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FDA Issues a CRL for Venatorx Pharmaceuticals’ Antibiotic for Treatment of Complicated UTI

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FDA Issues a CRL for Venatorx Pharmaceuticals’ Antibiotic for Treatment of Complicated UTI


Venatorx Pharmaceuticals and Melinta Therapeutics announced this morning that the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for cefepime-taniborbactam, a beta-lactam/beta-lactamase inhibitor combination antibiotic under review as a potential treatment for adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis caused by susceptible gram-negative microorganisms.1

According to the companies, the CRL did not identify clinical safety or efficacy issues, and the FDA did not request any new trials to support the approval of cefepime-taniborbactam. The FDA did request additional chemistry, manufacturing, and controls (CMC) information and related data about the antibiotic, testing methods, and manufacturing process.1

“While we are disappointed with this setback, we maintain utmost confidence in cefepime-taniborbactam,” Venatorx CEO Christopher J. Burns, PhD, said in a statement. “We are already hard at work generating the additional requested CMC data, and we will continue to work closely with the FDA so that we can make this important new medicine available to patients as quickly as possible.” 1

What the Data Demonstrated

Although this is a setback for the companies, the release of data this past week demonstrated efficacy vs another antibiotic. The data was published in the New England Journal of Medicine.

Specifically, the data was from the CERTAIN study, which was a global, randomized, double-blind, active-controlled non-inferiority phase 3 trial evaluating the efficacy, safety, and tolerability of cefepime-taniborbactam compared to meropenem in adults with cUTI, including acute pyelonephritis. 2

The study enrolled 661 adult patients who were randomized 2:1 to receive cefepime-taniborbactam 2.5g q8h or meropenem 1g q8h for 7 days (up to 14 days for patients with bacteremia).2

The primary efficacy endpoint evaluated the composite clinical and microbiologic response (i.e., bacterial eradication) at the Test of Cure (TOC) visit (Day 19-23) in the microbiological intent-to-treat (microITT) population as specified by FDA and European Medicines Agency guidance.2

Cefepime-taniborbactam met the primary efficacy endpoint of statistical noninferiority (NI) to meropenem in the microITT population at TOC with composite microbiologic and clinical success occurring in 70.0% of cefepime-taniborbactam treated patients and 58.0% of meropenem treated patients (treatment difference 11.9; 95% confidence interval (CI), 2.4, 21.6).2

A prespecified superiority test following confirmation of NI demonstrated the statistical superiority of cefepime-taniborbactam for the composite endpoint at TOC. The superiority of cefepime-taniborbactam was sustained for the composite microbiologic and clinical response at the Late-Follow-Up (Day 28-35) visit.2

Rates of treatment-emergent adverse events (TEAEs) were 35.5% for cefepime-taniborbactam and 29.0% for meropenem. Serious TEAEs occurred in 2.0% and 1.8% of cefepime-taniborbactam and meropenem treated patients, respectively.2

Treatment discontinuations due to TEAEs were infrequent, occurring in 3.0% of cefepime-taniborbactam patients and 0.9% of meropenem treated patients.2

Commercialization, Other Potential Indications

In a previous interview with Contagion, Venatorx’s Burns discussed commercialization plans. In recent months, Venatorx announced partnerships with Melinta Therapeutics in the United States and the Menarini Group internationally.2

Venatorx is also studying cefepime-taniborbactam for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults. “We are planning to imminently begin enrollment of what’s often euphemized, as a half-of-that study, of a hospital acquired bacterial pneumonia study,” Burns said in the previous interview.2

References
1.Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam. BusinessWire press release. February 23, 2024. Accessed February 23, 2024.
https://finance.yahoo.com/news/venatorx-melinta-status-u-drug-130000689.html

2. Parkinson J. Melinta Therapeutics Partnering with Venatorx Pharmaceuticals on Commercializing Antibiotic. ContagionLive. November 11. 2024. Accessed February 22, 2024. https://www.contagionlive.com/view/melinta-therapeutics-partnering-with-venatorx-pharmaceuticals-on-commercializing-antibiotic



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Beef Pot Pie Recipe | The Recipe Critic

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Beef Pot Pie Recipe | The Recipe Critic


This website may contain affiliate links and advertising so that we can provide recipes to you. Read my disclosure policy.

Classic comfort food with a homemade twist! This hearty beef pot pie features tender chunks of beef, savory veggies, and a rich gravy all nestled in a flaky double crust! (You can use store-bought crusts for easy prep!)

Hearty and homemade doesn’t have to mean a lot of preparation. Try this slow cooker chicken pot pie next!

Lifting a piece of beef pot pie out of a baking dish.

Easy Beef Pot Pie

For those days when you’re craving something hearty, beef pot pie is the way to go. This recipe is both hearty and comforting, perfect for a cozy night in. It features tender chunks of beef, savory vegetables, and a rich mushroom and onion gravy all nestled in a flaky double crust.

The best part? It’s surprisingly easy to make, even if you’re short on time. Simply use store-bought pie crusts to save on prep, and let your oven do all the work! In about an hour, you’ll have a delicious homemade pot pie that’s sure to please the whole family. So hearty and amazing!

Ingredient List

I love this beef pot pie recipe because it uses so many simple ingredients! If you have some pie crust dough on hand, you may have everything you need to put it together. Exact measurements are in the recipe card below.

  • Crust: Homemade is great, but you can also use store-bought pie crusts for easy prep. Want something gluten-free? Try this recipe for an almond flour pie crust!
  • Beef: Cut into chunks.
  • Veggies: I added frozen peas, onions, and carrots for a classic flavor and texture!
  • Fresh Garlic: Adds a punch of savory flavor to the meat mixture.
  • All-Purpose Flour: So everything thickens up nicely.
  • Beef Broth: Adds moisture and flavor to the beef pot pie.
  • Sauces: I used a mix of soy sauce and Worcestershire to boost the flavor of the filling.
  • Salt and Pepper: Simple seasonings, add to taste!

