a specific position regarding the freestanding emergency departments.

Commissioner Terri Wells called the wait times paramedics have been experiencing at the Mission ER “unacceptable.” Regarding the freestanding emergency departments, she added that she is “not convinced that they will Boost customer care or response time. I would appreciate seeing Mission’s leadership address any staffing and flow issues expeditiously, as well as work with county leadership to explore paths to decrease the long wait times at the ER.”

More: Candler resident's lawsuit against Mission Hospital to continue after her death

Buncombe County Manager Avril Pinder sent a letter June 2021 in support of Mission’s CON application for the freestanding emergency departments to then-head of the NCDHHS CON, Lisa Pittman. Mission included this letter in its application for the Arden emergency department, according to Sutton’s ruling.

“I believe this is Mission Hospital’s intent in providing a new state-of-the-art (freestanding emergency department) in southern Buncombe County that will help serve the community, the businesses, and visitors in the area. I urge you to approve Mission Hospital’s CON for a new (freestanding emergency department),” the letter reads.

Pinder expressed her support for a freestanding ER irrespective of owner in a July 28 statement to the Citizen Times.

“Adding a freestanding emergency room, regardless of the provider, increases access, reduces traffic to one singular location, and adds a critical resource when our loved ones are in medical crisis,” she said.

Pinder Letter re CON by Mitchell Black on Scribd

Commissioner Amanda Edwards acknowledged that the county is in a “crisis situation,” regarding emergency services in a July 27 conversation with the Citizen Times. “I think as elected leaders, we have to be very cautious about weighing in on business decisions.” Edwards added that the county needs to find “common ground” with HCA so they can “collaborate and best support each other.”

Commissioner Jasmine Beach-Ferrara said July 27 that “we obviously have an urgent, critical need and evidence of systems that aren’t working effectively to serve the people of Buncombe County.” She then added that this needs to be a “priority item for discussion.”

Commissioners Al Whitesides, Martin Moore and Parker Sloan did not respond to repeated requests for comment.

The next meeting for the Buncombe County Board of Commissioners is 5 p.m. Aug. 1 at 200 College St., Room 326 in downtown Asheville.

Mitchell Black covers Buncombe County and health care for the Citizen Times. Email him at mblack@citizentimes.com or follow him on Twitter @MitchABlack. Please help support local journalism with a subscription to the Citizen Times.

This article originally appeared on Asheville Citizen Times: Asheville Mission Hospital ER denied by judge; NC Health Dept. appeals