Oklahoma's Most Powerful Signal For Talk Radio - 100,000 Watts Of Freedom - Talk Radio - The New Freedom 96.9!

Health News

Should racism and discrimination be viewed as public health threats? A new study argues they should

Maskot/Getty Images

(LONDON) -- Racism and discrimination must be acknowledged as public health threats in the fight to address global health disparities, according to a new study.

As part of the four-paper series published in The Lancet medical journal Thursday, researchers from countries around the world, including the U.S., U.K., Brazil and India, carried out a major review of scientific literature and used data from hundreds of articles in recent years.

The tendency among health professionals has been to explain unequal health outcomes on either genetics or economic conditions, according to the study's authors. But in order to tackle racial health inequities, racism and discrimination themselves should be classified as public health threats globally, the authors say.

"Racism has always been a public health threat," Alexandre White, assistant professor of sociology and the history of medicine at John Hopkins University School of Medicine, told ABC News. "It has emerged time and time again, especially over the last 10 to 15 years."

Research into the intersection of race and health disparities has advanced in recent years, particularly in the U.S. According to the U.S. Centers for Disease Control and Prevention almost every two in three pregnancy-related deaths are preventable. A 2020 report found that non-Hispanic Black women experienced a higher pregnancy-related mortality rate -- a disparity placing them nearly three times more at risk of dying due to pregnancy-related causes compared to non-Hispanic white women.

The report's authors also found evidence of disproportionate impact from the pandemic, vaccine inequality and climate change on minority groups.

"This study is tremendously important [as] it sheds light on the fundamental role that racism, xenophobia and forms of discrimination actually play on health, both from a structural level and generational level over time," White said. "But also fundamentally since the COVID-19 pandemic we've seen the ways in which, especially racism and xenophobia, affects who gets sick, how seriously and why."

The study also reports that racial biases in health care can lead to a stress response -- affirming previous studies that found discrimination, whether overt or covert, can lead to chronic stress responses which can affect human neurological and immune systems. That chronic stress response can lead to lower life expectancies and is associated with other health complications such as anxiety, depression and heart disease.

"It's not only because of racism at the individual interpersonal level," Dr. Abi Deivanayagam, a public health doctor, researcher, activist and one of the study's authors, told ABC News. "It's racism in the way that our society is structured. And that's very real. And it's really important that we acknowledge this in a medical journal like The Lancet so that health people recognize that this is something this is our duty of care to patients. And our care really has to go beyond the individual to making sure that our systems are safe for our patients."

Although discrimination against minority groups comes in different forms around the world according to such factors as race, ethnicity and religion, a pattern of worse health outcomes for minority groups can be seen globally.

According to Deivanayagam, the study has drawn two major conclusions.

"One thing is that there is evidence globally that shows that racism, xenophobia and discrimination affect a range of different health outcomes, and that this is embedded across different levels of society and that it affects people across the course of their lives ranging from COVID-19, to vaccines, to actually getting health care access," she told ABC News. "The second thing is that we need to get to the root cause of this. And the way we do that as health professionals is to recognize that racism, xenophobia and discrimination are actually a public health threat."

Copyright © 2022, ABC Audio. All rights reserved.


What to know about stiff-person syndrome after Celine Dion reveals rare disorder

Jose Perez/Bauer-Griffin/GC Images

(NEW YORK) -- Céline Dion's public announcement that she has a neurological disease is shining a spotlight on the rare condition known as stiff-person syndrome.

In a taped video message shared to her Facebook and Instagram pages on Thursday, the iconic singer, 54, said, "Recently, I have been diagnosed with a very rare neurological disorder called the stiff-person syndrome, which affects something like 1 in 1 million people."

What is stiff-person syndrome?

Dr. Leah Croll, an assistant professor of neurology at the Lewis Katz School of Medicine at Temple University in Philadelphia, sees and treats patients with neurologic diseases that affect the brain, spinal cord or peripheral nerves, including stiff-person syndrome.

Croll agreed with Dion's statement that stiff-person syndrome is not common, calling it an "exceptionally rare disease."

"It occurs only in about one to two people per million," Croll told ABC News' Good Morning America.

Who can get stiff-person syndrome?

Croll explained that people between the ages of 20 and 50 tend to be diagnosed with stiff-person syndrome, and although rare, it can appear in children and older adults too.

Overall, women are "two to three times" more likely to have stiff-person syndrome than men.

"We think it's because this disease may have an autoimmune component, and in general, women are higher risk for autoimmune diseases," Croll said. "But this is theoretical. We're not totally certain as of yet."

What are the symptoms of stiff-person syndrome?

In her video, Dion revealed some of the symptoms of stiff-person syndrome she has experienced.

"While we are still learning about this rare condition, we now know this is what has been causing all of the spasms I have been having. Unfortunately, these spasms affect every aspect of my daily life, sometimes causing difficulties when I walk and not allowing me to use my vocal chords to sing the way I am used to," she said.

Croll said other symptoms that can indicate someone has stiff-person syndrome include rigidity and stiffness of certain areas of the body causing unsteadiness, slower movements and difficulties walking, something Dion said she has had in addition to difficulties singing.

"Typically, patients will present with stiffness in the muscles of the trunk, neck and back, and also … the shoulders and the hips. In some cases, patients may have the disease that only implicates maybe just one limb, so like just one leg is affected," Croll said.

"The key here is that this stiffness would be so profound that it impairs someone's ability to move normally," Croll added. "And the most common symptom for these patients is going to be difficulties with walking."

Croll also noted that people with stiff-person symptoms can also develop other conditions like anxiety and phobias as a result of their physical symptoms.

What treatment is available for stiff-person syndrome?

There are treatments to address the symptoms of stiff-person syndrome available but there is currently no cure for the chronic and progressive condition.

