Category: Health

HOUSTON– The end to the fentanyl crisis may be in sight, thanks to a team of researchers in Texas who claim they have successfully developed a vaccine that could be a “game changer” in addiction treatment.

A team led by the University of Houston has developed what they say is a fentanyl vaccine that can block the synthetic opioid from entering the brain — essentially curing addiction by eliminating the euphoric high.

“There’s no question about it. We developed something that’s a new game changer,” Dr. Colin Haile, a research associate professor of psychology at UH and the Texas Institute for Measurement, Evaluation, and Statistics (TIMES) told Fox News during a recent tour of the research facility.

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“It’s a completely different strategy of treating an individual with opioid use disorder.”

Their vaccine works in an entirely different way, said Dr. Haile, from other treatments for opioid use disorder and overdose deaths.

It essentially produces antibodies much like other vaccines make those antibodies against a virus or bacteria.

Dr. Haile’s vaccine does the same by blocking fentanyl from entering the user’s brain.

Proteins are used to keep the drug in the bloodstream—then it is flushed out through the kidneys.

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“It’s similar to the hepatitis B vaccine. The vaccine stimulates the body to make antibodies against fentanyl,” Dr. Haile said, “and if an individual consumes fentanyl, those antibodies will bind to the drug and prevent it from getting into the brain. “

He added, “Without the vaccine, fentanyl penetrates the brain quite readily, stimulates euphoric centers, and also can stimulate parts of the brain that control respiration, leading to overdose and death.”

A lethal dose of fentanyl is pictured next to a penny.
(Drug Enforcement Administration)

Testing on lab rats and mice showed very promising results, said Haile, and he believes they will see the same findings once human trials begin in the coming weeks.

“We have done extensive studies in mice and rats and the effect of the vaccine was quite dramatic,” he says. We demonstrated that, yes, the vaccine prevents fentanyl from penetrating the brain. It keeps it in the blood. And then the fentanyl is removed from the body.”

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He believes the vaccine could be available to the public within two years, he said.

“Given that the vaccine is already made up of components that are already on the market and already have been tested in humans, we feel that when it comes time to submit our application to the FDA, we are hopeful that the approval process will be expedited .”

The team began working on the fentanyl vaccine nearly six years ago.

Dr. Haile and his team began working on the vaccine nearly six years ago when an unprecedented rise in overdose death started to surface. The vaccine was developed from two protein strands already used in other vaccine treatments.

Fentanyl and other synthetic opioids have become the primary cause of overdose deaths in the US and it’s estimated that over 110,000 occurred between August 2021 and August 2022 – a stunning record for a single 12-month period.

Haile and his team say human trials will begin soon. They hope for FDA approval within the next two years.
(Fox News Media)

With over 150 people dying every day from overdoses of synthetic opioids, according to the CDC, the vaccine comes at a crucial time as the drug crisis grips the country.

“Unfortunately, starting about 10 years ago or so, the manufacture of fentanyl was increased, and it became much more part of the mainstream in terms of illicit drug markets, to see it first being part of the drug supply and more recently, just completely taking over for any other illicit opioid,” Dr. Wilson Compton, deputy director with the National Institute on Drug Abuse, which consults with Dr. Haile’s research team, said to Fox News.

“So, heroin [use] is dropping in many parts of the country because fentanyl is cheaper, easier to smuggle, and produces the same brain effects.”

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The vaccine development has been funded by the Department of Defense, where officials tell Fox News that backed the project after the need to address the prevalence of addiction among the families of many service members.

“We need this vaccine…There’s so many people that can be helped.”

Dr. Haile points out that this vaccine would be best for those who have already undergone detox, as it will prevent relapses.

“This vaccine is for individuals that want to quit. It is not for individuals that do not want to quit,” he says.

“A vaccinated individual — if they do not want to quit their opioid addiction, they can take other drugs, other opioid drugs, or just other drugs that are vaccine antibodies do not target.”

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People have already been contacting the team at the University of Houston asking to be added to the upcoming trials — something that Dr. Haile says underscores the need for this treatment.

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“We need this. We need this vaccine. And there’s so many people that can be helped,” he says.

“It needs to happen, and it will happen.”

Fox News’ Evan Goldman contributed to this report.

Trouble getting pregnant, fatigue, erectile dysfunction, and hair loss are all common symptoms of low testosterone. Ads from a booming testosterone industry remind us of this constantly, as do food and fitness “hacks” touted by so many influencers. Professional opinions on the right levels of testosterone for men vary widely — even among tenured experts. No wonder so many men obsess over their testosterone levels. A new study aims to clear up what can be defined as low T — by outlining the differences in testosterone through age. But some doctors wonder whether the proposed change could throw tens of millions of men into even more confusion over where they stand and what to do about their testosterone.

