Urinary tract infections in men: Here are 10 things to know | CNN

Editor’s Note: Dr. Jamin Brahmbhatt is a urologist and robotic surgeon with Orlando Health and president of the Florida Urological Society.



CNN
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While urinary tract infections are more common in women, men can still get what’s commonly known as a UTI. Here are 10 things I’d like you to know about urinary tract infections, including who’s more at risk and how to get treatment.

UTI is short for urinary tract infection. It’s an infection of the organs in your body – I call them pipes – that are meant to funnel your urine out of your system and into the urinal. Most UTIs are caused by bacteria that work their way into the urethra, prostate, bladder or kidneys.

Way more women than men are diagnosed with UTIs. Anatomically, we feel this happens because women have a shorter urethra – the tube that connects the bladder to the outside world. The shorter length makes it easier for bacteria to travel to the urinary system. Men have longer urethras and therefore can be protected against urinary infections.

But the length of the urethra alone cannot protect men against UTIs – over their lifetimes, 12% of men will get urinary symptoms linked to a UTI. This by no means implies a urethra or penis are short or small. In men, there is usually a more clear pathologic cause to the infection beyond just the length of the urethra.

There are many reasons why a guy may get a UTI – all of them we take seriously and should not be ignored.

Men older than 50 tend to get more infections than younger men. As a urologist, I see men get recurrent infections when they do not properly empty their bladder because of an enlarged prostate. Beyond the prostate, men may not empty their bladder if they have nerve damage from stroke, uncontrolled diabetes or injury to the spine.

Men can also get infections that start from the prostate or testicles that seed up into the bladder, or the opposite can happen where the infection goes from the bladder to the other organs. Kidney stones can also be a cause of infection. (I know this from personal experience – I’ve had a kidney stone myself!)

Younger men may also present with urinary infections because of sexually transmitted diseases. Men can also get an infection if they have a recent procedure done in the urinary system.

4. What are the signs and symptoms of a UTI?

Burning with urination (dysuria), increased urinary frequency, urgency, incontinence, foul smell, blood in the urine, fevers, chills, pain in the abdomen near the bladder. Believe it or not, some men may have zero symptoms and still get diagnosed with a UTI based on urine cultures done for other purposes.

UTI is diagnosed by sending your urine off for a culture. This is when a sample of your urine is processed and evaluated for various strains of bacteria. The most common bacteria identified in urinary tract infections is E.coli. Once the culture is done, the results can guide treatment, which is usually oral antibiotics. There is a test called a urine analysis which can be done quickly in our office which can suggest an infection. However, the best test is an actual culture.

Doctors do not wait for the culture results – which can take one to three days – to start treatment. If an infection is suspected, an antibiotic will be started immediately and then adjusted based on the culture results.

UTIs generally are treated with oral or IV antibiotics. Most infections can be treated with oral antibiotics. However there are superbugs that may be resistant to what we can give you by mouth that may require the use of stronger antibiotics through an IV. Most treatments last seven to 10 days, but can be longer.

In severe cases of infection that has spread to the bloodstream, strong IV antibiotics are started immediately to control the infection. Patients are placed in the hospital to start these strong treatments. You do not have to stay in the hospital for weeks if you have infection in your bloodstream. As long as you are doing well – no fever, normal labs, heart and pulse OK – then you may continue these IV treatments from home. Each treatment is tailored to your condition.

As a doctor, my answer is: No. Men should not try to treat infections on their own. If you have symptoms, get yourself to a doctor or emergency room.

The best prevention is making sure first there is nothing anatomical that needs to be corrected, such as an enlarged prostate, kidney stone or blockage.

Proper hygiene can help prevent infections. Men with uncircumcised penises should make sure they can retract the foreskin and clean under the foreskin and the glans properly. Cranberry supplements have been shown to help prevent infections. Staying hydrated by drinking enough fluids/water during the day can also help. Making sure you don’t hold your urine can help, too. Staying in good health to avoid chronic medical conditions such as diabetes and heart disease will also protect against infections.

9. My infection is gone. Are there any long-term effects on my body?

Recurrent, untreated infections could cause strictures, or tight scars, in your urethra that would slow your stream and make it difficult to empty your bladder. Infections could also cause the bladder to lose its ability to fill and empty properly. In the long run, if you are getting constantly treated with antibiotics, we may run out of antibiotics to give you due to resistance.

The first priority is to clear the infection with antibiotics.

From there, we do a full workup with a detailed history, evaluation of chronic medical problems and exam of the genitals to look for anatomic issues such as a foreskin that won’t retract back. Imaging may include a CT scan of the abdomen and pelvis to look for kidney stones, blocked tubes and other abnormalities.

If you see a urologist, you will likely get a cystoscopy, where we place a camera inside of a small tube into the urethra to look at the inside of your urine channel. The cystoscopy helps look for strictures, large obstructing prostates and changes to the bladder walls. Once a cause is found, it’s aggressively treated with either medication or surgery.

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Weight loss drugs boost sales at retail pharmacies, but they may not help profits much

A pharmacist displays boxes of Ozempic, a semaglutide injection drug used for treating type 2 diabetes made by Novo Nordisk, at Rock Canyon Pharmacy in Provo, Utah, U.S. March 29, 2023.

George Frey | Reuters

Drugmakers aren’t the only ones feeling the impact of the weight loss industry gold rush.

Retailers with pharmacy businesses, such as Walmart, Kroger and Rite Aid, said increased demand for prescription weight loss drugs helped boost sales for the second quarter.

But analysts note that those blockbuster treatments are minimally profitable for retail pharmacies – and may even come with margin headwinds.

“More recently, you’re starting to hear retailers talk about these drugs. But I wouldn’t say they’re necessarily beneficiaries of the increased popularity,” Arun Sundaram, an analyst at CFRA Research, told CNBC. “They’re really not making much of a profit on the drugs. So it’s really just a traffic driver and not really a profit pool for retailers.”

Buzzy drugs like Novo Nordisk‘s obesity injection Wegovy and diabetes treatment Ozempic have skyrocketed in popularity over the last year, with high-profile names like billionaire tech mogul Elon Musk among recent users.

Those treatments are known as GLP-1s, a class of drugs that mimic a hormone produced in the gut to suppress a person’s appetite.

Other drugmakers, such as Eli Lilly and Pfizer, are developing their own GLP-1s in a bid to capitalize on a weight loss drug market that some analysts project could be worth $200 billion by 2030. An estimated 40% of U.S. adults are obese, making successful treatments a massive opportunity for drugmakers.

But the boom in demand for GLP-1s is also being felt in other parts of the drug supply chain, including the pharmacies that dispense the prescription drugs to patients.

Are weight loss drugs profitable?

On an earnings call Thursday, Walmart CEO Doug McMillon said the company expects weight loss drugs to help drive sales for the rest of the year: “We still expect food, consumables, and health and wellness, primarily due to the popularity of some GLP-1 drugs, to grow as a percent total in the back half.”

In June, likewise, Rite Aid CFO Matthew Schroeder said a jump in pharmacy revenue and the company’s decision to hike its full-year revenue guidance was “due to the increase in sales volume in Ozempic and other high-dollar GLP-1s.” Schroeder was referring to the hefty price tags of GLP-1s, which range from around $900 to $1,300 in the U.S.

He said those drugs have high sales amounts per prescription, but emphasized that the increased volume of GLP-1s has a “minimal impact” on Rite Aid’s gross profit.

Kroger CEO Rodney McMullen similarly said during an earnings call in June that GLP-1 drug “sales dollars are a lot bigger than the margin dollars.”

“We would expect the GLP-1 type drugs to continue but remember, the impact on profitability is pretty narrow,” he said.

That’s because GLP-1s like Wegovy and Ozempic are branded drugs with “very, very low gross margins,” according to CFRA Research’s Sundaram.

He said retail pharmacies generate high sales for each GLP-1 prescription they dispense but rake in low profits, which is having a slight negative impact on the overall gross margins of retailers like Walmart and Kroger.

UBS analyst Michael Lasser similarly highlighted in a recent note that gross margins for Walmart’s U.S. business “would have looked even better had it not been for the contribution of the GLP-1 drugs since these carry very low profit rates.”

A selection of injector pens for the Saxenda weight loss drug are shown in this photo illustration in Chicago, Illinois, U.S., March 31, 2023.

Jim Vondruska | Reuters

Gross margins for branded medications are 3.5% on average for pharmacies, according to a 2017 study from USC’s Schaeffer Center for Health Policy and Economics. That suggests it may take years before a branded drug significantly contributes to a pharmacy’s bottom line.

In contrast, gross margins for generic drugs – the cheaper equivalents of branded medications – are 42.7% on average for pharmacies.