"Most patients, as a first line, will be given medications that are meant to help relax the muscles. And in some patients, their doctors may also choose to pursue certain therapies that are meant to modulate the immune system," Croll said. "It's important though, to point out that these are therapies that are meant to lessen the severity of symptoms or potentially slow the progression of symptoms, but we don't have a therapy available that specifically targets this disease."

As stiff-person syndrome is rare, there has not been sufficient research and Croll said there are currently no major clinic trials for the disease.

Does stiff-person syndrome affect life expectancy?

Doctors do not currently know whether stiff-person syndrome impacts an individual's life expectancy, according to Croll, who said some patients have lived a few years after diagnosis while others have gone on to live for decades.

The bottom line

Croll cautioned that stiff-person syndrome is not commonly seen in the general population but advised that individuals concerned about symptoms they're experiencing can start a discussion with their primary care provider who can also provide a referral to a neurologist.

"This is a very rare condition that most people should not worry about. But anyone who is experiencing symptoms in their muscles that are interfering with their ability to move normally would benefit from consultation with a neurologist to work that up," Croll said.

Copyright © 2022, ABC Audio. All rights reserved.


Some parents concerned over empty drug store shelves, shortage of popular antibiotic

Susan L. Angstadt/MediaNews Group/Reading Eagle via Getty Images

(NEW YORK) -- Across the country, parents are searching for solutions as demand for pediatric medications surges while over-the-counter medications, and a popularly prescribed antibiotic, are in reported short supply.

Aselyn Schott, a mother from Colorado, said her 5-year-old daughter was prescribed amoxicillin for an ear infection. She said her doctor warned her it would be difficult to find.

"I was just running down the line, 'Nope, we don't have it. Nope, we don't have it,'" Schott told Good Morning America. "And nobody was really giving me a suggestion as to what to do so I just kept calling and calling."

Oral amoxicillin is the most common antibiotic prescribed in primary care practices and it's used to treat some bacterial infections in children, such as bacterial ear and lung infections, according to the National Library of Medicine. It does not treat infections due to viruses.

The Food and Drug Administration added amoxicillin, specifically amoxicillin oral powder, to the drug shortage list on Oct. 28, 2022. There is currently no estimate of when supply of the drug will increase.

The FDA's most recent update on flu antivirals says there isn't an official shortage of Tamiflu, although "we are aware that there may be localized shortages where demand is especially high."

In a statement to ABC News, Walgreens said "although demand for pediatric and adult OTC medications have increased, Walgreens is prepared and able to continue meeting the needs of our customers and patients. We are working with our diverse set of suppliers and distributors to ensure our patients have the products they need most."

CVS said, "We're currently seeing increased demand for cold, flu and pain relief products. We're committed to meeting our customers' needs and are working with our suppliers to ensure continued access to these items. In the event a local store experiences a temporary product shortage, our teams have a process in place to replenish supply."

Erin Fox, the senior pharmacy director at the University of Utah Health, said very few over-the-counter drugs are truly in shortage, but some drugs many not be in the right place at the right time. She said if you are concerned about getting a prescription medication, ask your doctor for a written prescription instead of submitting it electronically or ask for a different formula or dosage that is less in demand.

"There are substitutes, there are chewable amoxicillin tablets that some children can use. There are also different strengths of liquid," Fox said to ABC News. "Maybe just go right back to the prescriber and say, 'Hey, I'm striking out, is there another strength? Or even is there another medicine?'"

For Schott, she said she tried 18 pharmacies before finding one pharmacy that could fill the prescription for her daughter.

"I was relieved just to hear those words, 'We have it in stock,' but that pharmacy was about 45 minutes away from me, so I was really nervous because they couldn't hold it for me," said Schott. "I was nervous that it was going to run out by the time that I even got there.

"Once I got there and had it in hand. It was just like a big sigh of relief and I actually gave her a dose of medicine right in the car," she said.

What can worried parents do?

  •     Visit different pharmacies and reputable medication retailers: Medications could be found by visiting different pharmacies and reputable medication retailers, by ordering online or in-person.
  •     Check back later: Stores can likely resolve the empty shelf problem once they place new orders.
  •     Generic alternatives: For over-the-counter drugs, your favorite brand name may not be available, but a generic is a safe alternative (i.e., If the Tylenol brand is not available, use generic acetaminophen).

Copyright © 2022, ABC Audio. All rights reserved.


New COVID booster authorization will sway parents to get young kids vaccinated, FDA vaccine chief hopes

d3sign/Getty Images

(WASHINGTON) -- Dr. Peter Marks, the Food and Drug Administration's vaccine chief, said he is well aware that COVID-19 booster uptake might be low for the latest shot, authorized by the government on Thursday morning for young children over 6 months old, but he told ABC News that he's hopeful increased access may also lead to some kids getting greater protection against the virus ahead of the winter, when infections can be more likely.

The updated bivalent booster that targets multiple newer strains of the virus, will likely be available early next week for the youngest children, Marks said in an interview. That age group is the last to become eligible for the new booster.

So far, according to the Centers for Disease Control and Prevention, less than 10% of kids under 5 have gotten their initial COVID-19 vaccines -- which means there's a very small pool of children who are even eligible for boosters. But Marks hopes that those vaccinated children will soon get their boosters, and unvaccinated children will be encouraged to get their first series.

"The whole point of today's action was to ensure that those parents who have decided to take advantage of the fact that we do have a vaccine that can help prevent the worst outcomes from COVID-19, such as hospitalization and death ... could have the benefit of having the most up-to-date version of the vaccine, which is the bivalent vaccine," Marks said.

"Hopefully this is also an opportunity that the 90% of parents who have not vaccinated their children in this age range will consider doing so. Because not being vaccinated at all puts one at risk for the worst outcomes from COVID-19," he added.

Under the new authorization, children under 6 who received the Moderna vaccine can get a bivalent booster at least two months after their first series of shots.