Getting To A New Testosterone Threshold

The new study, published in The Journal of Urology, argues that the standard cutoff point for clinically low testosterone levels in men needs to be adjusted. There’s currently a single cutoff for low blood testosterone: 300 nanograms per deciliter (ng/dL). But the study researchers argue that what counts as low T depends on a man’s age — an aspect previously overlooked because most data collected came from men over 40.

“Young men have different testosterone reference ranges than older men,” said lead author Alex Zhu, DO, a urology resident at Michigan Medicine, in a press statement. “Our findings suggest we should be using age-specific cutoffs when assessing testosterone levels in younger men.”

How much testosterone a cisgender man has in his body — measured through a blood test — can change throughout his lifetime, and most start experiencing a decline around age 30 to 40 as the glands that produce testosterone, including those in the testicles, start slowing down . Testosterone levels also drop when a man becomes a dad, which may have an evolutionary root in the dad giving up hunting for new mates and instead becoming a family man, increasing the survival of his baby.

Before that decline begins, “normal” testosterone levels range from about 264 ng/dL to 916 ng/dL, according to the Endocrine Society. But different studies over the years have yielded slightly varying results of what normal ranges can be.

To learn more about normal testosterone levels throughout a man’s lifetime, Zhu’s team analyzed testosterone data from nearly 1,500 US men between the ages of 20 and 44. For each age group, they split up the testosterone levels they found into thirds: a low third of the population, an average third, and a high third. They found that with every year a man gets older, his testosterone drops by an average 4.3 ng/dL.

The researchers found that a testosterone level anywhere below 409 ng/dL — well above the current low testosterone cutoff — is already low for a man in his early 20s compared to the average T levels of his 20- to 24-year-old peers. This calls for an update to low testosterone standards, Zhu’s team argues, and that man should be considered to have low T and be eligible for insurance-covered testosterone therapy.

The Argument For Age-Specific Testosterone Cut-Offs

With these findings, clinicians could use age-specific low T cutoffs instead of a “one size fit all” approach, according to Zhu’s team. Changing the official thresholds used by doctors — like the one set by the American Urological Association Testosterone Deficiency guidelines, which came out in 2018 and probably won’t get updated for a few more years — could make it easier for younger men who may need it to access testosterone therapy. Currently, insurance only tends to cover patients who fall below the standard 300 ng/dL cutoff.

But having lower testosterone than your peers — specifically, falling into the lower third of testosterone levels for your age group — doesn’t necessarily mean you’ll have symptoms of low testosterone or need treatment, says Kevin Campbell, MD, a urologist at the University of Florida Health who was not involved in the study. Not everyone under 300 ng/dL has symptoms that can be traced back to low T, and not everyone above that level is symptom-free.

“We do have to take it with a grain of salt,” says Campbell. Testosterone, like everything in the body, operates in a complex system — although blood levels of testosterone can be high or low, the amount of T actually available to the body might be different, because testosterone is bound to other molecules that orchestrate whether testosterone is used or not.

“The concept of age-appropriate thresholds for testosterone deficiency makes a lot of sense,” says Guillaume Paré, MD, a molecular epidemiologist at McMaster University in Ontario, Canada, who was not involved in the study. Paré does, however, worry that testosterone deficiency is too often defined as testosterone concentration below the 33rd percentile, basically saying that one in three men will always be testosterone-deficient. He doesn’t think that’s reasonable.

“By design, current thresholds categorize a third of males as having low testosterone. This is a large proportion of individuals and might not reflect whether biologically there is too little testosterone,” says Parè.

The Risks And Rewards Of Testosterone Treatment

He believes that there should be stricter thresholds for low testosterone, and worries that a diagnosis of testosterone deficiency at a young age could lead to overzealous long-term treatment with testosterone replacement therapy, of which the potential side effects are yet to be researched in detail .

“The potential side effects of such treatment are not well understood,” Parè says. “Our own research suggests it could lead to an increased risk of prostate cancer, high blood pressure, and baldness,” he says, pointing to his 2020 study in the journal eLife.

The FDA has issued warnings that testosterone therapies can increase the risk of heart failure. However, its European equivalent, the EMA, notes that the data doesn’t sufficiently support that testosterone therapy causes heart problems. The scientific jury is still out on other effects of the therapy, including whether it betters or worsens sleep apnea, for example.

