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Controlling type 2 diabetes: With and without medication – Medical News Today

Posted: October 5, 2021 at 7:26 pm

Many people may wonder how to control type 2 diabetes without medications. A healthy diet and lifestyle could help people manage type 2 diabetes and other aspects of their health.

To help people keep blood sugar blood glucose within a healthy range, the American Heart Association (AHA) recommends:

If making dietary and lifestyle changes do not help maintain a healthy blood sugar level, doctors may advise a person to take medications. However, if someone receives a diabetes diagnosis as an older adult and their blood sugar is only mildly elevated, medications may not be necessary.

In this article, we examine how to control type 2 diabetes without medication. We also look at the causes of type 2 diabetes and when people may need medication to manage their condition.

A 2020 study reports that healthy lifestyle practices could benefit people with type 2 diabetes or risk factors for the condition. Such measures may delay or prevent its development, as well as treat or potentially put it into remission. This method of controlling blood sugar can be so effective that the studys authors call it lifestyle medicine.

The following healthy lifestyle practices may help reduce blood sugar levels:

In people with overweight or obesity, significant weight loss may reduce blood sugar from the diabetic to the nondiabetic range.

Two ways to manage weight are eating a healthy, balanced diet and engaging in regular exercise. The key to weight loss involves consuming fewer calories than the body uses for activities and physiological processes.

A healthy diet consists of eating nutritious foods in appropriate portion sizes while avoiding or limiting non-nutritious foods.

Foods for people to eat may include:

Foods and ingredients for people to limit may include:

The American Diabetes Association (ADA) recommends a diet similar to the Mediterranean diet, which focuses on:

A 2020 review notes that following this eating plan improves blood sugar control.

Exercise promotes blood sugar management and burns calories, which contributes to weight loss. Physical activity also increases insulin sensitivity, which helps blood sugar to enter the cells from the bloodstream.

People should aim to get 30 minutes of moderate physical activity per day on most days, totaling at least 150 minutes each week. Experts classify a brisk walk as moderate exercise. Alternatively, 75 minutes per week of vigorous aerobic activity is equally beneficial.

Doctors advise people to stop smoking to help blood sugar control for several reasons. Smokers have a 3040% higher risk of developing diabetes than nonsmokers. Smoking also makes exercise more challenging.

Smoking also raises blood sugar temporarily, which poses an additional challenge in maintaining nondiabetic blood sugar levels. This increases the likelihood of a person developing complications of diabetes, such as kidney disease and nerve damage.

Research in 2019 suggests that although stress does not cause type 2 diabetes, it can worsen it. Stress stimulates the release of hormones that interfere with the bodys blood sugar regulation. It also makes a person more likely to engage in practices that make it harder to manage blood sugar, such as overeating and smoking.

One way to reduce stress involves taking a break from electronics and spending time in nature.

According to 2020 research, a person only needs medication if lifestyle practices do not put blood sugar levels in the nondiabetic range.

A doctors recommendation for medication for someone with type 2 diabetes may depend partly on their age when they receive a diagnosis. While many older adults with the condition have slightly higher blood sugar levels, this rarely causes problems.

On the other hand, doctors may prescribe medications to people who receive a diagnosis by the age 40 or 50. Even slightly elevated blood sugar levels can eventually lead to health problems, such as damage to nerves or blood vessels. Such damage may result in complications, such as kidney disease. The purpose of medications is to delay or prevent the harmful effects of diabetes.

According to the ADA, type 2 diabetes is progressive, making it more difficult to manage over time. Improvements in medical care enable people with the condition to live longer. However, despite the advancements, type 2 diabetes may reduce life expectancy by up to 10 years.

The effects of lifestyle practices alone on type 2 diabetes have not undergone extensive research, limiting statistics on the results of such interventions. However, a 2018 clinical trial examined the outcomes of a weight management program on 306 individuals with type 2 diabetes. After 12 months, the authors found about half the individuals who participated in the program went into remission.

Researchers cannot quantify the exact improvement that each healthy lifestyle practice may bring at this point in research. However, the outlook for people with type 2 diabetes who have a healthy lifestyle is better than those who do not.

Type 2 diabetes is a condition that involves high blood glucose or blood sugar.

The pancreas makes insulin, a hormone that enables cells to take glucose from the bloodstream for energy. In type 2 diabetes, the cells do not respond normally to insulin, called insulin resistance. As a result, the pancreas makes more insulin in an attempt to get glucose inside the cells.

After some time, the pancreas cannot keep up, and blood sugar increases, which leads to prediabetes and diabetes.

Symptoms frequently develop over several years, including:

Experts advise people interested in learning how to control type 2 diabetes without medications to adopt a healthy lifestyle.

Significant weight loss can help control blood sugar levels in some people. Two ways to pursue weight management involve people eating a healthy, balanced diet and getting regular exercise.

Good nutrition is vital for a person with type 2 diabetes. Some evidence suggests that a nutritious eating plan, such as the Mediterranean diet, may help control blood sugar in ways other than weight loss.

