Why Your Pain Happens, and What the Future of Alternative Pain Relief Really Looks Like in the Opioid Crisis – Prevention Magazine

Lets talk about what pain is, exactly. You know its an uncomfortable physical feeling, but its actually much more than that. In fact, the International Association for the Study of Pain (IASP) defines pain as an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage. The IASP goes on to point out that the lived feeling of pain is shaped by biological, psychological, and social factors, so your version of pain will always be different from that of your spouse or siblinga sensation you describe as merely annoying could have them reeling in agony.

As, well, painful as it may be, though, pain does serve a purpose. Pain is fundamentally our harm alarm, says Sean Mackey, M.D., Ph.D., a professor and chief of the Stanford Division of Pain Medicine in Palo Alto, CA. It is an experience that keeps us out of danger. Pain is an incredibly wonderful thing when its working correctly. The problem, of course, is that it doesnt always. Lets say you break your arm. In a healthy scenario, pain signals travel from the injury site through your spinal cord to your brain to let you know that you need care and you probably shouldnt repeat whatever behavior led to the fracture. But if theres a kink in that pain-perception system, the pain could become chronic, lasting long after the wound has healeda mystery researchers are trying to untangle.

Theres a bit of controversy over the nature of chronic pain and how it evolves, says Dr. Mackey. One theory, he says, is that after an injury like that broken arm, signals get rewired in the brain to perpetuate the experience of pain even though the original pain stimulus is gone. Another theory posits that after an injury, low-grade pain signals continue to travel to your spinal cord and brain, but its as if an amplifier has been installedyour brain interprets the signals to be more intense than they are.

Because so much is unknown about the mechanisms behind chronic pain, it can be difficult to treat. For acute pain like that of a headache or a broken arm, you might take acetaminophen or a nonsteroidal anti-inflammatory (NSAID) like ibuprofen, both of which are non-opioid analgesics that decrease the production of painful mediators called prostaglandins, says Anuj Malhotra, M.D., assistant director of the Pain Management Division at the Hospital for Special Surgery in New York City.

What causes chronic pain, though, is sometimes completely different, so the same treatments may not work. You dont have the same responsiveness to those medications, or they may become less safe in certain patient populations with longer-term use, says Dr. Malhotra. For instance, too much acetaminophen can lead to liver damage, while overusing NSAIDs can put you at risk for digestive problems, kidney damage, and bleeding.

Thats why scientists are constantly searching for innovative treatments for chronic pain. Consider this: Research shows that an estimated 20% of U.S. adults (about 50 million people) have chronic pain, and 8% struggle with high-impact chronic pain (pain that has lasted three months or longer and is accompanied by at least one major activity restriction). For those with high-impact chronic pain, it can be hard to move, work, sleep, socialize, get dressed, or bathe, says Mary Driscoll, Ph.D., an assistant professor of psychiatry and a research psychologist at Yale School of Medicine in New Haven, CT. And when people have pain, theres rarely a reprieve, so it may get better or worse, but its always there.

That physical stress can have emotional effects as well, she says: It can prompt people to become socially isolated or challenge their sense of self. It can also perpetuate fears of injury or disability and elicit feelings of helplessness, anger, and frustrationand contribute to things like depression and avoidance of activity. On top of all that, chronic pain is invisible to those around the sufferer, which makes it hard for others to understand and often leads people in pain to feel stigmatized. Its no wonder sufferers may try anything to get relief.

In the late 1990s and early 2000s, when Purdue Pharma sent sales reps all over the country claiming that its new opioid, OxyContin, was effective at treating pain and had a low risk of addiction, physicians and patients were desperate to believe it. Twenty years later, opioids are still causing harmand driving the news. In September, a settlement between Purdue Pharma and thousands of state, local, and tribal governments was approved by a bankruptcy judge, then unraveled by a federal judge. In October, Hulu launched its popular drama series Dopesick, inspired by real investigations into OxyContins deceptive marketing. Finally, in November, a report from the CDCs National Center for Health Statistics declared that the number of annual deaths related to drug overdoses topped 100,000 for the first time in 2021and 75% of those were linked to opioids.

The OxyContin saga is complicated, involving failures of government oversight and accusations of greed and lies, but the upshot for patients is that even though people didnt think they would become addicted, many did. Opioids cover pain regardless of the source, but they dont treat the cause of the pain, explains Dr. Malhotra. With no way to address the pain trigger, he says, your body gets used to the medication, so youre going to need a higher dose in order to get the same results. With a higher dose come more side effects and the potential for overdose or addiction, he adds. Indeed, research has long shown that taking opioids for chronic pain increases the chances of addiction.

Pain specialists and researchers have been consumed with the aftermath of the opioid epidemic, but the solution isnt as simple as no longer prescribing them. There was abuse, but as doctors attempted to restrict access, pain patients who were doing well on opioids found themselves forcefully tapered and accused of being addicts, says Dr. Mackey. On the other hand, theres a greater awareness that physicians were prescribing, in general, too many opioids, he says. As clinicians, we needed to reevaluate for whom we were prescribing opioids and in what circumstances and recognize that in most cases, opioids are not a first-line treatment for chronic pain.

If theres a silver lining to the opioid epidemic, its that it brought greater attention to innovative and non-pharmacological treatments. Physicians are having more conversations with patients about alternative options, for which insurance coverage is increasing, and new treatments are being studied.

One that looks promising is spinal cord stimulation, in which a small insulated wire or lead is placed along the spinal cord above the area where the pain is generated. For example, if you have pain in your legs, those signals come into the lumbar spine, so the leads are placed in the thoracic spine and you can modulate the signal before it gets to your brain, where you process it, says Dr. Malhotra. In some cases, he says, the modulation could be something you would feel, like warmth or a buzzing sensation that replaces the pain, or it could be at a high frequency that blocked the pain signal, meaning you wouldnt feel anything.

Another option thats gaining steam is virtual reality (VR). In one study, when hospitalized patients used VR goggles to access relaxation experiences, they reported less pain than patients who watched yoga and meditation videos on their hospital televisions. Other research suggests that VR therapy could help relieve the phantom-limb pain from which amputees often suffer. With the therapy, you could be skiing down a mountain and doing activities using your legs even after an amputation, tricking your brain to suppress symptoms of pain, explains Leena Mathew, M.D., a professor of anesthesiology and director of the Pain Medicine Fellowship at Columbia University Medical Center in New York City.

New medications are in the works too, one of which was inspired by congenital insensitivity to pain (CIPA), a condition that prevents people from feeling pain (not a good thingif you cant feel that a stove is hot, you might rest your arm on it). In people with CIPA, says Dr. Malhotra, often there is a mutation in a particular sodium channel throughout the body, so there are some medications that are targeted toward purposely inactivating this channel more specifically to treat painful areas. Another subset of medicines is aimed at a protein involved in pain transmission and inflammation in the brain and spinal cord.

Of course, these are just a few treatment optionsthere are plenty of other procedures, medications, and alternative therapies out there. But no matter what path you decide to take, remember that chronic pain is similar to conditions like diabetes and asthma: It often cant be cured, but there are tools to help mitigate it. Go in with a mindset that you need to work hand in hand with your clinician, and the solution may involve a degree of management of your pain to help you be more functional and have a better quality of life, Dr. Mackey says.

As much progress as weve made with pain treatment, not everyone has equal access to it. Not only is good insurance coverage a luxury in the U.S., but insurance is not the only barrier. People cant always afford to take time away from work or caregiving to go to physical therapy twice a week or cook healthy meals regularly. Plus, research shows that women are more likely than men to report having painful conditions, but women and people of color are less likely to have their pain taken seriously by health care providers than are men or white people. These issues are the result of an incredibly complex and unfair health care system, but by raising concerns with doctors, we can start to move the needle. At the very least, we all have to acknowledge that disparities exist, says Dr. Mathew. Try using the strategies below to advocate for yourself.

Seeking pain care can be a frustrating endeavor, admits Driscoll. But the more you can pinpoint how pain affects you and what aspects of your life you want to improve, she says, the easier it is to identify treatments. For example, if pain has led you to give up activities or dampens your mood, an intervention like CBT may help. If its affecting your ability to walk, then PT, yoga, or even a treatment such as pain injections might be key. Some literature suggests that when a woman comes in with fibromyalgia, providers may assume whats bothering her most is painand that may be true for some women, but in many cases its fatigue, says Driscoll. So if the provider is treating the pain or thinks pain is the biggest problem, then the woman walks out with a treatment plan thats not really addressing whats bothering her the most. Being clear with providers about how pain interferes with your life is essential.

If you have a diagnosis, reach out to patient advocacy organizations that focus on the condition and see if they have educational resources. Im not asking people to try to train to be doctorsthats not the message, says Dr. Mackey. But learn as much as you can, because that will make you more empowered to advocate for yourself.

This can be tough, especially if you live in a rural area or have an insurance plan with few in-network providers, but its impor tant. You need to find a clinician with whom you can establish a good partnership, somebody whos going to validate whats going on, says Dr. Mackey. If theres no one nearby, he suggests asking whether your insurance covers telemedicine.

A lot of my success in practice with patients is actually when theyre patient, so to speak, says Trahan. Healing takes time. Be willing to work with your doctor to try different approaches and put in the time to let them be effective.

Try these drug-free strategies for combating common pain points.

If neck tension or bad posture is causing your pain, try to sit up straight and gently bring your chin toward your chest. Slowly bring your chin back up and repeat several times. This lubricates the facet joints in the neck, which can help decrease stiffness and reduce pain, Trahan explains. You can also put a drop of lavender essential oil on each thumb, then use your thumbs to massage the soft tissue behind your ears. The combo of aromatherapy and massage should relax your neck muscles.

With pain in this area, you have to look at what youre doing throughout the day, says Trahan. Instead of crossing your legs when you sit, keep your knees hip-width apart. Rather than leaning on one hip when you stand, put equal weight on both legs. It might feel unnatural at first, but you get used to that posture and then start experiencing less hip pain because youre not overusing the muscles and tendons and ligaments of that joint, Trahan says. If you have osteoarthritis in your hips, she also suggests that you perform hip stretches, such as lying on your back with your knees bent and windshield-wipering your legs from side to side a few times a day. This motion helps wash out inflammatory proteins and the extra fluid in the hips while stretching and expanding the ligaments, she says.

Not sure whats causing your back to ache? Trahan suggests strengthening your core, because it works in tandem with and supports back muscles. A few exercises established by back expert Stuart McGill, Ph.D., can help you build a strong core for injury prevention and rehabilitation, including curl-ups: Lie on your back with one leg out straight and the other knee bent, foot on the floor. Place one or both hands under the curve of your low back and slowly raise your shoulders, chest, neck, and head a couple of inches off the floor in a straight line. Pause for a few deep breaths, then lower your body again.

Depending on the source of your pain, you may want to mention to your doc these science-backed non-pharmacological options.

During acupuncture, very thin needles are inserted into certain parts of the body. It can be viewed through the Eastern lens, which considers meridians or pathways in the body, says Dr. Malhotra, or the Western lens, which theorizes that the needles activate new nerve endings, taking your attention away from the original pain and telling your brain it was a false signal.

Physical therapy is a movement-based intervention in which a practitioner guides a person through specific exercises that can, when done repeatedly, help lessen pain. One 2021 study found that patients with lower-back pain who were prescribed PT in the emergency room had greater improvement in functioning and used fewer high-risk medications in the following three months compared with those with similar pain who received the usual care in the ER.

The idea of this therapy is not to imply that the pain is all in your headit is very real. But since pain can influence your emotional well-being (and vice versa), psychological treatments like cognitive behavioral therapy for chronic pain (CBT-CP) can help. CBT-CP gives you tools to recognize pain and cope with it in a more useful way. For example, pain is a stressor, which can lead to muscle tension, and when muscles are tight, that can make the underlying pain worse, says Driscoll. CBT-CP teaches people to recognize that this process is going on in the body and encourages use of a relaxation strategy like deep breathing or visualization to reduce the pain. Learning to pace yourself is another tool Driscoll says is often taught during CBT-CP, to help you recognize the impulse to push through activities that may lead to pain flares. Once youre aware of these impulses, CBT-CP helps you identify ways to accomplish tasks with less pain.

Yoga combines the benefits of movement with the perks of a mindfulness and relaxation practice. The key is to find an instructor who has experience and training in working with your conditionstart with one-on-one sessions if youre new to yoga. The instructor can give you modifications and tips on how to adapt the poses to your needs.

