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How Affordable Could Generic Ozempic Be? As Low as $5 a Month, Study Finds

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A new study finds that generic versions of Ozempic could cost far less than current prices. Maskot/Getty Images
  • The cost to make Novo Nordisk’s diabetes drug Ozempic is less than $5 a month, a new study suggests.
  • The list price in the U.S. for Ozempic is almost $1,000, although people with insurance coverage may pay less.
  • The study looked at the cost to manufacture Ozempic and other GLP-1s, as well as insulin.

Novo Nordisk’s diabetes drug Ozempic could be manufactured for less than $5 a month, a recent study suggests. The U.S. list price of this injectable drug is close to $1,000 a month, although people with insurance may pay much less.

The study, which was published Mar. 27 in JAMA Network Open, highlights the dramatic markup by manufacturers on GLP-1 receptor agonists and other newer diabetes medications, as well as insulin pens.

The results suggest that these drugs “can likely be manufactured for prices far below current prices, enabling wider access,” researchers from Yale University, King’s College Hospital in London and the nonprofit Doctors Without Borders concluded.

GLP-1 receptor agonists, or GLP-1s, are a class of drugs used to treat diabetes and for chronic weight management. They include Novo’s Ozempic and Wegovy, and Eli Lilly’s dual GLP-1/GIP receptor agonists Mounjaro and Zepbound.

Many insurance plans cover these medications when prescribed for diabetes, but the high prices have led to some insurers dropping them from their plans when used solely for weight loss.

Researchers estimate production costs

In the study, researchers used data on the costs of ingredients, packaging, logistics and taxes to estimate the lowest potential prices at which companies could still make a profit on several diabetes medications.

They concluded that drug companies could sell GLP-1s such as Ozempic for $0.89 to $4.73 a month — depending on the production volume — and still make a profit.

In contrast, the lowest market prices across the world for Ozempic ranged from $38.21 to $353.74 for a month’s supply, researchers found. The list price for Ozempic in the U.S., which may not be what people actually pay out of pocket, is $935.77 a month.

Researchers also found that a single pre-filled NPH insulin pen could be sold at a profit for $0.94 to $5.90. Around the world, the lowest market prices ranged from $2.00 to $90.69.

Similarly, a long-acting pre-filled insulin glargine pen could be sold at a profit for $1.30 to $6.57. The lowest market prices around the world ranged from $2.98 to $28.41.

Mariana Socal, MD, PhD, associate scientist in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health, said the findings of the new study are not surprising.

“It has long been recognized that the cost of production [of medications] pales in comparison to the prices that are charged when these drugs actually come to market,” she told Healthline.

High demand for GLP-1s like Ozempic results in shortages

Demand for GLP-1s continues to increase, which has led to ongoing shortages in the U.S. and more concerning access issues in other parts of the world.

“These new drugs are an absolute game changer for people living with diabetes, but are being kept out of the hands of hundreds of millions of people who need them in low- and middle-income countries,” Christa Cepuch, pharmacist coordinator at MSF’s Access Campaign, said in a release.

“Eli Lilly and Novo Nordisk can in no way supply the world with the amount of these medicines needed to meet global demand, so they must immediately relinquish their stranglehold and allow them to be produced by more manufacturers around the world,” she said.

In an emailed statement, Novo Nordisk declined to disclose its costs for the production of Ozempic, but noted that last year it spent almost $5 billion on research and development. It is also spending billions more in acquisitions meant to boost the supply of GLP-1s, the company said.

Onisis Stefas, PharmD, chief executive officer of VIVO Health, Northwell Health’s outpatient pharmacy network, said he understands the need of drug makers to price their products to cover their overall research and development costs, including the costs for drugs that never make it to market.

However, “I still think that, whether globally or in the U.S., we need to find a way to get patients access to these newer agents,” he told Healthline.

“If you’re a diabetic, and you can’t get access to insulin or other medications, you’re going to have negative outcomes,” he said. “Sometimes this results in medical expenses far higher than the cost of the medications themselves.”

Out-of-pocket costs lower than the list price

As with many brand-name medications, list prices for GLP-1s are higher in the U.S. than in other countries. Similarly, in 2018 the cost of insulin was five to 10 times higher in the U.S. compared to other countries, according to a report by RAND.

Diabetes drugs are typically covered by private insurance plans, Medicare and Medicaid, so people with coverage often pay less than the list price.

Novo also offers a savings card, which enables people with private or commercial insurance to pay as little as $25 for a 1-month, 2-month, or 3-month supply of Ozempic for up to 24 months. The company said in its statement that three-quarters of its gross earnings go to these kinds of rebates and discounts.

“At Northwell, we spend a lot of time working with patients, including trying to leverage copay assistance programs wherever pertinent,” said Stefas. “Sometimes we’ll reach out to foundations to see if there are ways that they can help subsidize some of those costs for the patients.”

A survey released last month from Evercore ISI found that more than half of Americans taking a GLP-1 for diabetes or weight loss said they were paying $50 or less out of pocket each month.

However, even when the cost of a drug is lower than the list price, insurance copays and deductibles can still be a significant barrier for people with diabetes.

“The burden of diabetes continues to grow, putting a lot of pressure on patients, in terms of their out-of-pocket expenses,” said Stefas. “In some instances, diabetics are not getting the appropriate medications because they can’t afford them.”

When will prices for Ozempic, Wegovy, and other GLP-1 drugs drop?

It is difficult to know when the list price of GLP-1s will drop. In the U.S., most brand-name drugs are protected from lower-priced generic drugs for 5 years. However, once a generic enters the market, the cost of the original brand-name drug may also decrease. 

“The presence of generic or biosimilar competition is the most effective tool that we have to bring down the prices of drugs in [the U.S.],” said Socal.

