Cancer Rules Rewritten by Air Pollution Discovery

The team at the Francis Crick Institute in London showed that rather than causing damage, air pollution was waking up old damaged cells. One of the world’s leading experts, Prof Charles Swanton, said the breakthrough marked a “new era”. And it may now be possible to develop drugs that stop cancers forming. The findings could explain how hundreds of cancer-causing substances act on the body.

The classical view of cancer starts with a healthy cell. It acquires more and more mutations in its genetic code, or DNA, until it reaches a tipping point. Then it becomes a cancer and grows uncontrollably. But there are problems with this idea: cancerous mutations are found in seemingly healthy tissue, and many substances known to cause cancer – including air pollution – don’t seem to damage people’s DNA.

So what is going on?

The researchers who also work at University College London, have produced evidence of a different idea. The damage is already there in our cell’s DNA, picked up as we grow and age, but something needs to pull the trigger that actually makes it cancerous.

The discovery came from exploring why non-smokers get lung cancer. The overwhelming majority of lung cancers are caused by smoking but still, one in 10 cases in the UK is down to air pollution. The Crick scientists focused on a form of pollution called particulate matter 2.5 (known as PM2.5), which is far smaller than the diameter of a human hair.

Through a series of detailed human and animal experiments they showed:

  • Places with higher levels of air pollution had more lung cancers not caused by smoking
  • Breathing in PM2.5 leads to the release of a chemical alarm – interleukin-1-beta – in the lungs
  • This causes inflammation and activates cells in the lungs to help repair any damage
  • But around one in every 600,000 cells in the lungs of a 50-year-old already contains potentially cancerous mutations
  • These are acquired as we age but appear completely healthy until they are activated by the chemical alarm and become cancerous

Crucially, the researchers were able to stop cancers forming in mice exposed to air pollution by using a drug that blocks the alarm signal. The results are a double breakthrough, both for understanding the impact of air pollution and the fundamentals of how we get cancer.

Dr Emilia Lim, one of the researchers who is based at the Crick and UCL, said people who had never smoked but developed lung cancer often had no idea why. “To give them some clues about how this might work is really, really important,” she said. “It’s super-important – 99% of people in the world live in places where air pollution exceeds the WHO guidelines so it really impacts all of us.”

Rethinking cancer

But the results also showed mutations alone are not always enough to cause cancer. It can need an extra element. Prof Swanton said this was the most exciting finding his lab had come across, as it “actually rethinks our understanding of how tumours are initiated”. He said it would lead to a “new era” of molecular cancer prevention.

The idea of taking a cancer-blocking pill if you live in a heavily polluted area is not completely fanciful. Doctors have already trialled an interleukin-1-beta drug in cardiovascular disease and found, by complete accident, they cut the risk of lung cancer. The latest findings are being presented to scientists at a conference of the European Society for Medical Oncology.

Speaking to the BBC from the conference, Prof Swanton said: “Pollution is a lovely example, but there are going to be 200 other examples of this over the next 10 years.”

And he said we needed to rethink how even smoking causes cancer – is it just the known DNA damage caused by the chemicals in tobacco or is the smoke causing inflammation, too? Curiously, the idea that mutated DNA is not enough and cancers need another trigger to grow was first proposed by scientist Isaac Berenblum in 1947.

“Philosophically, it’s fascinating. These incredible biologists have done this work 75 years ago and it’s largely been ignored,” said Dr Lim. Michelle Mitchell, chief executive of Cancer Research UK, stressed that “smoking remains the biggest cause of lung cancer”.

But she added: “Science, which takes years of painstaking work, is changing our thinking around how cancer develops. We now have a much better understanding of the driving forces behind lung cancer.”

By: James Gallagher

Source: Cancer rules rewritten by air-pollution discovery – BBC News

Critics by ESMO

A new mechanism has been identified through which very small pollutant particles in the air may trigger lung cancer in people who have never smoked, paving the way to new prevention approaches and development of therapies, according to late-breaking data [to be] reported at the ESMO Congress 2022 by scientists of the Francis Crick Institute and University College London, funded by Cancer Research UK.

The particles, which are typically found in vehicle exhaust and smoke from fossil fuels, are associated with non-small cell lung cancer (NSCLC) risk, accounting for over 250,000 lung cancer deaths globally per year. “The same particles in the air that derive from the combustion of fossil fuels, exacerbating climate change, are directly impacting human health via an important and previously overlooked cancer-causing mechanism in lung cells.