Your body cant function well if you dont provide it with all the nutrients it needs to do its job, preferably through a healthy, well-rounded eating plan. If your diet is deficient in certain nutrients, you might need to supplement, says Sarah Trahan, N.M.D., a staff physician at Southwest College of Naturopathic Medicine & Health Sciences in Tempe, AZ, who focuses on acute and chronic pain management using regenerative medicine. Common vitamins and minerals can be helpful in preventing or reducing pain, but research also supports the use of turmeric, omega-3 fatty acids, and cannabidiol (CBD). Therapeutic doses of these supplements can be just as effective as some analgesic meds, but make sure to talk to your doctor before taking any.

Studies have linked various lifestyle factorsincluding a high-fat diet, unmanaged stress, inadequate sleep, and smokingto increased pain. That means regardless of the approach to pain relief you and your physician decide on, its going to be a lot harder to feel a difference if you have a foundation of unhealthy habits. As Trahan says, You can fertilize the garden, but if you never water it, the fertilizer was just wasted money.

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Why Your Pain Happens, and What the Future of Alternative Pain Relief Really Looks Like in the Opioid Crisis - Prevention Magazine

Great Huts to host Wellness Day in Portland this Saturday – Jamaica Observer

Great Huts' Wellness Day will feature wellness practitioners sharing ancient wisdom and healing practices at various locations of the resorts picturesque cliffside property in Portland.

PORTLAND, Jamaica Great Huts will host its Wellness Day in Portland on Saturday, July 2, featuring an array of wellness practitioners sharing ancient wisdom and healing practices at various locations of the resorts picturesque cliffside property.

Our objective is to help Jamaicans and visitors alike heal by sharing traditional knowledge and supporting patrons on their own individual health journey. It is of tremendous benefit to our bodies, mind and spirits to immerse in nature, which makes this unique experience so incredible and why we are making it easy to travel to Portland with transport included as an option, said Vivene Levison, Managing Partner of the resort, in a press release.

Dubbed A celebration of body mind and spirit, the wellness day begins with yin yoga on the Great Huts beach with African trained Sky Barrett at 10 am followed by Learn the Fundamentals of Ayurveda; Ancient Science of Life with Dr Anjali Talcherkar.

The release stated that Ayurveda is one of the worlds oldest holistic healing systems and heavily practiced in Nepal and India where over 80 per cent of the population report using it, according to Wikipedia.

Patrons are encouraged to learn more from lead speaker Anjali who holds a doctorate in integrative medicine and a master's degree in psychology. Her focus is in the area of complementary and alternative medicine (CAM) in mental health, combining Eastern medicine and breath-based, yogic practices with traditional interventions, the release added.

The next workshop that follows is entitled Cultivating your Auric Field featuring Paula Hurlock, Covenor of Wellness Experience Jamaica, a consortium of practitioners.

Jamaica is home to over 80 per cent of the planets healing herbs. We share, endorse and validate ancestral wisdom and traditional Jamaican remedies. We believe that there is a knowledge gap and it is their hope that this platform will assist in sharing vital information for our population. But the average millenial or city dweller do not know the herbs our grandmothers used to heal the family, Hurlock said.

The days wraps up with a Tea Time Meditation with Usui Reiki Master Deanna Thomas.

Transportation is being offered from the Jamaica Pegasus in Kingston to Portland and back. The scheduled pick up at Jamaica Pegasus is at 7:30 am Saturday.

The days activities including the yoga, workshops, vegan lunch and Tea Time Meditation with transport cost J$13,500.

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Great Huts to host Wellness Day in Portland this Saturday - Jamaica Observer

FDA Regulatory News and Trends – Lexology

Welcome to the inaugural issue of FDA Regulatory News and Trends, designed to help you identify significant legal developments and navigate the evolving business, legal and regulatory world.

FDA Warning Letter focuses on GMP failures at 503B compounding outsourcing facility. After a brief hiatus from the string of Warning Letters sent to 503B outsourcing facilities in mid- to late 2021, on June 7, 2022, FDA issued a Warning Letter to Hybrid Pharma, LLC based on an inspection ending in September 2021. FDA appears to be coming back with a vengeance, as the same Hybrid Pharma facility received a previous Warning Letter in November 2018. Read more.

Guidance coming to supplements industry on new dietary ingredients. The FDA intends to release multiple draft guidance documents to the dietary supplements industry in the form of relatively small, discrete topics related to New Dietary Ingredients, an FDA executive said on May 26. Betsy Jean Yakes, acting director of the agencys Division of Research & Evaluation, made those comments at the IPA World Congress + Probiota Americas conference in Washington, DC. An FDA spokesperson elaborated that the agency has announced its intent to finalize the NDI Notification Procedures and Timeframes sections of its guidance in its Foods Program Guidance Under Development. Under the law governing NDIs, a manufacturer that wishes to introduce a new ingredient in a supplement must file a notification with the FDA 75 days before marketing the ingredient.

FDA says it now has the staff to review pre-submissions for non-COVID-19 products. The FDA said in a May 31 blog post that it now has the staff it needs to review pre-submissions for medical devices that arent related to the COVID-19 pandemic. In the post, Jeff Shuren, director of the agencys Center for Devices and Radiological Health (CDRH), and William Maisel, director of its Office of Product Evaluation and Quality (OPEQ), noted that since the beginning of the pandemic, the demand for medical devices has far exceeded the demand in any previous public health emergency. This, they said, had significantly overloaded the agencys ability to review requests for Emergency Use Authorization (EUAs) as well as conventional requests. The post also noted that in December 2021, the agency had highlighted that it was prioritizing work in this area that is related to COVID-19 and that it had a limited ability at that time to accept non-COVID pre-submissions. In the May 31 post, the agency said that things have changed and that it is pleased to announce that, as of June 1, 2022, CDRH plans to accept all non-COVID IVD pre-submissions and that due to the continued elevated workload related to COVID, its likely these IVD pre-submissions will initially be reviewed under an extended timeline.

FDA withdraws COVID-era guidance on marketing submissions and applications. On June 7, the FDA announced it is withdrawing a guidance document entitled Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical DevicesQuestions and Answers (Revised). This document was originally issued in June 2020 and updated in December 2020, during the height of the COVID-19 pandemic. The agency said it is withdrawing this guidance document because it recognizes that the conditions that created the need for these policies have evolved and that they are no longer needed essentially, that the pandemic has decreased in scope and severity. The effective date of the withdrawal of the guidance is July 7, 2022. A key aspect of the withdrawal is that the agency said it has determined it is in the interest of the public health to return to pre-pandemic policies regarding hold times for marketing submissions and applications to the FDA. Reverting to policies regarding hold times described in the preexisting guidance documents should facilitate more timely premarket review of innovative and potentially lifesaving devices, the agency said.

FDA issues industry guidance on tropical disease priority review vouchers. On June 13, the FDA issued a guidance for industry entitled Tropical Disease Priority Review Vouchers. The guidance explains how the agency implements provisions of section 524 of the Food, Drug, and Cosmetic Act and how sponsors may qualify for a priority review voucher based on eligibility criteria set forth in the statute. It also discusses how to use priority review vouchers and how priority review vouchers may be transferred to other sponsors. The idea behind section 524 is to stimulate research into possible drugs for certain tropical diseases that affect millions of people and to create a way to give priority review vouchers to sponsors of diseases that can treat those diseases. Priority review means that applications for those drugs take priority over any other type of drug application.

Ex-Eli Lilly employee files suit claiming she was fired for making allegations about the manufacture of Trulicity. Amrit Mula, a former senior human resources employee at Eli Lilly & Co., filed a federal lawsuit on June 6 claiming that she was fired after reporting manufacturing and data falsification issues related to the pharmaceutical companys products, including its blockbuster diabetes drug Trulicity. The suit was filed in the US District Court for the District of New Jersey. Mula, who was an associate director of employee relations at Eli Lilly in Branchburg, New Jersey, contends in the lawsuit that she repeatedly asked her superiors, starting in 2018, to remedy manufacturing violations involving several biologic drugs, including Trulicity. Lilly executives responded by marginalizing, harassing and eventually terminating her position under false pretenses, she said in the lawsuit. The US Department of Justice last year launched a criminal investigation into alleged manufacturing irregularities at the plant.

Guidance for small businesses on importation rule. On May 25, the FDA issued a nonbinding Industry Guidance document concerning the implementation of its 2020 rule on the importation of prescription drugs from Canada. The guidance document is specifically designed, the FDA said, to aid small businesses in their efforts to comply with the rule. The document reviews the structure of the importation program. It points out that the program, under section 804 of the Food, Drug and Cosmetic Act, will be implemented through time-limited Section 804 Importation Programs (SIPs), which will be reviewed and authorized by the agency and managed by states or Indian tribes, or in certain future circumstances by pharmacists or wholesale distributors. The purpose of the final rule, the guidance notes, is to achieve a significant reduction in the cost of covered products to the American consumer while posing no additional risk to public health and safety.

FDA rescinds approval for a drug being used against lymphoma. On June 1, the FDA withdrew for safety and health reasons -- its February 5, 2021 accelerated approval for a new cancer drug, Ukoniq or umbralisib. Ukoniq had been approved to treat two types of lymphoma, marginal zone lymphoma and follicular lymphoma. However, findings from a post-market clinical trial continued to show a possible increased risk of death in patients receiving the drug, leading the agency to determine that the risks of treatment with Ukoniq outweigh its benefits. Based on this determination, the drugs manufacturer, TG Therapeutics, announced it was voluntarily withdrawing Ukoniq from the market for the approved uses in these two types of lymphoma. The FDA told doctors to stop prescribing Ukoniq and to switch to alternative treatments for patients who were taking it. The drug had been approved in February 2021. The pending user fee legislative proposals contains additional authorities for FDA to require additional clinical studies for accelerated approvals and take enforcement action based on those results.

Appeals court rejects challenge to FDA ban on sale of raw butter. On June 10, the US Court of Appeals for the DC Circuit, affirming the ruling of a US district judge, found against a farmer who had asserted that the FDAs regulation banning the interstate sale of raw butter violates the federal Food, Drug, and Cosmetic Act. The appeals court found that the FDA acted reasonably when it concluded that raw butter was too dangerous to be sold interstate. The court pointed out that when Congress set a standard of identity for butter, it explicitly prevented the FDA from altering that definition. The plaintiff in the case, the court noted, contended that the pasteurization requirement for butter does alter that definition in violation of the law. But, the court concluded, That is incorrect: The pasteurization rule did not amend the statutory standard of identity for butter, either formally or functionally. Raw-cream butter, though unpasteurized, is still butter, notwithstanding the FDAs determination that its interstate sale would threaten public health.

FDA provides guidance on risk management for the pharma industry. On June 14, the FDA released a new guidance document titled Quality Risk Management that is intended to offer to pharmaceutical companies a systematic approach to quality risk management for better, more informed, and timely decisions. The agency, recognizing that the manufacture and use of pharmaceuticals necessarily entails some risk, said that the document specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle. The FDA noted that the guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products.

Program to help device makers find new ways to sterilize their devices. On June 7, the FDA announced it is considering a master file pilot program for premarket approval holders whose approved medical devices are sterilized using radiation. The FDA is doing this because of global supply chain constraints and the need to support sterilization supply chain resiliency. If implemented, this program would help medical device manufacturers advance alternative ways to sterilize their approved medical devices, including changing radiation sources. The FDA is working with sterilization experts, medical device manufacturers, and other government agencies to advance alternative ways to sterilize medical devices while maintaining device safety and effectiveness. Sterilization master file pilot programs are often used to encourage new ways to sterilize medical devices that reduce the potential impact of ethylene oxide on the environment and on public health. Ethylene oxide is used to sterilize about 50 percent of all sterilized medical devices, but long-term exposure to it is linked to certain cancers.

New FDA guidance points to priority in finding drugs to treat serious bacterial diseases. On May 24, the FDA issued a nonbinding Industry Guidance document titled Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases Questions and Answers (Revision 1). A major purpose of the guidance document is to emphasize that since many serious cases of bacterial disease persist in hospitals and other settings especially cases that cannot be treated by currently available drugs it is important to prioritize efforts to find new appropriate drugs. The guidance quotes a previous FDA statement noting that it is appropriate to exercise the broadest flexibility in applying the statutory standards, while preserving appropriate guarantees for safety and effectiveness. These procedures reflect the recognition that physicians and patients are generally willing to accept greater risks or side effects from products that treat life-threatening and severely debilitating illnesses, than they would accept from products that treat less serious illnesses. These procedures also reflect the recognition that the benefits of the drug need to be evaluated in light of the severity of the disease being treated.