How to Make Beef Pot Pie

This beet pot pie only has 20 minutes of prep time, and then it’s off to the oven! A great way to put some time back into your evening.

  1. Prepare Dough, Preheat Oven: Roll out the bottom pie crust so it will fit a 12-inch pie pan. Place the lined pie pan in the fridge to keep the dough cold, along with the top portion of the dough. Preheat the oven to 350 degrees Fahrenheit.
  2. Sear the Beef: Heat the butter in a large skillet over medium-high heat. Season the cubed beef with salt and pepper and then add it to the pan along with the onion. Sauté until the beef is evenly browned.
  3. Sauté Vegetables: To the pan add the mushrooms, carrots, peas, and garlic. Saute everything together for 8-10 minutes, until the carrots start to soften. Then reduce the heat to low.
  4. Push the meat and vegetables aside and tip the skillet to accumulate liquid in the open side of the pan, then whisk in the flour. Pour the beef broth over the flour mixture and mix it into the meat and veggies well.
  5. Add Sauces and Seasonings: Add in the Worcestershire sauce, soy sauce, salt and pepper. Stir to combine and simmer on low until the gravy thickens.
  6. Add Crust to Pan: Remove the pie crust from the fridge and fill it with the pot pie filling.
  7. Bake: Roll out the top crust and lay it over the top of the pie. Crimp the edges of the pie and place it in the oven, bake beef pot pie for 25 to 30 minutes until the crust is a golden brown.
  8. Cool and Enjoy: Remove from the oven and allow it to cool at least 10 minutes before enjoying!
4-photo collage of the beef filling being prepared and added to a pie crust.

Tips and Tricks

  • Individual Portions: Divide the beef filling into ramekins or muffin tins for individual pot pies. Bake for 15-20 minutes instead.
  • Homemade Crust: Want to take your pot pie to the next level? Try using this recipe for my grandma’s perfect pie crust!

Top-down view of beef pot pie with a slice taken out of it.

Storing Leftovers

Store leftover beef pot pie in the fridge in an airtight container for up to 4 days.

To keep the crust from getting soggy, reheat pot pie in the oven for 25 minutes at 350 degrees Fahrenheit.

More Mouthwatering Beef Recipes

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  • Roll out the bottom pie crust to fit a 12 inch pie pan. Place the lined pie pan in the fridge to keep the dough cold, along with the top portion of the dough. Preheat the oven to 350 degrees fahrenheit.

  • Heat the butter in a large skillet over medium high heat. Season the cubed beef with salt and pepper and add it to the pan along with the onion. Saute until the beef is evenly browned.

  • To the pan add the mushrooms, carrots, peas, and garlic. Saute everything together for 8-10 minutes, until the carrots start to soften. Reduce the heat to low.

  • Push the meat and vegetables aside and tip the skillet to accumulate liquid in the open side of the pan, whisk in the flour. Pour the beef broth over the flour mixture and mix it into the meat and veggies well.

  • Add in the worcestershire sauce, soy sauce, salt and pepper. Stir to combine and simmer on low until the gravy thickens.

  • Remove the pie crust from the fridge and fill it with the filling.

  • Roll out the top crust and lay it over the top of the pie. Crimp the edges of the pie and place it in the oven, bake for 25 to 30 minutes until the crust is a golden brown.

  • Remove from the oven and allow it to cool at least 10 minutes before enjoying!

Calories: 378kcalCarbohydrates: 25gProtein: 22gFat: 21gSaturated Fat: 10gPolyunsaturated Fat: 2gMonounsaturated Fat: 9gTrans Fat: 1gCholesterol: 74mgSodium: 604mgPotassium: 665mgFiber: 3gSugar: 4gVitamin A: 5675IUVitamin C: 11mgCalcium: 53mgIron: 3mg

Nutrition information is automatically calculated, so should only be used as an approximation.





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The time to file taxes is almost over. Here’s what to know

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The time to file taxes is almost over. Here’s what to know


Published on April 6, 2023

How to “reconcile” on your tax return

  • You’ll use your Form 1095-A to “reconcile” your 2022 premium tax credits when you file your taxes if you or anyone in your household had Marketplace coverage at any point in 2022.
  • Any difference between the amount of premium tax credit you used in advance during the year and the premium tax credit you actually qualify for based on your final income will affect whether you owe money or get a refund.
  • If you used premium tax credits you’ll report the excess advance payment of the premium tax credit on your tax return or file Form 8962, Premium Tax Credit (PDF, 110 KB).

Questions? Free help is available



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Stroke Risk in Black Americans: Expert Q&A

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Stroke Risk in Black Americans: Expert Q&A


Black people in the U.S. are more likely to have a stroke than people who are White, Hispanic, Native American, or Asian – and with worse outcomes. The odds of dying of a stroke are 3 to 4 times higher for Black Americans, compared to White Americans. 

Many things affect someone’s chances of having a stroke, including social factors. Eseosa Ighodaro, MD, PhD, is a stroke fellow at Emory University/Grady Hospital in Atlanta and advocates for initiatives that address racial disparities in neurologic health, particularly in stroke outcomes. She founded Ziengbe, a nonprofit organization aimed at ending neurological health disparities facing the Black community through education and empowerment. 

Here, Ighodaro answers questions about stroke risk in Black Americans, including symptoms everyone needs to know, what to do if those symptoms show up, and how to lower stroke risk.

It is essential to know what the signs and symptoms of stroke are. Remember the FAST acronym, which stands for 

  • Face drooping
  • Arm weakness
  • Speech difficulty
  • Time

Other signs of stroke can include numbness and vision loss. If you or someone you know is experiencing any of these signs and symptoms, time is of the essence. Don’t wait: Go to the nearest emergency department immediately. 