A 2022 study by Northwestern Medicine suggests that commercial brands providing testosterone therapy are quick to provide medication without going through its pros and cons — for example, 83.3% of the surveyed brands did not mention the possibility of an increase in blood thickness.

“We should make sure there is a clear benefit to each patient started on testosterone replacement therapy, as it might not be as benign as sometimes assumed,” Parè says

To avoid unnecessary treatment, it’s important not to interpret testosterone levels in isolation, says Richard Anderson, Ph.D., MD, co-director of the Center for Reproductive Health at The University of Edinburgh in Scotland, who wasn’t involved in the study. Whether the man is experiencing symptoms, has other health issues, has been under recent stress, or has experienced any lifestyle changes that could affect his testosterone levels, such as increased smoking or drinking, is imperative for interpreting testosterone blood levels in context.

Sometimes patients are able to wean off of testosterone replacement therapy, though they would likely have all the same symptoms that first brought them to therapy. And stopping high-dose testosterone therapy can cause drastic withdrawal symptoms.

“We know of the consequences of very low levels, and it is clear that treatment is beneficial,” says Anderson. “But this is not the case for less marked low levels, and we must avoid over-treatment, as it’s very difficult to stop treatment later.”

Most gym enthusiasts have one particular area of ​​their body that’s their main focus. For some individuals, it’s a thick waist. Others spend a solid amount of time strengthening flabby arms. Another frustrating issue to address during workouts happens to be man boobs, also known as “moobs.” If you fall into this frustrating category, we are here with four kettlebell exercises to get rid of moobs as you age.

To learn exactly how to tackle this stubborn area, Eat This, Not That! spoke with Chad Barribeau, BS, CSCS, a field support director for D1 Training, a leading fitness concept that spotlights the five basic tenets of athletic-based training to help individuals at any age accomplish their fitness goals. Barribeau is also a certified nutritionist and has worked with a ton of NFL, MLB, and NHL athletes. He specifically raves about using kettlebells in workout programs, as they provide a wealth of benefits that you won’t get with other equipment.

Barribeau explains, “How you can manipulate your grip and load the muscles is very different from using traditional dumbbells. Depending on the grip, you can create ‘chaos’ and make movements much more unstable, causing muscles to strain even more, further strengthening them through the entire range of motion.”

Barribeau suggests some specific kettlebell exercises for toning and strengthening your chest to get rid of moobs, including the bottoms-up kettlebell bench press. “This will cause a great change in balance/stability throughout the movement,” he tells us, adding, “A few other great movements to incorporate into your program would be supine lying kettlebell pullover, kettlebell chest flys, and standing kettlebell chest press. “

Kettlebells are a total staple for any solid routine, as they provide such variation and challenge to many basic moves. Let’s get started with this productive workout!

Bottoms-Up Kettlebell Bench Press

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First up is the bottoms-up kettlebell bench press. To get started, form a standard bench press position. Next, take hold of the kettlebell horn; the bell should be pointing up toward the sky. Using control, slowly start the movement using a similar form to a standard dumbbell bench press.

RELATED: 5 Everyday Habits To Get Rid Of Your ‘Moobs’ After 50, Expert Says

Supine Lying Kettlebell Pullover

Start this next exercise by lying flat on your back, using the floor or a bench. Then, take hold of the round bell part of your kettlebell. Lower the kettlebell to chest level, maintaining straight arms. Next, bring it back to the starting position.

Kettlebell Chest Flys

Begin your chest flys by taking the horn of your kettlebell; the round bell should be on the back of your forearm/wrist. While keeping your elbows bent and firm, start to lower both arms to each side. Squeeze your chest while returning your arms to the start position. This motion should look like hugging a tree.

RELATED: Eliminate Your Man Boobs With 5 Dumbbell Exercises, Trainer Says

Standing Kettlebell Chest Press

For the standing kettlebell chest press, stand straight and keep a firm hold on the kettlebell on one side as you attempt to push both of your hands together. At the same time, press the kettlebell slowly away from your torso, then get back into the starting position. You should be consistently squeezing the kettlebell throughout the move.

Alexa Mellardo

Research has identified suPAR as a protein that contributes to the development of atherosclerosis and kidney disease, offering new opportunities for treatment.

Traditionally, clinicians have approached the treatment of disease by controlling diabetes and blood pressure, and utilizing cardiovascular medications such as aspirin and statins to lower cholesterol.

However, heart disease continues to be the leading cause of death in the United States. Even when risk factors are managed, many patients still experience heart attacks, according to Salim Hayek, MD, physician-scientist and medical director of the University of Michigan Health Frankel Cardiovascular Clinics.