Warning Letter sent to maker of hand-sanitizing products. On May 23, the FDA sent a Warning Letter to Missouri-based Aire-Master of America, telling the company that it is engaging in significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. Because of these violations, the agency said, its drug products are to be considered adulterated under federal law. The company manufactures hand-sanitizing products. The FDA also noted several other violations and told the company that its products are unapproved new drugs because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from the FDA, the agency said in the Warning Letter. The FDA also strongly recommended that the company hire a consultant to help it meet the requirements of CGMP.

The future of diagnostic regulation. DLA Piper Partner Bethany J. Hills joined Dr. Timothy Stenzel, Director, Office of In Vitro Diagnostics and Radiological Health, CDRH, William G. Morice, Chair, Department of Laboratory Medicine and Pathology, Mayo Clinic and Mike Dobias, Officer, Health Care Products, The Pew Charitable Trusts to discuss important trends in diagnostic regulation at the Food Drug Law Institute Annual conference in Washington, DC on June 15, 2022. Dr. Stenzel provided a deep overview of the lessons learned by CDRH from the COVID pandemic, touching on important innovations in over-the-counter and home testing technologies. A key takeaway is that technologies that are well understood by the FDA can benefit from more efficient regulatory authorization review, while novel technologies take longer and Dr. Stenzel encouraged continued development of novel technologies. Dr. Morice spoke on topics of addressing health access disparities and the infrastructure issues that require updating and restructuring for the future success of deploying diagnostic technologies rapidly. Dr. Stenzel described a number of programs where government supported test validation was very effective and allowed for rapid deployment of tests that would have otherwise been inaccessible. Finally, Mike Dobias and Dr. Morice discussed in depth the pending legislation, the VALID Act, embedded in the proposed user fee bills, that will fundamentally change the way diagnostics are categories and regulated. Mr. Dobias provided an overview of the classification framework, the technology certification program for testing modifications and the available exemptions from pre-market authorization, while Dr. Morice focused on the need for clarity and predictability in the delivery and innovation of diagnostics and the ways the legislation could address those concerns. Key other topics included addressing cost barriers to diagnostic testing and dealing with large data and delivery gaps as tests become more available to consumers directly in their homes.

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Nasal washing for hay fever – how to reduce symptoms with alternative therapies – The Mirror

Avoiding pollen is next to impossible for most, and when it does strike the consequence to sufferers means a whole host of unpleasant symptoms. But there are a number of ways, some lesser-known, to help relieve hay fever

Image: Getty)

Hay fever patients across the UK are facing worsened symptoms as the summer gets underway and pollen count soars.

As the Met Office warned in June, very high pollen levels will affect the more than 10 million people who experience seasonal allergies.

And experts have noted that June has already seen the highest pollen levels in England and Wales so far this year.

Max Wiseberg, airborne allergens expert and creator of HayMax organic allergen barrier balms, said sufferers "need to be well prepared and do everything they can to lessen their hay fever symptoms".

Pharmaceutical remedies are generally based on either antihistamines or steroid nasal sprays, whilst natural remedies are based on physical preventative measures, immune boosters or natural antihistamines," Max explained.

"The interesting thing about this is that many of these remedies can be complementary to each other.

So, if one helps, but doesnt do the whole job, you may be able to try other remedies at the same time and get a better result.

In other words, you can create your own, bespoke hay fever first aid kit that suits your specific needs.

Popular treatments for hay fever sufferers include:

Nasal washing, or nasal sinus irrigation, is basically just pouring a saltwater solution into one nostril and letting it drain out the other.

The ancient Indian practice can help rinse out mucus, bacteria, and allergens like dust and pollen.

That means you may need less allergy medicine or nasal decongestants.

According to Head and Neck surgeons, nasal washing can be done following these steps:

Any container with a spout should work, but you can buy a specialist neti pot to help.

You can also buy natural eye drops which contain a herb called Euphrasia (more commonly known as Eyebright), adds Wiseberg.

Butterbur is a herbal extract believed to have an antihistamine-like effect on hay fever symptoms, and is widely available in capsules.

Quercetin is thought to limit the release of histamine. As well as being found naturally in many foods, it can also be taken in a capsule.

Turmeric is another lesser-known solution according to Wiseberg and has been shown to have anti-allergy properties.

Most often used in dried form, it can also be bought fresh and is available in tablet and capsule form, he advised.

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Nasal washing for hay fever - how to reduce symptoms with alternative therapies - The Mirror

Where is the best place to get treated for cancer? – Yahoo News

Where is the best place to get treated for cancer?

Mexico has become the first tourist destination for Americans when it comes to health matters. Several factors contribute to Americans decision to get their health issues treated in cities such as Tijuana and Mexicali.One of these factors, and perhaps the most relevant one to understand this social phenomenon, is the excellent quality of specialized doctors when it comes to treating cancer or malignant tumors. Also, patients can find breakthroughs in laparoscopy and robotic surgery in Tijuana.Economy is another important factor. Medical treatment costs are 30% to 70% cheaper in Mexico than in the United States. One can add to this relevant fact another one: geographical position. There is a symbiotic relation between both countries. For example, Mexico offers high-quality medical services and very affordable prices, while American patients play a tourist role. Every year, the number of foreigners who are looking for a medical center to treat their diseases in Mexico increases.According to an article published by the BBC, Tijuana received around 1,2 million people for medical tourism in 2018. This year, this number reached 2,5 million people. This has already been noticed by investors who are working to offer better lodging facilities not only for patients, but also their companions.

The low cost of treatments, consultations, and medications, as well as the prestige that doctors in the border have, have made Tijuana the first medical destination for Americans. In addition, there are a lot of Americans who are looking for alternative cancer treatments, which means they focus even more on this border city.If you want to find out more information about alternative cancer treatments, call MedBaja services at (619) 333-6066 or leave your information in the form down below:

Many patients are looking for alternative treatments because conventional ones such as chemotherapy tend to have a lot of side effects with hair loss in different parts of the body (known as alopecia) as the best known. However, it is a long list: anemia, changes in skin and nails, fertility problems in women and men, deliriums, diarrhea, edema, nausea, and vomiting are some of these side effects.Chemotherapy is a chemical process that acts directly on active human cells, stopping their multiplication and destroying them. Unfortunately, it not only destroys cancer cells, but also healthy cells.In an investigation titled Toxicity of oncological treatments, Doctor Christina Caballero writes that the most affected cells during chemotherapy are healthy cells, and the side effects, or toxic effects, have a direct consequence when it comes to quality of life, causing fear in some patients. She, however, adds at the end that the effects are bearable.

Despite the variety of medications that exist nowadays to treat cancerous conditions, side effects or toxic effects continue to appear. In the words of Doctor Caballero, despite the great number of selectivity with these directed therapies, a series of collateral effects, sometimes unpredictable, emerges.Physical wear caused by side effects makes patients look for other types of treatments, for example, alternative medicine.If you wish to combat your condition with more natural and less invasive treatments, ITC has the answer. Call MedBaja services at (619) 333-6066 or leave your information in the form down below:

Complementary or alternative medicine, instead of a conventional procedure as it is often done under the scientific method, consists of healing the body through therapies unrelated to the use of medications.In Tijuana, the capital of medical tourism, you will find Immunity Therapy Center, Cancer Tutor certified center to treat cancer. It offers a second point of view against traditional medicine and its difficult side effects. Immunity Therapy Center holds itself to account through strict assessment and evaluation processes that ratify it as a high-quality option, capable of assisting and treating cancer problems.

They also have around 28 alternative treatments to fight cancer. Some of these are: Vaccine Against Specific Killer Cells, Intravenous Curcumin Treatment, Viral Vaccination Cancer Treatment, Enzyme Therapy, Biomagnetic Therapy, among others.Get treated by the best professionals. Find out all about the ideal cancer treatment for you with MedBaja services at (619) 333-6066 or leave your information in the form down below:

Learn More about Immunity Therapy Center

Types of alternative cancer treatmentsMore than 21 alternative therapies and natural treatments for cancer are combined with traditional treatments. Some of the options are:

Enzyme therapy Vitamin and mineral therapies Oxygen therapy biomagnetic therapy Laser therapy HALO therapy Hyperthermia

It is important to note that most stays are for six weeks, but depending on the patient and the progress of their condition, this period may be longer or shorter. Instructions are provided so that the patient can continue their treatment at home after leaving the center.

This type of treatment is unique because of its use of alternative therapy, and therefore not covered by medical insurance, so each patient must pay for his or her own expenses. Patients can contact the center for help finding the best payment option.

Most patients come to the center accompanied by a loved one, so that they have the support and company of someone they trust, which is crucial when undergoing treatment for disease.

To learn more about the center and its therapies, visit the following link. This could be the life opportunity youve been looking for.

Get in contact with a specialist and learn about Alternative Cancer Treatments in Tijuana, fill-out the contact form below:

Alternative Cancer Treatment in Mexico | Survivor Testimonials

Call us at MedBaja Services on (619)333-6066 to find out more about this cheap, revolutionary, and holistic approach to cancer treatment, or fill out the form below so we may contact you immediately.

INDEX: CANCER TREATMENTS IN MEXICOIs it safe to travel to Tijuana to receive cancer treatment?What to expect from an Alternative Cancer Treatment in Mexico?What makes Tijuana a leader in alternative cancer treatments?Viral anti-cancer vaccine, an innovative alternative treatment in TijuanaWhy is cancer treatment significantly more affordable in tijuana?How to choose a cancer center in Mexico?Where can I find a Cancer Tutor Verified Center in Tijuana?ITC: The best level of healthcare for cancer patients is in TijuanaTestimonial from a Cancer Survivor Treated in Tijuana, MexicoGuanabana: Why Fly to Tijuana, Mexico, For This Alternative Treatment?Anticancer Uses of Turmeric: Why Travel to Tijuana For This Asian Cuisine?5 Safer Natural Alternatives to Chemotherapy Available in Tijuana, MexicoWhat is the Cost of Cancer Treatment in Mexico?5 groundbreaking alternative cancer treatments in MexicoViral anti-cancer vaccine, an innovative alternative treatment in Tijuana

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Where is the best place to get treated for cancer? - Yahoo News

India and US went pro-choice around the same time. Only one strengthened its abortion laws – ThePrint

PastForward is a deep research offering from ThePrint on issues from Indias modern history that continue to guide the present and determine the future. As William Faulkner famously said, The past is never dead. Its not even past. Indians are now hungrier and curiouser to know what brought us to key issues of the day. Here is the link to the previous editions of PastForward on Indian history, Green Revolution, 1962 India-China war, J&K accession, caste census and Pokhran nuclear tests.

In a judgment that will have far reaching consequences, the US Supreme Court last week overturnedits own 1973 Roe vs Wade judgment against state restriction on abortion, setting womens sexual and reproductive health rights back by many decades.

Roe vs Wade was a landmark when it was originally passed; but what is less known is that Indian womens right to abortion predated that seminal case when Norma McCorvey, a Texas resident, challenged Henry Wade district attorney of Dallas county, demanding the right to abort her baby. Although, by the time the right to abort came, McCorvey had already delivered her baby. Jane Roe was the alias used to protect her identity.

Two years before the US Supreme Court judgment, in India, womens right to seek an abortion was established by the Medical Termination of Pregnancy Act, 1971. Much water has flown under the bridge since then. In 2021, the revised MTP Act took into account changed social realities and also the advancements made in medical field, which expanded the safe abortion window considerably. The most important change that the 2021 law brought was not the expansion of permissible limit for abortion from 20 weeks of gestation to 24 weeks. It was in its recognition of the need to make abortions accessible for all women irrespective of their marital status.

ThePrint takes a look at how Indias abortion law evolved.

Also read: Who was Jane Roe of Roe v Wade? What overturning of the 1973 judgment means for American women

The MTP Act of 1971 allowed abortions up to 20 weeks provided two registered medical practitioners agreed that continuing the pregnancy involved a risk to the life of the pregnant woman or the unborn child, including mental or physical abnormalities. For a pregnancy caused by rape, the law allows abortion, holding that pregnancy in such a case presumed to constitute a grave injury to the mental health of the pregnant woman. Contraceptive failure was also an acceptable ground for abortion in case of a married woman as per this law.