There are several reasons for the lower margins of branded drugs. For one, branded drugs don’t directly compete with other medications because they have patent protections. That gives drug manufacturers more power when they negotiate drug discounts with wholesalers, which purchase medications and distribute them to pharmacies.

As a result, there is “little room for wholesalers and pharmacies to capture large margins due to their relative lack of negotiating power,” according to the Association for Accessible Medicines, a trade association representing the manufacturers and distributors of generic prescription drugs.

What other impacts do retailers face?

But there are also other impacts of GLP-1s to consider beyond a retailer’s pharmacy business.

For companies like Walmart and Kroger, GLP-1 drugs may be indirectly impacting other business categories in a positive way.

That makes some analysts less worried about margin headwinds in pharmacy: “The gross margin headwind is less of a risk overall for Walmart because any footstep in the door often ends up with multiple items in a basket,” KeyBanc analyst Bradley Thomas told CNBC.

“Walmart is generally not a quick store that you just pop in on the way home,” he said. “They’re going to make multiple purchases, and I think we’re seeing a lot of discretionary categories actually see a lift from some of this incremental traffic they’ve been getting lately.”

Thomas added that GLP-1 drugs only fall under one part of Walmart’s business: “If you’re listing off the most important things that are driving Walmart’s strong sales performance right now, it’s probably not making the top 10,” he said.

It’s a slightly different situation for Rite-Aid and similar companies like CVS Health and Walgreens.

Those companies have retail pharmacies but also other business segments that are directly affected in different ways by the boom in GLP-1 drugs.

For example, CVS also operates a health insurer and pharmacy benefit manager, or PBM, which maintains formularies and negotiates drug discounts with manufacturers on behalf of insurers and large employers.

The increased demand for GLP-1 drugs is likely more of a headwind for health insurers since they have to cover the costly drugs for beneficiaries, but CVS says “the risk is manageable” in that business division.

Meanwhile, PBMs may benefit more from the increase in GLP-1 use since they negotiate significant discounts on drugs and drive competition between manufacturers – but they often don’t pass along all of the savings to insurers.

“Each of the businesses kind of has GLP-1 in them and they are impacting them in a variety of different ways,” CVS CEO Karen Lynch said during an earnings call last month.

Correction: The Association for Accessible Medicines is a trade association representing the manufacturers and distributors of generic prescription drugs. An earlier version misstated its name.

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Here are our top 4 stocks and worst 4 stocks to start the second half of 2023

Traders work on the floor of the New York Stock Exchange (NYSE) in New York City, U.S., July 12, 2023.

Brendan McDermid | Reuters

Two weeks into the second half of the year, we put together a quick look at the top four performers and the bottom four in Jim Cramer’s Charitable Trust, the stock portfolio we use for the Investing Club.

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Black or ‘Other’? Doctors may be relying on race to make decisions about your health | CNN

Editor’s Note: CNN’s “History Refocused” series features surprising and personal stories from America’s past to bring depth to conflicts still raging today.



CNN
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When she first learned about race correction, Naomi Nkinsi was one of five Black medical students in her class at the University of Washington.

Nkinsi remembers the professor talking about an equation doctors use to measure kidney function. The professor said eGFR equations adjust for several variables, including the patient’s age, sex and race. When it comes to race, doctors have only two options: Black or “Other.”

Nkinsi was dumbfounded.

“It was really shocking to me,” says Nkinsi, now a third-year medical and masters of public health student, “to come into school and see that not only is there interpersonal racism between patients and physicians … there’s actually racism built into the very algorithms that we use.”

At the heart of a controversy brewing in America’s hospitals is a simple belief, medical students say: Math shouldn’t be racist.

The argument over race correction has raised questions about the scientific data doctors rely on to treat people of color. It’s attracted the attention of Congress and led to a big lawsuit against the NFL.

What happens next could affect how millions of Americans are treated.

Carolyn Roberts, a historian of medicine and science at Yale University, says slavery and the American medical system were in a codependent relationship for much of the 19th century and well into the 20th.

“They relied on one another to thrive,” Roberts says.

It was common to test experimental treatments first on Black people so they could be given to White people once proven safe. But when the goal was justifying slavery, doctors published articles alleging substantive physical differences between White and Black bodies — like Dr. Samuel Cartwright’s claim in 1851 that Black people have weaker lungs, which is why grueling work in the fields was essential (his words) to their progress.

The effects of Cartwright’s falsehood, and others like it, linger today.

In 2016, researchers asked White medical students and residents about 15 alleged differences between Black and White bodies. Forty percent of first-year medical students and 25% of residents said they believed Black people have thicker skin, and 7% of all students and residents surveyed said Black people have less sensitive nerve endings. The doctors-in-training who believed these myths — and they are myths — were less likely to prescribe adequate pain medication to Black patients.

To fight this kind of bias, hospitals urge doctors to rely on objective measures of health. Scientific equations tell physicians everything from how well your kidneys are working to whether or not you should have a natural birth after a C-section. They predict your risk of dying during heart surgery, evaluate brain damage and measure your lung capacity.

But what if these equations are also racially biased?

Race correction is the use of a patient’s race in a scientific equation that can influence how they are treated. In other words, some diagnostic algorithms and risk predictor tools adjust or “correct” their results based on a person’s race.

The New England Journal of Medicine article “Hidden in Plain Sight” includes a partial list of 13 medical equations that use race correction. Take the Vaginal Birth After Cesarean calculator, for example. Doctors use this calculator to predict the likelihood of a successful vaginal delivery after a prior C-section. If you are Black or Hispanic, your score is adjusted to show a lower chance of success. That means your doctor is more likely to encourage another C-section, which could put you at risk for blood loss, infection and a longer recovery period.

Cartwright, the racist doctor from the 1800s, also developed his own version of a tool called the spirometer to measure lung capacity. Doctors still use spirometers today, and most include a race correction for Black patients to account for their supposedly shallower breaths.

Turns out, second-year medical student Carina Seah wryly told CNN, math is as racist as the people who make it.

The biggest problem with using race in medicine? Race isn’t a biological category. It’s a social one.

“It’s based on this idea that human beings are naturally divided into these big groups called races,” says Dorothy Roberts, a professor of law and sociology at the University of Pennsylvania, who has made challenging race correction in medicine her life’s work. “But that’s not what race is. Race is a completely invented social category. The very idea that human beings are divided into races is a made-up idea.”

Ancestry is biological. Where we come from — or more accurately, who we come from — impacts our DNA. But a patient’s skin color isn’t always an accurate reflection of their ancestry.

Look at Tiger Woods, Roberts says. Woods coined the term “Cablinasian” to describe his mix of Caucasian, Black, American Indian and Asian ancestries. But to many Americans, he’s Black.

CNN RED TIGER WOODS

“You can be half Black and half White in this country and you are Black,” says Seah, who is getting her medical degree and a PhD in genetics and genomics at the Icahn School of Medicine at Mount Sinai in New York. “You can be a quarter Black in this country — if you have dark skin, you are Black.”

So it can be misleading, Seah says, even dangerous, for doctors to judge a patient’s ancestry by glancing at their skin. A patient with a White mother and Black father could have a genetic mutation that typically presents in patients of European ancestry, Seah says, but a doctor may not think to test for it if they only see Black skin.

“You have to ask, how Black is Black enough?” Nkinsi asks. And there’s another problem, she says, with using a social construct like race in medicine. “It also puts the blame on the patient, and it puts the blame on the race itself. Like being Black is inherently the cause of these diseases.”

Naomi Nkinsi is a third-year medical and masters of public health student at the University of Washington in Seattle. She has been advocating for the removal of race correction in medicine.

After she learned about the eGFR equation in 2018, Nkinsi began asking questions about race correction. She wasn’t alone — on social media she found other students struggling with the use of race in medicine. In the spring of 2020, following a first-year physiology lecture, Seah joined the conversation. But the medical profession is nothing if not hierarchical; Nkinsi and Seah say students are encouraged to defer to doctors who have been practicing for decades.

Then on May 25, 2020, George Floyd was killed by police in Minneapolis.

His death and the growing momentum around Black Lives Matter helped ignite what Dr. Darshali A. Vyas calls an “overdue reckoning” in the medical community around race and race correction. A few institutions had already taken steps to remove race from the eGFR equation. Students across the country demanded more, and hospitals began to listen.

History Refocused BLM White Coats

Four days after Floyd’s death, the University of Washington announced it was removing race correction from the eGFR equation. In June, the Boston-based hospital system Mass General Brigham where Vyas is a second-year Internal Medicine resident followed suit. Seah and a fellow student at Mount Sinai, Paloma Orozco Scott, started an online petition and collected over 1600 signatures asking their hospital to do the same.

Studies show removing race from the eGFR equation will change how patients at those hospitals are treated. Researchers from Brigham and Women’s Hospital and Penn Medicine estimated up to one in every three Black patients with kidney disease would have been reclassified if the race multiplier wasn’t applied in earlier calculations, with a quarter going from stage 3 to stage 4 CKD (Chronic Kidney Disease).