And once you get there, be prepared to advocate for yourself or your loved one. Say these words: “I’m concerned I’m having a stroke.” 

Black patients experience more delays in diagnosis and treatment once [they’re] in a hospital with stroke symptoms, which contributes to poorer outcomes. We also know that Black individualsare significantly less likely to receive the gold-standard treatments for stroke, which include the clot-busting drug tPA and mechanical thrombectomy, a technique for removing blood clots from the brain. 

These interventions are time-sensitive. We can only give clot-busting drugs within 4.5 hours [after symptoms start], and we can only do mechanical thrombectomy within 24 hours. 

So if you have facial droop or numbness and weakness on one side of your body, don’t wait at home, thinking it will go away. 

The reasons are multifaceted. When we talk about risk factors for stroke, there are two major categories: the ones we can modify and the ones that we cannot. Nonmodifiable risk factors include our age, sex at birth, race/ethnicity, and family history of stroke. Risk factors we can modify include poor diet, physical inactivity, being overweight, diabetes, hypertension, smoking, and high cholesterol. 

We know that Black Americans overall have a greater burden of these modifiable risk factors. Over half of Black adults have high blood pressure, Black Americans are more likely to have diabetes than White individuals, and nearly 25% of Black people have high levels of LDL cholesterol, the “bad” type of cholesterol. 

So when I see a patient in my stroke clinic, my main focus is on these modifiable risk factors, so that we can either prevent a first stroke or to reduce the risk of a second stroke. That means getting that individual on appropriate medications and interventions, like blood pressure medications, smoking cessation programs, and connecting people with diabetes to a primary care provider or endocrinologist to ensure that is under control. We know that the Mediterranean diet has been shown to improve stroke outcomes, so I also typically connect these patients with a dietitian to help them make sustainable changes in their eating habits.

But that’s not the whole picture. Studies have shown that even once we control for these modifiable and non-modifiable risk factors, we still see significant racial disparities in stroke outcomes, likely caused by other social determinants of health.

Social determinants of health are variables that are not medical but still play a role in our health. They include things like [social and economic] status, education level, language barriers, housing and food insecurity, access to safe and healthy space to get physical exercise, and of course, access to health care, hospitals, and pharmacies. In the United States, some states have only one advanced comprehensive stroke center, while others may have 15. People who live in a state with only one comprehensive stroke center, which may be 150 or 200 miles away, will not have the same access to advanced stroke care that someone who lives here in Atlanta does.

All of these factors can impact the risk of stroke and outcomes for people who have had a stroke. For example, data from one very important study of stroke disparities, Reasons for Geographic and Racial Differences in Stroke, or REGARDS, has shown that people with three or more social determinants of health risk factors were nearly two and a half times more likely to have a stroke, compared with people who had no such risk factors.

And a study published in 2023 found that “redlining” – the historical practice of discriminatory housing policy that affects Black communities to this day – is associated with increased stroke risk, over and above other social determinants of health. 

This is something we are still trying to measure and quantify: How does just being a Black individual in America, and the stresses that come with day-to-day experiences of racism and microaggressions over a lifetime, negatively affect the body, including stroke risk? 

We know that “allostatic load” – the wear and tear on the body that accumulates when a person is exposed to chronic stress – contributes to poorer health outcomes. And a study published in 2022 found that allostatic load predicted mental function scores among Black stroke patients, but not White or Hispanic patients, which suggests that these stressors may account for some of the racial disparities in stroke outcomes. We need to understand this better. 



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Top 5 Infectious Disease Stories: Week of February 17

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Top 5 Infectious Disease Stories: Week of February 17


This week, in efforts to navigate malaria with treatments, prevention, and the impact of climate change, the FDA is not requesting further trials for the investigational therapy cefepime-taniborbactam, sought details on its chemistry and manufacturing controls, examining immune responses to the COVID vaccine between cancer and non-cancer patients, influence of accessibility to HCV DAA in low and middle-income countries, and a study demonstrating the efficacy of HIV ART treatment in maintaining viral load suppression.



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Spanish Tortilla | The Recipe Critic

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Spanish Tortilla | The Recipe Critic


This website may contain affiliate links and advertising so that we can provide recipes to you. Read my disclosure policy.

Make this delicious traditional Spanish tortilla at home! Tender potatoes, eggs, and onions cooked together in a skillet and topped with fresh salsa. Bring the flavors of Spain to your kitchen!

I love making a hearty big breakfast on the weekends! If you need more weekend breakfast ideas then make these German pancakes, my Grandma’s pancakes, or omelet muffins.

Close view of Spanish tortilla on a large plate garnished with salsa and cilantro.

Spanish Tortilla

Also known as a Spanish omelet, this Spanish tortilla is a staple recipe in Spain cuisine. I love how simple the ingredients are but how flavorful it is. The diced potatoes cook up tender on the inside and slightly crispy on the outside. Then the eggs just bring it all together in one big tasty Spanish tortilla. It’s easy to cook in one large skillet, and fun to see it make one large tortilla-shaped omelet. Enjoy this Spanish tortilla for breakfast, lunch, or dinner because it’s delicious and satisfying any time of day. It’s commonly enjoyed at room temperature and even tastier with my fresh salsa served on top!

My kids love these for breakfast and after school! Serve these with homemade guacamole, fresh fruit, or my easy Spanish rice if you really want to fill their bellies after a long day of school.

Ingredients Needed

The ingredients to make this Spanish tortilla are simple and fresh! You’ll always want to have these ingredients on hand so you can whip up this recipe! Your family will love this for breakfast, lunch, or even dinner!