Sometimes drug makers are able to keep generics off the market, though, such as by making small tweaks to their drugs so they can sustain their monopoly for several more years.

If a brand name drug doesn’t have competition from a generic, its price may actually go up over time, rather than down, as is seen in other countries.

“Drugs [in the U.S.] can increase significantly in price over time,” said Socal, “and have done so, even in the absence of any improvements to the drug or any advances to the technology that the drug represents.”

In contrast, governments in other countries have effective mechanisms to keep prices under control over time, she said.

In the U.S., the federal government and Congress are starting to take steps to keep drug prices lower, even if just through a piecemeal approach.

Last year, a $35-a-month cap on insulin went into effect for Medicare enrollees as part of the Inflation Reduction Act (IRA).

Another provision of the IRA is Medicare’s price negotiation for certain drugs. The Congressional Budget Office expects semaglutide — which is the active ingredient in Ozempic and Wegovy — to be selected for price negotiation within the next few years. 

This provision of the IRA was a direct attempt to address some of the pricing problems seen in the U.S. market.

“The reason the Medicare drug price negotiation program had to be created in the first place is that the drugs that are in the program have been on the market for a long time without competition,” said Socal, which has led to high prices and created “all kinds of affordability issues.”

Takeaway

In a new study, researchers estimated the cost to produce diabetes drugs such as GLP-1s and insulin. They found that the market prices for these drugs are much higher than the production costs, especially in the U.S.

The list price for Novo Nordisk’s diabetes drug Ozempic is nearly $1,000, although people whose insurance covers this drug may pay less out of pocket. Drug makers also offer rebates and discounts that may lower the cost of diabetes drugs.

High prices for diabetes medications can deter people from taking their medication regularly, which can lead to more expensive medical care later on. Even high insurance copayments and deductibles can put these drugs out of reach for some.

To Cut Risk of Dying By Heart Disease, What to Know About BMI and Type 2 Diabetes

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A new study looks at how BMI may be linked to heart health for people with type 2 diabetes. Peathegee Inc/Getty Images
  • In individuals with type 2 diabetes, researchers found that the ideal BMI to reduce the risk of death from cardiovascular disease changed with age.
  • People over the age of 65 had better health outcomes when their BMI was in the “overweight” range, compared to those whose BMI was in the “normal” range.
  • Some experts interviewed by Healthline were wary of the findings. 
  • The science around BMI, obesity, and chronic disease remains controversial.

Is there a single, healthy BMI range for people with type 2 diabetes? Surprisingly, no, indicates new research, instead, a healthy BMI could change with age.

In research being presented at this year’s European Congress on Obesity (ECO) in Venice, Italy (12-15 May), scientists investigated what BMI range was most likely to reduce the risk of death from cardiovascular disease, including heart failure, stroke, and other complications of metabolic syndrome in people with type 2 diabetes. The research has not yet been published.

BMI lower than 25 was better for adults under age 65

They found that for middle-age adults, 65 years of age and younger, a BMI of 23-25, part of the “normal” range, was associated with the lowest risk of dying from cardiovascular disease. However, for people over age 65, the optimal BMI was 26-28, which corresponds to the “overweight” range.

“Our findings suggest that there exists a disparity in the optimal cut-off point for BMI and risk of cardiovascular mortality between elderly and non-elderly individuals with diabetes. Moreover, we have identified a relatively rational range of BMI values to determine the lowest incidence of cardiovascular death among elderly and non-elderly patients with diabetes, which is imperative in this aging society,”Shaoyong Xu, MD, the lead author of the research and member of the Department of Endocrinology  Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, told Healthline.

In terms of practical implications, the research suggests that there is no “one-size-fits-all” approach to cardiovascular risk assessment in patients with diabetes. Instead, an individualized approach is more likely to yield health benefits.

“Overweight” individuals over 65 had better outcomes

To investigate the link between BMI and cardiovascular disease outcomes in individuals with type 2 diabetes, the researchers relied on data from the UK Biobank, a medical database that includes genetic, lifestyle, and health information on about a half-million individuals throughout the United Kingdom.

The study included nearly 23,000 people with baseline type 2 diabetes. Participants were predominantly white, with an average age of 59 years; about two-thirds of them were women. Individuals were enrolled between 2006 and 2010, and had an average follow-up period of 12.5 years. During this time, 891 people died from cardiovascular disease. Using BMI and age data, researchers then looked at how those factors affected mortality.

They compared two groups based on age: the elderly (older than 65) and the middle-aged (65 and under). Middle-aged adults with a BMI in the “overweight” range had a 13% increased risk of death due to cardiovascular disease. In the elderly group, they saw the opposite effect, with “overweight” individuals showing a 28% decreased risk compared to elderly participants with a “normal” BMI range.

The study also identifies an optimal BMI cut-off point at which risk of death from cardiovascular disease begins to increase. For the middle-aged group, the cut-off was 24, while the cut-off for the elderly group was 27.

“I think this adds valuable data as we need to take more than BMI into consideration when making recommendations for weight loss. The research highlights that age is important and weight loss goals need to be individualized,” Ivania Rizo, MD, an Assistant Professor of Endocrinology, and Director of Obesity Medicine at Boston Medical Center, told Healthline. She wasn’t affiliated with the research.

Experts say more study is needed

Other experts were more wary of drawing conclusions from the research.

“I’m left with more questions,” Sun Kim, MD, MS, an Associate Professor of Endocrinology at Stanford Medicine, told Healthline. She wasn’t affiliated with the research.

She said that while the study investigated associations between baseline BMI and cardiovascular disease, it would also be important to document how participants’ BMI changed over the follow-up period. 