The risk of lung cancer from air pollution is lower than from smoking, but we have no control over what we all breathe. Globally, more people are exposed to unsafe levels of air pollution than to toxic chemicals in cigarette smoke, and these new data link the importance of addressing climate health to improving human health,” said Charles Swanton, the Francis Crick Institute and Cancer Research UK Chief Clinician, London, UK, who will present the research results at the ESMO 2022 Presidential Symposium on Saturday, 10 September.

The new findings are based on human and laboratory research on mutations in a gene called EGFR which are seen in about half of people with lung cancer who have never smoked. In a study of nearly half a million people living in England, South Korea and Taiwan, exposure to increasing concentrations of airborne particulate matter (PM) 2.5 micrometres (μm) in diameter was linked to increased risk of NSCLC with EGFR mutations.

In the laboratory studies, the  Francis Crick Institute scientists showed that the same pollutant particles (PM2.5) promoted rapid changes in airway cells which had mutations in EGFR and in another gene linked to lung cancer called KRAS, driving them towards a cancer stem cell like state. They also found that air pollution drives the influx of macrophages which release the inflammatory mediator, interleukin-1β, driving the expansion of cells with the EGFR mutations in response to exposure to PM2.5, and that blockade of interleukin-1β inhibited lung cancer initiation.

These findings were consistent with data from a previous large clinical trial showing a dose dependent reduction in lung cancer incidence when people were treated with the anti-IL1β antibody, canakinumab. In a final series of experiments, the Francis Crick team used state-of-the-art, ultradeep mutational profiling of small samples of normal lung tissue and found EGFR and KRAS driver mutations in 18% and 33% of normal lung samples, respectively.

“We found that driver mutations in EGFR and KRAS genes, commonly found in lung cancers, are actually present in normal lung tissue and are a likely consequence of ageing. In our research, these mutations alone only weakly potentiated cancer in laboratory models. However, when lung cells with these mutations were exposed to air pollutants, we saw more cancers and these occurred more quickly than when lung cells with these mutations were not exposed to pollutants, suggesting that air pollution promotes the initiation of lung cancer in cells harbouring driver gene mutations.

The next step is to discover why some lung cells with mutations become cancerous when exposed to pollutants while others don’t,” said Swanton. Commenting on the results, Tony Mok, Chinese University of Hong Kong, not involved in the study, said: “This research is intriguing and exciting as it means that we can ask whether, in the future, it will be possible to use lung scans to look for pre-cancerous lesions in the lungs and try to reverse them with medicines such as interleukin-1β inhibitors.

We don’t yet know whether it will be possible to use highly sensitive EGFR profiling on blood or other samples to find non-smokers who are predisposed to lung cancer and may benefit from lung scanning, so discussions are still very speculative.” Like Swanton, he stresses the importance of reducing air pollution to lower the risk of lung diseases, including cancer.

“We have known about the link between pollution and lung cancer for a long time, and we now have a possible explanation for it. As consumption of fossil fuels goes hand in hand with pollution and carbon emissions, we have a strong mandate for tackling these issues – for both environmental and health reasons,” Mok concluded.

Related contents:

Legal Agreement Spurs EPA to Take Stronger Steps to Reduce Smog Pollution in Areas of Five States With Some of Nation’s … Center for Biological Diversity (Press Release)

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A New Generation of Weight Loss Drugs Makes Bold Promises, But Who Really Wins

In the months after having her second child, Sarah found herself fed up. The 40-year-old Seattle resident was cutting carbs and sugar, and exercising regularly, but couldn’t seem to shed the pounds she had put on during pregnancy. So when an email newsletter mentioned a new weight-loss drug called Wegovy, Sarah decided to give it a try. Eight months later, she is out more than $10,000—and down more than 60 lbs.

“Wegovy made losing weight almost effortless,” Sarah, whose name has been changed to protect her identity, told Quartz. “I’m not hungry often anymore and it doesn’t take any willpower to eat less. I simply don’t have any desire to overeat.”

Sarah is one of 125,000 US-based patients now taking Wegovy (whose generic name is semaglutide), a member of a new class of weight-loss drugs. These drugs work differently than the appetite suppressants popular among previous generations of dieters. They are also hitting the market at a different moment: one in which people are more eager than ever for realistic, science-based methods for addressing excess weight, even as a growing faction of activists and doctors voice skepticism of weight as an accurate measure of health.