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Heart Health May Help Prevent Diabetes, Regardless of Genetics – HealthDay News

Posted: October 5, 2021 at 7:26 pm

TUESDAY, Oct. 5, 2021 (HealthDay News) -- Favorable cardiovascular health (CVH) is important for preventing type 2 diabetes among middle-aged individuals regardless of their genetic predisposition, according to a study published online Sept. 28 in the European Journal of Preventive Cardiology.

Kan Wang, from the Erasmus University Medical Center in Rotterdam, Netherlands, and colleagues calculated a CVH score and a genetic risk score for predisposition for diabetes among 5,993 individuals at baseline.

The researchers found that at age 55 years, the remaining lifetime risk for type 2 diabetes was 22.6 percent for ideal, 28.3 percent for intermediate, and 32.6 percent for poor CVH. The lifetime risk for type 2 diabetes was still the lowest for ideal CVH when stratifying by genetic risk score tertiles (lowest: 21.5 percent; second: 20.8 percent; highest: 23.5 percent) compared with intermediate and poor CVH.

"While genetics do contribute to the probability of developing type 2 diabetes, the findings indicate that maintaining healthy lifestyle habits, and especially having a healthy body weight, can help lower the lifetime risk of the condition," a coauthor said in a statement.

Abstract/Full Text

Editorial

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Heart Health May Help Prevent Diabetes, Regardless of Genetics - HealthDay News

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Blood thinners, diabetes meds among top causes of drug-related ER visits – UPI News

Posted: October 5, 2021 at 7:26 pm

Oct. 5 (UPI) -- Taking blood-thinners and diabetes drugs at higher-than-recommended doses or in error often leads to health complications that bring older adults to hospital emergency rooms, a study published Tuesday by JAMA found.

Adults age 65 and older account for nearly 28,000, or one-third, of the roughly 97,000 emergency room visits related to "medication harms" annually in the United States, the data showed.

Medication harms include people taking their medications in higher-than-recommended doses, taking medications prescribed for others or using medications to treat conditions for which the drugs have not been approved.

Of the 28,000 trips to the emergency room, roughly half result in hospital admissions, according to the researchers.

Anticoagulants -- blood thinners to prevent blood clots -- account for nearly 15% of emergency room visits related to medication harms, while pain medications make up 14%.

Sedatives used to treat mental health and behavior disorders are involved in about 12% of medication-related ER visits, and diabetes drugs are implicated in about 10%, the data showed.

"Among patients 45 years of age and older, therapeutic use of anticoagulants, or blood thinners, and diabetes medications were the most common causes of [ER] visits for medication-related harms," study co-author Dr. Dan Budnitz told UPI in an email.

"The rate of visits for harms due to therapeutic medication use increases with age, peaking among those 75 years of age or older," said Budnitz, who is director of the Center for Disease Control and Prevention's Office of Medication Safety.

Some medication misuse may be intentional and linked with acts of "self-harm," such as attempted suicide, according to Budnitz and his colleagues.

However, in some cases, medications may be prescribed or used in error, they said.

Self-harm accounts for nearly 14,000, or about 13%, of medication-related ER visits each year, but "therapeutic use," or intentional use of prescribed drugs, makes up more than 66,000, or nearly 70%.

Harms related to therapeutic use of drugs include side effects, which lead to roughly one-third of medication-related ER visits annually. Allergic reactions are involved in about 14%, the researchers said.

Medication errors, or not taking drugs at the recommended dose or on the prescribed schedule, account for 6% of these ER visits, according to the researchers.

The findings are based on an analysis of patient data from 60 hospital emergency departments participating in the CDC's National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project between 2017 and 2019, they said.

These projects track injuries and drug-related health reports nationally, the CDC said.

"Improved labeling can be part of the answer to reducing medication-related harms. Clearly identifying active ingredients and dosing instructions can help individuals choose the best medication and administer the correct dose," Budnitz said.

"However, most emergency department visits for medication-related harms would not be prevented by labeling changes alone. Identifying the most common medication-related harms for patients of different ages can help target prevention efforts," he said.

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AltaMed Health Services’ Mobile Unit Adds Free Glucose Testing and Highlights the Nutrition Benefits of Avocados for National Diabetes Month – KKCO-TV

Posted: October 5, 2021 at 7:26 pm

New strategic campaign innovatively integrates nutrition facts about fresh avocados in efforts to reduce Type 2 diabetes risk among Hispanics, who have a 50% chance of developing the disease in their lifetime

Published: Oct. 5, 2021 at 8:03 AM MDT|Updated: 9 hours ago

MISSION VIEJO, Calif., Oct. 5, 2021 /PRNewswire/ -- As November marks National Diabetes Month, AltaMed Health Services, the nation's largest independent federally qualified community health center, and Aguacates Frescos - Saborea Uno Hoy, a leading source of the healthiest reasons and tastiest ways to enjoy fresh avocados developed especially for Hispanic families, will join forces to improve nutritional education and access to glucose testing for the early detection and possible prevention of type 2 diabetes, a condition that impairs the body's ability to regulate sugar.