The genesis of the law lay in a government committee that was constituted in 1964, much before Roe vs Wades initiation date of 1970. Until then, Indian law had a provision for an imprisonment of up to three years for the provider of abortion services and of up to seven years for the woman seeking those services. Exception was allowed in the case of miscarriage to save the life of the pregnant woman in good faith.

In its report submitted in 1966, the committee headed by then-minister of public health, law and judiciary Shantilal Shah said: The committee considers the above provision too restrictive; and therefore recommends that it should be liberalised to allow termination of pregnancy by a qualified medical practitioner acting in good faith However, the committee was clear that abortion was unviable as a method to control population growth.

A 2016 article in the journal Indian Law Institute Law Review noted that the MTP Act was implemented in the month of April, 1972 and again revised in the year of 1975 to eliminate time consuming procedures for the approval of the place and to make services more readily available. This Act was amended in the year 2002 and again in 2005.

Also read: How changes to pregnancy termination bill give women better options for abortion

Throughout the amendments in the MTP Act, there was one constant abortions were legally allowed in the country only till 20 weeks of pregnancy. This had to do with the available medical facilities and the assessment at those points of time about what constitutes a safe window for abortion without jeopardising the life of the mother. But with the advent of advanced medical equipment, it became possible for doctors to detect foetal abnormalities well beyond the 20-week deadline, making the decision of carrying pregnancy through a fraught question for the would-be parents.

One such instance came in 2008 when Mumbai couple Haresh and Niketa Mehta approached the Bombay High Court for permission to abort their baby, which doctors said would be born with a congenital heart block. Their application was turned down and Niketa eventually miscarried. The case became one of the landmarks in the long journey of the Indian abortion law in allowing abortions beyond the 20-week barrier.

There have been cases where courts have granted permission beyond the permissible time limit. In 2015, a 14-year-old rape victim from Gujarat was permitted by the Supreme Court to abort after 20 weeks as a special case. The court, however, asserted that this case could not be used as a precedent to grant permission in another similar case.

On the other hand, in 2020, the Kerala High Court denied permission to a couple to abort their 35-week foetus.

The longstanding need to review the limit in gestation age, which doctors and patients have been arguing in favour of for years, was finally met in 2021 when a new MTP Act came into force that allowed abortion up to 24 weeks. The upper gestation limit, the law says, will not apply in cases of substantial foetal abnormalities diagnosed by a medical board. The board will include one paediatrician, one gynaecologist and one radiologist or sonologist. But why that law marked a shift in mindset lies in a paragraph which says: For the purposes of clause (that is when the pregnancy is less than 20 weeks old), where any pregnancy occurs as a result of failure of any device or method used by any woman or her partner for the purpose of limiting the number of children or preventing pregnancy, the anguish caused by such pregnancy may be presumed to constitute a grave injury to the mental health of the pregnant woman.

This was a major shift from the earlier law when contraceptive failure was an acceptable reason for abortion only for married women, leaving many unmarried pregnant women at the mercy of quacks and illegal service providers. The original draft of the Bill had included the contraceptive failure clause only for married women but the ministry of health pushed for a more inclusive language to ensure better access to safe abortion services. According to a 2018 study by the Guttmacher Institute, 50% of pregnancies in six of the largest Indian states Assam, Bihar, Gujarat, Madhya Pradesh, Tamil Nadu and Uttar Pradesh are unintended. According to United Nations Population Fund (UNFPA)s State of the World Population Report 2022, 67 per cent of all abortions that happened in India between 2007-2011 were unsafe.

Also read: Why Indias law on abortion does not use the word abortion

The two thorny questions in the abortion law have always been: who can deliver the essential health service and who can seek it the latter being more of a social nature but one that requires a legal framework. Indias position on this question has evolved with time, taking into account social realities so that the question of who needs an abortion is now looked at through the prism of individual rights rather than societal norms. But in a country where doctors are chronically in short supply even the 1966 report mentioned this problem the question of who is qualified to provide abortion services is complicated as well. So, around 2014-15, the ministry of health and family welfare proposed an amendment to the MTP Act, 1971 to allow ayurveda, naturopathy, and homeopathy practitioners to perform medical abortions that is, abortions that did not require any surgical intervention.

The proposal caused a backlash, particularly from the Indian Medical Association (IMA), the largest body of allopathic doctors in the country. But what put paid to the plan was not the uproar but the death of a woman in Maharashtras Sangli district in 2017, allegedly after she sought an abortion from an unqualified person. Ahomoeopathy doctor was later caught allegedly running an illegal sex-selective abortion racket. Following the incident, the MTP Act, despite being included in the agenda of the Union Cabinet, was not taken up for several months. The PMO stepped in and askedthe health ministry to ensure better implementation of the MTP Act, 1971 and the Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act, 1994 before trying to amend either. The PCPNDT Act is meant to stop sex selective abortions. The Sangli incident also caused concerns in the highest levels of the government about the implications of increasing the provider base in a country where regulations tend to fall repeatedly short.

The plan to allow practitioners of alternative medicine to perform abortions was dropped and eventually when the MTP Act, 2021 came into effect, the status of a provider was limited only to qualified allopathic practitioners.

The MTP Act, 2021 was hailed by the World Health Organization (WHO) as a progressive step towards equitable access to abortion services. In a historic move to provide universal access reproductive health services, India amended the Medical Termination of Pregnancy (MTP) Act 1971 to further empower women by providing comprehensive abortion care to all. The new Medical Termination of Pregnancy (Amendment) Act 2021 expands the access to safe and legal abortion services on therapeutic, eugenic, humanitarian and social grounds to ensure universal access to comprehensive care. The new law, which came into force from 25 March 2021, will contribute towards ending preventable maternal mortality to help meet the Sustainable Development Goals (SDGs) 3.1, 3.7 and 5.6, WHO said in a statement in April 2021.

(Edited by Prashant)

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India and US went pro-choice around the same time. Only one strengthened its abortion laws - ThePrint

Malone Testifies on Inadequacy and Illegality of Federal Pandemic Response at State Hearing – The Epoch Times

Dr. Robert Malone will present testimony before the Texas Senate Health and Human Services Committee hearing on Monday June 27th.

In stating his qualifications, Dr. Malone explained why he is in a unique position to provide an opinion regarding federal pandemic responses, I have been deeply involved in multiple prior outbreak responses including AIDS, the Post Anthrax/Smallpox scare, Pandemic Influenza, Ebola, Zika, and now SARS-CoV-2.

He explained how in all prior pandemic responses, the role of the Centers for Disease Control and Prevention (CDC) was to provide impartial and accurate data to advise state public health authorities who, according to the U.S. Constitution, have the right and duty to manage their own public health policy as well as the practice of medicine.

In the United States, each state has its own public health department and licensing board for medical doctors. Additionally, during the COVID-19 pandemic, the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Disease (NIAID) took a lead role over the CDC. This had never happened before.

Malone also related how, In my professional experience, during all prior outbreaks and vaccine development programs, risks and benefits have always been evaluated and stratified by risk group, and public health recommendations have been tailored to account for differences in risk/benefit ratios.

Rather than following tried and true methods, new protocols were developed by Drs. Anthony Fauci and Deborah Birx in a non-transparent way without public hearings, comment, or input from treating physicians.

These new protocols involved the rapid development of vaccines with inadequate safety trials and the aggressive blocking and suppression of the use of effective repurposed drugs and treatment regimes. None of the vaccines could have received Emergency Use Authorization if there existed an alternative efficacious treatment.

Since the COVID-19 vaccine role outs began, the CDC has purposefully withheld data that it thought would contribute to vaccine hesitancy and admitted that it did not monitor or analyze vaccine safety data, included cases reported to the Vaccine Adverse Event Reporting System (VAERS).

Malone said, This has compromised the informed consent process. Instead, the CDC has actively promoted and marketed vaccination with unlicensed (emergency use authorized) products, with over $1 Billion USD in federal funding expended to both market the products and to censor those who have raised concerns regarding vaccine safety and effectiveness.

He continued, [the] FDA, NIH, and CDC (together with WHO) have cooperated to actively restrict, demean, and deprecate use of multiple currently available licensed drugs for treatment of COVID-19 by licensed practicing physicians, and have facilitated retaliation against physicians who do not follow the treatment guidelines established and promoted by the NIH which has neither mandate nor significant prior experience in developing and implementing universal treatment guidance and protocols, and which has done so in a unilateral manner without seeking meaningful input from practicing physicians. He provided the example of the retaliation experienced by the highly qualified physician and scientist authors of the Great Barrington Declaration.

Both the NIH and CCD have promoted federal policies across the entire United States with no respect for state autonomy and evidence suggests they have gone so far as to withhold monoclonal antibody treatment from the state of Florida because Governor Desantis COVID management policies did not align with federal ones.

He stated, It is my professional opinion that in the case of the COVID crisis, we have seen an unprecedented weaponization of public health policies to advance political and economic agendas, which are not directly related to public health.

It is also my opinion that the federal government has incrementally usurped the constitutional rights of states to regulate health care and the practice of medicine, and that this has been accomplished using a variety of coercive tactics.

He urged Texas senators to develop their own state drug manufacturing not only for business and economic development but to also protect the health and safety of the citizens of Texas as, in his opinion, outsourcing drug development and manufacturing to places like China and India represents a threat to national security and public health.

Dr. Malone concluded, In sum, during the COVID crisis, I believe that we have seen an unprecedented encroachment of the U.S. Federal Government into the practice of medicine, the circumventing of both bioethical and regulatory norms that have been developed over decades, and heavy handed and politicized federal implementation of a wide range of interventions in our communities, businesses, churches, government, monetary policy and general commerce.

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Malone Testifies on Inadequacy and Illegality of Federal Pandemic Response at State Hearing - The Epoch Times

Contrast-enhanced mammography vs. MRI: Neoadjuvant therapy response in breast cancer – EurekAlert

image:A, CC (left) and MLO (right) low-energy images from pre-NAT CEM performed on 25th day of luteal phase show a 60-mm architectural distortion (line on CC) in the central portion of the right breast. B, CC (left) and MLO (right) recombined images from pre-NAT CEM show marked background parenchymal enhancement, hindering lesion evaluation; 90-mm non-mass regional enhancement (line) was described. C, Axial fat-saturated T1-weighted unenhanced MR image shows a 70-mm hypointense irregular mass (line) with not circumscribed margins in the central portion of right breast. D, Axial fat-saturated T1-weighted post-contrast MR images shows corresponding fast initial enhancement (line) with delayed plateau. view more

Credit: American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR)

Leesburg, VA, June 22, 2022According to ARRS American Journal of Roentgenology (AJR), contrast-enhanced mammography (CEM) may be a useful alternative test for neoadjuvant therapy (NAT) response assessment in patients with breast cancer who are unable to undergo MRI.

After NAT for breast cancer, CEM and MRI yielded comparable assessments of lesion size (both slightly overestimated vs pathology) and RECIST categories, and no significant difference in specificity for pathologic complete response, wrote corresponding author Rubina Manuela Trimboli of IRCCS Humanitas Research Hospital in Milan, Italy. Noting that MRI had higher sensitivity for pathologic complete response, delayed CEM acquisition may help detect residual ductal carcinoma in situ (DCIS).

Trimboli and teams prospective study included 51 patients (mean age, 46 years) with biopsy-proven breast cancer from May 2015 to April 2018, who were candidates for NAT. Patients underwent both CEM and MRI before, during, and after NAT: pre-NAT, mid-NAT, and post-NAT, respectively. Post-NAT CEM included a 6-minute delayed acquisition. One breast radiologist with experience in CEM reviewed CEM examinations; one breast radiologist with experience in MRI reviewed MRI examinations.

Compared with pathology, post-NAT CEM, MRI, and delayed CEM systematically overestimated residual tumor size by 0.8 mm, 1.9 mm, and 1.2 mm, respectively. For detecting pathologic complete response by post-NAT imaging, sensitivity and specificity were 81% and 83% for CEM, 100% and 86% for MRI, and 81% and 89% for delayed CEM.

While MRI remains the preferred test for NAT monitoring, the authors of this AJR article concluded, the findings support CEM as a useful alternative when MRI is contraindicated or not tolerated.