As to whether elderly individuals were really better off with a higher BMI, Kim is skeptical. “Does it also mean that older individuals who are normal weight should gain weight? Again, I think we need to see the limitations of this study here,” she said. Kim points out that the current guidelines from the American Diabetes Association indicate that losing any amount of weight is important.

However, she still agrees with the overarching message about the importance of individualized care:

“Some overweight individuals who are older may still benefit from weight loss if they have uncontrolled type 2 diabetes and other comorbidities with excess fat (not excess BMI). Another overweight individual with well-controlled cardiovascular risk factors, may benefit more from focusing on exercise and maintaining lean mass, which can decline with aging,” she said.

The controversial science around BMI

The science behind BMI, obesity, and related health outcomes has often been contentious. The BMI itself is criticized as inaccurate for not distinguishing between fat and lean muscle mass. It also doesn’t take into account race and ethnicity and is largely based on data from white men. 

It is a simple, easy-to-perform, if overly general, way to assess an individual’s weight. Directly measuring body fat is more difficult, takes more time, and requires specialized equipment. Basically, it’s not something that can readily be performed during a checkup.

“BMI is a surrogate measure for body fat. It’s not practical (at this time) to measure body fat in clinical practice but it would be great if we can do that to give patients a meaningful target,” said Kim.

 But there are even more controversies in the field as well. Scientists have documented that in some older individuals, those with obesity along with other chronic conditions, such as heart disease, may actually have a lower risk of death than peers with a healthy BMI. This supposedly “protective” effect of obesity is known as the “obesity survival paradox.” 

“The obesity paradox is controversial. It also highlights the need to evaluate other markers such as function, fragility, waist-to-height and waist circumference to better understand a person’s risk of cardiovascular death, especially in those 65 years of age and older. These may be better markers at evaluating the risk that adiposity has on that person’s health,” said Rizo.

Other methods of measuring adiposity, such as waist-to-height ratio and waist circumference may be better than BMI, but aren’t perfect either. 

Using multiple measurements together, rather than relying on them individually, undoubtedly reveals a clearer picture about not just a person’s weight, but their health in general.

“This research highlights the importance of looking at other anthropomorphic markers and not just BMI in all ages and especially those older than 65 years of age…It is important to also look at other factors such as waist circumference and waist-to-height ratio, as an upward trend in both these markers did have a positive relationship with cardiovascular events and mortality,” said Rizo.

The bottom line

Researchers found that the ideal BMI to reduce the risk of death from cardiovascular disease varied by age.

Elderly individuals with type 2 diabetes had better health outcomes when their weight fell in the “overweight” BMI range, compared with those whose weight was in the “normal” range.

Experts say the findings underscore the importance of individualized care and not a “one-size-fits-all” approach to cardiovascular risk assessment.

Some of the science around BMI, obesity, and health outcomes remains controversial.

Puerto Rico Just Declared a Public Health Emergency Due to Dengue, What to Know

A close up of a mosquito.
Dengue is spread via mosquitoes. Leslie F. Miller/Getty Images
  • Puerto Rico’s health department has declared an emergency due to dengue.
  • Cases of dengue and other mosquito-borne diseases are surging this year across the Americas, the Caribbean, and Brazil in particular.
  • While dengue is not serious for many people, the more severe form of the disease can result in hospitalization and death.

Cases of dengue, a mosquito-borne disease, are surging in Puerto Rico, prompting the island’s health department to declare a public health emergency.

There have been 549 reported cases of the disease this year, according to Puerto Rico’s health department. Meanwhile in 2023, the total number of cases was 1,293 for the entire year.

“This year, dengue cases have surpassed historical figures,” said Puerto Rico Secretary of Health, Carlos Mellado López, in a statement.

Dengue has regularly been documented in the continental United States, particularly in southern Florida. In 2023, there were 642 cases of dengue in the United States, according to the CDC.

About half of the world’s population is at risk of dengue, with between 100-400 million infections occurring annually, according to the World Health Organization. The majority of cases so far this year have appeared in the Americas and Caribbean. Brazil has become the epicenter for dengue, with more than 60% of global cases occurring there — about 2.9 million.

Other mosquito-borne diseases, including zika, chikungunya, yellow fever, have also been on the rise globally.

Why is dengue surging now?

Peter J. Hotez, MD, PhD, Co-director of the Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine, told Healthline that the causes for the increase in these diseases are complex and multifactorial.

“It’s happening because of a confluence of a number of forces, which include global warming, climate change, and urbanization together with poverty. Those three things seem to be creating a toxic mix,” he said.

Those factors have created an environment in which mosquitoes are thriving in close proximity to densely populated areas.

One mosquito in particular is responsible for transmitting dengue, chikungunya, yellow fever, and zika: the aedes aegypti or aedes mosquito.

“They’re really voracious feeders. The females are feeding all the time and they’re often biting multiple people,” Bob Bollinger, MD, MPH, a Professor of Infectious Diseases at Johns Hopkins University School of Medicine, told Healthline.

Dengue, which is caused by the dengue virus, is transmitted through blood, making mosquitoes the perfect vector.

“If they happen to bite somebody that has dengue virus in their blood, they’ll take that virus up in their blood meal, and then the next time they bite somebody they basically transmit it to that person as well,” said Bollinger.

Unlike viruses that originate in other animals which can then be spread to humans, dengue is spread directly from humans to mosquitoes and then to other humans. Although uncommon, dengue can also be passed down maternally from an infected mother, and through blood transfusions.

In areas where dengue is present, it is continually being transmitted, although it may be unnoticed and not rise to epidemic proportions.

“Dengue virus is kind of always percolating along at a low level right now in different parts of the world,” Dawn Wesson, PhD, an Associate Professor at Tulane University School of Public Health and Tropical Medicine, told Healthline.