A new class of weight-loss drug

In the mid-1990s, experiments on Gila monster venom found it contained hormones that could help lower blood sugar. That led to the diabetes drug Ozempic, which ultimately went on the market in 2018. People on that drug discovered a funny side effect: They lost weight.

In 2021, that same compound was approved by the US Food and Drug Administration (FDA) under the name Wegovy for the express purpose of weight loss. Drugs like Wegovy work in more complex ways than simply suppressing appetite, and promise fewer (though not zero) side effects.

Like Wegovy, many of these drugs were originally approved for other conditions; liraglutide (brand name Saxenda for weight loss) was also originally approved as a diabetes drug (Victoza). In fact, semaglutide and liraglutide work similarly in the body: They’re known as GLP-1 receptor agonists because they activate receptors for the glucagon-like peptide-1 (GLP-1) hormone, reducing appetite by slowing digestion and the rate at which the body takes up glucose.

Perhaps most important, the new drug promise significant weight loss. “The previous weight loss drugs were just modestly effective,” says John Buse, an endocrinologist at the University of North Carolina School of Medicine. The average patient would lose 5% of their body weight, in some cases up to 8%. But with semaglutide, he says, “we’ve gotten the kind of weight loss that makes people pay attention: 10-15% of body weight. That’s the average weight loss—half of people are losing more than that. It’s a gamechanger in the conversation…now that we have medicines for which a substantial proportion of patients can expect to lose 30 to 50 lbs.”

In one 68-week pre-approval clinical trial, patients on Wegovy did indeed lose 14.9% of their body weight on average, compared with 2.4% for people on a placebo. (Although, as several writers and scholars have pointed out, the study was funded by Novo Nordisk, which makes Wegovy.) Given the average weight of trial participants—100 kg, or 220 lbs.—that meant weight loss of about 15 kg, or 33 lbs. Other drugs in development have had similar results. In a recent trial for one called tirzepatide from Eli Lilly, more than half of patients lost at least 20% of their body weight—50 lbs. in many cases.

What it takes to lose weight

This new class of drugs is entering a market that at first glance seems ripe for breakthrough. According to the US Centers for Disease Control and Prevention (CDC), 42% of Americans—70 million people—meet the criteria for obesity (having a BMI of 30 or more). At one point or another, most of those people will try a diet and exercise regimen to lose weight.

But a growing body of research shows that diets are not an effective way to lose weight and keep it off. “Obesity is a complex disease… ​for most people, lifestyle modifications, diet, and exercise are just not enough,” says Katherine Saunders, a doctor at the Comprehensive Weight Control Center at Weill Cornell Medicine and co-founder of Intellihealth, an app-based platform that brings evidence-based obesity treatment to patients.

In part because of that complexity, bariatric surgery has since 2009 been considered the standard of care for patients looking to lose a substantial amount of weight. But these procedures can be invasive and expensive, and can come with significant and long-lasting complications.

The dearth of other options leaves some patients and doctors excited about this new generation of drugs. “Right now, the field is really looking for more efficacy, number one. People will do almost anything to lose weight,” says Buse. “We have more than just surgery now for promoting substantial weight loss. The most exciting thing is that obesity is on the ropes.”

A complicated picture

While hopes are high, the realities of taking these drugs can be more complicated for patients. There are often side effects—the most common for semaglutide and liraglutide are diarrhea, vomiting, and nausea. On Wegovy, Sarah says she’s experienced diarrhea so severe that a few times she had to delay her next dose.

Physicians can sometimes gloss over or downplay those effects. But a visit to dedicated Reddit pages for these drugs shows whole communities of patients struggling to adhere to the regimen when they’re feeling sick, and seeking support from a community to understand whether what seems like a severe reaction is normal. (Novo Nordisk did not respond to a request for comment.)

How well a patient can tolerate a drug “is something we think about quite a lot,” Saunders says. “We always start with lower doses and increase gradually as tolerated. Everyone is different. We keep in close touch with the patient and monitor them closely.”

And while these new drugs are relatively well-studied, there are still unknowns. They seem to help patients keep weight off more reliably than diet and exercise alone, but those benefits fade after people stop taking the drugs, and patients do often regain weight. There are also questions about long-term effects. In 1997, weight loss drug fenfluramine/phentermine (fen-phen) was pulled off the market after it was found to cause heart problems. More recently, Belviq (lorcaserin), which the FDA approved for weight loss in 2012, was pulled from the US market in 2020 because long-term use was found to increase the incidence of various types of cancers.