North Americas first radiological society, theAmerican Roentgen Ray Society (ARRS) remains dedicated to the advancement of medicine through the profession of medical imaging and its allied sciences. An international forum for progress in radiology since the discovery of the x-ray, ARRS maintains its mission of improving health through a community committed to advancing knowledge and skills with the worlds longest continuously published radiology journalAmerican Journal of Roentgenologythe ARRS Annual Meeting, InPractice magazine, topical symposia, myriad multimedia educational materials, as well as awarding scholarships via The Roentgen Fund.

MEDIA CONTACT:

Logan K. Young, PIO

44211 Slatestone Court

Leesburg, VA 20176

703-858-4332

lyoung@arrs.org

American Journal of Roentgenology

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Contrast-Enhanced Mammography Versus MRI in the Evaluation of Neoadjuvant Therapy Response in Patients With Breast Cancer: A Prospective Study

22-Jun-2022

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Contrast-enhanced mammography vs. MRI: Neoadjuvant therapy response in breast cancer - EurekAlert

Donating to help women get abortions is a First Amendment right protected by Supreme Court precedents – The Conversation

Several Texas abortion funds which are charities that help people who cant afford to get an abortion pay for their travel, lodging and medical bills paused disbursements on June 24, 2022, after the Supreme Court ruled that Americans have no constitutional right to the procedure.

The Lilith, Equal Access, Frontera and other funds said they were taking this step to assess the legal consequences of the courts ruling in Texas, which already had some of the nations strictest abortion laws. Abortion funds in some other states, including Oklahoma, were also reportedly halting their work.

Some funds active in Texas made this decision based on concerns that their financial assistance to women seeking abortions may now be illegal in that state, as well as fears that their donors could also be sued for violating Texas law.

But as an expert on reproductive rights and First Amendment law who has argued before the Supreme Court, I believe that donating to abortion funds even in places where helping people get abortions is illegal is protected by the U.S. Constitution.

The Supreme Court has ruled on several occasions that fundraising, whether its by charitable organizations or political candidates, is a form of speech protected by the First Amendment.

The court handed down the first relevant ruling in 1980, with its Schaumburg v. Citizens for a Better Environment decision. The court struck down an Illinois city ordinance that had prohibited charitable organizations from soliciting contributions unless 75% or more of their revenue was used directly for charitable purposes, rather than for salaries, administration and overhead costs.

The city of Schaumburg had defended that ordinance by contending it regulated conduct involving commercial transactions and was necessary to prevent fundraising for fraudulent causes. The Supreme Court rejected this characterization, asserting that fundraising is a form of protected speech because it is intertwined with informative and perhaps persuasive speech seeking support for particular causes or for particular views on economic, political, or social issues.

The court further noted that without the right to seek and receive donations, the flow of information and advocacy would likely cease.

Several campaign finance rulings have reinforced the Schaumberg ruling.

The best-known among them is Citizens United v. Federal Election Commission. Two other key rulings are Buckley v. Valeo, which preceded the Schaumberg case, and McCutcheon v. Federal Election Commission. All three established that contributions to political candidates, and spending by those candidates, is a form of speech protected by the First Amendment.

In the eyes of the law, seeking donations and making contributions are two sides of the same coin. The Supreme Court has said that both are important ways to show support for political preferences, advance ideas and advocate for policy changes.

The First Amendment right to solicit or give funds is not limited to charitable organizations or candidates. Simply panhandling on the street, the most basic form of soliciting funds, is entitled to First Amendment protection, according to several lower federal courts.

The Supreme Court has also held that the freedom of association principle embodied in the First Amendment protects the right to support a cause by making donations or paying dues.

Based on the freedom of association, which includes the right to join together with others for social or political purposes, the court has been very protective of the right of donors to remain anonymous. That has especially been the case for donors who support controversial causes and when revealing their identity might subject them to harassment, threats, public hostility or other forms of reprisal.

In 1958, the Supreme Court ruled in NAACP v. Alabama that the First Amendment barred Alabama from forcing the NAACP to disclose the names of its members or donors who resided in the state. The court pragmatically recognized that compelling disclosure of supporters of a civil rights group in Alabama in the 1950s could endanger the donors.

This First Amendment principle of protecting the speech and the rights of donors to fund charitable causes guards both sides of the political spectrum.

In July 2021, for example, the Supreme Court decided a case brought by two organizations considered to be conservative: the Americans for Prosperity Foundation and the Thomas More Law Center. The two organizations challenged a California law that required them to disclose the names of their donors who gave more than $5,000.

California tried to justify this law as necessary to prevent fraud by registered charities the same preventing fraud rationale that Schaumburg had unsuccessfully asserted as the reason it needed to restrict charitable solicitation.

Relying on the NAACP case among others, the Court held in Americans for Prosperity Foundation v. Bonta that the compelled disclosure requirement violated the donors right to freedom of association.

Based on this body of law, the First Amendment protects the right of abortion funds to seek contributions and to make contributions to individuals in Texas and other states where abortion is illegal to support their activities. The First Amendment also protects the right of people to make donations to abortion funds.

A 2021 Texas law known as Senate Bill 8 prohibits aiding and abetting an abortion after six weeks into pregnancy. The measure specifically mentions providing financial assistance as a form of aiding and abetting.

The law authorizes any person in the world to bring a civil damages lawsuit against anyone who aids and abets an abortion, and to recover attorneys fees in addition to at least $10,000.

One reason why abortion funds might be leery right now is that Texas law permits someone to seek a court order to force others to hand over information that might provide a basis for suing them.

Two individuals have already sought such an order to require the Lilith Fund to disclose information about its funding and donors in order to determine if they violated the 2021 restriction on aiding and abetting an abortion by giving money.

The Thomas More Law Society the same organization that successfully asked the Supreme Court to protect it from having to disclose its donors is representing the people seeking donor information from the Lilith Fund, and tweeted that Lilith Fund donors could face legal action for violating the Texas abortion laws aiding and abetting prohibition.

A Texas trial court judge has found that the provisions authorizing anyone to sue someone who provides or aids and abets an abortion likely violate the Texas Constitution, and has temporarily enjoined the law, meaning that it is on hold pending appeal.

The case is likely to go to the Texas Supreme Court. How that court rules will have a great impact on the liability risk faced by the Lilith Fund for providing financial assistance to women to help them get an abortion. While the legal process is playing out, the Lilith Fund is trying to minimize its legal risk by suspending the distribution of money to women.

If the Texas appellate courts eventually uphold S.B.8, the ban on providing financial assistance to Texas women could be enforced. In that event, the Lilith Fund would be able to make a strong case that they dont need to reveal any information because of First Amendment protections.

If states try to punish abortion funds or individuals for providing a woman with financial assistance to get an abortion in another state where it remains legal, including the money required to travel there, that would likely violate the Constitution.

Giving money to people who want to obtain a legal abortion would not be aiding and abetting a crime. Moreover, the Constitution protects the right to interstate travel. The freedom to cross state lines is a right deeply embedded in U.S. history dating to the Articles of Confederation, prior to the Bill of Rights.

Assisting someone with obtaining a legal abortion by giving them money also could be protected as a form of free speech because it can be one aspect of advocating for and supporting the right to legal abortion. Disbursing these funds could also be protected under the Constitution as an aspect of the freedom to associate with women who seek legal abortions by giving them financial support.

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Donating to help women get abortions is a First Amendment right protected by Supreme Court precedents - The Conversation

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Trumpists Call on Supreme Court to Let States Establish Religion Within Their Borders – Rolling Stone

America First Legal (AFL), a right-wing group whose team includes several former Trump administration officials, is urging the Supreme Court to do even more to shatter whats left of the wall between church and state.

On Tuesday, June 28, the group issued a statement essentially calling for a total overhaul of the First Amendments establishment clause, a key provision separating church and state. The statement arrived one day after the Supreme Court cracked part of the clauses foundation with its ruling in Kennedy v. Bremerton. In that case, the courts far-right majority ruled that public school officials in Bremerton, Washington, violated the First Amendment rights of high school football coach Joseph Kennedy when they fired him following a controversy stemming from his ritual of praying at the 50-yard line during football games. The 6-3 decision effectively overruled a 1971 precedent for interpreting the First Amendments establishment clause.

While the establishment clause exists to keep the government from establishing an official religion in the United States, or doing anything that might favor one religion over another, the AFL is now hopeful that the Supreme Court will eventually disincorporate the establishment clause in a future case. Doing so, the AFL suggests, would allow states to decide whether and to what extent they will establish religion within their borders.

The AFLs vice president and general counsel Gene Hamilton a former Trump official in the Departments of Justice and Homeland Security, whose hits include axing DACA and helping create the infamous family separation policy argued in a statement that the original intent of the establishment clause was to let the states decide just how much they want to separate church and state.

We are pleased that the Supreme Court decided in Coach Kennedys favor, Hamilton said. Perhaps the Court will, in a future case, finally restore the original meaning of the Establishment Clause and disincorporate it as to the states. But for today, we celebrate with Coach Kennedy and all Americans who value religious freedom.

Allowing individual states to establish their own official religions is just one possible tidal wave-sized ripple that could follow Kennedy v. Bremerton. Considering the current Courts apparent disdain for established precedent, it could also pave the way for overturning the landmark 1962 case that ruled prayer in public schools was unconstitutional.

Kennedy v. Bremerton is also just one of two major SCOTUS rulings this term to take a crack at the long-established boundaries between church and state. Earlier in June, the right-wing majority ruled in Carson v. Makin that taxpayer money from a tuition assistance program in Maine could be used to send kids to private religious schools.

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Trumpists Call on Supreme Court to Let States Establish Religion Within Their Borders - Rolling Stone

Did George Washington Violate the First Amendment?, by Terence P. Jeffrey – Creators Syndicate

Did George Washington in his first act as president violate the first principle soon to be enshrined in the First Amendment?

Did the Congress that approved the First Amendment compel him to do so?

On April 7, 1789, three weeks before Washington was inaugurated, the Journal of the Senate reported that the Senate had ordered "a committee ... to take under consideration the manner of electing Chaplains, and to confer thereupon with a committee of the House of Representatives."

On April 15, 1789, the committee reported back: "That two Chaplains, of different denominations, be appointed to Congress, for the present session, the Senate to appoint one, and give notice thereof to the House of Representatives, who shall, thereupon, appoint the other; which Chaplains shall commence their services in the Houses that appoint them, but shall interchange weekly."

Two days later, the House concurred.

Then, on April 25, 1789, the Journal of the Senate reported: "The Senate proceeded to the appointment of a Chaplain, in the manner agreed upon the 15th of April; and (t)he right reverend Samuel Provoost was elected."

Two days after that, the House resolved: "That this House will, on Friday next, proceed by ballot to the appointment of a Chaplain to Congress on the part of this House."

Two days after that, the House agreed to a resolution, already adopted by the Senate, that said: "That after the oath shall have been administered to the President, the Vice-President and members of the Senate, the Speaker and members of the House of Representatives, will accompany him to St. Paul's Chapel to hear divine service performed by the Chaplains of Congress."

The Congress was then meeting at Federal Hall in New York City.

On April 30, 1789, Washington stood on the balcony of that hall and was sworn in as this nation's first president.

"Washington took the oath with his hand on the Bible, and kissed the Bible after taking the oath," says the Mount Vernon website.

The Journal of the Senate includes the text of his inaugural address.

"(I)t would be peculiarly improper to omit, in this first official act," said Washington, "my fervent supplications to that Almighty Being who rules over the universe who presides in the councils of nations and whose providential aids can supply every human defect, that his benediction may consecrate to the liberties and happiness of the people of the United States, a government instituted by themselves for these essential purposes: and may enable every instrument employed in its administration to execute with success, the functions allotted to his charge.

"In tendering this homage to the Great Author of every public and private good, I assure myself that it expresses your sentiments not less than my own; nor those of my fellow citizens at large, less than either," Washington continued.

"No people can be bound to acknowledge and adore the invisible hand, which conducts the affairs of men, more than the people of the United States," he said.

Washington then followed through on the resolution Congress had passed earlier that week.

"The President, the Vice President, the Senate, and House of Representatives," reports the Journal of the Senate, "then proceeded to St. Paul's Chapel, where divine service was performed by the Chaplain of Congress, after which the President was reconducted to his house by the committee appointed for that purpose."

In 1983, the Supreme Court heard the case of Marsh v. Chambers. The issue then was whether the Nebraska state legislature had violated the First Amendment and established a religion by having a chaplain begin its sessions with a prayer.