Spanish Tortilla

  • Russet Potatoes: Russet potatoes are perfect for this recipe because they cook soft and tender!
  • Eggs: Use large room-temperature eggs.
  • Yellow Onion: Dice the yellow onion.
  • Garlic: Fresh minced garlic cloves add so much flavor.
  • Olive Oil: Helps coat the pan and gives the tortilla its golden brown color.
  • Salt and Pepper: Season to taste!

Fresh Salsa

Spanish Tortilla Recipe

I love that this is a one-skillet recipe! This Spanish tortilla is easy to make and it’s fun to recreate this traditional dish from Spain. It’s a great weekend breakfast for your family to enjoy! Follow my instructions below because I to walk you through every step of this Spanish tortilla recipe.

Salsa

  1. Make the Salsa: Make the fresh salsa topping by adding the diced tomatoes, diced green peppers, minced onion, and red wine vinegar to a bowl and mixing with salt and pepper to taste. Allow the salsa to sit and marinate while you make the Spanish tortilla.

Spanish Tortilla

  1. Prepare the Potatoes, Onions, and Garlic: Wash and peel the potatoes, then dice them into about ¼ inch pieces. Prepare the onion and garlic.
  2. Cook the Potatoes and Onions: Heat ¼ cup of the olive oil over medium-high heat in a large skillet and add the potatoes and onion. Cook the onion and potatoes for about 20 minutes, until the potatoes are fork-tender.
  3. Saute the Garlic: Add the garlic to the skillet and saute for another minute. Remove the potato mixture from the heat then set aside to cool.
  4. Whisk the Eggs: While the potatoes are cooking, whisk the eggs in a large bowl with salt and pepper. Once the potatoes are cooked and have cooled a bit, add them to the eggs and mix to combine.
  5. Cook the Eggs and Potatoes: Add 2 tablespoons to a medium skillet and heat over medium-low heat. Add half the egg mixture and potatoes to the skillet and cook uncovered for about 5 minutes. The bottom should be a golden brown color before flipping.
  6. Flip the Tortilla: To flip the tortilla, get a large plate and place it over the tortilla in the pan. Flip the pan over so the tortilla is on the plate. Oil the pan again with another 2 tablespoons of oil then carefully slide the tortilla off the plate and back onto the pan to cook the other side.
  7. Cook the Other Side: Cook the tortilla for another 5 minutes until it is fully cooked. Remove the tortilla from the pan and repeat with the remaining egg and potato mix.
  8. Serve With Salsa: Serve the Spanish tortillas with fresh salsa on top and enjoy!
First photo of onions and potatoes cooking in a skillet. Second photo of the eggs whisked together in a bowl. Third photo of the eggs added to the skillet of onions and potatoes. Fourth photo of the tortilla flipped over in the skillet.

Tips and Variations

This Spanish tortilla is simple to make with minimal ingredients. However, you can create them to fit your taste buds and your cravings. Add more seasonings or veggies! Any way you choose to make them will be AMAZING!

  • Potatoes: I diced my potatoes in this recipe, but you can thinly slice them if you prefer. The size and thickness of your potatoes will determine how fast they will cook.
  • Veggies: Sneak in vegetables by adding chopped peppers or zucchini! Adding vegetables isn’t how they are traditionally made, but if you want veggies then go for it!
  • Size: Your recipe will yield different amounts of tortillas based on the size of the pan you cook them in. A smaller pan will yield more tortillas.
  • Fresh Salsa: I like to make my fresh salsa first to let the flavors marinate together for a fuller-tasting salsa. It complements the Spanish tortilla perfectly!
  • Season: Add extra flavor by seasoning your potatoes or eggs with any spices you like. Chili powder, garlic powder, or cumin would be my first pick!

Top view of Spanish tortilla on a large plate topped with salsa and cilantro.

Storing Leftovers

The leftover Spanish tortilla is great for a quick breakfast or any time of day! Reheat leftovers in the microwave or oven. Follow the directions below to enjoy leftovers later.

  • In the Refrigerator: Store leftovers in an airtight container in the fridge for up to 5 days.
  • To Reheat: Reheat leftovers in the microwave until warmed through. Or place leftovers in an oven-safe skillet and reheat in the oven at 350° Fahrenheit for about 10 minutes.

Close view of a slice or Spanish tortilla on a small plate with a fork.

Tasty Mexican Breakfast Ideas

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Salsa

  • Make the fresh salsa topping by adding the diced tomatoes, diced green peppers, minced onion, and red wine vinegar to a bowl and mixing with salt and pepper to taste. Allow the salsa to sit and marinate while you make the Spanish tortilla.

Spanish Tortilla

  • Wash and peel the potatoes, then dice them into about ¼ inch pieces. Prepare the onion and garlic.

  • Heat ¼ cup of the olive oil over medium high heat in a large skillet and add the potatoes and onion. Cook the onion and potatoes for about 20 minutes, until the potatoes are fork tender.

  • Add the garlic to the skillet and saute for another minute. Remove the potato mixture from heat and set aside to cool.

  • While the potatoes are cooking, whisk the eggs in a large bowl with salt and pepper. Once the potatoes are cooked and have cooled a bit, add them to the eggs and mix to combine.

  • Add 2 tablespoons to a medium skillet and heat over medium-low heat. Add half the egg and potato mixture to the skillet and cook uncovered for about 5 minutes. The bottom should be a golden brown color before flipping.

  • To flip the tortilla, get a large plate and place it over the tortilla in the pan. Flip the pan over so the tortilla is on the plate. Oil the pan again with another 2 tablespoons of oil then carefully slide the tortilla off the plate and back onto the pan to cook the other side.

  • Cook the tortilla for another 5 minutes until it is fully cooked. Remove the tortilla from the pan and repeat with the remaining egg and potato mix.

  • Serve the Spanish tortillas with fresh salsa on top and enjoy!