For children under 5 who received the Pfizer vaccine, it's slightly different: Kids can get the newly authorized bivalent booster in place of the third shot in the Pfizer series for young kids. And going forward, any young child who gets the three-shot Pfizer series will get two primary shots and then the bivalent booster.

On a larger scale, vaccine uptake for the youngest age group has traditionally been far lower than other groups throughout the pandemic.

And even for older age groups, booster uptake has been very low over the three months that bivalent shots have been on the market.

According to the CDC, just under 13% of people over 5 years old have gotten a bivalent booster. The rate is highest for people over 65, for whom around one-third have been boosted.

Everyone over age 12 became eligible for bivalent boosters in September, so long as it had been three months since their last vaccine. Then in October, the eligibility expanded to everyone over age 5.

And now, in December, babies as young as 6 months old are eligible as well.

Public health officials have long hoped that the arrival of cold weather and flu season would give people a natural push to get up-to-date on both their flu vaccines and their COVID-19 boosters.

But that bump in COVID-19 shots hasn't quite materialized, Marks acknowledged, and he's not sure that uptake will budge all that much over this winter season -- despite his avid recommendations.

"I don't quite fully understand why there's significant hesitancy to get the bivalent boosters. I think I'm the first to acknowledge that these vaccines are not perfect. They're not going to give you 100% protection against COVID-19. And perhaps because people have heard, 'Well, I got the booster but I got COVID,' there's some skepticism there," Marks said.

But inoculation will still cut down on the chances of contracting the virus and keep people out of the hospital, he said.

"Even if it's not perfect -- it's the best you can do," Marks said. "I will repeat something that has done me well to date, which is perfection is the enemy of good."

Marks particularly encouraged getting vaccinated and boosted ahead of the winter season, when he predicted that cases were likely to go up and hospitals could be strained from the combination of heavy RSV and flu cases.

Already, wastewater surveillance systems across the country have begun to pick up upticks in COVID-19 cases, and Marks called the increasing slope of cases "disturbing."

"From what I can see happening over the recent past, I think the good news is, we're not likely to see the number of deaths that we've seen in previous winters. The part that is concerning is that we could see a large number of cases," he said.

"We're also seeing hospitalizations rise significantly and deaths, which had been declining, are starting to increase again. Once people see that, my guess is that will drive them to potentially consider this," Marks said. "Though I wouldn't wait for that."

Copyright © 2022, ABC Audio. All rights reserved.


Los Angeles County holds off on mask mandate even as it enters 'high' COVD transmission category

EMS-FORSTER-PRODUCTIONS/Getty Images

(LOS ANGELES) -- Los Angeles County said Thursday it is holding off on issuing an indoor mask mandate amid rising COVID-19 cases and hospitalizations.

During a press conference, LA County Public Health Director Barbara Ferrer said the county had moved into the "high" COVID-19 community transmission category, as defined by the Centers for Disease Control and Prevention, but it would be sticking with its "strong recommendation."

Public Health Director Dr. Barbara Ferrer left the option of a mask mandate on the table, but if and only if 10% of county hospital beds are filled with COVID patients.

Right now that number is only 6.9%, and the rate of increase has slowed in the past week. Ferrer said it's not a forgone conclusion that the county will reach that critical level during the current surge.

"Being at a high community level does not mean returning to the more restrictive and disruptive measures that we used at earlier times in the pandemic, before we had good access to vaccines, boosters, testing and therapeutics," she said at the conference.

This is a reversal from previous policy in the county that moving into the CDC's "high" transmission level would spur a mandate. The changing guidance comes as the health department has dangled the prospect of an impending mask mandate for weeks in a row for the second time this year.

"We do ask that while we are in surge everyone ages two and older wear a mask in indoor public spaces," Ferrer said.

As of Wednesday, Los Angeles County is recording more than 5,000 daily cases, the highest number recorded since Aug. 1, according to an ABC News analysis of health department data.

It's also an 80% increase from the 2,805 cases recorded just two weeks ago on Nov. 23, the analysis found.

However, officials have previously stated that the true number of cases is likely much higher due to people testing positive and not reporting their results to the department or not testing at all.

What's more, a total of 1,293 people are hospitalized with the virus as of Wednesday, a figure not seen since July 18, according to the analysis.

Masks continue to be compulsory indoors at healthcare and congregate-care facilities, at business where required and for anyone who has been exposed to COVID in the last 10 days.

Officials have stressed the importance of being vaccinated and boosted to prevent infection and severe disease, especially as the holiday season approaches.

As of Nov. 27 -- the latest date for which health department data is available -- 73% of all residents are fully vaccinated but the percentages vary widely by age.

Seniors aged 65 and older have the highest rate with 92% fully vaccinated while children between ages 6 months and 4 years have the lowest rate with just 6% fully vaccinated.

ABC News' Matthew Fuhrman contributed to this report.

Copyright © 2022, ABC Audio. All rights reserved.


At least 63 children are sick with measles in Ohio

DIGICOMPHOTO/SCIENCE PHOTO LIBRARY/Getty Images

(COLUMBUS, Ohio) -- An ongoing measles outbreak in central Ohio has ballooned to 63 cases as of Thursday. Twenty-five children have been hospitalized.

The state's health system is also fighting the surge in respiratory illness -- flu, RSV and COVID-19. The high rates of those illnesses are making it harder for doctors to flag measles cases, Mysheika Roberts, the health commissioner in Columbus, Ohio, told ABC News.

"Measles can present an issue like a cold, like a mild RSV, or mild flu. And it’s not until that rash appears that most providers and parents say, oh, this is different," she said. "By that point, the case has already exposed other individuals, whether it’s at day care, at home, at church."

Three of the 63 children have received one dose of the measles, mumps and rubella (MMR) vaccine, a highly effective vaccine that protects against the three diseases. The remaining 60 children are unvaccinated. The majority of the children are under 5 years old.