The court voted 6-3 that it had not. Chief Justice Warren Burger wrote the opinion for the majority. In this opinion, Burger pointed to the historical fact that the House and Senate first elected their chaplains in April 1789 and voted later that same year to pay them a salary.

"A statute providing for the payment of these chaplains was enacted into law on September 22, 1789," he noted.

"On September 25, 1789, three days after Congress authorized the appointment of paid chaplains, final agreement was reached on the language of the Bill of Rights," said Burger. "Clearly the men who wrote the First Amendment Religion Clauses did not view paid legislative chaplains and opening prayers as a violation of that Amendment, for the practice of opening sessions with prayer has continued without interruption ever since that early session of Congress."

Burger noted that James Madison personally supported the payment of congressional chaplains.

"It bears note," said Burger, "that James Madison, one of the principal advocates of religious freedom in the Colonies and a drafter of the Establishment Clause ... voted for the bill authorizing payment of the chaplains."

The Establishment Clause says: "Congress shall make no law respecting an establishment of religion."

If the men who wrote the Establishment Clause also voted to pay for a chaplain to work for the very Congress in which they served, how can an assistant football coach at a public school violate the Establishment Clause by personally saying a prayer after a game?

He cannot.

The Supreme Court this week decided this question correctly. But three justices Sonia Sotomayor, Elena Kagan and the retiring Stephen Breyer voted the wrong way.

Which side would incoming Justice Ketanji Brown Jackson have taken?

We now live in a nation where fundamental rights remain just two or three votes shy of cancellation.

Terence P. Jeffrey is the editor-in-chief of CNSnews.com. To find out more about him, visit the Creators Syndicate webpage at http://www.creators.com.

Photo credit: MikeGoad at Pixabay

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Did George Washington Violate the First Amendment?, by Terence P. Jeffrey - Creators Syndicate

Do Not Expect Section 230 And The 1st Amendment To Save Antitrust Bills From Abuse – Techdirt

from the fix-the-damn-bill dept

Over the last few weeks, weve written quite a bit about the American Innovation and Choice Online Act (AICOA), which has become the central push by a bunch of folks in Congress to create a special antitrust bill for big tech. There are some good ideas in the bill, but, as weve been highlighting, a major problem is that the language in the bill is such that it could be abused by politically motivated politicians and law enforcement to go after perfectly reasonable content moderation decisions.

Indeed, Republicans have made it clear that they very much believe this bill will enable them to go after tech companies over content moderation decisions they dislike. Most recently, theyve said that if the bill is clarified to say that it should not impact content moderation, that they will walk away from supporting the bill. That should, at the very least, give pause to everyone who keeps insisting that the bill cant be abused to go after content moderation decisions.

We recently wrote about four Senators, led by Brian Schatz (with Ron Wyden, Tammy Baldwin, and Ben Ray Lujan), suggesting a very, very slight amendment to the bill, which would just make it explicit that the law shouldnt be read to impact regular content moderation decisions.

In response to that Schatz letter, Rep. David Cicilline (who is spearheading the House version of the bill, while Senator Amy Klobuchar is handling the Senate side), sent back a letter insisting that Section 230 and the 1st Amendment already would prevent AICOA from being abused this way. Heres a snippet of his letter.

Moreover, even if a covered platforms discriminatory application of its terms of servicematerially harmed competition, the Act preserves platforms content-moderation-relateddefenses under current law. Section 5 of S. 2992 states expressly that [n]othing in this Act maybe construed to limit ... the application of any law.

One such law is Section 230(c) of the Communications Decency Act. Under thatprovision, social-media platforms may not be treated as the publisher or speaker of anyinformation provided by another information content provider. They also may not be heldcivilly liable on account of any action voluntarily taken in good faith to restrict access to oravailability of material that the provider or user considers to be obscene, lewd, lascivious, filthy,excessively violent, harassing, or otherwise objectionable, whether or not such material isconstitutionally protected. Accordingly, as with other liability statutes enacted since thepassage of Section 230, Section 230 provides an affirmative defense to liability under [the Act]for ... the narrow set of defendants and conduct to which Section 230 applies. Another stillapplicable law is the First Amendment to the U.S. Constitution, which the Act does notandindeed, cannotabrogate.

He then goes on in more detail as to why he believes the bill really cannot be abused. And while he does note that that he remains committed to doing what is necessary to strengthen and improve the bill and that he is happy to keep working with these Senators on it, the very clear message from his letter is that hes pretty sure the bill is just fine as is, and that Section 230 and the 1st Amendment already protect against abuse.

Finally, your proposed language for the Actalthough well intentionedis alreadyreflected in the base text of the bill. As detailed above, among other things, section 5 of S. 2992preserves the continued applicability of current laws, including 47 U.S.C. 230(c), that protectsocial-media platforms from liability for good-faith content moderation. Although I agree thatlegislation is necessary to address concerns with misinformation and content-moderationpractices by dominant social-media platforms, I have consistently said that this legislation is notthe avenue for doing so. As such, this legislation is narrowly tailored to address specificanticompetitive practices by dominant technology firms online. And as the Department of Justicehas noted, it is a complement to and clarification of the antitrust laws as they apply to digitalmarkets. As such, it does not supersede other laws.

Except Cicilline is wrong. Very wrong. We at the Copia Institute this week signed onto a letter from TechFreedom and Free Press (two organizations that rarely agree with each other on policy issues) along with some expert academics explaining why.

The letter explains why Cicillines faith in Section 230 and the 1st Amendment is misplaced. It walks through, step by step, ways in which motivated state AGs (or even the DOJ) might get around those concerns, by claiming that moderation decisions were not actually content-based decisions, but business conduct, focused on anti-competitive behavior.

We dont have to look far to see how that played out: the Malwarebytes case was an example of that in action. That was a case where a company was able to avoid Section 230 by claiming that a moderation decision (calling an app malware), was actually done for anti-competitive reasons. But with AICOA, we could get that on steroids. As the letter notes:

There is a substantial risk that courts will extend the Malwarebytes reasoning to exclude AICOA claims from Section 230 protectionincluding politically motivated claims aimed at content moderation. Specifically, courts may try to harmonize the two statutesi.e., strive to give effect to bothby accepting some showing of anticompetitive results as sufficient to circumvent Section 230(c)(2)(A) in non-discrimination claims.

Anticompetitive animus is not required by the plain text of AICOA 3(a)(3). Allowing only AICOA claims that allege (and, ultimately, prove) anticompetitive motivation to bypass Section 230s protection would infer an intent requirement where Congress chose not to include one. While courts do sometimes infer intent requirements, they may reasonably conclude that doing so here would effectively read Section 3(a)(3) out of the statute. How could a platform with no direct stake in the market where competitive harm is alleged ever have an anticompetitive intent? Thus, how could any plaintiff ever bring a Section 3(a)(3) claim regarding harm to competition between downstream business users that would survive Section 230(c)(2)(A)? For Rep. Cicillines presumptions about Section 230 to be correct, courts would have to effectively render Section 3(a)(3) a nullity by holding that only claims of self-preferencingbut not discrimination between other business usersare actionable. This is an implausible reading that clearly contradicts what the present draft of AICOA says.

The Malwarebytes court relied heavily on Section 230s history and purpose as evincing Congressional intent to protect competition. Here, there is explicit statutory language and legislative history from which a court could conclude that AICOAs purpose is to prohibit anticompetitive results, regardless of motiveand thus to carve those claims out from Section 230. This result would apparently be statutorily required if another bill co-sponsored by Sen. Klobuchar becomes law: The SAFE TECH Act (S. 299) would amend Section 230 to exempt any action brought under Federal or State antitrust law.

Theres a lot more in the letter, but the point is clear. The idea that 230 will magically stop the abuse of this bill seems contradicted by the way the law is currently drafted, and actual cases on the books.

Filed Under: 1st amendment, aicoa, amy klobuchar, ben ray lujan, brian schatz, content moderation, david cicilline, ron wyden, section 230, tammy baldwin

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Do Not Expect Section 230 And The 1st Amendment To Save Antitrust Bills From Abuse - Techdirt

Judge rejects request by Boston cops to dismiss First Amendment action over the way they pepper sprayed and hit George Floyd protesters in 2020 -…

A federal judge ruled today that four people at a George Floyd vigil on the Common on May 31, 2020 can try to convince a jury that Boston Police officers violated their First Amendment rights by attacking them with pepper spray, fists and a bicycle afterwards and that the city created a culture where such a thing could happen.

Among other reasons to seek dismissal, the cops alleged they did not violate the protesters' First Amendment rights because they did not know the four were on Tremont Street because of the Common protest and so did not know they had a First Amendment right to be there.

That assertion "strains credulity," US District Court Judge Alison Burroughs wrote in a decision today that rejected requests by the cops and the city to reject the First Amendment and civil-rights allegations by the four protesters for what happened after police broke up the vigil and ordered nearby T stops shut, on a night that ended with violence and looting across downtown, the Back Bay and the South End.

Here, the chronology of events, the location of each incident, and all other surrounding circumstances, plainly allow for a reasonable inference that each of the Officer Defendants would have known the Plaintiffs were protestors and that they used force against them for that reason. ... Nothing in the record thus far, which includes photos of the Plaintiffs with their arms up and backing away from officers, provides a plausible non-retaliatory motive for the Officer Defendants use of physical force against the Plaintiffs. Further, because the uses of force against Ackers, Hall, and Chambers-Maher occurred while the officers were being openly recorded, it would be reasonable to infer that the civilians filming of the officers formed an unlawful retaliatory motive for the use of force. ... Put simply, the Officer Defendants argument that they could not have known that the Plaintiffs participated in the protest is untenable. Based on the record currently before the Court, it is evident that each one of these incidents occurred while the BPD was seeking to disperse protesters.

Burroughs added, however, that the officers will be able to better rebut the allegation than they have to date during pre-trial discovery and then at trial;

The point of discovery and then trial will be to sort out whether these particular uses of force did or did not implicate the First Amendment.

But, she continued:

Courts around the country, flooded with First Amendments claims pleaded on similar facts following the May 2020 protests, have agreed that the use of force against non-violent protestors can support the inference that officers meant to intimidate protestors and deter antipolice messaging.

Burroughs also allowed the four to continue their lawsuit against the city itself for allegedly creating an atmosphere that allowed and even encouraged misbehavior by police, in large part by ignoring complaints against officers in the past, but also through "a custom of using excessive force." But as she did with the police on the First Amendment issue, she cautioned the four protesters haven't really made a good, detailed case of this to date - something they will have to do at trial to win against the city.

To be sure, Plaintiffs support for this claim is presently thin, particularly since Plaintiffs have done little to link their allegations together to present a systemic pattern of persistent failure to discipline or investigate, but more is not required at the pleading stage. Plaintiffs have specifically articulated that the City knew constitutional violations occurred and either chose not to investigate or otherwise delayed or discouraged investigation. Taking Plaintiffs factual allegations as true and viewing the Amended Complaint in the light most favorable to Plaintiffs, the allegations allow for a reasonable inference that the City has a custom of failing to discipline police misconduct.

Burroughs continued:

The Amended Complaint contains numerous allegations that officers used OC spray, batons, and other physical force against the four Plaintiffs during the May 31 protest. Plaintiffs sufficiently allege, though just barely, that similar constitutional violations occurred on May 29, giving decisionmakers sufficient notice that officers would continue to use unreasonable force against peaceful protestors in the demonstrations to come. The City's argument that the allegations are not enough to support a Monell claim because they rest only on "one night of civil unrest" is unavailing. In addition to the fact that Plaintiffs have suggested that similar conduct occurred during demonstrations on surrounding days, "egregious instances of misconduct" even when "relatively few in number but following a common design, may support an inference that the instances would not occur but for municipal tolerance of the practice in question." Foley v. City of Lowell, 948 F.2d 10, 14 (1st Cir. 1991). ... Here, Plaintiffs describe four similar incidents of excessive force used against peaceful protesters. Further, Plaintiffs may not know, or cannot know, without discovery the full extent of the unreasonable force used by the City against protesters during the May 2020 protests. This Court, in line with several other district courts presented with similar facts, finds that Plaintiffs have sufficiently pleaded that the City had notice of the unlawful use of force against protestors and was deliberately indifferent to those constitutional violations.

She also pointed to a decision by Police Commissioner William Gross to have riot batons distributed to officers beforehand and to have nearby T stations shut as the vigil was dispersed as legitimate acts for a jury to consider whether BPD had a policy that led to the incidents:

Because three of the four Plaintiffs injuries occurred while they were trying to leave the protest area and some of the alleged injuries were caused by blows from riot batons, it can be reasonably inferred that Commissioner Grosss policy decisions led to the constitutional deprivations. ...