That reclassification is good and bad, says Dr. Neil Powe, chief of medicine at Zuckerberg San Francisco General Hospital. Black patients newly diagnosed with kidney disease will be able to see specialists who can devise better treatment plans. And more patients will be placed on kidney transplant lists.

On the flip side, Powe says, more African Americans diagnosed with kidney disease means fewer who are eligible to donate kidneys, when there’s already a shortage. And a kidney disease diagnosis can change everything from a patient’s diabetes medication to their life insurance costs.

Dr. Neil Powe says by simply removing race from the eGFR equations,

Powe worries simply eliminating race from these equations is a knee-jerk response — one that may exacerbate health disparities instead of solve them. For too long, Powe says, doctors had to fight for diversity in medical studies.

The most recent eGFR equation, known as the CKD-EPI equation, was developed using data pooled from 26 studies, which included almost 3,000 patients who self-identified as Black. Researchers found the equation they were developing was more accurate for Black patients when it was adjusted by a factor of about 1.2. They didn’t determine exactly what was causing the difference in Black patients, but their conclusion is supported by other research that links Black race and African ancestry with higher levels of creatinine, a waste product filtered by the kidneys.

Put simply: In the eGFR equation, researchers used race as a substitute for an unknown factor because they think that factor is more common in people of African descent.

Last August, Vyas co-authored the “Hidden in Plain Sight” article about race correction. Vyas says most of the equations she wrote about were developed in a similar way to the eGFR formula: Researchers found Black people were more or less likely to have certain outcomes and decided race was worth including in the final equation, often without knowing the real cause of the link.

“When you go back to the original studies that validated (these equations), a lot of them did not provide any sort of rationale for why they include race, which I think is appalling.” That’s what’s most concerning, Vyas says – “how willing we are to believe that race is relevant in these ways.”

Vyas is clear she isn’t calling for race-blind medicine. Physicians cannot ignore structural racism, she says, and the impact it has on patients’ health.

Powe has been studying the racial disparities in kidney disease for more than 30 years. He can spout the statistics easily: Black people are three times more likely to suffer from kidney failure, and make up more than 35% of patients on dialysis in the US. The eGFR equation, he says, did not cause these disparities — they existed long before the formula.

“We want to cure disparities, let’s go after the things that really matter, some of which may be racist,” he says. “But to put all our stock and think that the equation is causing this is just wrong because it didn’t create those.”

In discussions about removing race correction, Powe likes to pose a question: Instead of normalizing to the “Other” group in the eGFR equation, as many of these hospitals are doing, why don’t we give everyone the value assigned to Black people? By ignoring the differences researchers saw, he says, “You’re taking the data on African Americans, and you’re throwing it in the trash.”

Powe is co-chair of a joint task force set up by the National Kidney Foundation and the American Society of Nephrology to look at the use of race in eGFR equations. The leaders of both organizations have publicly stated race should not be included in equations used to estimate kidney function. On April 9, the task force released an interim report that outlined the challenges in identifying and implementing a new equation that’s representative of all groups. The group is expected to issue its final recommendations for hospitals this summer.

Race correction is used to assess the kidneys and the lungs. What about the brain?

In 2013, the NFL settled a class-action lawsuit brought by thousands of former players and their families that accused the league of concealing what it knew about the dangers of concussions. The NFL agreed to pay $765 million, without admitting fault, to fund medical exams and compensate players for concussion-related health issues, among other things. Then in 2020, two retired players sued the NFL for allegedly discriminating against Black players who submitted claims in that settlement.

01 race correction Kevin Henry Najeh Davenport SPLIT

The players, Najeh Davenport and Kevin Henry, said the NFL race-corrected their neurological exams, which prevented them from being compensated.

According to court documents, former NFL players being evaluated for neurocognitive impairment were assumed to have started with worse cognitive function if they were Black. So if a Black player and a White player received the exact same scores on a battery of thinking and memory tests, the Black player would appear to have suffered less impairment. And therefore, the lawsuit stated, would be less likely to qualify for a payout.

Race correction is common in neuropsychology using something called Heaton norms, says Katherine Possin, an associate professor at the University of California San Francisco. Heaton norms are essentially benchmark average scores on cognitive tests.

Here’s how it works: To measure the impact of a concussion (or multiple concussions over time), doctors compare how well the patient’s brain works now to how well it worked before.

“The best way to get that baseline was to test you 10 years ago, but that’s not something we obviously have for many people,” Possin says. So doctors estimate your “before” abilities using an average score from a group of healthy individuals, and adjust that score for demographic factors known to affect brain function, like your age.

Heaton norms adjust for race, Possin says, because race has been linked in studies to lower cognitive scores. To be clear, that’s not because of any biological differences in Black and White brains, she says; it’s because of social factors like education and poverty that can impact cognitive development. And this is where the big problem lies.

In early March, a judge in Pennsylvania dismissed the players’ lawsuit and ordered a mediator to address concerns about how race correction was being used. In a statement to CNN, the NFL said there is no merit to the players’ claim of discrimination, but it is committed to helping find alternative testing techniques that do not employ race-based norms.

The NFL case, Possin wrote in JAMA, has “exposed a major weakness in the field of neuropsychology: the use of race-adjusted norms as a crude proxy for lifelong social experience.”

This happens in nearly every field of medicine. Race is not only used as a poor substitute for genetics and ancestry, it’s used as a substitute for access to health care, or lifestyle factors like diet and exercise, socioeconomic status and education. It’s no secret that racial disparities exist in all of these. But there’s a danger in using race to talk about them, Yale historian Carolyn Roberts says.

We know, for example, that Black Americans have been disproportionally affected by Covid-19. But it’s not because Black bodies respond differently to the virus. It’s because, as Dr. Anthony Fauci has noted, a disproportionate number of Black people have jobs that put them at higher risk and have less access to quality health care. “What are we making scientific and biological when it actually isn’t?” Roberts asks.

Vyas says using race as a proxy for these disparities in clinical algorithms can also create a vicious cycle.

“There’s a risk there, we argue, of simply building these into the system and almost accepting them as fact instead of focusing on really addressing the root causes,” Vyas says. “If we systematize these existing disparities … we risk ensuring that these trends will simply continue.”

Nearly everyone on both sides of the race correction controversy agrees that race isn’t an accurate, biological measure. Yet doctors and researchers continue to use it as a substitute. Math shouldn’t be racist, Nkinsi says, and it shouldn’t be lazy.

“We’re saying that we know that this race-based medicine is wrong, but we’re going to keep doing it because we simply don’t have the will or the imagination or the creativity to think of something better,” Nkinsi says. “That is a slap in the face.”

Shortly after Vyas’ article published in The New England Journal of Medicine, the House Ways and Means Committee sent letters to several professional medical societies requesting information on the misuse of race in clinical algorithms. In response to the lawmakers’ request, the Agency for Healthcare Research and Quality is also gathering information on the use of race-based algorithms in medicine. Recently, a note appeared on the Maternal Fetal Medicine Units Network’s website for the Vaginal Birth After Cesarean equation — a new calculator that doesn’t include race and ethnicity is being developed.

Dorothy Roberts is excited to see change on the horizon. But she’s also a bit frustrated. The harm caused by race correction is something she’s been trying to tell doctors about for years.

“I’ve taught so many audiences about the meaning of race and the history of racism in America and the audiences I get the most resistance from are doctors,” Roberts says. “They’re offended that there would be any suggestion that what they do is racist.”

Nkinsi and Seah both encountered opposition from colleagues in their fight to change the eGFR equation. Several doctors interviewed for this story argued the change in a race-corrected scores is so small, it wouldn’t change clinical decisions.

If that’s the case, Vyas wonders, why include race at all?

“It all comes from the desire for one to dominate another group and justify it,” says Roberts. “In the past, it was slavery, but the same kinds of justifications work today to explain away all the continued racial inequality that we see in America… It is mass incarceration. It’s huge gaps in health. It’s huge differences in income and wealth.”

It’s easier, she says, to believe these are innate biological differences than to address the structural racism that caused them.



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FDA advisors recommend that new Covid vaccines target an omicron XBB variant this fall

A woman receives a booster dose of the Moderna coronavirus disease (COVID-19) vaccine at a vaccination centre in Antwerp, Belgium, February 1, 2022.

Johanna Geron | Reuters

The U.S. Food and Drug Administration‘s independent panel of advisors on Thursday recommended that updated Covid shots for the fall and winter target one of the XBB variants, which are now the dominant strains of the virus nationwide.

The committee unanimously voted that the new jabs should be monovalent — meaning they are designed to protect against one variant of Covid — and target a member of the XBB family.