Even if a patient does want to go on one of these drugs, she might not be able to. Many patients keen to try Wegovy can’t access it at the moment, due to a supply chain issue that its manufacturer doesn’t expect to resolve until later this year. Even then, most US health insurers, including Medicare, do not cover drugs like Wegovy, and paying out of pocket can cost thousands of dollars per month. After Sarah’s doctor told her she doesn’t prescribe Wegovy, Sarah secured a prescription through an online health provider; she pays for it out of pocket.

The lack of insurance coverage is in spite of the fact that the American Medical Association declared obesity to be a disease in 2013. “The conversation around insurance coverage needs to be had with insurance companies, but also with employers,” says Kimberly Gudzune, the medical director for the American Board of Obesity Medicine. “It needs to be seen as an investment in your workforce.” The Treat and Reduce Obesity Act, which would expand Medicare to include obesity treatments, has been introduced to US Congress every year since 2012, but has never passed.

America’s love/hate relationship with weight

Though excess body fat was once considered a sign of wealth or fertility, over the past century a stigma has developed against larger bodies. Today doctors associate excess weight with medical conditions like heart disease, cancer, type 2 diabetes, sleep apnea, osteoarthritis, and depression. Studies also show that life is harder when you move through the world in a larger body. Fat people are less likely to be hired for a job, are paid less, are less likely to get married, and are less likely to be happy (though not if they’re living around other fat people). One 2006 study found that 46% of respondents would rather give up one year of life than be obese; 5% said they’d rather lose a limb.

The current state of research makes it impossible to unravel the full complexity of weight and health, but the conversation is starting to accommodate more nuance. Ubiquitous metrics such as body mass index are increasingly understood to be unreliable indicators (though doctors often still use them), and even the language around larger bodies is under review. Many physicians use “obese” to describe people who have excess weight or a BMI over 30, but activists are shying away from the word. “The reason…we are reluctant to use the words ‘overweight’ and ‘obesity’ is that they are made up, they can change,” says Tigress Osborn, a fat activist and chair of the National Association to Advance Fat Acceptance.

In fact, some research suggests that fat may have a protective effect on the body. “The body’s weight-regulating mechanism is about survival. It’s a system with more moving parts than we understand,” says Marilyn Wann, a fat activist and author of the book Fat!So? “Trying to remove weight from an individual or from the population is like trying to take a sledgehammer to the weather—we don’t know the unintended negative consequences we’re going to create.”

There are signs that in the future physicians may be more accepting of bodies of different sizes. But as weight loss drugs get more effective and more available, those cultural gains for body positivity (or body neutrality, or fat acceptance) may also be called into question.

A new relationship between doctors and patients

Overweight patients who come to see Shelly Crane might have an experience they’ve never had before. “I don’t initiate a weight-loss conversation with a patient,” says Crane, a family physician at Advocate Aurora Health in Milwaukee, Wisconsin. Most weight-loss programs come with more risk of harm than good, she says, and there’s not enough evidence that people who do lose weight are healthier in the end.

Crane doesn’t regularly prescribe new drugs for weight loss, though she says more patients are coming in and asking for them lately. Instead, she prefers to keep conversations focused on goals of care. “Patients say, ‘I know I need to lose weight,’ and I say, ‘Why do you think you need to lose weight? What would change in your life if your weight was lower?’” That gives her an opening to talk about health more broadly—how is the patient’s sleep? Their diet? Their mobility? “I try to stay in my sphere of what I’m able to do as a family doctor and really address the root of the health issue as much as I can.”

Crane was drawn to this approach by listening to her patients talk about experiencing size discrimination, and by following the work of fat activists such as Ragen Chastain and Aubrey Gordon. Though she’s been trained in a more integrative style of medicine, her approach toward body acceptance was also shaped by her discovery of intuitive eating during medical school. Since then, she’s been working on deprogramming herself and her colleagues from anti-fat bias.

Crane is part of a burgeoning movement among doctors to improve the treatment of larger patients. For some, that means skipping the dreaded weigh-in, a practice that is somewhat controversial within medicine. Medical organizations like the Association of American Medical Colleges also offer guidelines to reduce anti-fat bias among clinicians.