Beginning in the fall, the AltaMed mobile unit will travel throughout Southern California to offer free glucose testing and education that integrates messaging on how dietary fiber, like that found in avocados, may help maintain healthy blood glucose levels.Delicious recipes and meal planning tools featuring fresh avocadoswill be shared in English and Spanish to inspire families to eat healthy and boost fiber intake with the traditional favorite.

"We are excited to partner with Aguacates Frescos - Saborea Uno Hoy in the fight against type 2 diabetes by educating the community on the value of fresh fruits and vegetables with bilingual tools, like nutritious recipes that include fresh avocados," said Cesar Sauza, Registered Dietitian, Manager, Clinical Nutrition of Health Education and Wellness with AltaMed. "Creatively integrating the benefits of fresh avocados into our conversations about improving the quality of diet supports our commitment to be respectful of cultural preferences in our approach to help the community grow healthy."

If unmanaged, diabetes can be life-threatening and according to the CDC,US adults overall have a 40% chance of developing type 2 diabetes. But for a Hispanic/Latino American adult, there is more than a 50% chance, and it is likely to develop at a younger age. Diets rich in healthy foods containing fiber, may reduce the risk of type 2 diabetes.

"Fiber, like that found in avocados, slows down food digestion which promotes satiety and prevents rapid rises in blood glucose following a meal," said Krista Linares, Registered Dietitian and Saborea Uno Hoy spokesperson. "Since most adults don't get enough dietary fiber, it is beneficial to raise awareness of easy ways to boost intake. Delicious avocados add fiber to the diet and are already a much-loved staple in Hispanic homes."

The Dietary Guidelines for Americans point to strong evidence that healthy eating patterns are associated with positive health outcomes. The Hass Avocado Board's Avocado Nutrition Center is continually studying how eating fresh avocados can have a positive effect on reducing risk factors for type 2 diabetes. Meal planning tools, recipes, articles by dietitians as well as access to clinical research that looks at how replacing carbohydrates with avocado affected glucose and insulin levels are available at SaboreaUnoHoy.com/AltaMed.

About Saborea Uno Hoy and the Hass Avocado BoardSaborea Uno Hoyis a leading source of the healthiest reasons and tastiest ways to enjoy fresh avocados developed especially for Hispanic families. A science-based resource, it provides delicious and culturally-relevant recipes and articles in Spanish and English to help make it easy for consumers and health professionals to learn more about the nutritional benefits of fresh avocados and ways to include them in everyday menus.

About the Hass Avocado BoardThe Hass Avocado Board (HAB) exists to help make avocados America's most popular fruit. HAB is the only avocado organization that equips the entire global industry for success by collecting, focusing and distributing investments to maintain and expand demand for avocados in the United States. HAB provides the industry with consolidated supply and market data, conducts nutrition research, educates health professionals, and brings people together from all corners of the industry to collectively work towards growth that benefits everyone. The organization also collects and reallocates funds to California and importer associations to benefit specific countries of origin in promoting their avocado brands to customers and consumers across the United States. For more information, visitSaboreaUnoHoy.comor follow HAB on Facebook,Instagram,Twitter,PinterestandYouTube.

About AltaMedAltaMed understands that when people have health care that looks at their individual health needs and respects their cultural preferences, they grow healthyand help their families do the same. So we're delivering complete medical services to communities across Southern California. Since 1969, our team of qualified multicultural and bilingual professionalsfrom these same communitieshas focused on eliminating barriers to primary care services, senior care programs, and even essential community services. With nearly 50 accredited health centers and service facilities, we remain committed and ready to help you grow healthy at any age.

Contact: Vickie Fite (310) 613-0937

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SOURCE Aguacates Frescos - Saborea Uno Hoy; AltaMed Health Services

The above press release was provided courtesy of PRNewswire. The views, opinions and statements in the press release are not endorsed by Gray Media Group nor do they necessarily state or reflect those of Gray Media Group, Inc.

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US is Out of Step on Primate Research With Rest of World – NewsClick

Posted: October 5, 2021 at 7:17 pm

In the last two years, the US National Institutes of Health (NIH) has invested nearly$29 million to breed more monkeys for biomedical research, with an additional $7.5 million to be spent by October. The investments, which include infrastructure improvements at the US National Primate Research Centers (NPRCs), have been made in the wake of the COVID-19 pandemic, as researchers have been testing numerous vaccines on non-human primates, most commonly rhesus macaques (Macaca mulatta)a species of Old World monkey commonly used to study infectious diseasesbefore human trials began.

Using the pandemic as the pretext, the Biden administration hasproposedusing even more taxpayer money to conduct primate research, suggesting a 27% funding increase for the NPRCs in its fiscal year 2022 budget request. If Congress gives the administration its stamp of approval, an additional $30 million would be given to the centres.