Those strains of Covid are descendants of the omicron variant, which caused cases to surge to record levels early last year. They are some of the most immune-evasive strains to date.

Advisors also generally agreed that the new shots should specifically target a variant called XBB.1.5. The panel only discussed that specific strain selection and did not vote on the matter.

XBB.1.5 accounted for nearly 40% of all Covid cases in the U.S. as of early June, according to data from the Centers for Disease Control and Prevention. That proportion is slowly declining, and cases of the related XBB.1.16 and XBB.2.3 variants are on the rise.

Advisors noted that XBB.1.5 appears most ideal for the fall since vaccine manufacturers Pfizer, Moderna and Novavax have already started to develop jabs targeting the strain.

“The 1.5 looks good. It seems like it’s the most feasible to get across the finish line early without resulting in delays and availability,” said Dr. Melinda Wharton, a senior official at the National Center for Immunization and Respiratory Diseases. “The vaccine we can use is the vaccine that we can get. And so it feels like this would be a good choice.”

The FDA typically follows the advice of its advisory committees, but is not required to do so. It’s unclear when the agency will make a final decision on strain selection.

There is also uncertainty about which age groups the FDA and CDC will advise to receive the updated shots this fall.

But the panel’s recommendation is already a win for Pfizer, Moderna and Novavax — all of which have been conducting early trials on their respective XBB.1.5 shots ahead of the meeting.

“Novavax expects to be ready for the commercial delivery of a protein-based monovalent XBB COVID vaccine this fall in line with today’s [advisory committee] recommendation,” said John Jacobs, the company’s president and CEO.

The U.S. is expected to shift vaccine distribution to the private sector this fall. That means the vaccine makers will start selling their new Covid products directly to health-care providers and vie for commercial market share.

The panel’s recommendation coincides with a broader shift in how the pandemic impacts the country and the world at large.

Covid cases and deaths have dropped to new lows, governments have rolled back stringent health mandates like masking and social distancing and many people believe the pandemic is over altogether.

But Dr. Peter Marks, head of the FDA’s vaccine division, said the agency is concerned that the U.S. will have another Covid wave “during a time when the virus has further evolved, immunity of the population has waned further and we move indoors for wintertime.”

Updated Covid vaccines that are periodically updated to target a high circulating variant will restore protective immunity against the virus, said Dr. David Kaslow, a senior official in the FDA’s vaccine division.

It’s a similar approach to how the strains are selected for the annual flu shot. Researchers assess strains of the virus in circulation and estimate which will be the most prevalent during the upcoming fall and winter.

But it’s unclear how many Americans will roll up their sleeves to take the updated shots later this year.

Only about 17% of the U.S. population — around 56 million people —have received Pfizer and Moderna’s boosters since they were approved in September, according to the CDC.

More than 40% of adults 65 and older have been boosted with those shots, while the rate among younger adults and children ranges between 18% and 20%.

Those boosters were bivalent, meaning they targeted the original strain of Covid and the omicron subvariants BA.4 and BA.5.

Pfizer, Moderna and Novavax shot data

During the meeting, Pfizer, Moderna and Novavax presented preliminary data on updated versions of their shots designed to target XBB variants.

Moderna has been evaluating shots targeting XBB.1.5 and XBB.1.16 — another transmissible omicron descendant, according to Rituparna Das, the company’s vice president of Covid vaccines.

Preclinical trial data on mice suggests that a monovalent vaccine targeting XBB.1.5 produces a more robust immune response against the currently circulating XBB variants than the authorized bivalent shot targeting BA.4 and BA.5, according to Das.

She added that clinical trial data on more than 100 people similarly demonstrates that the monovalent XBB.1.5 vaccine produces protective antibodies against all XBB variants. All trial participants had previously received four Covid vaccine doses.

Das said that comprehensive protection against XBB strains is likely due to the fewer unique mutations between the variants, which means their composition is similar.

There are only three unique mutations between the variants XBB.1.5 and XBB.1.16, according to Darin Edwards, Moderna’s Covid vaccine program leader. By comparison, there are 28 mutations between omicron BA.4 and BA.5.

That means the immune response an updated shot produces against XBB variants will likely be similar, regardless of which specific variant it targets, Edwards said.

Pfizer also presented early trial data indicating that a monovalent vaccine targeting an XBB variant offers improved immune responses against the XBB family.

The company provided specific timelines for delivering an updated vaccine, depending on the strain the FDA selects.

Pfizer will be able to deliver a monovalent shot targeting XBB.1.5 by July and a jab targeting XBB.1.16 by August, according to Kena Swanson, the company’s senior principal scientist.

Pfizer won’t be able to distribute a new shot until October if the FDA chooses a completely different strain, Swanson said.

Novavax did not provide a specific timeline for delivering a shot targeting XBB.1.5, but noted that an XBB.1.16 shot would take eight weeks longer.

Novavax unveiled preclinical trial data indicating that monovalent vaccines targeting XBB.1.5 and XBB.1.16 induce higher immune responses to XBB subvariants than bivalent vaccines do.

Data also demonstrates that an XBB.1.5 shot produces antibodies that block XBB.2.3 from binding to and infecting human cells, according to Dr. Filip Dubovsky, Novavax’s chief medical officer.

Dubovsky said the trial results support the use of a monovalent XBB.1.5 shot in the fall.

Novavax’s jab uses protein-based technology, a decades-old method for fighting viruses used in routine vaccinations against hepatitis B and shingles.

The vaccine works differently than Pfizer’s and Moderna’s messenger RNA vaccines but achieves the same outcome: teaching your body how to fight Covid.

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Stem Cells Fast Facts | CNN



CNN
— 

Here is some background information about stem cells.

Scientists believe that stem cell research can be used to treat medical conditions including Parkinson’s disease, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis and rheumatoid arthritis.

Sources: National Institutes of Health, Mayo Clinic

Stem cell research focuses on embryonic stem cells and adult stem cells.

Stem cells have two characteristics that differentiate them from other types of cells:

– They are unspecialized cells that can replicate themselves through cell division over long periods of time.

– Stem cells can be manipulated, under certain conditions, to become mature cells with special functions, such as the beating cells of the heart muscle or insulin-producing cells of the pancreas.

There are many different types of stem cells, including: pluripotent stem cells and adult stem cells.
Pluripotent stem cells (ex: embryonic stem cells) can give rise to any type of cell in the body. These cells are like blank slates, and they have the potential to turn into any type of cell.
Adult stem cells can give rise to multiple types of cells, but are more limited compared with embryonic stem cells. They are more likely to generate within a particular tissue, organ or physiological system. (Ex: blood-forming stem cells/bone marrow cells, sometimes referred to as multipotent stem cells)

Embryonic stem cells are harvested from four to six-day-old embryos. These embryos are either leftover embryos in fertility clinics or embryos created specifically for harvesting stem cells by therapeutic cloning. Only South Korean scientists claim to have successfully created human embryos via therapeutic cloning and have harvested stem cells from them.

Adult stem cells are already designated for a certain organ or tissue. Some adult stem cells can be coaxed into or be reprogrammed into turning into a different type of specialized cell within the tissue type – for example, a heart stem cell can give rise to a functional heart muscle cell, but it is still unclear whether they can give rise to all different cell types of the body.

The primary role of adult stem cells is to maintain and repair the tissue in which they are found.

Regenerative medicine uses cell-based therapies to treat disease.

Scientists who research stem cells are trying to identify how undifferentiated stem cells become differentiated as serious medical conditions, such as cancer and birth defects, are due to abnormal cell division and differentiation.

Scientists believe stem cells can be used to generate cells and tissues that could be used for cell-based therapies as the need for donated organs and tissues outweighs the supply.

Stem cells, directed to differentiate into specific cell types, offer the possibility of a renewable source of replacement cells and tissues to treat diseases, including Alzheimer’s diseases.

Cloning human embryos for stem cells is very controversial.

The goal of therapeutic cloning research is not to make babies, but to make embryonic stem cells, which can be harvested and used for cell-based therapies.

Using fertilized eggs left over at fertility clinics is also controversial because removing the stem cells destroys them.

Questions of ethics arise because embryos are destroyed as the cells are extracted, such as: When does human life begin? What is the moral status of the human embryo?

1998 – President Bill Clinton requests a National Bioethics Advisory Commission to study the question of stem cell research.

1999 – The National Bioethics Advisory Commission recommends that the government allow federal funds to be used to support research on human embryonic stem cells.

2000 – During his campaign, George W. Bush says he opposes any research that involves the destruction of embryos.

2000 – The National Institutes of Health (NIH) issues guidelines for the use of embryonic stem cells in research, specifying that scientists receiving federal funds can use only extra embryos that would otherwise be discarded. President Clinton approves federal funding for stem cell research but Congress does not fund it.