For doctors, the updated approach at least engenders trust, which can in turn get patients to seek medical care more frequently and improve their overall health. At most, it broadens the definition of what “healthy” means, and looks like.

Some fat activists see this shift as an important step. “The thing we hear most often from the public is, ‘I thought I had this thing, but all the doctor wanted to talk to me about is weight loss, and now the thing is worse,’” Osborn says. “It’s progress to have people in the medical establishment recognizing that there are other healthcare concerns besides weight, if weight is a healthcare concern.”

The hope is that this evolution continues. Activists want more people, in the medical profession and outside of it, to respect their autonomy. That becomes even more pressing in a possible future filled with weight-loss drugs—a future where a person can simply take a drug and stop being fat. “The ease with which I could become smaller—why should I? That should be up to me. Just like, if you believe it’s a medical disorder, the treatment I choose should be up to me,” Osborn says. “Like with anything else, if you believe fat is a disorder, we should let people decide whether people will get treated or not.”

“Fatness isn’t a problem to be solved in and of itself. It is not the root cause of all ills, as much as [medicine] would like to think it is,” Crane says. “We can help people live full, rich lives when we focus on goals of care and not on weight.”

By Alexandra Ossola

Source: A new generation of weight loss drugs makes bold promises, but who really wins? — Quartz

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Restricting Calories Leads To Weight Loss, Not Necessarily The Window of Time You Eat Them In

1

Results of a new weight loss study were published this week, leading to headlines proclaiming intermittent fasting “isn’t a magic diet trick after all”.The researchers aimed to test whether adding a restriction on what time of day you were allowed to eat (or not) to the usual low calorie (or kilojoule) diet led to greater weight loss compared to just following a low calorie diet. They recruited 139 adults whose average weight was 88 kilograms and age 32 years.

The participants were randomised to follow either the low calorie diet that had reduced their usual daily energy intake by 25%, or the same low calorie diet with the addition of a time period during which they were allowed to eat in an eight-hour window between 8am and 4pm each day.This approach is called “time-restricted eating” or a “16-hour intermittent fast”. Both groups received support from health coaches to follow their diets for 12 months.

Results showed that after one year, people in both groups lost 7-10% of their baseline body weight. While the low calorie group lost an average of 6.3 kilograms, the low calorie plus time restricted eating group lost 8 kilograms. Although there was a 1.8 kilogram difference between the groups, it was not a statistically significant difference.

Participants in both groups also had better blood sugar and blood fat levels and improved insulin sensitivity, but again there was no significant differences between groups.

1. It wasn’t based in the US

Most intermittent fasting studies have been conducted in the United States. This trial was done in China and recruited people in Guangzhou, so it provides important data using a culturally sensitive, prescribed calorie restriction over 12 months.

2. It showed small extra time restrictions on eating don’t make much difference

In their normal lives, the participants in Guangzhou had a usual window for daily eating of about 10.5 hours. Studies in other populations, particularly the US, show about 90% of adults have an eating window of 12 hours, with only 10% of adults having an overnight fasting period greater than 12 hours.

For more than 50% of people in countries like the US, the overnight fast is less than nine hours, meaning they eat over a 15 hour time period each day. So in the current study, the time restriction on eating was only minor – at about two hours less per day than what’s usual for people in China. This would not have been too big a difference from usual.

The researchers also reported that in China, the biggest meal is usually eaten in the middle of the day, so that was not influenced by the time restriction. In countries where the evening meal is the biggest or people snack all evening, then time restriction may still be a beneficial way to reduce intake.

A 2020 review of 19 studies that used time-restricted intermittent fasting found it was an effective treatment for adults with obesity, leading to greater loss of body weight and body fat, with significantly lower systolic blood pressure and blood glucose.

3. It showed support is imperative

Both groups in this trial were given a lot of support to adhere to the kilojoule-restricted diet. They were provided with one meal replacement shake per day for the first six months, to make it easier to follow the kilojoule restriction and help improve adherence to the diet.

They also received dietary counselling from trained health coaches for the 12 months of the trial. They received dietary information booklets that included advice on portion size and sample menus. They were encouraged to weigh foods to improve their accuracy in reporting kilojoule intakes and were required to keep a daily log with photographs of foods eaten and the time, using the study app.

