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

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

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

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

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

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

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

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

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

Los Angeles County holds off on mask mandate even as it enters ‘high’ COVD transmission category
Los Angeles County holds off on mask mandate even as it enters ‘high’ COVD transmission category
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(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.

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At least 63 children are sick with measles in Ohio

At least 63 children are sick with measles in Ohio
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.”

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FDA authorizes updated COVID-19 boosters for kids under 5

FDA authorizes updated COVID-19 boosters for kids under 5
FDA authorizes updated COVID-19 boosters for kids under 5
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(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.

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

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

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

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

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Walgreens launches free Paxlovid delivery service with DoorDash and Uber

Walgreens launches free Paxlovid delivery service with DoorDash and Uber
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.”

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