Plaintiffs will have to overcome significant issues of proof if they are to prevail at trial. Nonetheless, the Court finds that, at this stage, Plaintiffs have adequately pleaded municipal liability based on the role that City customs and policies allegedly played in the constitutional violations.

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Judge rejects request by Boston cops to dismiss First Amendment action over the way they pepper sprayed and hit George Floyd protesters in 2020 -...

The abortion apocalypse threatens the First Amendment, too – Arkansas Times

The U.S. Supreme Court threw womens rights under the bus yesterday and protests were instantaneous and large. See the Arkansas Capitol last night and you can also see a good crowd at Fayetteville in 40/29s tweet.

Thats good but only symbolic venting. Relief will be a long time coming, if ever.

Also concerning are other trappings of rule by minority that the Supreme Court reversal of Roe embodies along with the minority-favoring Electoral College, states rights only for gun laws with fascist approval, the end of voting rights, political gerrymandering and the end of government regulation (except for that of womens bodies).

Also: what about the First Amendment? There was violence last night. Against speech and assembly, theoretically protected by the First Amendment. Check out:

Arizona:

Or Los Angeles, where police declared an assembly unlawful and broke it up:

Or Cedar Rapids, where a truck drove into a crowd of demonstrators (the second truck-demonstrator collision in Iowa in a week):

And from Rhode Island (the cop has been suspended from duty)

And from a Virginia legislator:

We should be grateful that Secretary of State John Thurston didnt unleash teargas and non-lethal, face-breaking loads against the hundreds who gathered in Little Rock last night.

Count on the Arkansas legislature to join the assault on the First Amendment to further enhance Arkansass status as the most anti-woman state in the country. Interstate travel; advertising for abortion options; medication by mail; advice and financial support by Arkansans for Arkansas women? Expect them all to be under attack. And youll also soon see how empty the assurances were from the Supreme Court majority that same-sex relationships and marriage and contraception are not endangered by Fridays ruling. It provided a road map, as Clarence Thomas made clear, to erode those hard-won rights as well. Trust Kavanaugh or Barrett or Gorsuch not to go along with Thomas, Alito and Roberts on rolling back decisions they opposed? Even Susan Collins might not offer assurances on the next go-round.

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The abortion apocalypse threatens the First Amendment, too - Arkansas Times

Sports Illustrated Is Now A Bullhorn For Attacks On The First Amendment – The Federalist

Younger readers probably wont comprehend how important magazines like Sports Illustrated were in pre-internet culture. Most sports news wasfound in local papers and in short segments at 10 p.m. on the nightly news. Sports Illustrated was oftenthough, periodically, competition would pop upthe sole venue in which a sports fan could find deeply reported, well-crafted features and profiles, not to mention often-remarkable photography (the swimsuit issues, naturally, sold best). The magazines circulation hit around 3.5 million in the mid-1980s, with another million copies being bought on newsstands.

In my late 20s, I brieflyworkedfor the company (well, the website, which was then called CNN/SI.comperhaps a portend of terrible things to come), where I occasionally interacted with one of my writing heroes, Frank Deford. What a dream it was. I would have done it for free. I guess I almost did.

Ive largely ignored the magazine for the past decade or so, not for any philosophical reasons or any animosity, but with all the choices it simply fell off my radar. But after running across an astoundingly nonsensical pieceheadlinedWhen Faith and Football Teamed Up Against American Democracy, Im glad I did.

Ostensibly, the feature is about Kennedy v. Bremerton School District, a SCOTUS case regarding a school district punishing a football coach named Joseph Kennedy for a 30-second silent prayer on the 50-yard line after every game. The pieces subhead describes the case as so:

The U.S. Supreme Court will soon decide the case of a football coach at a public high school who was told he wasnt allowed to pray on the field in front of players. The expected result is a win for the coachand the further erosion of the separation between church and state.

In frontof players? Can you imagine? How will our brittle democracy survive an open display of religiosity? Greg Bishop, who could easily have written this piece for The Nation, offers no explanation of how a prayer is eroding separation of Church and State. Even this atheist, after all, understands that the Establishment Clause doesnt ban praying in public placesnot in schools, and not even in Congress, where prayers are recited before every session.

Bishop anoints Rachel Laser of Americans United for Separation of Church and State his proxy, allowing her to frame the debate over Kennedy in the most preposterously hyperbolic, partisan terms imaginable, even though the only thing her organization excels at is losing cases. The bad-faith retelling of Kennedys story is crammed with partisan platitudes about democracy being under attack on issues like voting rights, LGBTQ rights, and the potential overturning of Roe v. Wade.

Now, its unimaginable that a major publication would allow areporter to throw around phrases like voting integrity, religious freedom, and protecting the life of the unbornwithout quotation marks intimating that the ideas arent realand thats probably always been the case. Though the piece brings upRoethree times, no one explains how a court (concerned solely with the constitutionality of laws) is undermining democratic institutions by giving abortion rights, unmentioned in the Constitution, back to voters. Washington State, home of Bremerton High School, sadly, will not be restricting abortion any time soon.

In any event, Bishop also uses appeals to authority, tapping independent scholars or legal experts who hold no vested interest in the outcomeone of the only names offered isconspiracy theoristLaurence Tribe. He warns readers about the nefarious, big-money forces propping up Kennedy. First Liberty($7,255,961in assets), writes Bishop, is a powerful Christian conservative law firm, part of apowerful right-wing machinepowerfulis the key word herewhile Americans United for Separation of Church and State($11,141,577in assets, not counting in-kind contributions from places like the Meredith Corporation, which has $6.727 billion in assets), are simply terrified and transported to an alternate universe of disinformation and propagandaand, in that world, even democracy is in danger.

Disinformation? Its all just progressive mad libs. Thats what happens when democracy is a euphemism for achieving political ends in whatever fashion happens to be convenient. Sometimes, when the numbers are there, it means crass majoritarianism and centralized federal power; and when the numbers arent there, it can mean compulsion or a court dictating rights by fiat.

In this case, a school district, not the coach, is attempting to limit speech. There is no prohibition on praying in public institutions. Such a prohibition has never existed. Any scholarand Bishop claims to have spoken to many for the piecewho claims that the Constitutions authors would have found the act of kneeling after a competition perilous to foundational American ideals is a complete fraud. Then again, When Faith and Football Teamed Up Against American Democracy is a microcosm of the incurious activism that dominates journalism these days. Its one thing to put up with relentless bias thats infected virtually every area of mainstream culture, but another to see once-respected magazines putting out such banal, predictable propaganda.

Excerpt from:

Sports Illustrated Is Now A Bullhorn For Attacks On The First Amendment - The Federalist

Trump Plans to Appeal Dismissal of Twitter First Amendment Lawsuit in Ninth Circuit – Law & Crime

Former U.S. President Donald Trump gives the keynote address at the Faith & Freedom Coalition during their annual Road To Majority Policy Conference at the Gaylord Opryland Resort & Convention Center June 17, 2022 in Nashville, Tennessee.

Former PresidentDonald Trump has filed a notice that he will appealthe dismissal of his First Amendment lawsuit against Twitter, documents filed in appellate court reveal.

The 45th president and several additional plaintiffs including anti-vaccine advocates, COVID-19 misinformation spreaders, and conservative activists signaled their intent to appeal by filing a notice of appeal as well as a series of procedural exhibits in a Monday filing with the U.S. Court of Appeals for the Ninth Circuit.

In May of this year, the lawsuit was dismissed by U.S. District Judge James Donato, who found that the content moderation decisions made by Twitter in no way impacted the First Amendment because Twitter is not the government.

Plaintiffs main claim is that defendants have censor[ed] plaintiffs Twitter accounts in violation of their right to free speech under the First Amendment to the United States Constitution, the judge noted in an 18-page order. Plaintiffs are not starting from a position of strength. Twitter is a private company, and the First Amendment applies only to governmental abridgements of speech, and not to alleged abridgements by private companies.'

In an inline citation to case law, the opinion offers a basic distillation of First Amendment doctrine [emphasis in original]:

[T]he Free Speech Clause prohibits only governmental abridgement of speech. The Free Speech Clause does not prohibit private abridgment of speech.

The only possible way for Trump and the other plaintiffs to make a First Amendment claim against Twitter, Donato noted, was the narrowly-applied state action doctrine, which holds that government activity can be viewed as dominating a private activity to such an extent that its participants must be deemed to act with the authority of the government and, as a result, be subject to constitutional constraints. But that doctrine, the judge went on, is not an easy claim to make.

In response to Twitters eventually-granted motion to dismiss, Trump and the others plaintiffs were found not to have strongly argued that the state action doctrine actually applied to their case on the merits. Rather, the thrust of their argument, Donato noted, was a procedural pleading that the inquiry was too fact-intensive to be dealt with on a motion for summary judgment. The judge rejected that out of hand and then described Trumps pleaded facts.

From the May dismissal:

Twitter is said to have closed Mr. Trumps account because of the risk of further incitement of violence and threats to physical safety. Twitter closed plaintiff [Linda] Cuadross account due to a post about vaccines, and Dr. [Naomi] Wolfs account for vaccine misinformation; Plaintiff [Rafael] Barbozas account was closed after retweeting President Trump and other conservatives on January 6, 2021,; plaintiff [Dominick] Latella after he post[ed] positive messages about Republican candidates and President Trump, and plaintiff [Wayne Allen] Root for messages he posted related to COVID-19 and the 2020 election results.

If anything, these explanations indicate that Twitter acted in response to factors specific to each account, and not pursuant to a state rule of decision, the order granting Twitter motion to dismiss explained.

Trump and the others cited a handful of comments made by Democratic Party politicians to argue that the state was directing Twitters censorial moves, however, the judge noted, the comments of a handful of elected officials are a far cry from a rule that is actually being enforced by the state.

There is no way to allege with any degree of plausibility when, if ever, the comments voiced by a handful of members of Congress might become a law, or what changes such a law might impose on social media companies like Twitter, Donato went on.

The plaintiffs will soon have to re-litigate their theories of alleged state action in one of the nations traditionally most left-leaning and Free Speech-favoring appellate courts.

Substantive pleadings in the case stylized as Trump v. Twitter have yet to be filed.

The notice of appeal is available below:

[image via Seth Herald/Getty Images]

Have a tip we should know? [emailprotected]

The rest is here:

Trump Plans to Appeal Dismissal of Twitter First Amendment Lawsuit in Ninth Circuit - Law & Crime

Opinion | What Cassidy Hutchinson Said that Could Prove Trump’s Criminal Undoing – POLITICO

As Ive explained previously, it could be difficult to prove beyond a reasonable doubt that Trump had the corrupt state of mind needed to convict him, for example, of obstructing an official proceeding.

In addition, a prosecution of Trump for inciting violence would face a serious First Amendment hurdle. The Supreme Court has long held that only incitement to imminent unlawful action is sufficient. The speaker had to know that the crowd would immediately break the law.

Courts have routinely set this bar very high in the context of political speech because the First Amendment broadly protects speech of that type. A political statement by the president of the United States would be presumptively protected by the First Amendment.

But now we have Hutchinsons testimony that Trump said he didnt f---ing care that they have weapons. Theyre not here to hurt me and that they would be going to the Capitol later. This is precisely the sort of smoking gun evidence needed to prove that the person speaking meant to incite imminent violence.

The DOJ will understandably be concerned that the Supreme Court particularly the current court would find that Trumps speech was constitutionally protected by the First Amendment. But this evidence should be enough to make them at least consider an incitement prosecution. Before Hutchinsons testimony, an incitement prosecution would likely fail to clear the high First Amendment hurdle. Now, it is at least a close call and something DOJ should seriously consider.

And to be clear, Hutchinsons testimony would not be hearsay if offered by the DOJ at court against Trump. Statements by a party opponent are not considered hearsay, according to Federal Rule of Evidence 801(d)(2). In this case, Trump would be the DOJs party opponent in a criminal prosecution of Trump, and her testimony regarding Trumps statements could be used against him in court.

Hutchinson also provided testimony that gets DOJ closer to what they would need to prosecute Trump for obstructing an official proceeding. That charge requires corrupt intent. She testified that Trump tried to grab the steering wheel of his official vehicle (The Beast) when Secret Service agents refused to take him to the Capitol. She also testified that when an agent physically blocked Trump from seizing the wheel, Trump himself placed his hand on the agents clavicles, just under his neck.