They also received follow-up calls or app messages twice a week and met with the health coach individually every two weeks for the first six months. In the second six months, they continued to fill out their dietary records for three days per week and received weekly follow-up telephone calls and app messages and met with a health coach monthly. They also attended monthly health-education sessions.

This was a lot of support and is very important. Receiving long-term support to achieve health behaviour changes typically achieves a weight loss of 3–5% of body weight, which significantly lowers risk of weight-related health conditions, including a 50% lower risk of developing type 2 diabetes over eight years.

4. Even with good adherence, individual weight loss varies

Individual weight loss responses were very variable, even though adherence was high in this trial.

About 84% of participants adhered to the prescribed daily calorie targets and time restricted eating period. Weight loss at 12 months varied from 7.8 to 4.7 kilograms in the low calorie only group, and 9.6 to 6.4 kilograms in the low calorie plus time-restricted eating group.

As we have seen many times previously, this study confirms there is no one best diet for weight loss. It also shows small decreases in the window of time you’re eating probably won’t make a difference to weight loss.

By:

Laureate Professor in Nutrition and Dietetics, University of Newcastle

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Scientists are Studying Blood Tests For Dementia

As pharmaceutical companies spend hundreds of millions of dollars on a potential treatment for Alzheimer’s disease, other researchers are focusing on a more elemental question. How can you tell whether a family member or loved one has Alzheimer’s or another form of dementia?

These researchers say a new generation of blood tests could offer an easier and accurate way to detect signs of Alzheimer’s, a disease that afflicts an estimated 6.5 million Americans. New research found one blood test can detect hallmarks of the disease in older adults with memory problems. It is among more than a half dozen blood tests being developed and tested to detect early stages of Alzheimer’s disease.

Experts say the tests are important because they would be easier, cheaper and available to more people than brain scans or spinal taps now used to detect biological hallmarks of the disease.

Developers of blood tests say the immediate payoff would be testing older adults with signs of memory loss as well as quickly screening large numbers of people necessary to test new drugs that aim to slow or halt Alzheimer’s disease. Eventually, the tests might be useful in detecting the earliest signs of disease, informing individuals of their risk years before memory and thinking problems take root.

Blood tests represent “a very early start to a new era of diagnosis for Alzheimer’s disease,” said Stephen Salloway, a professor of neurology and psychiatry at Brown University who directs a memory and aging program at Butler Hospital in Providence, Rhode Island. “I see them as being transformative for Alzheimer’s, because once we validate them a little bit further, and hopefully get coverage for them, we can use them both to screen for clinical trials and to screen for treatment.”

Diagnosing the disease is time-consuming and inaccessible to those who live far away from memory clinics or other specialists. Doctors might quiz a patient or family members about habits, changes in behavior or personality. Specialists conduct memory and cognitive tests and rule out other potential causes such as depression. Brain scans and spinal taps confirm biological signs of the disease.

One blood test, called the PrecivityAD test, which uses a technology called mass spectrometry, measures amyloid proteins and genetic risk for the disease. In two studies published April 21 in Journal of the American Medical Association Open, the test accurately detected the protein amyloid in 81% of samples when compared with a brain scan.

Amyloid accumulates and forms clumps in the brains of Alzheimer’s disease patients. Researchers and drug companies have spent hundreds of million of dollars over the past two decades on the theory that drugs clearing amyloid from the brain could slow memory decline, but those drugs have not proven to halt Alzheimer’s disease.

Other drug studies are now underway to administer amyloid-targeting drugs even earlier, before memory and thinking problems emerge. C2N Diagnostics CEO Joel Braunstein said the peer-reviewed study is an important step for doctors who want to see more evidence before recommending his company’s test to patients with memory and cognitive problems.

“Clinicians like to see evidence that a test works,” Braunstein said. “This was an important step forward because of the transparency of the scientific findings.”

The test, which has been available since 2020, is now mostly used to accelerate research for new drugs being studied to slow cognitive decline and memory loss in people with Alzheimer’s disease or other forms of dementia. Braunstein believes more doctors will be willing to recommend the test as they grow comfortable from findings in the studies.

Blood tests promise quicker, cheaper diagnosis

Scans and spinal taps now used can be invasive and don’t work for all patients. For example, people who are on blood-thinning medication might not be able to get a spinal tap, Salloway said. In such cases, a validated blood test would be suitable replacement.