But a study led by Michigan Medicine has uncovered a protein produced by the immune system that causes atherosclerosis – the hardening of arteries that affects over a billion people worldwide – which offers the promise of new treatments.

“Targeting the immune component central to the development of atherosclerosis is the Holy Grail for the treatment of heart disease,” said Hayek, senior author of the study “This is the first time that a component of the immune system is identified that meets all the requirements for being a promising treatment target for atherosclerosis.”

This protein, called soluble urokinase plasminogen activator receptor, or suPAR, is produced by the bone marrow. It acts as a regulator, essentially a thermostat for the activity of the immune system, or “immunostat”.

Past studies have shown suPAR to be a marker of cardiovascular disease. But this study, published in the Journal of Clinical Investigation, is the first evidence showing that the protein actually causes atherosclerosis when at high levels.

Three-pronged findings

First, the research team analyzed the Multi-Ethnic Study of Atherosclerosis, which consists of over 5,000 people without known cardiovascular disease and found that those who had higher suPAR levels were much more prone to develop atherosclerosis and experience cardiovascular events, regardless of their underlying risk factors.

Then, the investigators did a genetic study of 24,000 people to find whether certain genetic variations affected levels of suPAR in blood. They discovered a specific variant in the PLAUR gene that codes for suPAR, and people with that genetic variant tended to have higher suPAR levels. Most importantly, that genetic variant was linked to atherosclerosis in a Mendelian randomization analysis of 500,000 participants in the UK Biobank, which was replicated in two other large data sets.

“We also found that participants lacking a copy of the PLAUR gene have a lower risk of heart disease,” said first author and geneticist George Hindy, MD, Ph.D., of Regeneron Genetics Center. “Altogether, the genetic data is truly compelling for high suPAR being a cause of atherosclerosis.”

Finally, in mouse models with high suPAR levels, researchers saw a dramatic increase in atherosclerotic plaques of mouse aortas compared to mice with normal suPAR levels.

“Even prior to developing atherosclerosis, the mouse aortas with high suPAR levels contained more inflammatory white blood cells, and the immune cells circulating in the blood were in an activated state, or ‘attack-mode,’” said Daniel Tyrrell, Ph.D ., co-first author and research fellow at the UM Health Frankel Cardiovascular Center. “High suPAR levels appear to activate the immune cells and prime them to overreact to the high cholesterol environment, causing these cells to enter the blood vessel wall and accelerate the development of atherosclerosis.”

What is unique about this study, Hayek says, is that it brings to light high-quality clinical, genetic, and experimental data – all pointing to suPAR as a cause of atherosclerotic disease.

“Now, we’re looking into developing treatments to reduce suPAR levels safely as a strategy to prevent and treat heart disease, especially since traditional therapies for atherosclerosis have no impact on suPAR,” he said.

suPAR linking kidney and cardiovascular disease

The study doesvetails findings that suPAR is known to be a pathogenic factor that causes kidney disease, which impacts one in seven Americans. People often experience the two conditions together: two-thirds of people with kidney disease are affected by cardiovascular disease, and over 40% of patients with cardiovascular disease have signs of kidney disease.

“This paper places suPAR as the link between kidney and cardiovascular disease; a common factor causing both through this inappropriate, persistent activation of the immune system,” said co-author Jochen Reiser, MD, Ph.D., chair of the Department of Medicine at Rush University and an expert in the study of suPAR. “This is pointed out in the Mendelian randomization genetic analysis done by the investigators, showing that high suPAR is also linked to kidney disease.”

For both conditions, suPAR has long been known as a biomarker for poor outcomes and disease progression. In a 2020 study, Hayek’s team found that suPAR can worsen acute kidney injury and that blocking suPAR prevents it. A recent study led by Hayek found that levels of protein are high in patients with heart failure and predict death for patients.

Research into suPAR’s role in health and disease has advanced rapidly in the past 10 years. Hayek says suPAR has great potential to be a successful treatment target for cardiovascular and kidney disease. His lab has already begun work designing anti-suPAR therapies and planning clinical trials.

“My hope is that we are able to provide these treatments to our patients within the next three to five years,” he said. “This will be a game changer for the treatment of atherosclerotic and kidney disease”.