Calories: 274kcalCarbohydrates: 24gProtein: 7gFat: 17gSaturated Fat: 3gPolyunsaturated Fat: 2gMonounsaturated Fat: 11gTrans Fat: 0.01gCholesterol: 123mgSodium: 56mgPotassium: 648mgFiber: 2gSugar: 3gVitamin A: 491IUVitamin C: 24mgCalcium: 44mgIron: 2mg

Nutrition information is automatically calculated, so should only be used as an approximation.





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It’s Not Too Late to Get Vaccinated for the Flu, COVID-19, and RSV

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It’s Not Too Late to Get Vaccinated for the Flu, COVID-19, and RSV


Getting vaccinated is the most effective way to protect yourself against influenza (flu), COVID-19, and respiratory syncytial virus (RSV). That’s especially true for people who are at a higher risk of severe illness from respiratory diseases, including young children, older adults, pregnant people, and people with underlying medical conditions.

The incidence of these viruses can fluctuate. Cases are currently on the decline in the Philadelphia region, but they are rising in other parts of the country and could rise again in our area.

The good news is that if you haven’t gotten vaccinated, there’s still time for you to schedule your vaccinations and get protected.

An Alarming Decline in Vaccinations

Current vaccination rates for respiratory viruses, especially COVID-19, are low worldwide. In the U.S., the Centers for Disease Control and Prevention (CDC) issued an advisory in December to alert health care providers about low rates of vaccination for flu, COVID-19, and RSV.

In the Philadelphia region, many health systems have also noticed a decrease in vaccinations for flu, COVID-19, and RSV. This has prompted some health systems to begin requiring staff to wear masks. They have also reached out to me and other medical directors at Independence Blue Cross to help spread the word about the importance of vaccinations.

Why Aren’t People Getting Vaccinated?

There are a number of reasons for the decline in vaccination rates. Some of the most likely reasons include:

  • Confusing messaging. When flu was the primary winter illness that people were concerned about, the message was simple — “Get your annual flu shot!” But now we face more than just one serious viral threat. The surge in COVID-19 and RSV cases means that we must now promote three vaccinations instead of one.
  • Vaccine fatigue. The constant stress many people felt when the pandemic was at its peak has left them wanting to move on from thinking about COVID-19 and vaccines. While that’s understandable, serious viruses still exist and continue to be potentially dangerous, so we need to take precautions against them.
  • COVID-19 vaccine requirements lifted. Some employers required their workers to get COVID-19 vaccinations. Many of these mandates have been lifted, which may have caused vaccination rates to drop.
  • Vaccine hesitancy. Misinformation about the effectiveness and potential side effects of vaccines has caused some people to rethink getting vaccinated.
  • Timing. Many people feel getting a flu shot is only worthwhile at the start of flu season. They may also remember not feeling well for a day or two after getting previous vaccinations, so they have concerns about missing work or not being able to take care of other responsibilities due to side effects.

All of these factors can affect whether people get vaccinated. The reasons for not getting vaccinated may be personal, but that choice can negatively impact family, friends, colleagues, and neighbors. When vaccination rates are low, everyone is more vulnerable to illness. That includes people who are unable to get vaccinated due to age, health conditions, or other medical issues.

It’s Not Too Late to Get Vaccinated Now

It may be February, but we’re not out of the woods yet — the flu season can extend into April, so it’s not too late to get vaccinated and protect yourself and your loved ones.

If you’re feeling hesitant, let me assure you that vaccines for respiratory viruses work. All vaccines go through multiple clinical trials to ensure they are safe and effective before they’re approved for public use. They also don’t make you sick. While you may experience some temporary side effects, they’re typically short-lived and much less severe than the symptoms of flu, COVID-19, and RSV. If you’re worried the side effects may impair your ability to work, schedule your vaccines for a weekend and use them as an excuse to relax.

Additionally, getting vaccinated for respiratory diseases is easier than ever. Vaccines are available in many stand-alone pharmacies, as well as the pharmacy sections of many supermarkets. You can even get multiple shots during the same appointment.

If you’re having trouble scheduling vaccinations due to lack of access to transportation, see if your community offers local transport options like para-transit. Public transportation may also offer free or low-cost services based on your age. Lastly, check with your primary care doctor’s staff. They might be able to connect you with local resources that can help.

Make a Plan for This Fall

While it’s not too late to get vaccinated for respiratory viruses, you shouldn’t make late-season vaccinations a habit. Vaccines for new viruses usually come out in September, so you have plenty of time to get vaccinated before the viruses start circulating widely.

Next fall, I recommend that you make getting vaccinated part of your — and your family’s — annual routine. Prioritize it in the same way you schedule a dentist’s checkup or an annual physical. It’s an easy, fast, and effective way to set up you and your loved ones for a healthy fall and winter.

Remember, we’re all in this together! The higher the vaccination rates are in a region, the less likely viruses are to spread. Do your part and get vaccinated for flu, COVID-19, and, if you’re eligible, RSV. Come September, get a head start and protect yourself early.

This blog was originally published on Philly Voice.



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The Amazing Benefits of Collard Greens

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The Amazing Benefits of Collard Greens


Renowned for their thick leaves and earthy flavor, collard greens are a culinary staple and a powerhouse of nutrients. They’re one of the first vegetables to pop up in my garden in the spring and I love incorporating them into soups and stir-fries. Here’s more on their health benefits and how you can make this versatile leafy green taste great (so even the kids will eat it!).

What Are Collard Greens?

Collard greens are one of those “green leafy vegetables” you’re always hearing about. They may also be a vegetable that’s harder to get kids to eat (more on that later). Collards and other leafy greens are the superstar veggies that can help you get enough calcium without dairy. But that’s not all they do.

Collards are also part of a family called cruciferous vegetables, or “brassica.” Other members of this family include broccoli, cauliflower, bok choy, and Brussels sprouts. However, radishes, turnips, and horseradish are also brassicas. 