We have been making investments to bring the levels up and to plan for the future, James Anderson, director of the NIH Division of Program Coordination, Planning, and Strategic Initiatives in Bethesda, Maryland,toldNature. What happens if [a pandemic] happens again, with another virus in three years? We want to be ready for that.

A couple of years ago, we were feeling the pinch, Nancy Haigwood, director of the NPRC in Beaverton, Oregon,toldNature. Citing the pandemic, Haigwood said, we are truly out of animals, thoughNaturereports that the centre she runs houses some 5,000 primates.

Animal rights advocates are rebuffing the proposed increase in funding, which would subject many more animals to cruel and deadly experiments.

In an email to Earth | Food | Life, Barbara Stagno, president and executive director ofCitizens for Alternatives to Animal Research and Experimentation(CAARE), an animal rights non-profit organisation based in New York, countered the claim that there is a dearth in primates for research. The group has launched apublic petitionurging Congress to reject the additional funding for primate research.

While the centres are claiming that there are not enough primates to conduct research, Stagno presented figures from the US Department of Agriculture showing that the opposite is true. In 2019 there were40,269monkeys held on reserve, in addition to the68,257monkeys subjected to experiments, said Stagno. Not only were over 40,000 monkeys warehoused on hold for use in experiments, but that number is a 14 percent increase from 2018, clearly demonstrating a growing surplusnot a shortageof monkeys.

In contrast to the falsehoods being pushed by the primate centres, monkeys are not essential for COVID-19 research. In fact,due to vast differences in genetics and physiology, primates do not experience COVID-19 as humans do, said Stagno.

In fact, scientists at the NIHconcludedin 2015 that research on SARS and MERS, two strains of coronaviruses that crossed the species barrier to infect humans within the preceding 12 years, had been largely unsuccessful in part because of difficulties in developing animal models that provide consistent and reproducible results.

In addition, Stagno pointed out that the trajectory of the COVID-19 biomedical response actually proved that non-human animal testing for vaccines is unnecessary. With the urgency imposed by the pandemic, key vaccine developers Pfizer and Moderna were given approval to run human trials ahead of normally required animal testing, she said. The result was that vaccines for COVID-19 were developed and made accessible to the public in record time, with less animal testing than ever before. In bypassing animal testing to evaluate the vaccines, the scientific community acknowledged that these tests are not scientifically predictive of human response, but rather are based on regulatory requirements that are a hindrance to rapidly developing safe and effective treatments.

Indeed, as CAAREhighlights, the most informative work addressing the COVID-19 pandemic comes from human-based science. Other organisations, notably thePhysicians Committee for Responsible Medicine, a non-profit animal rights group based in Washington, D.C., also strongly support alternatives to non-human animal research, arguing that the US doesnt need more monkeys for vaccine testing, but rather a new strategy altogether.

Instead of monkeys and other animals, more ethical, effective, and sustainable human-based methods are the future, the groupsays. Because they use human cells and tissues, these approaches can better replicate the pathology of human diseases, including COVID-19 examples of powerful human-based COVID-19 research include studies that have used donated human tissue, human brain organoids, human lung airway chips, human stem cell-derived cardiac tissue, human intestinal organoids, and mini human lungs in a dish. Learning from these human-relevant findings and supporting much more of this kind of research is the only way we will solve this crisis and better prepare for future pandemics.

Stagno criticised the federal governments request for more funding for primate research by comparing the US position to that of Europe. At a time when theEuropean Parliament voted [on September 15] to phase out animal experiments, the US Department of Health and Human Services [under whose jurisdiction the NIH falls] is asking for another $30 million to expand primate research. This is totally out of step with where modern science needs to go.

While the past decade has seen amazing new developments in alternatives to animal testing, policymakers, regulators and parts of the scientific community are yet to fully recognize the potential of these new methods,saidMember of the European Parliament Tilly Metz. The resolution we voted on today aims to accelerate the shift in mentalities, regulation and funding.

Sheadded, There are no excuses to perpetuate the current level of reliance on animal experiments. It is clear that an ambitious phase-out plan, with clear milestones and achievable objectives, is the next step needed to start reducing significantly the use of animals in science. And while Europe is leading todays charge to eliminate animal testing, animal welfare in general has also beengaining ground across Asia in recent years.

When it comes to cruel, deadly and unnecessary experiments, particularly on our close evolutionary cousins, its time for the United States to get in sync with modern science. Congress shouldnt just reject additional funding for primate researchit should ban it altogether.

Reynard Loki is a writing fellow at theIndependent Media Institute, where he serves as the editor and chief correspondent forEarth | Food | Life.

This article was produced byEarth | Food | Life, a project of the Independent Media Institute.

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Fasting boosts stem cells regenerative capacity | MIT …

Posted: October 5, 2021 at 7:15 pm

As people age, their intestinal stem cells begin to lose their ability to regenerate. These stem cells are the source for all new intestinal cells, so this decline can make it more difficult to recover from gastrointestinal infections or other conditions that affect the intestine.