August 9, 2001 – President Bush announces he will allow federal funding for about 60 existing stem cell lines created before this date.

January 18, 2002 – A panel of experts at the National Academy of Sciences (NAS) recommends a complete ban on human reproductive cloning, but supports so-called therapeutic cloning for medical purposes.

February 27, 2002 – For the second time in two years, the House passes a ban on all cloning of human embryos.

July 11, 2002 – The President’s Council on Bioethics recommends a four-year ban on cloning for medical research to allow time for debate.

February 2005 – South Korean scientist Hwang Woo Suk publishes a study in Science announcing he has successfully created stem cell lines using therapeutic cloning.

December 2005 – Experts from Seoul National University accuse Hwang of faking some of his research. Hwang asks to have his paper withdrawn while his work is being investigated and resigns his post.

January 10, 2006 – An investigative panel from Seoul National University accuses Hwang of faking his research.

July 18, 2006 – The Senate votes 63-37 to loosen President Bush’s limits on federal funding for embryonic stem-cell research.

July 19, 2006 – President Bush vetoes the embryonic stem-cell research bill passed by the Senate (the Stem Cell Research Enhancement Act of 2005), his first veto since taking office.

June 20, 2007 – President Bush vetoes the Stem Cell Research Enhancement Act of 2007.

January 23, 2009 – The FDA approves a request from Geron Corp. to test embryonic stem cells on eight to 10 patients with severe spinal cord injuries. This will be the world’s first test in humans of a therapy derived from human embryonic stem cells. The tests will use stem cells cultured from embryos left over in fertility clinics.

March 9, 2009 – President Barack Obama signs an executive order overturning an order signed by President Bush in August 2001 that barred the NIH from funding research on embryonic stem cells beyond using 60 cell lines that existed at that time.

August 23, 2010 – US District Judge Royce C. Lamberth issues a preliminary injunction that prohibits the federal funding of embryonic stem cell research.

September 9, 2010 – A three-judge panel of the US Court of Appeals for the District of Columbia Circuit grants a request from the Justice Department to lift a temporary injunction that blocked federal funding of stem cell research.

September 28, 2010 – The US Court of Appeals for the DC Circuit lifts an injunction imposed by a federal judge, thereby allowing federally funded embryonic stem-cell research to continue while the Obama Administration appeals the judge’s original ruling against use of public funds in such research.

October 8, 2010 – The first human is injected with cells from human embryonic stem cells in a clinical trial sponsored by Geron Corp.

November 22, 2010 – William Caldwell, CEO of Advanced Cell Technology, tells CNN that the FDA has granted approval for his company to start a clinical trial using cells grown from human embryonic stem cells. The treatment will be for an inherited degenerative eye disease.

April 29, 2011 – The US Court of Appeals for the District of Columbia lifts an injunction, imposed last year, banning the Obama administration from funding embryonic stem-cell research.

May 11, 2011 – Stem cell therapy in sports medicine is spotlighted after New York Yankees pitcher Bartolo Colon is revealed to have had fat and bone marrow stem cells injected into his injured elbow and shoulder while in the Dominican Republic.

July 27, 2011 – Judge Lamberth dismisses a lawsuit that tried to block funding of stem cell research on human embryos.

February 13, 2012 – Early research published by scientists at Cedars-Sinai Medical Center and Johns Hopkins University shows that a patient’s own stem cells can be used to regenerate heart tissue and help undo damage caused by a heart attack. It is the first instance of therapeutic regeneration.

May 2013 – Scientists make the first embryonic stem cell from human skin cells by reprogramming human skin cells back to their embryonic state, according to a study published in the journal, Cell.

April 2014 – For the first time scientists are able to use cloning technologies to generate stem cells that are genetically matched to adult patients,according to a study published in the journal, Cell Stem Cell.

October 2014 – Researchers say that human embryonic stem cells have restored the sight of several nearly blind patients – and that their latest study shows the cells are safe to use long-term. According to a report published in The Lancet, the researchers transplanted stem cells into 18 patients with severe vision loss as a result of two types of macular degeneration.

May 2, 2018 – The science journal Nature reports that scientists have created a structure like a blastocyst – an early embryo – using mouse stem cells instead of the usual sperm and egg.

June 4, 2018 – The University of California reports that the first in utero stem cell transplant trial has led to the live birth of an infant that had been diagnosed in utero with alpha thalassemia, a blood disorder that is usually fatal for fetuses.

January 13, 2020 – In a study published in the Proceedings of the National Academy of Sciences, researchers announce they have created the world’s first living, self-healing robots using stem cells from frogs. Named xenobots after the African clawed frog (Xenopus laevis), the machines are less than a millimeter (0.04 inches) wide, small enough to travel inside human bodies. Less than two years later, scientists announce that these robots can now reproduce.

February 15, 2022 – A US woman becomes the third known person to go into HIV remission, and the first mixed-race woman, thanks to a transplant of stem cells from umbilical cord blood, according to research presented at a scientific conference on Retroviruses and Opportunistic Infections.

November 7, 2022 – Scientists announce they have transfused lab-made red blood cells grown from stem cells into a human volunteer in a world-first trial that experts say has major potential for people with hard-to-match blood types or conditions such as sickle cell disease.

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Using melatonin for sleep is on the rise, study says, despite potential health harms | CNN

Editor’s Note: Sign up for the Sleep, But Better newsletter series. Our seven-part guide has helpful hints to achieve better sleep.



CNN
— 

More and more adults are taking over-the-counter melatonin to get to sleep, and some may be using it at dangerously high levels, a study has found.

The overall use among the US adult population is still “relatively low,” but the study does “document a significant many-fold increase in melatonin use in the past few years,” said sleep specialist Rebecca Robbins, an instructor in the division of sleep medicine for Harvard Medical School. She was not involved in the study.

The study, published in the medical journal JAMA, found that by 2018 Americans were taking more than twice the amount of melatonin than a decade earlier.

Melatonin has been linked to headaches, dizziness, nausea, stomach cramps, drowsiness, confusion or disorientation, irritability and mild anxiety, depression and tremors as well as abnormally low blood pressure. It can also interact with common medications and trigger allergies.

While short-term use for people with jet lag, shift workers and those who have trouble falling asleep appears to be safe, long-term safety is unknown, according to the National Center for Complementary and Integrative Health at the National Institutes of Health.

“In an associational study we found that older adults who reported frequent use — every night or most nights — of a sleep aid (over the counter or prescription) had a higher risk of incident dementia and early mortality,” Robbins said.

However, researchers could not determine which type of sleep aid — over-the-counter medications, such as melatonin, or prescription medications — was responsible for the findings.

Since 2006, a small but growing subset of adults are taking amounts of melatonin that far exceed the dosage of 5 milligrams a day typically used as a short-term treatment, the study found.

However, pills for sale may contain levels of melatonin much higher than what is advertised on the label. Unlike drugs and food, melatonin is not fully regulated by the US Food and Drug Administration, so there are no federal requirements that companies test pills to ensure they contain the amount of advertised melatonin.

“Previous research has found that that melatonin content in these unregulated, commercially available melatonin supplements ranged from — 83% to +478% of the labeled content,” said Robbins, who coauthored the book “Sleep for Success! Everything You Must Know About Sleep But are Too Tired to Ask.”

Nor are there any requirements that companies test their products for harmful hidden additives in melatonin supplements sold in stores and online. Previous studies also found 26% of the melatonin supplements contained serotonin, “a hormone that can have harmful effects even at relatively low levels,” according to the National Center for Complementary and Integrative Health.

“We cannot be certain of the purity of melatonin that is available over the counter,” Robbins said.

Taking too much serotonin by combining medications such as antidepressants, migraine medications and melatonin can lead to a serious drug reaction. Mild symptoms include shivering and diarrhea, while a more severe reaction can lead to muscle rigidity, fever, seizures and even death if not treated.

Because it is purchased over the counter, experts say many people view melatonin as an herbal supplement or vitamin. In reality, melatonin is a hormone made by the pineal gland, located deep within the brain, and released into the bloodstream to regulate the body’s sleep cycles.

“There is a view that if it’s natural, then it can’t hurt,” Robbins told CNN in an earlier interview on the impact of melatonin on children. “The truth is, we just really don’t know the implications of melatonin in the longer term, for adults or kids.”

Another reality: Studies have found that while using melatonin can be helpful in inducing sleep if used correctly — taking it at least two hours before bed — but the actual benefit is small.

“When adults took melatonin, it decreased the amount of time it took them to fall asleep by four to eight minutes,” Dr. Cora Collette Breuner, a professor in the department of pediatrics at Seattle Children’s Hospital at the University of Washington, told CNN in 2021.

“So for someone who takes hours to fall asleep, probably the better thing for them to do is turn off their screens, or get 20 to 40 minutes of exercise each day, or don’t drink any caffeinated products at all,” Breuner said.