The Centers for Disease Control and Prevention recommends that all children get two doses of the MMR vaccine -- the first when they’re 12 to 15 months old and the second when they’re 4 to 6 years old. One dose is 93% effective against measles and two doses are 97% effective.

The vaccine’s effectiveness helped the United States officially eliminate measles in 2020, a designation that means the virus is no longer continuously circulating in the country. But there can still be periodic outbreaks if the virus is brought into a community where many people are unvaccinated. Rises in vaccine hesitancy over the past decade eroded MMR vaccination rates in some areas, which creates pockets in the U.S. particularly susceptible to measles spread.

For example, research showed that low vaccination rates were responsible for the 2015 Disneyland outbreak, which spread to over 125 people.

Roberts said that the children affected by the Ohio outbreak appear to be unvaccinated because their families rejected the vaccine, not because they had delays in their vaccinations as a result of the COVID-19 pandemic. The Columbus health department offers the vaccine at its clinic but the department hasn’t seen any uptick in the number of people seeking out the MMR vaccine in response to the outbreak, officials said.

It’s still not clear how large this outbreak could become. The health department doesn’t have good visibility into the percentage of people who are vaccinated against measles in the state of Ohio, Roberts said. Her team is working with the CDC, insurance providers and medical providers to get a better estimate of that number.

"Once we get that information about the population here in central Ohio, the CDC is optimistic they’ll be able to get us an estimate of how large this outbreak could get," she noted. "But at this point, just looking at past outbreaks in other communities, we’re just hoping that we don’t get as large as some of those."

Copyright © 2022, ABC Audio. All rights reserved.


FDA authorizes updated COVID-19 boosters for kids under 5

Witthaya Prasongsin/Getty Images

(SILVER SPRING, Md.) -- The U.S. Food and Drug Administration authorized bivalent COVID-19 boosters for children between the ages of 6 months and 4 years old Thursday.

The booster, available from both Pfizer and Moderna, was previously authorized for everyone 5 years and older in October.

"More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so -- especially as we head into the holidays and winter months where more time will be spent indoors," FDA Commissioner Robert Califf said in a statement.

"As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations, and deaths."

The updated booster targets BA.4 and BA.5, which are subvariants of the omicron variant.

Children are eligible to receive the booster at least two months from the completion of their primary series or after receiving a separate booster dose.

The authorization means there are now more than 267 million people eligible for the booster in the U.S., according to data from the Centers for Disease Control and Prevention.

However, as of Nov. 30, only about 13% of those eligible have received an updated booster dose.

The final step before the booster can be distributed to the under age 5 category is authorization from the CDC, which must be signed off on by the agency's director, Dr. Rochelle Walensky.

When considering authorizing the updated booster, the FDA said it looked at immune response data from adults who had received the original booster, which targeted the original omicron variant BA.1, as well data from a study comparing children who received the original booster and children who only received the primary series.

"Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19."

"Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing," the statement continued.

Copyright © 2022, ABC Audio. All rights reserved.


CDC report shows how infectious mpox is and how important vaccination was in stemming outbreak

Jasmin Merdan/Getty Images

(ATLANTA) -- A new report from the Centers for Disease Control and Prevention shows how infectious mpox can be and how important vaccination was in reducing the outbreak over the summer.

Last month, the World Health Organization renamed "monkeypox" as "mpox" over concerns of stigmatization of the disease.

The study, published Thursday, looked at cases by vaccination status among men ages 18-49 between July 31 and Oct. 1 in the U.S.

The outbreak, which has significantly decreased in recent weeks, has primarily been concentrated among gay, bisexual and other men who have sex with men, although the CDC has noted that anyone -- regardless of sexual orientation -- can contract the virus.

Currently, the only vaccine used in the U.S. is the JYNNEOS vaccine, which is a two-dose shot given four weeks apart and approved by the Food and Drug Administration to prevent smallpox and mpox.

To increase the number of doses available, the FDA announced a new strategy in August to inject the vaccine intradermally, just below the first layer of skin, rather than subcutaneously, or under all the layers of skin.

This allows one vial of vaccine to be given out as five separate doses rather than a single dose.

Over the two-month period, 9,544 cases were reported in this age group. Of those cases, 87.2% were among unvaccinated individuals.

Cases among unvaccinated people were 9.6 times higher compared to vaccinated individuals, according to the study.

Additionally, mpox infections were 7.4 times higher among people who received only the first vaccine dose.

"Monitoring mpox incidence by vaccination status using currently available surveillance data provides an indication of the real-world impact of JYNNEOS vaccine on prevention of mpox to guide rapid public health decision-making," the authors wrote.

The team also determined there was no difference if the vaccine was administered subcutaneously or intradermally.

"This supports previous clinical trial data that indicated similar immune responses to JYNNEOS vaccination over time after intradermal or subcutaneous administration," the authors wrote.

The authors noted that the study had limitations, including not controlling for behaviors that affect the risk for virus exposure and whether the vaccine was administered pre-exposure or post-exposure.

But the study shows that at-risk individuals should get the JYNNEOS vaccine as soon as possible, they said.

Copyright © 2022, ABC Audio. All rights reserved.


FDA weighs whether Lasik patients should be given extra warning about possible risks

Thomas Northcut/Getty Images

(NEW YORK) -- The Food and Drug Administration is weighing whether or not surgeons should provide additional warnings about the risks of Lasik, a popular corrective eye-sight surgery.

In a draft guidance from July, the agency suggested that patients should be explicitly informed about the risks of dry eye, problems driving at night, visual disturbances -- or other rare but more serious side effects related to the surgery.

The FDA is still finalizing the guidance. If implemented, companies would be asked to create a checklist of possible risks and surgeons would be asked to go through that checklist with patients to ensure they understand the possible risks and benefits of the procedure.