This age-related loss of stem cell function can be reversed by a 24-hour fast, according to a new study from MIT biologists. The researchers found that fasting dramatically improves stem cells ability to regenerate, in both aged and young mice.

In fasting mice, cells begin breaking down fatty acids instead of glucose, a change that stimulates the stem cells to become more regenerative. The researchers found that they could also boost regeneration with a molecule that activates the same metabolic switch. Such an intervention could potentially help older people recovering from GI infections or cancer patients undergoing chemotherapy, the researchers say.

Fasting has many effects in the intestine, which include boosting regeneration as well as potential uses in any type of ailment that impinges on the intestine, such as infections or cancers, says Omer Yilmaz, an MIT assistant professor of biology, a member of the Koch Institute for Integrative Cancer Research, and one of the senior authors of the study. Understanding how fasting improves overall health, including the role of adult stem cells in intestinal regeneration, in repair, and in aging, is a fundamental interest of my laboratory.

David Sabatini, an MIT professor of biology and member of the Whitehead Institute for Biomedical Research and the Koch Institute, is also a senior author of the paper, which appears in the May 3 issue of Cell Stem Cell.

This study provided evidence that fasting induces a metabolic switch in the intestinal stem cells, from utilizing carbohydrates to burning fat, Sabatini says. Interestingly, switching these cells to fatty acid oxidation enhanced their function significantly. Pharmacological targeting of this pathway may provide a therapeutic opportunity to improve tissue homeostasis in age-associated pathologies.

The papers lead authors are Whitehead Institute postdoc Maria Mihaylova and Koch Institute postdoc Chia-Wei Cheng.

Boosting regeneration

For many decades, scientists have known that low caloric intake is linked with enhanced longevity in humans and other organisms. Yilmaz and his colleagues were interested in exploring how fasting exerts its effects at the molecular level, specifically in the intestine.

Intestinal stem cells are responsible for maintaining the lining of the intestine, which typically renews itself every five days. When an injury or infection occurs, stem cells are key to repairing any damage. As people age, the regenerative abilities of these intestinal stem cells decline, so it takes longer for the intestine to recover.

Intestinal stem cells are the workhorses of the intestine that give rise to more stem cells and to all of the various differentiated cell types of the intestine. Notably, during aging, intestinal stem function declines, which impairs the ability of the intestine to repair itself after damage, Yilmaz says. In this line of investigation, we focused on understanding how a 24-hour fast enhances the function of young and old intestinal stem cells.

After mice fasted for 24 hours, the researchers removed intestinal stem cells and grew them in a culture dish, allowing them to determine whether the cells can give rise to mini-intestines known as organoids.

The researchers found that stem cells from the fasting mice doubled their regenerative capacity.

It was very obvious that fasting had this really immense effect on the ability of intestinal crypts to form more organoids, which is stem-cell-driven, Mihaylova says. This was something that we saw in both the young mice and the aged mice, and we really wanted to understand the molecular mechanisms driving this.

Metabolic switch

Further studies, including sequencing the messenger RNA of stem cells from the mice that fasted, revealed that fasting induces cells to switch from their usual metabolism, which burns carbohydrates such as sugars, to metabolizing fatty acids. This switch occurs through the activation of transcription factors called PPARs, which turn on many genes that are involved in metabolizing fatty acids.

The researchers found that if they turned off this pathway, fasting could no longer boost regeneration. They now plan to study how this metabolic switch provokes stem cells to enhance their regenerative abilities.

They also found that they could reproduce the beneficial effects of fasting by treating mice with a molecule that mimics the effects of PPARs. That was also very surprising, Cheng says. Just activating one metabolic pathway is sufficient to reverse certain age phenotypes.

Jared Rutter, a professor of biochemistry at the University of Utah School of Medicine, described the findings as interesting and important.

This paper shows that fasting causes a metabolic change in the stem cells that reside in this organ and thereby changes their behavior to promote more cell division.In a beautiful set of experiments, the authors subvert the system by causing those metabolic changes without fasting and see similar effects, says Rutter, who was not involved in the research. This work fits into a rapidly growing field that is demonstrating that nutrition and metabolism has profound effects on the behavior of cells and this can predispose for human disease.

The findings suggest that drug treatment could stimulate regeneration without requiring patients to fast, which is difficult for most people. One group that could benefit from such treatment is cancer patients who are receiving chemotherapy, which often harms intestinal cells. It could also benefit older people who experience intestinal infections or other gastrointestinal disorders that can damage the lining of the intestine.

The researchers plan to explore the potential effectiveness of such treatments, and they also hope to study whether fasting affects regenerative abilities in stem cells in other types of tissue.