“Even during the dry season or in times when there’s not a lot of transmission going on, there’s some low level transmission. So it’s never stopping in some of these tropical parts of the world. It’s just kind of constantly going and at certain times it erupts,” she said.

What are the signs and symptoms of dengue?

There are two forms of the disease caused by the dengue virus: dengue and severe dengue. One-in-four people infected will get sick, while only one-in-20 will experience symptoms of severe dengue, according to the CDC.

In its mildest form, it may even go unnoticed, though it is still transmissible. 

“A lot of people can have it. They can feel just fine and get on a plane and go someplace else. So, it wouldn’t surprise me as a result of this if we start seeing cases in southern Florida,” said Wesson.

Signs and symptoms of dengue can include:

  • Fever (the most common symptom)
  • Nausea
  • Vomiting
  • Aches and pains
  • Rash
  • Pain behind the eyes

Dengue usually lasts 2-7 days and individuals will typically recover on their own after about one week.

Some people will develop severe dengue. Those who have previously been infected with dengue are more likely to develop the more serious condition.

Severe dengue can be fatal and may require hospitalization.

Symptoms of severe dengue include:

  • Persistent vomiting
  • Bleeding gums or nose
  • Severe abdominal pain
  • Rapid breathing
  • Blood in vomit or stool
  • Weakness

Severe dengue is also more likely to affect vulnerable populations.

“Severe dengue is more common in people with underlying conditions, very much like covid, meaning diabetes and hypertension. So those are the ones often that wind up having to go to the ICU,” said Hotez.

How to prevent dengue

There is no treatment for dengue, that is, there is no antiviral medication formulated specifically for the disease. While there is a vaccine for the disease, it is not widely available, nor is it approved in all areas of the world. Dengue is treated with supportive care and pain medication, such as acetaminophen, and severe dengue can require hospitalization.

In the United States, there is an approved dengue vaccine for children between the ages of 9-16, and only if they have already had a laboratory-confirmed case of dengue. It is only administered in areas where dengue is endemic, and occurs regularly.

A dengue vaccine has proven difficult to create due to the genetic makeup of the dengue virus. There are four serotypes (varieties) of dengue virus, which share much of their genetic material but are all slightly different. Someone who has been infected with one serotype will become immune to just that one variety, although they will also have some limited immunity to the others for a few months.

After the immunity has worn off, that person can then be infected by the other serotypes, and puts them at a greater risk of severe dengue.

Due to the lack of treatment and effective vaccines, the top priority in dengue (and other mosquito-borne illness) prevention is through controlling mosquito populations.

“If you control the mosquito, you’re going to reduce transmission. However, this mosquito is a very difficult mosquito to deal with,” said William Schaffner, MD, a Professor of Infectious Diseases and Preventative Medicine at Vanderbilt University.

Mosquitoes require water to breed, so making sure to clean up areas of standing water, even small amounts of it, around the home will help control mosquito populations.

The other major component of prevention, said Schaffner, is personal protection. That means common sense things like wearing long clothing, using insect repellant, and installing screens or other protective measures around the home.

“Do whatever you can to protect yourself if you’re not vaccinated, and most people aren’t. So keep that repellent on hand and use it when you are out and the mosquitoes are out,” said Wesson.

The bottom line

The Puerto Rico health department has declared an emergency due to surging cases of dengue. Dengue is a mosquito-borne disease that causes fever, aches, and nausea.

A more serious form of dengue, called severe dengue, can cause internal bleeding, hospitalization, and death.

There is currently no treatment for dengue, but most people recover in about a week. While there is a vaccine, it is only available to children who have already had a confirmed case of dengue.

How Olivia Munn’s Doctor Helped Calculate Her Breast Cancer Risk, Leading to Early Diagnosis

Dr. Thaïs Aliabadi
Dr. Thaïs Aliabadi (pictured above) shares how she calculated actor Olivia Munn’s Breast Cancer Risk Assessment Score, which led to an early breast cancer diagnosis that may have saved her life. Photography by Mike Thompson
  • Earlier this month, actor Olivia Munn publicly shared her journey with breast cancer.
  • Munn’s doctor shares insight on the assessment test that Munn said saved her life.
  • Understanding the benefits of knowing your Breast Cancer Risk Assessment Score can help you advocate for yourself.

On March 13, 43-year-old actor Olivia Munn announced on Instagram that she underwent a double mastectomy after being diagnosed with breast cancer.

In her post, she thanked her gynecologist Dr. Thaïs Aliabadi, co-host of the SHE MD Podcast, for calculating her Breast Cancer Risk Assessment Score, which determined that Munn has a 37% lifetime risk of getting breast cancer.

Because of this, Munn qualified for an MRI, which led to an ultrasound and a biopsy that found Luminal B Cancer in both breasts.

In her post, Munn credits the assessment and follow-up preventive MRI screening for saving her life. Just months before, in February 2023, she took a genetic test that looked at 90 different cancer genes, for which she tested negative. Around the same time, she also had a normal mammogram.

“I wouldn’t have found my cancer for another year — at my next scheduled mammogram — except that my OBGYN, Dr. Thaïs Aliabadi, decided to calculate my Breast Cancer Risk Assessment Score,” she wrote. “The fact that she did saved my life.”

Dr. Aliabadi also calculated her own risk that led to a diagnosis

Aliabadi also saved her own life after calculating her own lifetime risk of breast cancer. Knowing her risk led to a double mastectomy and, after surgery, the discovery of Stage 1 cancer in her breast tissue. She personally relates to her patients like Munn.