Collards and other brassica vegetables are also known for a detoxification substance called sulforaphane. Sulforaphane may fight inflammation, support balanced hormones, and protect against chronic disease. It’s so sought after that it’s also available as a supplement (I use BrocElite).

While broccoli sprouts are the best food source, collards also provide this super nutrient.

Why Are Collard Greens Good for You?

Collard greens are an excellent way to get phytonutrients on an overall low-carbohydrate diet. Their carbohydrates primarily appear as dietary fiber. While not fully digested, fiber helps to maintain a healthy microbiome. 

Nutritional Breakdown of Collard Greens 

Collard greens are incredibly nutritious and rich in vitamins. They’re packed with vitamin A (as beta carotene), B vitamins (especially folate), and vitamin C. One cup of collard greens has over 300% of the daily value for vitamin A. It also provides over 50% of the daily value of vitamin C and nearly half (44%) of the daily value of folate. While folic acid is made in a lab, folate is the naturally occurring version.

Along with kale, mustard greens, and Swiss chard, collards are one of the best sources of vitamin K1. One cup of collards supplies 836 mcg of vitamin K1. That’s a whopping 1,045 percent of the recommended daily value! Collards also provide important minerals like potassium, manganese, calcium, magnesium, and phosphorus, supporting bones, muscles, and overall health. 

These vitamins, minerals, and other nutrients are part of why collard greens are so beneficial to our health. You’ll notice they support many systems of the body, including the circulatory, gastrointestinal, and immune systems.

6 Health Benefits of Collard Greens

Here are six research-backed ways collard greens may support your overall health:

1. Promoting Heart Health 

Many nutrients in collards are known for benefitting metabolic syndrome and reducing the risk of heart disease. The fiber and potassium in collards help to lower blood pressure and blood sugar. This alone can help to lower the risk of heart attacks, strokes, and type 2 diabetes.

2. Anti-Cancer Effects 

Collard greens provide vitamin A (as beta carotene) and vitamin C. For those reasons and more, collards support a healthy immune system. A robust immune response is critical for protecting the body against cancer. 

Collard greens also have compounds like glucosinolates and sulforaphane, which are both subjects of cancer research. Glucosinolates are compounds that are converted to isothiocyanate (ITC). ITC protects the cells from damage that could lead to cancer.

Increasing leafy green vegetables like collards in the diet is a known method for reducing cancer risk. Studies have shown benefits for prostate, breast, skin, bladder, oral, and colon cancers. 

3. Supporting Bone Health 

Along with vitamin K2 found in animal foods, the vitamin K1 in collard greens is crucial for bone health. Our bodies need vitamin K for calcium absorption and to reduce the risk of fractures. The combination of calcium, vitamin K, and vitamin D (from both plant and animal foods) helps guard against developing osteoporosis.

4. Good For The Eyes

Collards can also powerfully support eye health. An excellent source of beta carotene (pro-vitamin A) and lutein, collard greens can help maintain healthy vision over time. Getting plenty of leafy greens like collards may lead to a lower risk of age-related macular degeneration.

5. Anti-Inflammatory Properties 

Some compounds in collard greens have anti-inflammatory properties. For that reason, including them regularly may benefit conditions like arthritis and other inflammatory diseases. Antioxidants in collards like lutein, carotenoids, and zeaxanthin help fight free radicals. The reduced oxidative stress throughout the body helps to lower inflammation.

6. Supporting Gut Health

The fiber in leafy greens supports digestive health by promoting a healthy microbiome. Ultimately, that can contribute to regularity and avoiding constipation. It may even support weight loss. Researchers have also found a unique sugar in green leafy vegetables called sulfoquinovose (SQ). This sugar helps feed good gut bacteria, supporting digestion.

Who Should Avoid Collard Greens?

Collard greens are an excellent food for the vast majority of us. However, those currently on blood thinning medications like Warfarin should be cautious.

Because collards are high in vitamin K (named after the German word Koagulationsvitamin), they promote blood clotting. That’s usually a good thing, as it keeps us from bleeding out in case of an injury. However, it also means foods high in vitamin K can interfere with how blood-thinning drugs work. If you plan on adding more leafy greens to your diet, be sure to keep your doctor in the loop. 

Occasionally, collard greens may come up on a food allergy test. If that’s the case, you’ll want to avoid them until your immune system is back in balance.

Collard greens otherwise don’t tend to have side effects — unless you eat large amounts. In that case, the fiber may cause uncomfortable bloating and digestive distress. A serving or two goes a long way!

What About Oxalates?

Some people may wonder whether collard greens are high in oxalates. Oxalates are compounds in certain plants that may cause health issues if your gut bacteria cannot break them down. 

Overall, collard greens are lower in oxalates than spinach, kale, and other leafy greens. If you’re limiting your oxalates because of hypothyroidism, kidney stones, or other health conditions, collards can be a safer option.

How to Get Your Collard Greens In

When shopping for collard greens, look for fresh-looking, dark green leaves with no blemishes or wilting. The freshest leaves come straight from the garden. They’re excellent sauteed on the stovetop with olive oil and garlic. However, they’re quite versatile and work well in many dishes. Here are some ways to incorporate more collards into your meals:

  • Salads: Finely chop or shred the greens and use them as a base for salads. Massage the leaves with olive oil and lemon juice to soften them, like you would kale. For example, substitute them for kale in this salad recipe.  
  • Soups and Stews: Add chopped collards to soups, stews, or broths. They add nutrients and a unique flavor. Try collards in place of kale in Sweet Potato Zuppa Toscana.
  • Wraps: Use blanched collard leaves as a healthier alternative to tortillas or wraps. Fill them with your favorite ingredients like hummus, vegetables, and your favorite protein. Raw collard greens are popular in raw food diets as wraps. Give it a try by using collards instead of chard in this delicious Chard Wrapped Salmon recipe. 
  • Stuffed Collard Leaves: Make stuffed collard greens by filling blanched leaves with a mixture of grains, beans, and spices, then rolling them up and baking or steaming them until tender.
  • Braised Collard Greens: Slow-cook collard greens with broth, onions, and your choice of seasoning until tender and flavorful. Red pepper flakes can add an extra zing. In the American South, collard greens are a popular side dish. Southerners like to flavor them with bacon fat and garlic and serve them alongside smoked pork.
  • Green Smoothies: You can also use them in smoothies for an added nutrient boost. They blend well with fruits and other greens like spinach. A high-speed blender works best for those tough leaves.  