Blood tests also might be more affordable than positron emission tomography, or PET scans, which cost consumers $3,000 out of pocket, according to the Alzheimer’s Association. Hospitals charge for administering a PET scan, which includes special chemical tracers to reveal the amyloid. Consumers also can expect a bill from an imaging specialist who interprets the results to verify whether a patient has amyloid.

The PrecivityAD test, which is not yet covered by Medicare or private insurers, costs $1,250. The company offers financial assistance for eligible consumers, Braunstein said, while it is “making progress” in efforts to get Medicare and private insurers to pay for the test.

The company is allowed to market the test under Food and Drug Administration rules because it’s performed at the company’s lab, which is certified under the Clinical Laboratory Improvement Amendments, the federal laboratory law known as CLIA. Doctors or testing sites ship samples to the lab and the company completes the test within 10 days, Braunstein said.

Braunstein said the company’s lab has the capacity to handle tests performed within the United States and Canada. As the company seeks to offer the test overseas, it probably will partner with other labs that can perform the intricate measurements the test requires.

Another blood test developed by Eli Lilly detected signs of Alzheimer’s disease 20 years before cognitive problems were expected in a group of people who carry a rare genetic mutation, according to a study published in 2020 in JAMA. The p-tau217 test measured the tau protein on more than 1,400 people already enrolled in dementia studies in Sweden, Arizona and Colombia.

Eli Lilly used the test during a 257-patient Phase 2 study of its Alzheimer’s drug called donanemab. The drugmaker also will use the test to screen people for a prevention trial to test donanemab in at-risk patients who have not yet exhibited memory and thinking problems. Lilly plans to send mobile units to communities and use the test to screen people, which would expand the company’s efforts to recruit patients from diverse populations, a Lilly spokeswoman said.

Quest Diagnostics, a national lab company, launched a new blood test in March that measures two amyloid variants, a Quest spokeswoman said.

Advocacy organizations would like to see tests that are simple, inexpensive and accessible to doctors and their patients, said Heather Snyder, vice president of medical and scientific relations at the Alzheimer’s Association.

“We ultimately want to be at a place where we can identify an individual at the earliest possible point who may be at the greatest risk and may have initial changes associated with the disease,” Snyder said.

She said it’s important for the field to have “a toolbox of potential interventions” such as medications or lifestyle changes “that would allow us to stop or slow the progression of the underlying biology at that time.”

In 2021, the Food and Drug Administration approved Biogen’s Aduhelm, a $28,000-a-year drug that yielded mixed results in clinical trials, even though the agency’s own experts suggested the agency reject the application. The agency that oversees Medicare decided to pay for the drug only in clinical trials.

Aduhelm is part of class of Alzheimer’s drugs known as monoclonal antibodies, several of which could soon land before FDA decision-makers. Lilly expects to submit donanemab, a monoclonal antibody, for approval later this year. Roche’s Genentech has studied two Alzheimer’s drugs, gantenerumab and crenezumab, in late-stage clinical trials.

By:

Source: Scientists are studying blood tests for dementia: ‘A new era of diagnosis for Alzheimer’s disease’

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More contents:

As Medication Abortion Becomes Dominant, Red States Restrict Pills

The abortion drug mifepristone was approved by the FDA more than 20 years ago. The FDA recently relaxed some of the rules for dispensing the drug. Now, some legislatures are trying to restrict access.

For most of the almost 50 years since the Roe v Wade Supreme Court decision legalized abortion nationwide, clinics have been the focus of the battle over abortion rights.

Protesters gather outside on sidewalks. And Republican state lawmakers try to regulate what happens inside — through laws restricting which healthcare providers can perform abortions, the kind of counseling required and which procedures are allowed.

But now, more than half of abortions are taking place with pills.

According to data released by Guttmacher earlier this year, abortion pills – not surgical procedures – accounted for 54 percent of abortions in 2020. That makes medication abortion the dominant choice in the United States for the first time since the Food and Drug Administration approved an abortion pill, mifepristone, more than 20 years ago. It’s part of a two-drug protocol approved to terminate pregnancies up to 10 weeks gestation. That protocol also is prescribed to manage some miscarriages.

During the pandemic, the FDA relaxed rules so that the tightly regulated drug mifepristone could be obtained through telehealth appointments and mail-order pharmacies, rather than in person. That made it easier for patients in some states to get a medication abortion at home. The Biden administration recently made those changes permanent.