The research was funded by the National Institutes of Health, the V Foundation, a Sidney Kimmel Scholar Award, a Pew-Stewart Trust Scholar Award, the MIT Stem Cell Initiative through Fondation MIT, the Koch Institute Frontier Research Program through the Kathy and Curt Marble Cancer Research Fund, the American Federation of Aging Research, the Damon Runyon Cancer Research Foundation, the Robert Black Charitable Foundation, a Koch Institute Ludwig Postdoctoral Fellowship, a Glenn/AFAR Breakthroughs in Gerontology Award, and the Howard Hughes Medical Institute.

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US stem cell clinics boomed while FDA paused crackdown …

Posted: October 5, 2021 at 7:15 pm

WASHINGTON -- Hundreds of clinics pushing unproven stem cell procedures caught a big break from the U.S. government in 2017: They would have three years to show that their questionable treatments were safe and worked before regulators started cracking down.

But when the Food and Drug Administration's grace period expired in late May extended six months due to the pandemic the consequences became clear: Hundreds more clinics were selling the unapproved treatments for arthritis, Alzheimers, COVID-19 and many other conditions.

It backfired, says Leigh Turner, a bioethicist at the University of California, Irvine. The scale of the problem is vastly larger for FDA today than it was at the start.

The continuing spread of for-profit clinics promoting stem cells and other so-called regenerative therapies including concentrated blood products illustrates how quickly experimental medicine can outpace government oversight. No clinic has yet won FDA approval for any stem cell offering and regulators now confront an enormous, uncooperative industry that contends it shouldn't be subject to regulation.

Although emerging research suggests stem cells could someday have broad use for a number of medical conditions, experts say they should not be used outside of well-controlled studies or a handful of established uses. For instance, stem cells collected from blood or bone marrow have long been used to treat leukemia and other blood diseases.

Many clinics use so-called adult stem cells collected from tissue like fat or bone marrow not the more versatile but controversial stem cells from embryos used in research.

Turner and other experts have tracked the growth of the clinics for nearly a decade. Clinics charge between $2,000 to $25,000 for adult stem cell injections and other infusions which they advertise for an assortment of diseases, including diabetes, autism, cancer, multiple sclerosis and vision problems. Some clinics use stem cells derived from fat, harvested via liposuction then reinjected into patients, aiming to repair joints or fight disease. Others use bone marrow or blood taken from umbilical cords after birth.

There is no government tally of how many clinics operate in the U.S. But Turner counted more than 1,200 of them in 2019, up from the 570 clinics he and a co-author identified in 2016. Hes working on an update but says the number has consistently grown.

The FDA has repeatedly warned Americans to steer clear of unapproved and unproven stem cell therapies, which have occasionally caused blindness, bacterial infections and tumors. During FDA's three-plus years of enforcement discretion, the agency sent formal warning letters to more than a dozen businesses performing the riskiest procedures. Regulators also prevailed in a Florida court case to shutdown a major clinic offering unproven treatments. Another case against a similar prominent company is pending in California.

Its time to actually get the data we need, to assess clinics' stem cell procedures, FDA's Dr. Peter Marks said at an industry conference in June. He pointed to a multiyear effort by FDA to help clinics through the review process.

Many stem cell doctors continue to argue that their in-office procedures are outside FDAs purview. But FDA has concluded that processing stem cells and giving them to patients with serious diseases amounts to creating a new drug, which the agency regulates.

The FDA hasnt disclosed how many clinics sought approval since 2017, but public comments suggest it was troublingly low.

We have been very disappointed in the number of clinics that have come in, FDAs Dr. Wilson Bryan said at the same conference.

Bryan, who directs FDA's cell therapies division, added that he is extremely concerned by how many stem cell and related offerings remain available.

Tracking injuries from the procedures is difficult. Drugmakers and hospitals are required to report drug-related complications to the FDA, but no such requirements exist for individual doctors. And patients often don't know where to report problems.

David Stringham of Provo, Utah, says undergoing a procedure for joint pain at a local clinic was the worst decision of my life.

In 2018, Stringham was looking for an alternative to surgery for chronic pain in his right shoulder and elbows after years of weightlifting. He paid $2,400 for injections of so-called platelet-rich plasma at a clinic. It doesn't involve stem cells but the procedure is similar: doctors take a blood sample, process it to concentrate the platelets and then reinject them into the patient's problem areas in an attempt to speed healing.

The procedure went smoothly, but within hours Stringham was wracked by pain in his back, shoulder and arms.

It was a crazy amount of pain and I kept calling them saying something is not right," said the 51-year-old. And to this day Im not right."

The clinic gave Stringham medication for the pain and told him to be patient. But things didn't improve, even after months of physical therapy. Since then, a neurologist has told Stringham he probably suffered nerve damage at the places where he was injected.

His case was included in a Pew Charitable Trusts review of 360 reported injuries from stem cell and other regenerative procedures between 2004 and 2020. Nearly all the reports came from medical journals, government publications, social media or news reports. Just five came from FDAs database for medical injuries.

There are a lot of holes in the safety system, said Liz Richardson of Pew, who led the project.