Whether cooked or raw, collard greens offer a unique taste and texture that can complement a wide range of dishes.

Do you eat collard greens? What’s your favorite way to prepare them? Share with us below!



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Navigating Malaria Control

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Navigating Malaria Control


Malaria poses a critical challenge to global health, linking parasitic infection complexities with climate change and public health inequities. The mosquito-transmitted infectious disease is caused by protozoan parasites of the Plasmodium genus, with P falciparum responsible for the most severe cases. This disease spreads through the bite of an infected mosquito, introducing the parasite into the human bloodstream. The significant presence of malaria in Africa is attributed to the Anopheles mosquitoes’ long lifespan and preference for biting humans.1

“Parasites are as complex, you can think of them as being as complex as a human cell. Because they code for 1000s of proteins, as opposed to viruses, which only have a minimal genome, they make only a handful of proteins,” Prakash Srinivasan, PhD, assistant professor, Johns Hopkins Malaria Research Institute said. “So, parasites are a lot more complex than viruses. And the reason why it becomes such a big challenge to develop vaccines against parasites, such as the malaria parasite plasmodium.”

Climate Change’s Impact on Malaria

Malaria remains a burden in sub-Saharan Africa, further exacerbated by climate change. Fluctuations in temperature and precipitation influence the disease’s vectors and incidence rates (IR). A study in BioMed Central outlines how average temperature changes affect malaria incidence rates in nine sub-Saharan countries, noting a 20–80% decrease from 2000 to 2018. Malaria remains a significant public health concern in sub-Saharan Africa, despite a marked decline in incidence rates observed in most of the countries studied.2

This study aligns with recent findings, showing a 20–80% decrease in malaria IR from 2000 to 2018. However, there’s significant variability in IR, with high rates in Uganda, Mozambique, Nigeria, and Zambia; moderate in Ghana, Zimbabwe, and Kenya; and low in South Africa and Ethiopia in 2018. It highlights how IR varies with average temperature changes in some countries and points out an inverse temperature-IR relationship, especially during periods of IR decrease in Ghana and Nigeria that matched with temperature increases. These decreasing IR trends, affected by temperature fluctuations, are likely shaped by intervention efforts and rainfall changes. Yet, the threat of vulnerability and changing climate may challenge further reductions in malaria IR.

“Malaria represents an emblematic example of how climate change can directly influence human health, facilitating the spread of infectious diseases previously confined to well-defined geographical areas,” Mariana Torres, MD, head of surveillance at BlueDot said. “Responding to this challenge requires a coordinated approach that includes environmental monitoring, vector control, research and development of new diagnostic and therapeutic tools, and public information and awareness campaigns.”

Main Takeaways

  1. Malaria is caused by Plasmodium parasites, with P falciparum leading to the most severe cases.
  2. Climate change influences malaria transmission patterns, with fluctuations in temperature and precipitation affecting vector behavior and disease incidence rates.
  3. The WHO has approved two malaria vaccines, RTS,S (Mosquirix) and R21 (Matrix-M), marking significant progress in the fight against malaria.
  4. Effective malaria control also relies on vector control measures, such as insecticide-treated nets and indoor residual spraying, and the early diagnosis and treatment of cases.
  5. Combating malaria requires a coordinated global and local effort, including environmental monitoring, research, and development of new tools, public information campaigns, and international cooperation.

Symptoms, Prevention, and Recent Advancements

The Centers for Disease Control and Prevention (CDC) monitors malaria as it becomes more prevalent in the US, emphasizing the risk of serious health issues and fatalities if untreated. In 2020, there were 241 million global instances and 627,000 deaths, mostly among young children in sub-Saharan Africa. Symptoms appear 10-15 days post-infection, with early testing crucial to prevent severe health complications.

Symptoms of malaria typically emerge 10-15 days after a bite from an infected mosquito, and early testing is crucial due to the potential for some malaria strains to lead to serious health complications or death. High-risk groups include infants, children under 5, pregnant women, travelers, and individuals with HIV or AIDS. Critical symptoms encompass severe fatigue, loss of consciousness, repeated seizures, breathing difficulties, discolored or bloody urine, yellowing of the skin (jaundice), and unusual bleeding. Immediate medical attention is necessary for those experiencing severe symptoms. Malaria in pregnant women can result in early delivery, stillbirth, or the birth of an underweight infant. Prevention strategies include mosquito bite avoidance and prophylactic medication, while treatments exist to prevent the progression of mild cases.2

Hernán Acosta, MD, Internal Medicine Specialist and Clinical Lead at BlueDot, notes the importance of vector control and early diagnosis in endemic areas, highlighting challenges like insecticide resistance,

“While highly endemic areas focus on vector control as well, they implement insecticide-treated nets and indoor residual spraying as part of disease control and elimination strategies. However, the increase in insecticide resistance among the Anopheles mosquitoes requires urgent action to maintain and improve malaria control efforts,” Acosta said. “Early diagnosis and treatment and preventive chemotherapy are also part of the population-based strategy in endemic areas. The latter focuses on the use of antimalarial medication during pregnancy, infancy, and in children living in high-risk areas per WHO guidelines.”