“Olivia’s journey is truly remarkable, and as a breast cancer survivor myself, I couldn’t be prouder of her,” Aliabadi told Healthline. “By raising awareness about the importance of risk assessment and screening, she’s not only making a difference in her own life but also in the lives of countless others…I adore her.”

Aliabadi said Munn’s advocacy is a step toward achieving her ultimate goal as a doctor, which is for every female to know their lifetime risk of breast cancer, no matter their family history or lifestyle.

“In my office, we calculate the lifetime risk of breast cancer for every single woman,” she said. “Knowledge empowers, and it’s vital for each individual to advocate for their own health.”

Who can get a breast cancer assessment?

Any female over age 18 can ask for a breast cancer risk assessment from their doctor or through a specialized healthcare professional in the cancer risk space, such as a genetic counselor, said Sara Pirzadeh-Miller, president-elect of the National Society of Genetic Counselors and associate director of cancer genetics at UT Southwestern Medical Center.

In fact, the U.S. Preventive Services Task Force (USPSTF) recommends that “primary care clinicians assess women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with breast cancer susceptibility 1 and 2 (BRCA1/2) gene mutations with an appropriate brief familial risk assessment tool. Women with a positive result on the risk assessment tool should receive genetic counseling and, if indicated after counseling, genetic testing.”

“Overall, it is important for anyone to understand their cancer risk, whether it is breast or other cancers, to be empowered to make critical healthcare decisions,” Pirzadeh-Miller told Healthline.

The Tyrer-Cuzick (T-C model) breast cancer risk assessment, is one model used for calculating lifetime breast cancer risk. The model considers the following:

  • Age
  • Height and weight
  • Age when you started having periods
  • Obstetric history (if you’ve had your first child after the age of 30 or have never birthed a child)
  • Age of menopause
  • History of hormone replacement therapy use
  • Family history of breast cancer, including age when breast cancer was diagnosed

The Tyrer-Cuzick model can be used to formally qualify someone for breast MRI by having a lifetime breast cancer risk of 20-25% or higher. Breast MRI can find some breast cancers that are missed on a mammogram. However, because MRI can wrongly identify some things as cancer, it is recommended in addition to a mammogram, not as a replacement for it.

“It is important to have the conversation of which models make the most sense given the individual, their risk factors and specific clinical scenarios for each individual,” said Pirzadeh-Miller.

She noted that data in general populations and breast cancer screening and mammography centers has shown up to 25% of women have a family history of breast cancer that qualifies for further breast cancer risk assessment (genetic testing and/or high-risk breast cancer screening protocols). These women would have >20% lifetime breast cancer risk, said Pirzadeh-Miller.

What if my doctor says “no” to the assessment?

If your doctor gives you pushback on requesting the breast cancer assessment, connect with another provider.

“If a person doesn’t feel comfortable with the answers they receive from their healthcare provider to their inquiries on how to best create a well-rounded cancer prevention plan, it is important to obtain a second opinion,” said Pirzadeh-Miller.

If you have a personal or family history of breast cancer and/or other cancers that contain ‘red flags’ for hereditary cancer risk, consider seeing a genetic counselor for genetic risk assessment.

Aliabadi is launching a breast cancer risk calculator, which will be able to be accessed on her website.

“Following the assessment, we will provide clear guidelines on the necessary steps every woman should take based on the final risk percentage. This will enable women to have a clear action plan to discuss with their doctor,” said Aliabadi.

Benefits of knowing your breast cancer risk assessment score

Knowing your breast cancer risk will enable important conversations with your doctor about cancer risk management and prevention strategies.

Like Munn, women who meet the greater than 20 to 25% lifetime breast cancer risk when calculated through the appropriate breast cancer risk models qualify for extra and possibly earlier breast cancer screening through breast MRI and other modalities.

“Other preventive measures for lowering the risk of breast cancer include medications like selective estrogen receptor modulators (SERMs) or aromatase inhibitors, maintaining a healthy diet and lifestyle, regular exercise, limiting alcohol intake, and considering risk-reducing mastectomies for high-risk individuals,” said Aliabadi.

What to consider before getting tested

Before women undergo genetic testing or before finding out their breast cancer risk calculations, they should consider how it might affect them emotionally and psychologically.

Weighing what they would do with the information if their risk is high is something to consider.

“Will the individual use the information to make proactive decisions on breast cancer risk management? Will they not use it at all? The answers to these questions could impact a person’s choice to obtain the breast cancer risk score information,” said Pirzadeh-Miller.

While some women may choose to hold onto the information, others may take Munn’s approach of acting on it and spreading awareness.

“Anyone sharing their story, like a breast cancer diagnosis and their journey surrounding it, will bring awareness to those who ingest the information,” said Pirzadeh-Miller.

Public statements by celebrities also provide an opportunity to discuss facts surrounding breast cancer risk assessment.

“Olivia also reported that she had a ‘negative 90 gene test result.’ This statement brings an opportunity to highlight that there are other breast cancer risk factors that can elevate lifetime risk outside of genetic or inherited factors,” said Pirzadeh-Miller.

A negative genetic test doesn’t equal the same clinical interpretation for everyone, she explained, because some people who have a negative test result still have an elevated breast cancer risk for other reasons that need detailed evaluation by healthcare providers.

“This is where a specialist in this space, like genetic counselors, can provide detailed, evidence-based recommendations for ongoing risk management discussions with the healthcare team,” Pirzadeh-Miller said.

FDA OKs New Drug To Boost COVID-19 Protection for Immunocompromised People

Woman in a face mask seen walking.
Klaus Vedfelt/Getty Images
  • The FDA has authorized a new treatment that may help immunocompromised people be protected from COVID-19.
  • The treatment is a monoclonal antibody infusion that is expected to be available this April.
  • People with severely compromised immune systems may need regular infusions.