Now, Republican lawmakers in several states are pushing back. In South Dakota, Gov. Kristi Noem recently signed legislation designed to restrict access to the drugs.

Already, more than a dozen states restrict limit the use of telemedicine to provide abortion pills. And this year, Planned Parenthood says new restrictions have been introduced in two dozen states, some of which would ban the pills altogether if Roe v Wade is overturned.

In Georgia, Republican state Sen. Bruce Thompson sponsored SB 456, a bill banning abortion pill delivery by mail and requiring doctors to examine patients in person before prescribing them. During floor debate, Thompson said his bill was intended “to protect the cherished doctor-patient relationship.”

But that position is at odds with that of major medical groups, including the American College of Obstetricians and Gynecologists and the American Medical Association, who’ve long supported easing access to the pills and called for lifting the in-person dispensing requirement.

Thompson opposes abortion rights, but he claims this bill is all about patient safety.

“Why would we not do everything within our power to protect women’s health and safety during this difficult time in their lives?” he said.

But opponents say the bill would make patients less safe. Several lawmakers noted that Georgia is among the states with the highest rates of maternal mortality – and that those death rates are dramatically higher for Black women.

State Sen. Kim Jackson, a Democrat, noted that many people, particularly in rural areas, lack access to pregnancy care.

“What’s really cruel about this bill is that those who are already the most vulnerable are the ones who are most likely to be burned by this injustice,” Jackson said. “People who are poor, people who live in rural communities. People with disabilities, and people of color.”

The bill passed Georgia’s state senate on March 1 and is awaiting a vote in the House.

“As soon as the FDA made medication abortion more accessible, Georgia pretty much turned around and was like, ‘No, we actually want to make it really difficult for people to get one,'” said K. Agbebiyi, a Georgia-based advocate with the reproductive rights group URGE, which is fighting the bill.

Agbebiyi said medication abortion could become the only option for a growing number of people in states where clinics are few and far between because of abortion restrictions.

“We know, and our opponents know, that medication abortion is going to grow in popularity if Roe is overturned,” Agbebiyi said. “And that’s precisely why they’re trying to put as many barriers in place as possible.”

It’s more difficult to put up barriers on the internet, where abortion pills are available through mail-order pharmacies and other groups.

Ushma Upadhyay, a reproductive health researcher at the University of California, San Francisco, warned that if states try to block access to abortion pills, patients will find them online without a doctor’s help.

“That is what I’m concerned about,” she said. “It is extremely safe, but all patients should have the access to clinical support if they need it, if they have questions about how to take it, or whether what’s happening is normal.”

Meanwhile, some states are trying to make access to medication abortion easier. A bill moving forward in Delaware would allow a wider array of healthcare providers to prescribe the pills to their patients.

By:

Source: Republican state lawmakers are working to restrict access to abortion pills. : NPR

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Critics:

By: Shefali Luthra

“Medication abortion is the existential threat of the anti-abortion movement,” said Greer Donley, an assistant professor at the University of Pittsburgh Law School who specializes in laws surrounding medication abortion access. When they’re on the precipice of getting the Supreme Court to overturn Roe v. Wade, there’s a technological advance that has made it impossible to control abortions.” 

Texas, which is so far the only state that has ended access to abortions after six weeks of pregnancy, provides some insight. The number of Texans receiving abortions has only fallen somewhat — a far larger number of people are now making journeys out of state or ordering medication abortion pills online from the European nonprofit Aid Access, which operates outside the U.S. health care system but has worked to provide Americans with telemedicine-based medication abortions since 2018.

In a post-Roe world, the options would likely look different. With more states banning or severely restricting abortion access, travel likely poses a greater burden, especially for people who live where neighboring states also have legislatures that have restricted access. But health care providers in states where abortion rights are protected could, under the new FDA guidance, could potentially prescribe pills through a phone call or video-chat and mail them to people in other states.

There are accessibility questions. Not everyone has sufficient internet access to find a virtual provider, noted Abigail Aiken, an associate professor at the University of Texas at Austin who has studied the Texas law’s impact on medication abortion requests. And not everyone knows about services like Aid Access or other ways to navigate the health care system and find an out-of-state provider.

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The Coronavirus Crisis

More Patients Seek Abortion Pills Online During Pandemic, But Face Restrictions

Consider This from NPR

The New Texas Abortion Law Is Putting Some Patients In Danger

National

With Abortion Restrictions On The Rise, Some Women Induce Their Own

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