“These are all sleep hygiene tools that work, but people are very reticent to do them. They rather just take a pill, right?”

There are other proven sleep tips that work just as well, if not better than sleeping aids, experts say. The body begins secreting melatonin at dark. What do we do in our modern culture? Use artificial light to keep us awake, often long past the body’s normal bedtime.

Research has found that the body will slow or stop melatonin production if exposed to light, including the blue light from our smartphones, laptops and the like.

“Any LED spectrum light source may further suppress melatonin levels,” said Dr. Vsevolod Polotsky, who directs sleep basic research in the division of pulmonary and critical care medicine at Johns Hopkins University School of Medicine, in an earlier CNN interview.

So ban those devices at least an hour before you want to fall asleep. Like to read yourself to sleep? That’s fine, experts say, just read in a dim light from a book or use an e-reader in night mode.

“Digital light will suppress the circadian drive,” Polotsky said, while a “dim reading light will not.”

Other tips include keeping your bedroom temperature at cooler temperatures — about 60 to 67 degrees Fahrenheit (15 to 20 degrees Celsius). We sleep better if we’re a bit chilly, experts say.

Set up a bedtime ritual by taking a warm bath or shower, reading a book or listening to soothing music. Or you can try deep breathing, yoga, meditation or light stretches. Go to bed and get up at the same time each day, even on weekends or your days off, experts say. The body likes routine.

If your doctor does prescribe melatonin to help with jet lag or other minor sleep issues, keep the use “short term,” Robbins said.

If you are planning to use melatonin for a short-term sleep aid, try to purchase pharmaceutical grade melatonin, she advised. To find it, look for a stamp showing that the independent, nonprofit US Pharmacopoeial Convention Dietary Supplement Verification Program has tested the product.

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HIV/AIDS Fast Facts | CNN



CNN
— 

Here’s a look at the origins, treatments and global response to HIV and AIDS.

HIV stands for human immunodeficiency virus.

AIDS stands for acquired immunodeficiency syndrome.

HIV/AIDS is spread through sexual contact with an infected person, sharing needles with an infected person, through transfusions of infected blood or through an infected mother.

People infected with HIV go through three stages of infection:

  1. Acute infection, or acute retroviral syndrome, which can produce flu-like symptoms in the first month after infection.
  2. Clinical latency, or asymptomatic HIV infection, in which HIV reproduces at lower levels.
  3. AIDS, in which the amount of CD4 cells fall below 200 cells per cubic millimeter of blood (as opposed to the normal level of 500-1,500).

HIV-1 and HIV-2 can both cause AIDS. HIV-1 is the most common human immunodeficiency virus; HIV-2 is found mostly in western Africa.

Antiretroviral therapy (ART) involves taking a cocktail of HIV medications used to treat the virus. In 1987, Azidothymidine (AZT) became the first FDA-approved drug used to attempt to treat HIV/AIDS.

from UNAIDS:

38.4 million – Number of people living with HIV/AIDS worldwide in 2021.

5.9 million – Approximate number of people living with HIV globally that are unaware of their HIV-positive status in 2021.

160,000 – Newly infected children worldwide in 2021.

1.5 million – New infections worldwide in 2021.

650,000 – Approximate number of AIDS-related deaths worldwide in 2021.

Of the 4,500 new infections each day in 2019, 59% are in sub-Saharan Africa.

40.1 million – Approximate number of AIDS-related deaths worldwide since the start of the epidemic.

Sub-Saharan Africa is comprised of the following countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of the Congo, Ivory Coast, Djibouti, Equatorial Guinea, Eritrea, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Republic of the Congo, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, Sudan, South Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.

1981 The Centers for Disease Control and Prevention (CDC) publish the first reports of men in Los Angeles, New York and San Francisco who were previously healthy and are suffering from rare forms of cancer and pneumonia, accompanied by “opportunistic infections.”

1982 The CDC refer to the disease as AIDS for the first time.

1983 French and American researchers determine that AIDS is caused by HIV.

1985 Blood tests to detect HIV are developed.

December 1, 1988 – First World AIDS Day.

1999 Researchers in the United States find evidence that HIV-1 most likely originated in a population of chimpanzees in West Africa. The virus appears to have been transmitted to people who hunted, butchered and consumed the chimpanzees for food.

January 29, 2003 In his State of the Union speech, US President George W. Bush promises to dramatically increase funding to fight HIV/AIDS in Africa.

May 27, 2003 – Bush signs H.R. 1298, the US Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003, also known as PEPFAR (US President’s Emergency Plan for AIDS Relief), that provides $15 billion over the next five years to fight HIV/AIDS, tuberculosis and malaria abroad, particularly in Africa.

July 30, 2008 H.R. 5501, The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, becomes law and authorizes up to $48 billion to combat global HIV/AIDS, tuberculosis and malaria. Through 2013, PEPFAR plans to work in partnership with host nations to support treatment for at least four million people, prevention of 12 million new infections and care for 12 million people.

October 2011 – In his book, “The Origins of AIDS,” Dr. Jacques Pepin traces the emergence and subsequent development of HIV/AIDS to suggest that initial AIDS outbreaks began earlier than previously believed.

July 24, 2012 – Doctors announce during the 19th International AIDS Conference that Timothy Ray Brown, known as the “Berlin patient,” has been clinically “cured” of HIV. Brown, diagnosed with leukemia, underwent a bone marrow transplant in 2007 using marrow from a donor with an HIV-resistant mutation. He no longer has detectable HIV.

March 3, 2013 Researchers announce that a baby born infected with HIV has been “functionally cured.” The child, born in Mississippi, was given high doses of antiretroviral drugs within 30 hours of being born. A year later, the child now has detectable levels of the virus in her blood, 27 months after being taken off antiretroviral drugs, according to scientists involved with her case.

June 18, 2013 Marking the 10th anniversary of PEPFAR, Secretary of State John Kerry announces that the millionth child has been born HIV-free due to prevention of mother-to-child transmission programs (PMTCT).

March 14, 2014 – The CDC reports on a case of likely female-to-female HIV transmission. Unlike previous announcements of other cases involving female-to-female transmission, this case excludes additional risk factors for HIV transmission.

July 24, 2017 – A 9-year-old child from South Africa is reported to have been in remission for over eight years without treatment, according to Dr. Avy Violari, who spoke at the 9th International AIDS Society Conference on HIV Science in Paris.

November 2018 – According to PEPFAR’s website, they have “supported life-saving antiretroviral treatment (ART) for more than 14.6 million men, women and children” since 2003.

March 5, 2019 – According to a case study published in the journal Nature, a second person has sustained remission from HIV-1. The “London patient” was treated with stem cell transplants from donors with an HIV-resistant mutation. The London patient has been in remission for 18 months since he stopped taking antiretroviral drugs. The study also includes a possible third remission after stem cell transplantation, this person is referred to as the “Düsseldorf patient.”

May 2, 2019 – A study of nearly 1,000 gay male couples, where one partner with HIV took antiretroviral therapy (ART), found no new cases of transmission to the HIV-negative partner during sex without a condom. The landmark, eight-year study, published in the Lancet medical journal shows that the risk of passing on the HIV virus is eliminated with effective drugs treatment.

October 7, 2019 – Governor Gavin Newsom signs a bill making HIV prevention drugs available without a prescription in California starting on January 1, 2020. The medications covered by the new legislation are pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), which both help prevent HIV infections. California becomes the first state in the country to allow pharmacists to provide the drugs without a physician’s prescription.

November 6, 2019 – According to a study published in the Journal of Acquired Immune Deficiency Syndromes, a team of scientists has detected a new strain of HIV. The strain is a part of the Group M version of HIV-1, the same family of virus subtypes to blame for the global HIV pandemic, according to Abbott Laboratories, which conducted the research along with the University of Missouri, Kansas City.

June 15, 2020 – A study is published in the journal JAMA Network Open showing that the life expectancy of people with HIV approaches that of people without the virus, when antiviral therapy is started early in infection. However, disparities still remain in the number of chronic health problems that people with HIV endure.

July 7, 2020 – Scientists presenting at the 23rd International AIDS Conference announce a new study that found an injection of the investigational drug cabotegravir every eight weeks was more effective at preventing HIV than daily oral pills. It is also announced that a Brazilian man might be the first person to experience long-term HIV remission after being treated with only an antiviral drug regimen – not stem cell transplantation.

November 16, 2021 – A new study finds a second patient whose body has seemingly rid itself of HIV. The international team of scientists reports in the Annals of Internal Medicine that the patient, originally from the city of Esperanza, Argentina, showed no evidence of intact HIV in large numbers of her cells, suggesting that she may have naturally achieved what they describe as a “sterilizing cure” of HIV infection. The 30-year-old woman in the new study is only the second patient who has been described as achieving this sterilizing cure without help from stem cell transplantation or other treatment.