New emergency use authorization of a monoclonal antibody infusion by the Food and Drug Administration (FDA) means that immunocompromised people starting at age 12 will be able to add another layer of protection from COVID-19.

Pemgarda, made by the company Invivyd, is a successor to the previous monoclonal antibody Evusheld, which was withdrawn from use by the FDA in January of 2023 when it became clear that it was not effective against new COVID-19 variants. It could be a welcome relief for people whose immune systems are severely threatened by Covid itself — with infection leading to serious illness — or those for whom vaccination does not provoke enough protective immune responses.

Pemgarda, which is expected to become available in April, is administered as an hourlong infusion at a medical office. Invivyd believes that it will be covered under regular insurance plans and by Medicare. For people with severely compromised immune systems, it could be possible that a regular infusion — perhaps every three months — would be necessary.

What makes this treatment different from past infusions?

Both Pemgarda and Evusheld are monoclonal antibodies — a passive form of immunization as opposed to the active form provided by vaccines. Essentially, a vaccine’s role is to provoke antibodies to a particular disease in whomever receives it. But for people who are severely immunocompromised, like cancer patients, anyone with an autoimmune disease, or those who have had major organ transplants, the body’s response to a vaccine can be limited and not adequately create the antibodies needed. A monoclonal antibody helps to infuse the antibodies directly.

No monoclonal antibody is intended to be a medicine for active COVID-19 infections.

It’s not a cure for the virus itself, just a shield for the most vulnerable. Pemgarda is expected to be available to about 6% of the population — the number of severely or moderately immunocompromised people in the U.S., according to the Centers for Disease Control and Prevention.

Monica Gandhi, MD, Ph.D, a professor of medicine and the associate division chief of the Division of HIV, Infectious Diseases, and Global Medicine at UCSF/San Francisco General Hospital, told Healthline that in addition to monoclonal antibodies, there are oral treatments for immunocompromised patients — and that vaccines shouldn’t be ruled out.

“The currently available oral treatments for COVID (molnupiravir and Paxlovid) work well in patients with immunocompromise and should be used if COVID is contracted,” Gandhi said. “The currently available COVID-19 vaccines actually work better among those with immunocompromise than often reported, although repeated booster are necessary.”

William Schaffner, MD, a professor of preventive medicine in the Department of Health Policy and a professor of medicine in the Division of Infectious Diseases at the Vanderbilt University School of Medicine in Tennessee, told Healthline that the evolution of the virus rendered Evusheld ineffective.

“With the changing virus, that combination of monoclonal antibodies that was included in Evusheld was no longer functional; it didn’t provide protection against Omicron and its severity. And so this new monoclonal antibody has been developed in response to the latest viral variants,” Schaffner said. “It doesn’t take all that to create the monoclonal antibody. What takes a little time is, of course, to test it in populations sufficient for the Food and Drug Administration to give it an emergency use authorization. So it’s the clinical testing that takes longer than, actually, the development of the monoclonal antibody.”

Why was Evusheld not effective?

The development of new variants was a significant factor. Evusheld simply couldn’t keep up with how the COVID-19 virus was evolving. But another issue, according to Schaffner, was that Evusheld was not disbursed in an efficient enough manner.

“This is a well-awaited and welcome addition to our capacity to protect these most vulnerable people against COVID. Now the question is, can we get it widely used by the providers who take care of such patients?” Schaffner said, saying that the CDC’s Advisory Committee on Immunization Practices (ACIP) did not make specific recommendations for Evusheld, which was possibly a factor in it not being as widely promoted as it could have been. “The Advisory Committee on Immunization Practices has made recommendations for the use of another monoclonal antibody, Nirsevimab, which prevents serious RSV infections in infants and young children. And that’s been adopted very, very widely by pediatricians. So there are some of us who hope that the ACIP will review Pemgarda and provide some recommendations.”

Can this treatment prevent infection from new COVID variants?

“Most people are protected from a combination of vaccines and prior exposure to COVID-19 at this point,” said Gandhi. “This monoclonal antibody gives additional protection of antibodies against the circulating strains. It is effective against the most common circulating strain of COVID, which is JN.1.”

But as has been seen in the four years since the pandemic began, how the virus circulates and what type of protein spike evolutions occur in the future are not easily predictable. This makes it hard to determine how effective Pemgarda can be against new strains that haven’t been studied, Schaffner said.

“It all depends on what the virus does,” Schaffner said. “If the virus develops a mutation that is substantially different than the current Omicron family of viruses, then we’ll have to go back to the beginning, and we would have to update our vaccine, and we would also have to update the Pemgarda.”

Takeaway

The Food and Drug Administration granted an emergency use authorization for Pemgarda, a monoclonal antibody for people who are immunocompromised.

Pemgarda would not be a treatment for active COVID-19 infections; it’s a preventative, passive form of immunization that provides people with several compromised immune systems with another level of protection.

Pemgarda should be available for about 6% of the U.S. population.

Arnold Schwarzenegger Recovering from Surgery After Getting a Pacemaker

Arnold Schwarzenegger
Arnold Schwarzenegger revealed he recently underwent surgery to get a pacemaker implanted to help manage irregular heartbeat. Bellocqimages/Bauer-Griffin/GC Images via Getty Images
  • Arnold Schwarzenegger is now living with a pacemaker following several open heart surgeries, some dating back to the 1990s.
  • Pacemakers are small battery-powered devices that help to control the rhythm of the heart by delivering tiny electrical impulses
  • The former Governor of California is in good health following the procedure and is encouraging his fans to speak openly with their doctors about their health.