Trumps failed attempt to go to the Capitol, in itself, would not be a criminal offense. But the episode inside The Beast would be powerful evidence of Trumps intent. Up until now, the picture that emerged of Trump was of someone who engaged in inaction while the Capitol was under attack, declining to call off his supporters or to call in police or troops. In itself, that is dereliction of duty, not a crime.

But episodes like trying to wrest the steering wheel show that Trump wanted to be at the Capitol and would have been there if he hadnt been kept from doing so. He wanted to be there, hands on, for the attack itself. That sheds a powerful light on his state of mind.

Juries are typically instructed to infer a defendants state of mind from his words and actions. In this situation, Trumps actions speak loudly, and they can be used as evidence of Trumps state of mind when he engaged in earlier actions.

Prosecutors will still need to put together a case that shows that Trump was involved in a conspiracy or scheme that obstructed the Jan. 6 certification proceeding. Thats not the simple task that many would have you believe. But its easier than establishing intent.

Hutchisons testimony is a game changer. Until now, the only readily provable crimes based on what is known publicly were potentially narrow criminal charges against crooked lawyers. Now it looks like an (otherwise unlikely) incitement prosecution is possible, and there may be the smoking gun needed for an obstruction charge.

The committee was smart to lock in public testimony from Hutchinson when it had the chance, given the potentially unlawful pressure against her to change her tune. Committee members have to hope that others follow in her footsteps. But they already have much of what they need.

Continued here:

Opinion | What Cassidy Hutchinson Said that Could Prove Trump's Criminal Undoing - POLITICO

EarthSky | Fate of SpaceX Starbase in Boca Chica soon

Parts of the Starship Heavy Lift Vehicle stand waiting at the SpaceX Starbase facility in Boca Chica, Texas. Expansion plans for the site have been frustrated by delayed approval from the Federal Aviation Administration (FAA). But that approval could come soon enough to allow a Starship test later this month. Image via Wikipedia.Delayed FAA report coming soon

The Federal Aviation Administration (FAA) said yesterday (Tuesday, May 31, 2022) that after multiple month-long delays it will soon release a key document related to the fate of SpaceXs Starbase in Boca Chica, Texas. The FAA said it has now set a date for publication of the final Programmatic Environmental Assessment (PEA) for the SpaceX Starship Super Heavy Launch Vehicle Program at Starbase. The final PEA should be available within two weeks. Its publication will be a major step forward in SpaceXs ability to launch Starship from the site, which is located near environmentally sensitive coastal wetlands.

The FAA said on Tuesday:

The FAA intended to release the Final PEA on May 31, 2022. The FAA now plans to release the Final PEA on June 13, 2022, to account for ongoing interagency consultations. A notice will be sent to individuals and organizations on the project distribution list when the Final PEA is available.

In early May, SpaceX president Gwynne Shotwell said she expects Starship will make its maiden orbital flight some time this summer. It could be as soon as this month, though that now seems unrealistic given the timing of the FAAs release of the PEA.

Still, Shotwell is optimistic, as reported by Bloomberg on May 5, 2022:

SpaceXs massive new Starship rocket designed to land NASA astronauts on the moon and eventually take humans to Mars will conduct a test flight from Texas in June or July, President Gwynne Shotwell said Thursday.

SpaceX has been awaiting regulatory approvals for launches from its site at Boca Chica, Texas, including an environmental assessment by the Federal Aviation Administration that has been delayed multiple times since December. Last week, the agency said its working to complete that review by the end of this month.

Shotwell, speaking at an engineering conference, didnt elaborate on how SpaceX established the latest plan. The timing marks another slip in the schedule for a rocket that company leaders have been aiming to launch since 2019. As recently as February, SpaceX founder Elon Musk said Starship could be ready to launch in May.

At the same conference, Shotwell stated again SpaceXs goal of putting human beings on Mars within this decade. She reiterated the interplanetary plan during an interview on CNBC on May 6, 2022.

In March, SpaceX CEO Elon Musk expressed hope the company could fly the Starship Heavy Lift Vehicle into orbit as soon as this month. Musks declaration coincided with the FAA receiving a favorable environmental report on SpaceXs plans to expand the Starbase launch facility in Boca Chica, Texas.

The tweet, which Musk posted March 21, 2022, described the extreme power of the companys new generation of rocket motors and announced enough units were completed to send Starship on a test flight out of Earths atmosphere:

Musks announcement came three weeks after the U.S. Department of the Interiors Fish and Wildlife Service sent the document to the FAA for review. It conducted a detailed 141-page environmental review of SpaceXs plans to expand launches in Texas. News that the draft BCO (Biological and Conference Opinion) was in the FAAs hands came via an exclusive report from the broadcast network CNBC, which obtained it through a Freedom of Information Act request.

The report deals mainly with a group of endangered species living on the Starbase property and in the coastal wetlands surrounding it. The area is home to two species of endangered wildcats, the ocelot and the jaguarundi. The northern Aplomado falcon; a pair of shorebirds, the piping plover and the red knot; and four species of sea turtles, the Kemps ridley, loggerhead, hawksbill, green and leatherback, also live in the area.

The Kemps ridley is the worlds rarest and most endangered sea turtle. Yet, risk to the Kemps ridley and other endangered species in the area can be mitigated by simple actions if expansion plans are approved, the report said. According to the Fish and Games cover letter for the BCO:

In the accompanying BCO, the Service determined that the action, as proposed, is not likely to jeopardize the continued existence of the species listed above. The action area encompasses a relative small portion of the rangewide habitat of each of the species addressed in this opinion and small portion of each species population.

Actions to lessen impacts on the at-risk species includes SpaceX-funded conservation of similar habitat elsewhere, fewer lights and less noise, monitoring how the species react to the upcoming changes and making sure anomalies in the form of crashed spacecraft and the resulting debris removal disturb the local wildlife as little as possible.

The species with the most to lose as SpaceX reaches for the moon and Mars is the piping plover. From the BCO:

The proposed action will result in the direct loss of 446.27 acres of piping plover habitat and critical habitat from construction and operation and the corresponding conversion of wind tidal flats. The proposed action will also result in an impact to 903.67 acres of occupied piping plover habitat and critical habitat in Critical Habitat Units TX-1.

The red knot also stands to see a large portion of its local habitat impacted by the proposed expansion. However, the 446.27 acres of red knot habitat that will be affected should be offset by Fish and Games plan to designate more than 680,000 acres elsewhere as critical habitat for the bird. The BCO describes a similar offset to protect the piper plover, which will see just 0.4 percent of its total habitat affected by SpaceXs plans.

Perhaps most concerning is the reports prediction of the impact to the extremely endangered Kemps ridley sea turtle, which could see the death of up to eight adults annually and the loss of three nests, along with as many as 330 hatchlings and eggs.

Either the FAA or the Fish and Game Service could initiate a new environmental review of the Starbase site at Boca Chica if certain conditions arise, chief among them being the death of too many individual animals from the various species listed in the BCO.

A renewed environmental review could also be started if new negative effects on the at-risk animals are discovered, if new species are discovered to be affected by SpaceXs operations or if the scope of review is modified in the future.

Should the number of endangered animals killed or harmed known as the take becomes too large, the controlling agencies will bring things to a halt. From the BCO:

In instances where the amount or extent of incidental take is exceeded, any operations causing such take must cease pending reinitiation.

Finally, the BCO could be the final biological report needed for SpaceX to fully begin upgrades at Starbase. From the BCOs closing pages:

If the Service determines there have been no significant changes in the action as planned or in the information used during the conference, the Service will confirm the conference opinion as the biological opinion for the project and no further section 7 consultation will be necessary.

Bottom line: SpaceXs Starbase in Boca Chica, Texas, has been waiting and waiting for an environmental assessment. The FAA says well have it in two weeks, around mid-June.

Award-winning reporter and editor Dave Adalian's love affair with the cosmos began during a long-ago summer school trip to the storied and venerable Lick Observatory atop California's Mount Hamilton, east of San Jose in the foggy Diablos Mountain Range and far above Monterey Bay at the edge of the endless blue Pacific Ocean. That field trip goes on today, as Dave still pursues his nocturnal adventures, perched in the darkness at his telescope's eyepiece or chasing wandering stars through the fields of night as a naked-eye observer.A lifelong resident of California's Tulare County - an agricultural paradise where the Great San Joaquin Valley meets the Sierra Nevada in endless miles of grass-covered foothills - Dave grew up in a wilderness larger than Delaware and Rhode Island combined, one choked with the greatest diversity of flora and fauna in the US, one which passes its nights beneath pitch black skies rising over the some of highest mountain peaks and greatest roadless areas on the North American continent.Dave studied English, American literature and mass communications at the College of the Sequoias and the University of California, Santa Barbara. He has worked as a reporter and editor for a number of news publications on- and offline during a career spanning nearly 30 years so far. His fondest literary hope is to share his passion for astronomy and all things cosmic with anyone who wants to join in the adventure and explore the universe's past, present and future.

Link:

EarthSky | Fate of SpaceX Starbase in Boca Chica soon

SpaceX: 5G expansion could kill US Starlink broadband – The Register

If the proposed addition of the 12GHz spectrum to 5G goes forward, Starlink broadband terminals across America could be crippled, or so SpaceX has complained.

The Elon Musk biz made the claim [PDF] this week in a filing to the FCC, which is considering allowing Dish to operate a 5G service in the 12GHz band (12.2-12.7GHz). This frequency range is also used by Starlink and others to provide over-the-air satellite internet connectivity.

SpaceX said its own in-house study, conducted in Las Vegas, showed "harmful interference from terrestrial mobile service to SpaceX's Starlink terminals more than 77 percent of the time, resulting in full outages 74 percent of the time." It also claimed the interference will extend to a minimum of 13 miles from base stations.In other words, if Dish gets to use these frequencies in the US, it'll render nearby Starlink terminals useless through wireless interference, it was claimed.

The rocket maker criticized a 2021 study that was submitted in favor of Dish to the regulator by RS Access, a group focused on bringing the 12GHz spectrum to 5G in the US. RS Access worked closely with Dish Networks, which is trying to expand into 5G service using the 12GHz band.

"The key technical question before the [Federal Communications Commission] is whether 5G operations can coexist with non-geostationary satellite orbit Fixed-Satellite Service (NGSO FSS) and Direct Broadcast Satellite (DBS) licensees in the band," RS Access concluded [PDF] in its report to the FCC.

By that, it means Starlink is the NGSO FSS; and Dish, which offers satellite TV, cellular plans, and more, is the DBS.RS Access's argument is that these two should be able to work alongside each other.

"The commission does not face a binary choice to either do nothing or sacrifice DBS and NGSO services in the 12GHz band," RS Access wrote. SpaceX's filing has no immediate effect on the proposals, and a debate over the rollout is ongoing.

Starlink also noted RS Access's report found that "only tens of thousands of Americans, which RS Access deems as negligible," would be affected by Dish's 12GHz expansion. "Yet, as the vast majority of comments about this submission have noted, the analysis is riddled with errors and faulty assumptions," it added.

The 5G for 12GHz Coalition, which includes Dish, RS Access, VMWare, and others, and is working with the FCC to see the proposals through, noted in a statement that "after 18 months and both a robust comment and reply period," SpaceX has finally submitted its response to the plans.

"Our engineers and technical experts are reviewing the filing in depth and remain committed to working in good faith with the FCC and stakeholders to ensure that the American public is able to reap the immense benefits of 5G services in this band," the coalition said.

Interestingly enough, in April 2021, the FCC approved a request by SpaceX to modify its license for operating Starlink satellites, a change that could potentially cause interference in the 12GHz range. Dish and RS Access both objected to the decision, which they said would compromise their 5G plans for the spectrum.

In that ruling, the FCC said it wasn't going to hold up the licensing decision because of the 12GHz proceedings, and added a caveat: "We condition this grant, subject to any modification necessary to bring it into conformance with future actions in commission rulemakings, including but not limited to the 12GHz proceeding Therefore, SpaceX proceeds at its own risk."

Starlink has a goal of providing internet to underserved locations, and by many accounts has done so. At the same time, thousands of Starlink satellites orbiting Earth are congesting the night sky so badly that AI models have been developed to help separate stars from Starlink kit blocking the view.

Read more here:

SpaceX: 5G expansion could kill US Starlink broadband - The Register