An FDA spokesperson said in a statement, "The FDA issued a draft guidance in July 2022 that recommends content and formatting for patient labeling information for laser-assisted in situ keratomileusis (LASIK) devices. As part of the guidance process, this document was published in the Federal Register, giving the public an opportunity to comment. The comment period for the draft guidance recently closed on November 25, 2022. With the comment period now closed, the FDA is now reviewing and considering comments for the final guidance. The timeline for the final guidance issuing is dependent on a number of factors and we cannot provide a firm timeline at this point."

The American Academy of Opthalmology weighed in on the proposed guidance and raised concerns about the checklist.

"Much of the content presented is important for the informed consent process but it is presented with insufficient depth and nuance," said Dr. Stephen McLeod, CEO of the academy. "The academy’s position is that effective informed consent is a process of shared information and decision-making that occurs between the physician and the patient. Risks and benefits do not exist in a vacuum, and for them to be meaningful rather than abstract, they must be interpreted and discussed in the context of a specific patient. We are also concerned that there are several statements that are not well supported by the latest evidence, and some that have actually been disproved.”

According to the FDA, Lasik is a procedure intended to reduce a person's dependency on glasses or contact lenses. The agency said that the surgery is one of the most commonly performed and estimated that nearly 600,000 Lasik surgeries are performed each year.

In a video, the agency summarizes some risks to the procedure, stating that "Lasik is not for everyone."

The newly drafted guidance succeeds two previous FDA measures on disclosing the risks of Lasik surgery.

In May 2009, the FDA issued a letter to eye care professionals providing them with important information about promoting and advertising Lasik after receiving complaints that consumers were not told of the risks associated with the procedure.

Two years later, the FDA issued a second letter "to remind eye care professionals of their legal responsibility to provide balanced information about medical products," including disclosing risk information in eye care professionals' promotional material.

In 2017, after the agency reportedly received complaints about side effects from the surgery, from dry eye to more serious stories of chronic eye pain, it commissioned studies to investigate whether patients were being adequately informed about risks, as well as clear benefits.

The 2022 draft guidance suggests that manufacturers and surgeons should explicitly walk patients through a "checklist" that includes clear warnings and benefits.

The drafted Lasik "checklist" includes part of the following.

Six months after surgery:

  • Up to 27% of patients experience dry eye symptoms
  • About 41% of patients may experience visual symptoms such as glare, halos, starbursts or double images
  • Around 4% of patients may have "very" or "extremely" bothersome symptoms
  • Around 2% of patients may have "a lot of difficulty" when not wearing glasses or contacts

Five years after surgery:

  • About 17% of patients still used eye drops for dry eyes
  • Fewer than 2% of patients still notice some visual disturbance
  • About 8% of patients have trouble driving at night
  • There are rare (fewer than 1%) reports of severe, constant pain

Copyright © 2022, ABC Audio. All rights reserved.


Walgreens launches free Paxlovid delivery service with DoorDash and Uber

patty_c/Getty Images

(NEW YORK) -- Walgreens has launched a new delivery service for the COVID-19 oral antiviral therapy Paxlovid in partnership with DoorDash and Uber to get the treatment "directly to the doorsteps of those who need it."

Walgreens on Thursday said it has more than 8,000 locations offering same-day delivery services, available to anyone who lives within 15 miles of participating stores. Walgreens said that means real access to a lot of Americans -- offering it to roughly 92% of the population.

That's the whole point of this initiative, Walgreens said -- increasing access to COVID treatments -- with "a focus on reaching those in socially vulnerable or medically underserved areas at a time when COVID-19 cases are beginning to rise again across the United States."

Paxlovid, from Pfizer, is one of the few treatments still expected to hold up against currently circulating subvariants and comes as coronavirus hospitalizations are trending upward in the elderly.

The drug stops the virus from replicating in the body and works best when taken within five days of getting symptoms. It has proven highly effective at reducing the risk of hospitalization and preventing higher-risk patients from getting even sicker.

To use Walgreens' new delivery service, eligible patients must have a Paxlovid prescription from a health care provider.

After the pharmacy has filled the prescription, and before it gets picked up, individuals can go online to select Same Day Delivery by visiting Walgreens.com/PrescriptionDelivery, using the Walgreens app or by calling their local store.

To use Same Day Rx Delivery, customers must be opted into Prescription Status Alerts, which will appear as an option if an order is before a particular store's cutoff time on a given day. Walgreens noted that certain health plans do not cover or participate in Same Day Rx Delivery, and it advised customers to check with individual health plan providers for further details. They also noted that while most prescriptions are "expected to be delivered same day, some deliveries may not be eligible for delivery due to prescription type, delivery address, holidays, weather or other delivery constraints."

"The COVID-19 pandemic has exacerbated health disparities and emphasized the need to address long-standing barriers, including access to treatments," Anita Patel, PharmD, vice president of pharmacy services development at Walgreens, said in a statement. "Our pharmacy teams will continue to play a trusted and essential role in helping to keep people protected from COVID-19, including getting people vaccinated, tested and treated as safely, equitably and effectively as possible."

Copyright © 2022, ABC Audio. All rights reserved.


Doctors should ask heart patients if they take supplements to manage heart failure

Chris Rogers/Getty Images

(NEW YORK) -- Doctors should ask patients with heart failure if they’re using any supplements, specific diets, or other types of complementary and alternative medicines to help manage potential benefits and risks, the American Heart Association said in a scientific statement published Thursday.

Research shows that about a third of people with heart failure use complementary and alternative medicines, a category that refers to non-traditional treatments used along with or instead of prescribed medications, to manage their conditions. However, most people don’t bring them up with their doctors, experts said.