The FDA didn't clearly assert its authority over such clinics until 2017. The next year, it began sending form letters to some 400 clinics, warning that they may be violating FDA rules. But the names of the clinics havent been publicized, and such warnings are often ignored.

Traditional medical researchers welcome the FDA actions but say its impossible to gauge their effect.

The business model is this: We can keep offering these products until things get serious with the FDA and then we can just take down our website', said Laertis Ikonomou, a stem cell researcher at the University of Buffalo who also heads a task force on the topic for the International Society for Cell and Gene Therapy.

He and other specialists say the clinics have damaged the reputation of legitimate stem cell research while also siphoning off patients who might otherwise enroll in studies.

Lawyers representing stem cell clinics say they have no choice but to resist FDA regulation.

FDA is pushing them into this drug development pathway, which nobody is adopting because it requires a million dollars worth of toxicology and animal studies just to show something is safe for human use, said Marc Scheineson, a former FDA attorney.

For now, people on both sides are waiting to see what FDA does.

We shouldnt feel too confident that the FDA has this wrapped up said Turner, the bioethicist. They really have invested some resources and they are trying to do something here but I think theyre just outmatched and overwhelmed.

Follow Matthew Perrone on Twitter: @APFDAwriter

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. The AP is solely responsible for all content.

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What is Stem Cell Research? | The Benefits of Stem Cell Research

Posted: October 5, 2021 at 7:12 pm

Stem cell research is one of the most innovative research methods being used in modern society. However, it is also not very well known in todays society. Most people are either introduced to it when exposed to the treatment themselves or through a loved one.I was exposed to stem cell research in the ninth grade. Since I went to a STEM(science, technology, engineering, and mathematics) high school, my biology teacher assigned us a report on stem cell research. Since doing that report, I have become passionate about stem cell research and have followed closely the advancements made in the field. Current research can easily be tracked on the National Institute for Health website.

So what is a stem cell? Astem cell is simply a cell that can either reproduce another stem cell or a specialized cell an infinitive amount of times. The specialized cells that can be produced have specific function related to where they are produced in the human body.Stem cell research is also categorized by the stem cell typeused.

Adult stem cells, or somatic cells, are produced from the human body once an individual is born. It can renew itself or become a specialized cell within the body just like the stem cells I explained above. They have no known origin, but they are used in most of the groundbreaking research that is currently happening.

Embryonic stem cells are more controversial since they are produced in the embryo stage of development. All embryonic stem cells originate from an embryo. They are usually grown in a laboratory within a cell culture. There are many misconceptions of embryonic stem cells which will be addressed in the next blog post.

Both types of stem cells have advantages and disadvantages, but the advantage of stem cell research heavily outweigh the disadvantages. It is slowly becoming the future of medicine.

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What is Stem Cell Research? | The Benefits of Stem Cell Research

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Stem Cells | National Institutes of Health (NIH)

Posted: October 5, 2021 at 7:12 pm

Stem cell research holds great promise for biomedical sciencefrom helping us better understand how diseases develop and spread, to serving as accurate screens for new drugs, to developing cell-based therapies for diabetes, heart failure, Parkinsons disease, and many other conditions that affect millions of Americans. There are 2 basic types of human stem cells: embryonic stem (ES) cells and non-embryonic, or adult stem cells. Just a few years ago, scientists discovered how to make a third type, by reprogramming ordinary skin cells that have already grown up into those that look and act like cells from an embryo. These cells have been named induced pluripotent stem cells, or iPS cells.

NIH research is progressing on multiple fronts to learn more about the differences between the 3 stem cell types and to create patient-specific cells for in-depth study of many diseases. The ability to create iPS cells is a significant breakthrough, since the reprogramming technique is relatively simple to perform with standard laboratory methods, and because skin cells are easy to gather and grow. The most exciting aspect of this research is its potential to speed progress toward achieving personalized therapies. With refinements, this method could yield an unlimited supply of customized cells.

Regenerative medicine is moving toward a day when we can repair and replace damaged tissues. In time, we will be able to make insulin-secreting pancreatic cells, bone cells to heal breaks and defects, and eye and ear cells to restore vision and hearing. NIH researchers are hard at work using stem cells as a powerful tool to study neurological disorders like Parkinsons, Huntingtons disease, amyotrophic lateral sclerosis (ALS), and spinal cord injury, to name a few.

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Stem Cells | National Institutes of Health (NIH)

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An Overview of Stem Cell Research | The Center for Bioethics …

Posted: October 5, 2021 at 7:12 pm

Post Date: 04/2005, Updated 08/2009Author: CBHD Research Staff

In November of 1998, scientists reported that they had successfully isolated and cultured human embryonic stem cellsa feat which had eluded researchers for almost two decades. This announcement kicked off an intense and unrelenting debate between those who approve of embryonic stem cell research and those who are opposed to it. Some of the most prominent advocates of the research are scientists and patients who believe that embryonic stem cell research will lead to the development of treatments and cures for some of humanitys most pernicious afflictions (such as Alzheimers disease, Parkinsons disease, heart disease, and diabetes). Among the most vocal opponents of the research are those who share the desire to heal, but who object to the pursuit of healing via unethical means. CBHDs view is that because human embryonic stem cell research necessitates the destruction of human embryos, such research is unethicalregardless of its alleged benefits. Ethical alternatives for achieving those benefits should be actively pursued, and have demonstrated a number of promising preclinical and clincial results without the ethical concers present with embryonic stem cells.