Arnold Schwarzenegger, the former Governor of California, Hollywood superstar, and bodybuilding champion, announced this week that he recently got a pacemaker. The procedure marks the latest in a string of surgeries for his heart, some dating back to the 1990s.

“I had surgery for a pacemaker and became a little bit more of a machine,” the Terminator star said on the most recent episode of the Arnold’s Pump Club podcast. Schwarzenegger appears to be in good health and feeling better than ever, following the procedure.

In the ten-minute episode, he also goes on to reveal further details about his heart, medical history, and his hope that the revelations will help to lower the stigma around discussing health issues.

“I know a lot of you are probably dealing with your own health challenges, and I want you to know that you aren’t alone. If you’re putting something off out of fear, I hope I inspire you to listen to your doctors and take care of yourself,” he said.

Why did Schwarzenegger get a pacemaker?

Schwarzenegger got a pacemaker on the recommendation of his medical team due to an irregular heartbeat, also known as an arrhythmia.

An arrhythmia is when the heart beats too slowly, too quickly, or has an irregular rhythm.

Despite his renowned physique and level of fitness, the 76-year-old Schwarzenegger has been plagued by heart problems over the years. He admits on his podcast that he has a congenital heart defect known as a bicuspid aortic valve.

The normal aortic valve in the heart has three valves or leaflets, but individuals with this condition only have two leaflets.

The condition led him to have aortic valve surgery back in 1997.

“My mother and her mother’s bicuspid valves killed them. I’m still here because of medical innovation and being very diligent about staying in touch with my doctors and listening to them. My mother refused to have the valve replacement surgery,” he said.

The replacement valves were intended to last 12-15 years, he explains in the podcast, but due to the quality of the surgery they lasted more than twenty.

However, in 2018 he went in to finally have them replaced. Although the procedure was initially supposed to be relatively noninvasive, due to “a screw-up,” the procedure ended up being an open heart surgery.

In the end, he only had one of the valves replaced; the second was replaced in 2020.

While the surgeries were successful, his team told him he would need to pay close attention to his heart rhythm and potentially get a pacemaker.

“They advised me that it was time to go through with this because some scar tissue from my previous surgery had made my heartbeat irregular. It had been like that for a few years,” said Schwarzenegger on the podcast.

Leading up to the surgery, he admitted he was having trouble keeping up his energy levels during long days overseeing his Arnold Sports events in Europe. 

“That’s one thing you learn about an irregular heartbeat. All that extra work your heart does wears you out,” he said.

How do pacemakers work?

A pacemaker is a small battery-powered device that is capable of delivering an electrical charge to the heart if it detects irregularities in heart rhythm.

“Pacemakers are designed to prevent very slow heartbeats. What the pacemaker does is it watches the rhythm of the heart, and if the heartbeat goes below a certain value, which can be programmed into the device, it will deliver a tiny dose of an electrical impulse to cause the heart to contract,” Dr. Rod Passman, MD, Director of the Center for Arrhythmia Research at Northwestern University’s Feinberg School of Medicine, told Healthline.

Pacemakers are most commonly used to treat an abnormally slow heartbeat, known as bradycardia.

While the devices used to be large, requiring open heart surgery, today they are quite discreet and can be implanted with minimal invasive techniques using small incisions.

In fact, Schwarzenegger said that he was in and out of the hospital for the procedure on the same day.

“There have been great advances in pacing,” said Passman. 

“Most people forget they have it. They don’t feel the pacemaker itself, and the procedure itself has a very low complication rate. This is a therapy that can improve the quality of life and the duration of life,” he said.

Bradycardia and abnormal heart rhythms

Dr. Abha Khandelwal, MD, a Clinical Associate Professor of Cardiovascular Medicine at Stanford Medicine, explained to Healthline that, like a house, a heart requires sound structure, electrical, and plumbing. All of those components can affect one another, making them function irregularly.

In Schwarzenegger’s case, the scar tissue from his previous surgeries was impacting how electrical signals moved through his heart, resulting in irregularities.

“When you have scar tissue, it can be a source of ectopic rhythm. So, for instance, when people have scar tissue on their ventricles, that can cause what we call ventricular ectopy, meaning extra beats,” she said.

Arrhythmia or abnormal heart rhythm can manifest in a variety of forms, including tachycardia (rapid heartbeat), bradycardia (slow heartbeat), and premature or extra heartbeats (these can feel like the heart fluttering or skipping a beat.

While it is unclear exactly what kind of abnormal heart rhythm Schwarzenegger is experiencing, pacemakers are most commonly used to treat bradycardia.

Bradycardia can result in the following:

  • Lightheadedness
  • Tiredness
  • Fainting spells
  • Shortness of breath

More extreme complications from a slow heartbeat include:

The bottom line

Arnold Schwarzenneger recently got a pacemaker at the Cleveland Clinic. 

Schwarzenneger, who has lived his whole life with a congenital heart defect, has had multiple open-heart surgeries.

His medical team told him that scarring from the surgeries was affecting his heart rhythm.

Pacemakers are small battery-powered devices that help to control heart rhythm by delivering tiny electrical impulses. They are typically used to treat bradycardia or abnormally slow heart rhythm.

Bird Flu Spreads to Dairy Cows In Multiple States, What to Know

A black and white cow is seen in a barn.
James MacDonald/Bloomberg/Getty Images
  • Sick dairy cows from Kansas and Texas have tested positive for bird flu.
  • Federal and state veterinary and public health officials have been investigating an illness affecting cows in Texas, Kansas and New Mexico.
  • There is currently no concern about the safety of the commercial milk supply or risks to consumers, USDA officials said.

Sick dairy cows in two states have tested positive for bird flu, federal officials said on March 25.