Reference: “Increased soluble urokinase plasminogen activator levels modulate monocyte function to promote atherosclerosis” by George Hindy, Daniel J. Tyrrell, Alexi Vasbinder, Changli Wei, Feriel Presswalla, Hui Wang, Pennelope Blakely, Ayse Bilge Ozel, Sarah Graham, Grace H. Holton, Joseph Dowsett, Akl C. Fahed, Kingsley-Michael Amadi, Grace K. Erne, Annika Tekmulla, Anis Ismail, Christopher Launius, Nona Sotoodehnia, James S. Pankow, Lise Wegner Thørner, Christian Erikstrup, Ole Birger Pedersen, Karina Banasik , Søren Brunak, Henrik Ullum, Jesper Eugen-Olsen, Sisse Rye Ostrowski, on behalf of the DBDS Consortium, Mary E. Haas, Jonas B. Nielsen, Luca A. Lotta, on behalf of the Regeneron Genetics Center, Gunnar Engström, Olle Melander, Marju Orho-Melander, Lili Zhao, Venkatesh L. Murthy, David J. Pinsky, Cristen J. Willer, Susan R. Heckbert, Jochen Reiser, Daniel R. Goldstein, Karl C. Desch and Salim S. Hayek, 4 October 2022, Journal of Clinical Investigation.
DOI: 10.1172/JCI158788

The study was funded by the National Heart, Lung, and Blood Institute (NHLBI), the Michigan Institute for Clinical & Health Research (MICHR), and the Gilead Sciences Research Scholar Program in Cardiovascular Disease.

Hayek and the University of Michigan have patents filed for the use of suPAR levels in the management of cardiovascular disease and the use anti-suPAR therapies as a strategy to prevent and treat atherosclerosis. Hayek and Reiser are scientific advisory board members of Walden Biosciences, a company devising therapeutics targeting suPAR in kidney disease. Hindy, Haas, Nielsen and Lotta receive salary, stocks and stock options from Regeneron Pharmaceuticals, Inc. Eugen-Olsen is a co-founder, shareholder, and chief scientific officer of Virogates and a named inventor on patents related to suPAR.

New York and New Jersey are among 12 states involved in a small outbreak of an “extensively” drug-resistant bacteria, according to an alert released Wednesday evening by the Centers for Disease Control and Prevention. The CDC has linked several of the cases to EzriCare Artificial Tears, a brand of over-the-counter eye drops.

The germ is a rare, mutant strain of Pseudomonas aeruginosa, a type of bacteria commonly found in freshwater, soil and other environmental settings.

But in recent years, antibiotic-resistant forms of the bacteria have become a scoop of health care settings because it easily survives on surfaces, forming “biofilms” on equipment and devices. It can also spread via contaminated hands. To cause an infection, the germ must get through the skin — via a needle stick during an IV, for example, or via an organ transplant.

But Pseudomonas aeruginosa can also invade the body through a person’s wet, skinless mucosal eyes. These infections are typically seen when people wear contact lenses for too long.

Of the 55 cases identified so far, 35 patients are linked to clusters in four health care facilities. So far, one patient has died, and others have been hospitalized or suffered permanent vision loss.

Many but not all of the patients developed eye infections, and most used artificial tears or lubricating eye drops. Although patient investigators told about more than 10 different brands, the most common was EzriCare Artificial Tears.

“Patients and health care providers should immediately stop the use of EzriCare Artificial Tears pending additional information and guidance from CDC and FDA,” the CDC stated.

The CDC said subsequent testing of opened EzriCare bottles detected a strain of Pseudomonas aeruginosa that’s resistant to a dozen antimicrobial drugs. But federal health investigators found the germ is still susceptible to the antibiotic cefiderocol. The CDC said it continues to test unopened bottles to see if the contamination occurred during the manufacturing process.

In a statement posted on its website on Wednesday, EzriCare wrote that its Artificial Tears product is manufactured in India by Global Pharma Healthcare PVT Limited and imported into the US by Aru Pharma Inc. The company is based in Lakewood, New Jersey.

“EzriCare LLC’s only role in introducing the product to the market was to design an exterior label and to market it to our customers,” the company stated. “We understand that the same product is also marketed under other brand names. We understand that Global Pharma Healthcare PVT Limited will be initiating a recall of the product.”

The company said that it is contacting customers to advise them against using its product. The CDC said health care providers treating new or current patients with eye inflammation should ask them if they’ve recently used EzriCare Artificial Tears.

Pseudomonas aeruginosa is one of several bacteria known to gain the ability of drug resistance. According to CDC data, multidrug-resistant forms of Pseudomonas aeruginosa hospitalized 32,600 people in 2017 and killed 2,700.

The same report shows that ahead of the COVID-19 pandemic, rates of this germ were dropping due to infection control efforts. But it and other antibiotic-resistant germs rebounded during the pandemic. The CDC estimates that more than 2.8 million antimicrobial-resistant infections occur each year, leading to more than 35,000 deaths.