December 20, 2021 – The US Food and Drug Administration announces that it has approved the first injectable medication for pre-exposure prophylaxis (PrEP) to lower the risk of getting HIV through sex.

February 15, 2022 – A US woman becomes the third known person to go into HIV remission, and the first mixed-race woman, thanks to a transplant of stem cells from umbilical cord blood, according to research presented at a conference on Retroviruses and Opportunistic Infections.

December 1, 2022 – An experimental HIV vaccine, called eOD-GT8 60mer, has been found to induce broadly neutralizing antibody precursors among a small group of volunteers in a Phase 1 study. The clinical trial results, published in the journal Science, suggest that a two-dose regimen of the vaccine, given eight weeks apart, can elicit immune responses against the human immunodeficiency virus.

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Opioid Crisis Fast Facts | CNN



CNN
— 

Here’s a look at the opioid crisis.

Experts say the United States is in the throes of an opioid epidemic. An estimated 9.2 million Americans aged 12 and older misused opioids in 2021, including 8.7 million prescription pain reliever abusers and 1.1 million heroin users.

Opioids are drugs formulated to replicate the pain-reducing properties of opium. Prescription painkillers like morphine, oxycodone and hydrocodone are opioids. Illegal drugs like heroin and illicitly made fentanyl are also opioids. The word “opioid” is derived from the word “opium.”

Nearly 110,000 people died of drug overdoses in 2022, and more than two-thirds of those deaths involved a synthetic opioid.

Overdose deaths have been on the rise for years in the United States, but surged amid the Covid-19 pandemic: Annual deaths were nearly 50% higher in 2021 than in 2019, CDC data shows.

Prescription opioid volumes peaked in 2011, with the equivalent of 240 billion milligrams of morphine prescribed, according to the market research firm, IQVIA Institute for Human Data Science.

Alabama, Arkansas, Louisiana and Tennessee had the highest opioid dispensing rates in 2020.

Opioids such as morphine and codeine are naturally derived from opium poppy plants more commonly grown in Asia, Central America and South America. Heroin is an illegal drug synthesized from morphine.

Hydrocodone and oxycodone are semi-synthetic opioids, manufactured in labs with natural and synthetic ingredients.

Fentanyl is a fully synthetic opioid, originally developed as a powerful anesthetic for surgery. It is also administered to alleviate severe pain associated with terminal illnesses like cancer. The drug is up to 100 times more powerful than morphine. Just a small dose can be deadly. Illicitly produced fentanyl has been a driving factor in the number of overdose deaths in recent years.

Methadone is another fully synthetic opioid. It is commonly dispensed to recovering heroin addicts to relieve the symptoms of withdrawal.

Opioids bind to receptors in the brain and spinal cord, disrupting pain signals. They also activate the reward areas of the brain by releasing the hormone dopamine, creating a feeling of euphoria or a “high.”

Opioid use disorder is the clinical term for opioid addiction or abuse.

People who become dependent on opioids may experience withdrawal symptoms when they stop using the medication. Dependence is often coupled with tolerance, meaning that users need to take increasingly larger doses for the same effect.

A drug called naloxone, available as an injection or a nasal spray, is used as a treatment for overdoses. It blocks or reverses the effects of opioids and is often carried by first responders.

More data on overdose deaths

The 21st Century Cures Act, passed in 2016, allocated $1 billion over two years in opioid crisis grants to states, providing funding for expanded treatment and prevention programs. In April 2017, Health and Human Services Secretary Tom Price announced the distribution of the first round of $485 million in grants to all 50 states and US territories.

In August 2017, Attorney General Jeff Sessions announced the launch of an Opioid Fraud and Abuse Detection Unit within the Department of Justice. The unit’s mission is to prosecute individuals who commit opioid-related health care fraud. The DOJ is also appointing US attorneys who will specialize in opioid health care fraud cases as part of a three-year pilot program in 12 jurisdictions nationwide.

On October 24, 2018, President Donald Trump signed opioid legislation into law. The SUPPORT for Patients and Communities Act includes provisions aimed at promoting research to find new drugs for pain management that will not be addictive. It also expands access to treatment for substance use disorders for Medicaid patients.

State legislatures have also introduced measures to regulate pain clinics and limit the quantity of opioids that doctors can dispense.

1861-1865 – During the Civil War, medics use morphine as a battlefield anesthetic. Many soldiers become dependent on the drug.

1898 – Heroin is first produced commercially by the Bayer Company. At the time, heroin is believed to be less habit-forming than morphine, so it is dispensed to individuals who are addicted to morphine.

1914 – Congress passes the Harrison Narcotics Act, which requires that doctors write prescriptions for narcotic drugs like opioids and cocaine. Importers, manufacturers and distributors of narcotics must register with the Treasury Department and pay taxes on products

1924 – The Anti-Heroin Act bans the production and sale of heroin in the United States.

1970 – The Controlled Substances Act becomes law. It creates groupings (or schedules) of drugs based on the potential for abuse. Heroin is a Schedule I drug while morphine, fentanyl, oxycodone (Percocet) and methadone are Schedule II. Hydrocodone (Vicodin) is originally a Schedule III medication. It is later recategorized as a Schedule II drug.

January 10, 1980 – A letter titled “Addiction Rare in Patients Treated with Narcotics” is published in the New England Journal of Medicine. It looks at incidences of painkiller addiction in a very specific population of hospitalized patients who were closely monitored. It becomes widely cited as proof that narcotics are a safe treatment for chronic pain.

1995 – OxyContin, a long-acting version of oxycodone that slowly releases the drug over 12 hours, is introduced and aggressively marketed as a safer pain pill by manufacturer, Purdue Pharma.

May 10, 2007 – Purdue Pharma pleads guilty for misleadingly advertising OxyContin as safer and less addictive than other opioids. The company and three executives are charged with “misleading and defrauding physicians and consumers.” Purdue and the executives agree to pay $634.5 million in criminal and civil fines.

2010 – FDA approves an “abuse-deterrent” formulation of OxyContin, to help curb abuse. However, people still find ways to abuse it.

May 20, 2015 – The DEA announces that it has arrested 280 people, including 22 doctors and pharmacists, after a 15-month sting operation centered on health care providers who dispense large amounts of opioids. The sting, dubbed Operation Pilluted, is the largest prescription drug bust in the history of the DEA.

March 18, 2016 – The CDC publishes guidelines for prescribing opioids for patients with chronic pain. Recommendations include prescribing over-the-counter pain relievers like acetaminophen and ibuprofen in lieu of opioids. Doctors are encouraged to promote exercise and behavioral treatments to help patients cope with pain.

March 29, 2017 – Trump signs an executive order calling for the establishment of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. New Jersey Governor Chris Christie is selected as the chairman of the group, with Trump’s son-in-law, Jared Kushner, as an adviser.

July 31, 2017 – After a delay, the White House panel examining the nation’s opioid epidemic releases its interim report, asking Trump to declare a national public health emergency to combat the ongoing crisis

September 22, 2017 – The pharmacy chain CVS announces that it will implement new restrictions on filling prescriptions for opioids, dispensing a limited seven-day supply to patients who are new to pain therapy.

November 1, 2017 – The opioid commission releases its final report. Its 56 recommendations include a proposal to establish nationwide drug courts that would place opioid addicts in treatment facilities rather than prison.

February 9, 2018 – A budget agreement signed by Trump authorizes $6 billion for opioid programs, with $3 billion allocated for 2018 and $3 billion allocated for 2019.

February 27, 2018 – Sessions announces a new opioid initiative: The Prescription Interdiction & Litigation (PIL) Task Force. The mission of the task force is to support local jurisdictions that have filed lawsuits against prescription drugmakers and distributors.

March 19, 2018 – The Trump administration outlines an initiative to stop opioid abuse. The three areas of concentration are law enforcement and interdiction; prevention and education via an ad campaign; and job-seeking assistance for individuals fighting addiction.

April 9, 2018 – The US surgeon general issues an advisory recommending that Americans carry the opioid overdose-reversing drug, naloxone. A surgeon general advisory is a rarely used tool to convey an urgent message. The last advisory issued by the surgeon general, more than a decade ago, focused on drinking during pregnancy.

May 1, 2018 – The Journal of the American Medical Association publishes a study that finds synthetic opioids like fentanyl caused about 46% of opioid deaths in 2016. That’s a three-fold increase compared with 2010, when synthetic opioids were involved in about 14% of opioid overdose deaths. It’s the first time that synthetic opioids surpassed prescription opioids and heroin as the primary cause of overdose fatalities.

May 30, 2018 – The journal Medical Care publishes a study that estimates the cost of medical care and substance abuse treatment for opioid addiction was $78.5 billion in 2013.