As of Monday, the highly pathogenic avian influenza (HPAI) virus was detected in unpasteurized, clinical milk samples from sick cattle at two dairy farms in Kansas and one in Texas, the U.S. Department of Agriculture (USDA) announced in a press release. A cow at another dairy in Texas also tested positive.

The USDA, the Centers for Disease Control and Prevention (CDC), and state veterinary and public health officials have been investigating an illness affecting mainly older dairy cows in those two states, as well as in New Mexico. Symptoms include decreased milk production and low appetite.

The infections appear to be due to wild birds, the USDA wrote. Farms have also reported finding dead wild birds on their properties.

“At this stage, there is no concern about the safety of the commercial milk supply or that this circumstance poses a risk to consumer health,” the USDA wrote.

Commercial milk supply is safe

Janet Buffer, with the Food and Policy Institute within the Milken Institute School of Public Health at George Washington University in Washington, D.C., said consumers do not need to be concerned about the avian flu virus or other viruses or bacteria when consuming pasteurized milk and milk products made from pasteurized milk.

“Milk that enters into the food system is tested and pasteurized to ensure it is safe for human consumption,” Buffer told Healthline. Pasteurization kills any viruses, bacteria or other microbes in the milk, without altering the milk’s taste, appearance or nutritional value.

In addition, milk from sick cows is diverted or destroyed so it doesn’t enter the food supply, the USDA wrote.

“The concern is when raw milk is purchased and consumed,” Buffer said.

Sales of raw milk, also known as unpasteurized milk, are regulated by each state. Many states have declared the sale of raw milk illegal, but others allow for its sale with conditions.

Raw milk can contain dangerous bacteria such as Salmonella, E. coli, Listeria and Campylobacter, or other harmful microbes. Raw milk is especially dangerous to children, older adults, pregnant women, and people with weakened immune systems.

Low risk to the public from bird flu

Federal and state agencies are conducting additional testing, including viral genome testing, the USDA said in its release. This will provide a better understanding of which strain or strains of the bird flu virus are involved in these cases.

Initial genetic testing by the National Veterinary Services Laboratories did not find any changes to the virus that would make it spread more easily to people. “[This] would indicate that the current risk to the public remains low,” the USDA wrote.

This is the first time HPAI has been detected in dairy cattle and only the second time it has been detected in a ruminant, the American Veterinary Medical Association (AVMA) said on March 25 in a press release.

Ruminants are animals that chew their cud, and include cattle, goats and sheep.

“The first detection of HPAI in dairy cattle in Texas and Kansas underscores the importance of adherence to biosecurity measures, vigilance in monitoring for disease, and immediately involving your veterinarian when something seems ‘off’,” AMVA President Dr. Rena Carlson said in the release.

For dairies whose herds are showing symptoms, on average about 10% of each affected herd is impacted, the USDA wrote in its release. Few or no cows have died as a result of their infection. 

In addition, “milk loss resulting from symptomatic cattle to date is too limited to have a major impact on supply, and there should be no impact on the price of milk or other dairy products,” the department wrote.

What is bird flu?

The bird flu is a disease in birds caused by infection with avian influenza Type A viruses. These viruses occur naturally among wild aquatic birds but can infect domestic poultry such as chickens.

Avian influenza Type A viruses are classified into two categories:

  • Low Pathogenic Avian Influenza (LPAI): The most common type, and causes no signs of disease or mild disease in chickens and other domestic poultry.
  • Highly Pathogenic Avian Influenza (HPAI): Can cause severe disease and high death rates in infected poultry.

Some bird flu viruses can also spread to domestic animals such as cats and dogs, as well as to wild mammals.

Bird flu viruses don’t usually infect people, but can in rare cases. Infections in people range from no symptoms or mild illness to severe illness that can result in death. The bird flu viruses responsible for the most infections in people have been H7N9 and H5N1.

“Viruses jumping from one species to another should always be of concern,” Darin Detwiler, an associate teaching professor at Northeastern University and food safety advocate, told Healthline.

“This ‘flu’ has resulted in the killing of huge numbers of birds and impacted food availability and cost.”

From 2019 to 2022, the global avian flu outbreak has resulted in the loss of 40 million domestic birds and economic costs ranging from $2.5 to $3 billion, according to an industry report from the non-profit group FAIRR.

While pasteurization protects consumers from ingesting harmful pathogens in milk and milk products, Buffer said people should remain diligent when around domestic farm animals or wild animals. This will reduce the risk of becoming ill with any disease carried by those animals.

“If choosing to interact with animals such as cows, chickens, sheep and goats, always avoid touching your face with your hands, especially your eyes, nose and mouth,” she said, “and always wash your hands after coming into contact with the animals and their surroundings.”

What are the symptoms of bird flu?

Symptoms of bird flu infection in people include:

  • eye redness (conjunctivitis)
  • mild flu-like upper respiratory symptoms, such as cough, sore throat, and runny or stuffy nose
  • pneumonia
  • fever
  • muscle or body aches
  • headaches
  • fatigue
  • shortness of breath or difficulty breathing

Takeaway

Milk samples from sick cattle at two dairy farms in Kansas and one in Texas tested positive for highly pathogenic avian influenza (HPAI) virus, aka “bird flu” virus. A cow at another dairy in Texas also tested positive.

Officials from the USDA said there is no concern about the safety of the commercial milk supply due to the illness among cattle. Milk from affected animals is diverted or destroyed to keep it out of the food supply. Milk is also pasteurized, which kills any viruses, bacteria or other microbes.

Bird flu viruses occur naturally among wild aquatic birds, but can infect domestic chickens and other poultry. These viruses can also infect mammals, including domestic dogs and cats. In rare cases, people can become infected, with symptoms ranging from mild to severe.

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