"Many patients do not routinely report the use of alternative therapies to health care providers, and health care professionals do not routinely ask about or monitor dietary supplements," Sheryl Chow, the chair of the AHA scientific statement writing committee and an associate professor at the Western University of Health Sciences in California, told ABC News.

That’s a concern because research shows that some alternative treatments can be risky for people with heart failure and may interact with prescribed medications. If providers don’t know what patients are using, they can’t address any potential risk or safety concerns, Chow said.

The AHA reviewed the published data from studies on the efficacy and safety of commonly used complementary and alternative medicines in patients with heart failure. Its scientific statement highlighted the ones that might be beneficial, might be harmful, and have mixed evidence. Fish oil has the strongest evidence of benefit and might help the heart pump better in people with heart failure, for example. Yoga and tai chi might help blood pressure, the study showed.

Other supplements can be riskier, according to researchers. For example, high doses of vitamin D could interact with some common heart failure medications like calcium channel blockers. Some research shows vitamin E is associated with an increased risk of hospitalization for heart failure.

Patients, though, tend to think that alternative medicine can’t be harmful, said Rich Krasuski, a cardiologist at the Duke University School of Medicine who’s done research surveying heart patients on alternative medicine.

"I think patients look at natural or naturally occurring substances as somehow being safer for them than taking a pharmacologic agent," he told ABC News.

Providers who work with heart failure patients also may not realize that those patients are likely to use complementary or alternative therapies, Krasuski said. Doctors know that people with back pain or cancer tend to seek out alternatives, he says.

"In heart failure, we don’t often think about that," he said.

Chow hopes the AHA statement helps close the awareness gaps around complementary and alternative medicine in heart failure patients, and gives both providers and patients an easy reference to turn to around the issue.

"Patients aren’t reporting when they use the therapies, but even if they are reporting it, what do providers do with that information?" Chow said. "In general, I feel like health care professionals don’t have great resources for their patients."

That’s why Krasuski said he’s glad to see this type of statement from the AHA. Rather than dig through research to find information about a specific supplement a patient might be taking, he’ll be able to refer back to this document.

It’d also be a good starting point for the conversations about alternative medicine with patients, he said. The conversations aren’t necessarily to discourage or discount alternative treatments. As long as a supplement or food group isn’t affecting proven medications, Krasuski said he doesn’t have a problem with patient’s using them.

"It's important to recognize that these are all approaches that patients take," he said. "I think to improve their health, it's important that we not only address traditional but also non-traditional types of therapy."

Copyright © 2022, ABC Audio. All rights reserved.


What to know about Pfizer's RSV vaccine for older adults as FDA prepares to review

ER Productions Limited/Getty Images

(NEW YORK) -- A respiratory syncytial virus, or RSV, vaccine for older adults could be on the horizon after Pfizer announced Wednesday the U.S. Food and Drug Administration would fast-track review of its experimental vaccine.

The federal health agency will make a decision by May 2023 and, if it decides to approve, it will be the first vaccine available in the country to protect against the virus that has swept the country.

"This is huge," Dr. Gregory Poland, head of the Mayo Clinic's vaccine research group, told ABC News. "This will be a turning point because of the burden of disease. No one needs to die or be hospitalized for this disease, again, if they take the vaccine and if they have a healthy enough immune system to respond."

Here is everything we know about the vaccine and the review process:

How does RSV affect older adults?

Although RSV is known as a children's disease, this is not the case, and the virus can affect adults too.

According to the Centers for Disease Control and Prevention, older adults aged 65 and above are at high risk for severe infection, particularly those with chronic lung or heart conditions and weakened immune systems.

"Older adults are at greater risk than young adults for serious complications from RSV because our immune systems weaken when we are older," the CDC website states.

Data from the agency shows senior citizens are being hospitalized with the virus at this point in the season at a rate much higher than seen in seasons past.

As of the week ending Nov. 26, the latest date for which data is available, adults aged 65 and older are being hospitalized at a weekly rate of 2.7 per 100,000.

Although the raw number might seem small, it is much higher than usually seen at this time of year. CDC data going back to the 2014-15 season shows the rate has never been higher than 1.0 per 100,000 in early November.

What's more, an estimated 60,000 to 120,000 older adults are hospitalized every year and between 6,000 and 10,000 die.

Why has there not been a vaccine before?

This is not the first time researchers have attempted to develop an RSV vaccine.

In the late 1960s, a vaccine was produced in which the virus was inactivated with formalin, a chemical that kills viruses. The shot was given to children in Washington, D.C., but 80% of those immunized became sick and two children died.

Studies found that the vaccine did not generate enough antibodies to fight off the virus and instead triggered an overactive immune system response.

"That stymied vaccine development for 50, 60 years in this field," Poland said.

How does the vaccine work?

In 2013, researchers at the National Institutes of Health studied a protein from the virus called the F protein, which attaches to human cells and infects people.

They found a way to freeze the protein in the form it takes before it's ready to attach to cells, known as prefusion form.

The Pfizer vaccine contains this prefusion form of the protein. It also is bivalent, meaning it helps protect against both the A and B strains, which are the two most common strains of the virus.

How effective is the vaccine?

Pfizer ran a phase III clinical trial testing its vaccine in adults aged 60 and older against a placebo.

In late August, the company announced that its vaccine was 66.7% effective in preventing lower respiratory tract illness and 85.7% effective at preventing severe disease.

Additionally, Pfizer said there were no safety concerns and that the vaccine was "well tolerated" among participants.

"This is outstanding," Poland said. "We have literally gone from a vaccine that harmed people inadvertently, a shutdown in RSV vaccine research to now a phase III large global trial that showed this vaccine has excellent efficacy and preventing lower respiratory tract disease."

What is next?

Pfizer has submitted what is known as a Biologics License Application, which is tens of thousands of pages long.

The FDA will internally review and analyze the data and make a decision on whether the vaccine is potentially ready to be marketed, Poland explained.