June 7, 2018 – The White House announces a new multimillion dollar public awareness advertising campaign to combat opioid addiction. The first four ads of the campaign are all based on true stories illustrating the extreme lengths young adults have gone to obtain the powerful drugs.

December 12, 2018 – According to the National Center for Health Statistics, fentanyl is now the most commonly used drug involved in drug overdoses. The rate of drug overdoses involving the synthetic opioid skyrocketed by about 113% each year from 2013 through 2016.

January 14, 2019 – The National Safety Council finds that, for the first time on record, the odds of dying from an opioid overdose in the United States are now greater than those of dying in a vehicle crash.

March 26, 2019 – Purdue Pharma agrees to pay a $270 million settlement to settle a historic lawsuit brought by the Oklahoma attorney general. The settlement will be used to fund addiction research and help cities and counties with the opioid crisis.

July 17, 2019 – The CDC releases preliminary data showing a 5.1% decline in drug overdoses during 2018. If the preliminary number is accurate, it would mark the first annual drop in overdose deaths in more than two decades.

August 26, 2019 – Oklahoma wins its case against Johnson & Johnson in the first major opioid lawsuit trial to be held in the United States. Cleveland County District Judge Thad Balkman orders Johnson & Johnson to pay $572 million for its role in the state’s opioid crisis. The penalty is later reduced to $465 million, due to a mathematical error made when calculating the judgment. In November 2021, the Oklahoma Supreme Court reverses the decision.

September 15, 2019 – Purdue files for bankruptcy as part of a $10 billion agreement to settle opioid lawsuits. According to a statement from the chair of Purdue’s board of directors, the money will be allocated to communities nationwide struggling to address the crisis.

September 30, 2019 – The FDA and DEA announce that they sent warnings to four online networks, operating a total of 10 websites, which the agencies said are illegally marketing unapproved and misbranded versions of opioid medicines, including tramadol.

February 25, 2020 – Mallinckrodt, a large opioid manufacturer, reaches a settlement agreement in principle worth $1.6 billion. Mallinckrodt says the proposed deal will resolve all opioid-related claims against the company and its subsidiaries if it moves forward. Plaintiffs would receive payments over an eight-year period to cover the costs of opioid-addition treatments and other needs.

October 21, 2020 – The Justice Department announces that Purdue Pharma, the maker of OxyContin, has agreed to plead guilty to three federal criminal charges for its role in creating the nation’s opioid crisis. They agree to pay more than $8 billion and close down the company. The money will go to opioid treatment and abatement programs. The Justice Department also reached a separate $225 million civil settlement with the former owners of Purdue Pharma, the Sackler family. In November 2020, Purdue Pharma board chairman Steve Miller formally pleads guilty on behalf of the company.

March 15, 2021 – According to court documents, Purdue files a restructuring plan to dissolve itself and establish a new company dedicated to programs designed to combat the opioid crisis. As part of the proposed plan, the Sackler family agrees to pay an additional $4.2 billion over the next nine years to resolve various civil claims.

September 1, 2021 – In federal bankruptcy court, Judge Robert Drain rules that Purdue Pharma will be dissolved. The settlement agreement resolves all civil litigation against the Sackler family members, Purdue Pharma and other related parties and entities, and awards them broad legal protection against future civil litigation. The Sacklers will relinquish control of family foundations with over $175 million in assets to the trustees of a National Opioid Abatement Trust. On December 16, 2021, a federal judge overturns the settlement.

February 25, 2022 – Johnson & Johnson and the three largest US drug distributors – McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp – finalize a $26 billion nationwide opioid settlement.

March 3, 2022 – The Sackler families reaches a settlement with a group of states the first week of March, according to court filings. The settlement, ordered through court-ordered mediation that began in January, requires the Sacklers to pay out as much as $6 billion to states, individual claimants and opioid crisis abatement, if approved by a federal bankruptcy court judge.

November 2, 2022 – CVS and Walgreens agree to pay a combined $10 billion, over 10 and 15 years, to settle lawsuits brought by states and local governments alleging the retailers mishandled prescriptions of opioid painkillers.

November 15, 2022 – Walmart agrees to the framework of a $3.1 billion settlement, which resolves allegations from multiple states’ attorneys general that the company failed to regulate opioid prescriptions contributing to the nationwide opioid crisis.

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Covid-19 is no longer a public health emergency, but others remain | CNN



CNN
— 

The Covid-19 pandemic hit a major milestone this month as public health emergency declarations were ended by both the United States government and the World Health Organization. Emergency declarations for mpox also recently ended.

This doesn’t mean Covid-19 and mpox are no longer of concern, but it does mark the end of the availability of certain logistical capabilities to manage them.

Still, other critical health challenges were identified as health emergencies years before the start of the Covid-19 pandemic and continue to be so: the opioid crisis in the US and the global spread of poliovirus.

Some public health concerns can be serious health threats without a formal emergency declaration, said Dr. Tom Frieden, former director of the US Centers for Disease Control and Prevention.

It largely boils down to the logistics of government operations.

“When there’s an unusual situation that requires multiple parts of an agency or multiple parts of the government or multiple parts of society to come together and coordinate, collaborate and work efficiently, then an emergency declaration can be a useful tool,” said Frieden, president and CEO of Resolve to Save Lives, an organization focused on global epidemic prevention and cardiovascular health.

“Sometimes, an emergency is declared to make the point that it’s a big problem, to get people’s attention. Sometimes, an emergency is declared to get things done because that’s the only way you can bring certain governmental capacities to bear.”

According to WHO, a public health emergency of international concern is “an extraordinary event” that poses public health risk through the international spread of disease.

It creates an agreement between countries to abide by WHO’s recommendations for managing the emergency, often requiring a “coordinated international response.” Each country, in turn, declares its own public health emergency – declarations that carry legal weight. Countries use them to marshal resources and waive rules in order to ease a crisis.

In the US, the secretary of the Department of Health and Human Services can declare a public health emergency for diseases or disorders that pose a threat, including “significant outbreaks” of an infectious disease, bioterrorist attacks or otherwise.

This triggers the availability of a set of resources and actions for the federal government, such as additional funds and data and reporting requirements.

Emergency declarations typically last up to 90 days, with formal renewal required as necessary every three months after that.

The opioid crisis was determined to be a public health emergency in October 2017, during the Trump administration, driven by the rising rates of opioid-related deaths and opioid use disorder.

The declaration has been renewed for more than five years, most recently at the end of March.

According to the CDC, the opioid epidemic started in 1999 with a rise in prescription opioid overdose deaths. Deaths started to increase precipitously as synthetic opioids – particularly fentanyl – started to take over in 2013.

In 2021, overdose deaths reached record levels in the US, and about three-quarters – more than 80,000 deaths – involved opioids.

Within the first year of the opioid emergency declaration, HHS used expanded authorities to field a survey about treatment for opioid use disorder among providers and to expedite research on the topic.

Public health emergencies are also declared to help with recovery after natural disasters, most recently for severe storms that hit Mississippi in March.

However, the Government Accountability Office considers both federal management of the public health emergency system and efforts to combat drug misuse to be “high-risk” areas that are vulnerable or in need of broad reform.

In a recent report, the federal watchdog group said that it has found “persistent deficiencies in HHS’s leadership role preparing for and responding to public health emergencies” and no demonstrated progress in federal agencies’ actions to address drug misuse.

WHO has considered poliovirus a public health emergency of international concern since 2014.

A committee formed to address the emergency reviewed the most recent data on cases and spread this month and voted unanimously that ongoing risks merited an extension of the emergency declaration, which the director-general formalized Friday.

The committee was “encouraged by reported progress” but says that risks remain high for factors including weak vaccination rates that could have been affected by the Covid-19 pandemic.

WHO identified seven counties with potential risk for international spread. And the US is among a group of 37 countries with recently detected cases.

In July, a polio case identified in New York became the first in the US in nearly a decade. The identified case, along with several positive wastewater tests in nearby communities, met WHO criteria to consider the US a country with circulating poliovirus.

Experts warned that it could just be the “tip of the iceberg,” with hundreds of cases spreading silently.

Childhood vaccination rates in the US dropped during the Covid-19 pandemic. A CDC report found that about 93% of kindergarteners enrolled in the 2021-22 school year got the required vaccines, including measles, mumps and rubella (MMR); diphtheria, tetanus and acellular pertussis (DTaP); and polio. Coverage fell for the second year in a row amid the pandemic, from about 94% the previous year and below the federal target of 95%.

While no longer under a formal emergency declaration, Covid-19 continues to be part of the “landscape of health threats,” Frieden said.

But the efficiency and coordination that the formal declaration helps facilitate should always be the goal.

“I think there are really important lessons from Covid, including the need to have a much more resilient public health system so that we can find problems quickly and implement effective solutions quickly,” Frieden said.

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