Human embryonic stem cells are the cells from which all 200+ kinds of tissue in the human body originate. Typically, they are derived from human embryosoften those from fertility clinics who are left over from assisted reproduction attempts (e.g., in vitro fertilization). When stem cells are obtained from living human embryos, the harvesting of such cells necessitates destruction of the embryos.

Adult stem cells (also referred to as non-embryonic stem cells) are present in adults, children, infants, placentas, umbilical cords, and cadavers. Obtaining stem cells from these sources does not result in certain harm to a human being.

Fetal stem cell research may ethically resemble either adult or embryonic stem cell research and must be evaluated accordingly. If fetal stem cells are obtained from miscarried or stillborn fetuses, or if it is possible to remove them from fetuses still alive in the womb without harming the fetuses, then no harm is done to the donor and such fetal stem cell research is ethical. However, if the abortion of fetuses is the means by which fetal stem cells are obtained, then an unethical means (the killing of human beings) is involved. Since umbilical cords are detached from infants at birth, umbilical cord blood is an ethical source of stem cells.

Yes. In contrast to research on embryonic stem cells, non-embryonic stem cell research has already resulted in numerous instances of actual clinical benefit to patients. For example, patients suffering from a whole host of afflictionsincluding (but not limited to) Parkinsons disease, autoimmune diseases, stroke, anemia, cancer, immunodeficiency, corneal damage, blood and liver diseases, heart attack, and diabeteshave experienced improved function following administration of therapies derived from adult or umbilical cord blood stem cells. The long-held belief that non-embryonic stem cells are less able to differentiate into multiple cell types or be sustained in the laboratory over an extended period of timerendering them less medically-promising than embryonic stem cellshas been repeatedly challenged by experimental results that have suggested otherwise. (For updates on experimental results, access http://www.stemcellresearch.org.)

Though embryonic stem cells have been purported as holding great medical promise, reports of actual clinical success have been few. Instead, scientists conducting research on embryonic stem cells have encountered significant obstaclesincluding tumor formation, unstable gene expression, and an inability to stimulate the cells to form the desired type of tissue. It may indeed be telling that some biotechnology companies have chosen not to invest financially in embryonic stem cell research and some scientists have elected to focus their research exclusively on non-embryonic stem cell research.

Another potential obstacle encountered by researchers engaging in embryonic stem cell research is the possibility that embryonic stem cells would not be immunologically compatible with patients and would therefore be rejected, much like a non-compatible kidney would be rejected. A proposed solution to this problem is to create an embryonic clone of a patient and subsequently destroy the clone in order to harvest his or her stem cells. Cloning for this purpose has been termed therapeutic cloningdespite the fact that the subject of the researchthe cloneis not healed but killed.

Underlying the passages of Scripture that refer to the unborn (Job 31:15; Ps. 139:13-16; Lk. 1:35-45) is the assumption that they are human beings who are created, known, and uniquely valued by God. Genesis 9:6 warns us against killing our fellow human beings, who are created in the very image of God (Gen. 1:26-27). Furthermore, human embryonic lifeas well as all of creationexists primarily for Gods own pleasure and purpose, not ours (Col. 1:16).

Many proponents of human embryonic stem cell research argue that it is actually wrong to protect the lives of a few unborn human beings if doing so will delay treatment for a much larger number of people who suffer from fatal or debilitating diseases. However, we are not free to pursue gain (financial, health-related, or otherwise) through immoral or unethical means such as the taking of innocent life (Deut. 27:25). The history of medical experimentation is filled with horrific examples of evil done in the name of science. We must not sacrifice one class of human beings (the embryonic) to benefit another (those suffering from serious illness). Scripture resoundingly rejects the temptation to do evil that good may result (Rom. 3:8).

No forms of stem cell research or cloning are prohibited by federal law, though some states have passed partial bans. Private funds can support any practice that is legal, whereas federal funds cannot be used for research on embryonic stem cell lines unless they meet the guidelines set forth by the National Institutes of Health in July 2009. For the latest developments you can stay informed via CBHD's newsblogwww.bioethics.com and thecoalition site http://www.stemcellresearch.org.

Editor's Note: This piece was originally published by Linda K. Bevington, MA, by CBHD in April 2005 under the title "Stem Cell Research and 'Therapeutic' Cloning: A Christian Analysis." The piece was subsequently revised and updated by CBHD research staff in August 2009.

Posted 4/2005, Updated 8/2009

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