If the FDA decides it is ready to be marketed, it will call a meeting of its independent advisory panel, the Vaccines and Related Biological Products Advisory Committee.

During this meeting, the company will present its data, the FDA will present its analysis, there will be public commentary and the committee will discuss several questions about the vaccine including whether this is the right age group and if the vaccine is safe and efficacious.

If the committee votes to recommend authorization, the FDA will either agree with the advisory panel and authorize the vaccine or not, which should occur by May 2023.

Following this, the final step will be a similar meeting among the CDC's advisory committee and the CDC deciding to follow or go against the recommendation.

If the vaccine is approved, it will likely be available by fall 2023.

Copyright © 2022, ABC Audio. All rights reserved.


Kirstie Alley's death at 71 puts spotlight on colon cancer: What women need to know

KATERYNA KON/SCIENCE PHOTO LIBRARY/Getty Images

(NEW YORK) -- Kirstie Alley's unexpected death at age 71 has put a spotlight on colon cancer, the disease that took her life.

Alley had been recently diagnosed with colon cancer prior to her Dec. 5 death, a rep for the actress confirmed to ABC News.

"We are sad to inform you that our incredible, fierce and loving mother has passed away after a battle with cancer, only recently discovered," Alley's children True and Lillie Parker wrote in a statement shared to Alley's Twitter account Monday night. "She was surrounded by her closest family and fought with great strength, leaving us with a certainty of her never-ending joy of living and whatever adventures lie ahead. As iconic as she was on screen, she was an even more amazing mother and grandmother."

Colorectal cancer -- the umbrella term for colon and rectal cancers -- is the fourth most common cancer in men and women in the United States, according to the Centers for Disease Control and Prevention.

It affects men and women almost equally. The lifetime risk of developing colorectal cancer is 1 in 23 for men and 1 in 25 for women, according to the American Cancer Society.

At age 71, Alley was in the age demographic -- ages 45 to 75 -- when colon cancer is most likely to occur, CDC data shows.

It is not known exactly when Alley was diagnosed with colon cancer, or what stage she was in or what treatment she received. Her family said only that her cancer was "recently discovered."

While colon cancer does have signs and symptoms, they often may not show until the disease is in its later stages, according to ABC News chief medical correspondent Dr. Jennifer Ashton.

"The key thing is that in early stages of colon cancer, there can be no symptoms or someone could be asymptomatic," Ashton said Wednesday on "Good Morning America." "When you get to more advanced stages, there can be signs and symptoms like abdominal pain, unexplained weight loss, blood in stool or anemia that is detected, but those are the signs typically when you're talking about metastatic or later stages."

Risk factors for colon cancer include everything from family history and certain genetic mutations to lifestyle factors like obesity, inactivity, smoking and alcohol to excess, and a diet low in fiber, fruits and vegetables, according to Ashton.

"It's typically not one thing," she said of the risk factors.

Colon cancer has been more in the spotlight in recent years with the death of Chadwick Boseman at age 43 and, more recently, with '80s pop star Taylor Dane revealing she battled the same disease.

Earlier this year, a major study found that more young people are being diagnosed with late-stage colon cancer, prompting renewed calls among doctors for early detection and screening.

Researchers from University of Colorado School of Medicine found that young patients under 40 years old have had the highest increase in rates of new late-stage colon cancer cases diagnosed, meaning the cancer has already spread at the time of diagnosis. In particular, subgroups of non-Hispanic Black and Hispanic participants had the highest increases.

The United States Preventive Services Task Force, the leading organization on preventative medicine, recently changed the guidelines to start screening for colon cancer to age 45, down from 50, in light of the trends of increasing cases of colon cancer in younger people.

There are several different ways of screening for colon cancer, including visual exams and stool tests.

The most commonly known test, a colonoscopy, requires a doctor to use a flexible tube with a camera at the end to directly look at your colon and rectum. Flexible sigmoidoscopy can also be done where only the lower third of the colon and rectum is examined. During both tests, suspicious areas can be biopsied and removed if necessary.

A “virtual colonoscopy” uses a CT scan to take images of your colon and rectum. All these tests require a bowel prep to allow for good visualization.

Stool-based tests include three blood tests that look for hidden blood, antibodies or abnormal DNA in the stool, all indicative of cancer or polyp cells. If a test other than a colonoscopy is performed and turns up abnormal results, it should be followed up with a colonoscopy.

While a colonoscopy can be a daunting test for some due to the prep work involved -- including drinking a prescription laxative drink -- Ashton said there are steps people can take to make it easier.

"The first thing I tell my patients is you have anesthesia. You are asleep. You will feel no discomfort, no embarrassment," said Ashton. "But the key thing for the prep ... I say start two days before with a clear liquid diet."

Some examples of liquids to consume include ginger ale, clear chicken broth, Jell-O and coconut water, according to Ashton.

"That will make the day before [the colonoscopy] much easier," said Ashton. "And it will make the job of a gastroenterologist easier because they'll be able to get a better visualization."

Amrit K. Kamboj, MD, an internal medicine resident, and Vanya Jain, a medical student from New Jersey Medical School, who previously worked with the ABC News Medical Unit, contributed to this report.

Copyright © 2022, ABC Audio. All rights reserved.


Experts share advice on making New Year's resolutions that last

Nora Carol Photography/Getty Images

(NEW YORK) -- For a New Year's resolution that lasts, start now, start simple and be specific.

Almost half of all Americans make a New Year's resolution each year, research shows.

Most commonly, people aspire to lose weight, exercise more, quit smoking or eat healthier. Many will abandon their resolution by a month or less into the new year.

One barrier is that forming a habit takes time -- about 66 days, on average, at least one study suggests.

"It takes about two to three months for someone to start feeling confident and comfortable with a new habit, but the repetition of the habit can start to become more of a routine after several days" Dr. Beth Frates, president of the American College of Lifestyle Medicine, told ABC News.