The approval and deployment of RTS, S/AS01, and R21/Matrix-M vaccines represent a milestone in malaria control, potentially saving about 450,000 lives a year. With 80 million children eligible for vaccination in sub-Saharan Africa, there is a high need for doses. The availability of these vaccines brings at-risk children offered protection against malaria.

Treatment

The World Health Organization (WHO) has approved 2 vaccines, RTS, S (Mosquirix) and R21/Matrix-M, marking significant progress in malaria control. These vaccines show promise in reducing the disease’s impact, with the R21/Matrix-M vaccine demonstrating up to 75% efficacy.

A phase 3 trial published in The Lancet for the R21/Matrix-M vaccine, involving 4,800 children in Burkina Faso, Kenya, Mali, and Tanzania, demonstrated that the vaccine was safely tolerated and had a positive safety profile. Over 12 months, the vaccine showed an efficacy rate of 75% in regions with high seasonal malaria transmission and 68% in areas with perennial transmission. It was also observed that administering a booster dose significantly improved its effectiveness, maintaining a 74% efficacy rate over 18 months in seasonal transmission areas.3

Both vaccines have been deemed safe and effective in preventing malaria in children, who are disproportionately affected, especially in regions such as Africa, where nearly 500,000 children die each year from the disease.

“Demand for the RTS, S vaccine far exceeds supply, so this second vaccine is a vital additional tool to protect more children faster, and to bring us closer to our vision of a malaria-free future,” said WHO Director-General Tedros Adhanom Ghebreyesus, in a statement.

Based on data from an ongoing clinical trial and other studies, the R21 vaccine has been shown to have a high degree of efficacy when administered just before the high transmission season, with data showing a 75% reduction in cases of malaria in the 12 months following the 3-dose series. A fourth booster dose administered 1 year later helped maintain efficacy.5

Travelers and Malaria in the US

Travelers to malaria-endemic regions face varied risks, necessitating personalized prevention strategies. Despite the approximately 2000 annual US cases of travelers’ malaria, local transmission remains rare, thanks to environmental conditions and mosquito behaviors.4

Malaria in the US is primarily associated with travelers’ malaria. This includes people visiting from malaria-endemic countries or US residents who travel to countries with ongoing transmission. Upon their return, they may already be infected, bringing the parasites back with them and starting to show symptoms, according to Prakash Srinivasan, PhD.” “So that’s what is called travelers malaria. And usually, there are about 2000 cases of travelers malaria every year in the US. But this year after almost two decades, of no local transmission of malaria.”

In June 2023, the CDC posted a health advisory on its website that stated that 5 cases of malaria were identified in the continental United States. There were 4 individual cases in Florida and 1 case diagnosed in Texas within the last 2 months.6

Progress and Challenges Ahead

Efforts to combat malaria through improved understanding, prevention, and treatment are making headway, with vaccines offering a new tool for reducing its impact. However, continued efforts in mosquito control, public health education, and international cooperation are essential. The fight against malaria exemplifies the importance of research, innovative solutions, and global collaboration in addressing infectious diseases.

The development of vaccines represents significant progress in combating malaria. Climate change alters malaria’s spread, requiring adaptable public health strategies. The battle against malaria emphasizes the need for continued research, international collaboration, and innovative solutions to mitigate the threat of malaria. Combining scientific developments with prevention strategies is essential for reducing, and potentially eradicating, the impact of malaria.

References

  1. Malaria. WHO | Regional Office for Africa. Accessed February 21, 2024. https://www.afro.who.int/health-topics/malaria
  2. Leal Filho W, May J, May M, Nagy GJ. Climate change and Malaria: Some Recent Trends of Malaria Incidence Rates and Average Annual Temperature in Selected Sub-Saharan African Countries from 2000 to 2018. Malaria Journal. Published August 28, 2023. Accessed February 21, 2024. doi:10.1186/s12936-023-04682-4
  3. Datoo M, Dicko A, Tinto H, Ouédraogo J, Hamaluba M, et. al. Safety and Efficacy of Malaria Vaccine Candidate R21/Matrix-M in African children: a Multicentre, Double-Blind, Randomised, Phase 3 Trial. Published February 1, 2024. Accessed February 21, 2024. doi: https://doi.org/10.1016/S0140-6736(23)02511-4
  4. CDC. Navigating Malaria Control. Published June 13, 2023. Accessed February 21, 2024. https://www.cdc.gov/malaria/travelers/index.html
  5. Bigicia, A. New Malaria Vaccine Endorsed by WHO Could Help Resolve Supply Issues. Contagion. Published October 6, 2023. Accessed February 21, 2024. https://www.contagionlive.com/view/new-malaria-vaccine-r21-matrixm-endorsed-by-who-could-help-resolve-supply-issues
  6. Parkinson, J. The CDC Sends Out Health Advisory on Locally Acquired Malaria Cases in Continental US. Contagion. Published June 27, 2023. Accessed February 21, 2024. https://www.contagionlive.com/view/the-cdc-sends-out-health-advisory-on-locally-acquired-malaria-cases-in-continental-us



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Going once, going twice…Open Enrollment ends soon!

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Going once, going twice…Open Enrollment ends soon!


Published on January 11, 2024

The clock is ticking for you to get health coverage for 2024. Open Enrollment for Marketplace health plans ends January 16. Coverage starts February 1.

Act now: Enroll in health coverage that meets your budget & needs

  • New to HealthCare.gov? Create an account to fill out an application for the first time.
  • Already have an account? Log in to update your application, compare plans, and change or renew for 2024. Even if you were automatically re-enrolled, it’s important to:
    • Update any income and household changes. Otherwise, your savings might not be correct.
    • Compare plans. There may be new plans and prices that better meet your needs and budget.

Questions? Help is available



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