When deciding on a resolution, Frates recommends considering the six pillars of health: nutritious diet, physical activity, restorative sleep, elimination of substances (e.g. cigarettes), positive relationships and stress reduction.

"A potential first step is to compare your daily habits to the established national guidelines for these pillars," said Frates. "A person can see where they are in relationship to the guidelines and rate how important each guideline is to their health and wellbeing."

And studies show that simpler habits form faster than complicated ones.

Drinking a glass of water each morning will stick a lot more quickly than doing jumping jacks before work every day, for example.

"But at the same time, you don't want to pick a behavioral goal that is too easy, since that is unlikely to be challenging enough to hold your attention," said Dr. Jennifer Ashton, ABC News chief medical correspondent and author of The Self Care Solution, a book about creating self-care habits that stick.

Proper planning is also important.

"A reasonable goal for someone is a SMART goal," said Frates, explaining that a "SMART" goal is one that is specific, measurable, achievable, relevant and time-bound.

A goal to "run 4 days a week for 30 minutes" is more specific than "I will run more."

One way to measure success is by marking a calendar or an app with each run.

Achievability of a goal should be based on one's current patterns. For those who currently don't run at all, a goal to "run 2 days per week for 20 minutes" is a smarter initial choice for long-term success.

To keep a goal relevant, consider the "why" behind it, such as "running will make my heart stronger."

A time-bound goal has a deadline for when to reassess success. After four weeks, for instance, a new SMART goal can be made based on the previous month's progress.

"Setting a short-term goal that aligns with your long-term goals will help you to stay on track," said Frates.

The good news: One missed day is OK. Research shows that missing one day does not reduce the chance of habit formation.

The key is to keep going.

"The process of getting through the lapse and successfully getting back on track usually happens within the first two months," said Frates.

So starting now, experts say, is the choice that could boost that New Year's resolution from a pattern to a habit by January's end.

Copyright © 2022, ABC Audio. All rights reserved.


Women not getting equal medical advice when it comes to heart health, study finds

The Good Brigade/Getty Images

(NEW YORK) -- Heart disease is the leading cause of death in the United States for both men and women, but women may not be receiving the same treatment, according to a new study.

Though guidelines for heart disease prevention are gender neutral, researchers report that, in practice, doctors advise less aggressive strategies for women.

Researchers from Massachusetts General Hospital examined the advice doctors gave to patients at high risk for heart disease to help prevent their first cardiac event and found that women were advised more often to make lifestyle changes alone.

"Our study found that women are advised to lose weight, exercise and improve their diet to avoid cardiovascular disease, but men are prescribed lipid-lowering medication," Dr. Prima Wulandari, a cardiology clinical researcher at Massachusetts General Hospital in Boston, said in the study findings. "This is despite the fact that guideline recommendations to prevent heart disease are the same for men and women."

The researchers examined the advice that nearly 3,000 high-risk men and women received for prevention of heart disease, based on participants in the U.S. National Health and Nutrition Examination Study from 2017 to 2020.

They found that though both men and women were eligible, men were 20% more likely to be prescribed statins. Women, on the other hand, were almost 40% more likely to receive recommendations for behavioral modifications, like losing weight, exercising more and stopping smoking.

The study was presented Dec. 3 at a medical conference in Singapore.

Close to 700,000 people die of heart disease in the U.S. every year making it the most common cause of death, according to the Centers for Disease Control and Prevention.

Among women, heart disease causes 1 in 5 deaths, and around 1 in 16 women over 20 years of age have coronary heart disease, the most common type of heart disease, according to the CDC.

Coronary heart disease can present with chest pain, nausea, and breathlessness, among other symptoms. However, typical symptoms are mostly seen in men.

Women tend to experience less chest pain than men. Instead, they experience more pain in the middle or upper back, neck or jaw, more dizziness, extreme tiredness, pressure in chest and stomach pain -- all symptoms that can easily lead to misdiagnosis.

Multiple studies have shown that in health care overall, inherent biases among doctors lead to women not being diagnosed or having a delay in diagnosis.

When it comes to why the prevention of heart disease in women is sub-optimal, according to the study, the reasons vary.

One reason, according to Wulandari, is that heart disease may still be seen as something that predominantly impacts men, despite the statistics showing women are also affected.

The rate of coronary heart disease is higher in men until 75 years of age, and women present with more atypical symptoms which could lead to misdiagnosis of their disease.

"A potential root of the discrepancy in advice is the misconception that women have a lower risk of cardiovascular disease than men," said Wulandari. "Our findings highlight the need for greater awareness among health professionals to ensure that both women and men receive the most up-to-date information on how to maintain heart health."

Another potential reason for the treatment bias is that there is an underrepresentation of women in research studies that can lead to practitioners being cautious of generalization of the heart disease management to both genders.

In addition, women themselves may underestimate their own risk of heart disease, and for other chronic health care conditions, it has been consistently shown that women prefer lifestyle intervention over medications.

According to ABC News chief medical correspondent Dr. Jennifer Ashton, in addition to a greater awareness among health care professionals, there are prevention strategies of which patients themselves should be aware.

Around 80% of heart disease can be prevented, Ashton said Tuesday on "Good Morning America," citing American Heart Association data.

Some health changes that can help prevent heart disease include weight management, exercise, eating more fiber and less saturated fat, consuming less alcohol, monitoring blood glucose and not smoking cigarettes.

Ashton, a board-certified OB-GYN, said it is also important to take prescribed medications if indicated.

"If indicated, blood pressure medication, cholesterol-lowering medication for both men and women have been shown to save lives," she said.

Dr. Sristi Sharma is a preventive medicine physician and is a member of the ABC News Medical Unit.

Copyright © 2022, ABC Audio. All rights reserved.


Weather

Facebook

Fox News

Sports News