by tyler | May 9, 2023 | CNN, health
When Caitlyn Pace moved from the United States to Hong Kong three years ago to take a teaching job, she loved the food, the sights and the birth control.
She was was pleasantly surprised to find that in Hong Kong, she could get oral contraceptives at her neighborhood drugstore without a prescription.
“My jaw probably dropped the first time I did it. I just walked in and kind of looked around and was like ‘is this really happening?’ ” said Pace, 34. “It’s like buying aspirin.”
For years, medical organizations have fought to have over-the-counter birth control pills in the US, too.
On Tuesday and Wednesday, a group of external advisers to the US Food and Drug Administration will discuss an application from a pharmaceutical company to put their prescription birth control pill over-the-counter.
Although professional organizations including the American Medical Association and the American College of Obstetricians and Gynecologists support over-the-counter sales of the drug, called Opill, the FDA seems skeptical, citing a list of concerns in a 130-page document posted online Friday.
“I am worried” about the FDA’s decision, said Dr. Kristyn Brandi, a spokesperson for the American College of Obstetricians and Gynecologists.
The FDA scientists say they have two main concerns about Opill, a “mini pill” that uses only the hormone progestin.
One has to do with obesity. The FDA approved Opill as a prescription drug in 1973, and “the prevalence of obesity in adults in the United States has changed dramatically since the original clinical studies were conducted over 50 years ago,” the scientists wrote in the document, citing a 13% obesity rate in 1960 compared with a 42% obesity rate now.
“The degree to which efficacy of [Opill] is diminished in individuals who are overweight or obese (which together now represent approximately 60% of the U.S. reproductive-aged population … ) remains unknown,” they added.
The agency cited a 2016 report analyzing data from four studies that suggested women who were obese had an increased risk of pregnancy after taking emergency contraception. The data in those four studies was “limited and poor to fair quality,” the authors wrote.
Brandi said she was surprised by the FDA’s statements.
In a practice document for its members, the American College of Obstetricians and Gynecologists cites several studies showing that “women with obesity can be offered all hormonal contraceptive method options with reassurance that the efficacy of hormonal contraception is not significantly affected by weight.”
Brandi, an obstetrician-gynecologist in New Jersey, noted that even though obesity has been on the rise, there has not been a higher rate of failure for birth control pills.
The FDA scientists were also concerned that studies by Perrigo, the company that manufactures Opill, showed some women didn’t follow the label instructions. They said some women in the study didn’t take the pill within the same three-hour window every day, which is important for efficacy.
But Brandi said even when doctors prescribe pills, patients don’t always take them properly all the time.
“They make mistakes, and we know that,” she said. “People are humans, and that’s OK.”
The Opill label tells women that if they’re more than three hours late taking their pill, they should take a pill as soon as they remember and use an additional form of birth control, such as a condom, for two days.
“I trust patients that they’ll be able to read the instructions and follow the instructions and be able to use the medication safely and effectively,” Brandi said. “I don’t worry, because I trust women. I trust my patients.”
In a statement, Perrigo said that “data from our eight year development program show that consumers can use Opill safely and effectively as guided by the proposed labelling.”
The FDA also expressed concern that without counseling from a doctor, women might not realize when Opill wasn’t appropriate for them.
For example, the Opill label states that the drug should not be used by women with a history of breast cancer. But when 205 study subjects with a history of breast cancer read the label, six of them said the pill was right for them.
Women with undiagnosed abnormal vaginal bleeding also are not supposed to use Opill, but in a study, more than half of those with this condition said the pill was appropriate for them.
The FDA is under pressure to allow Opill to go over-the-counter from elected officials as well as health-care providers.
Unwanted pregnancies are a public health issue in the US, where almost half of all pregnancies are unintended, according to the FDA briefing document, and rates are especially high among lower-income women, Black women and those who haven’t completed high school.
In March 2022, 59 members of Congress wrote a letter to FDA Commissioner Dr. Robert Califf about OTC contraception.
“This is a critical issue for reproductive health, rights, and justice. Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system,” the lawmakers wrote.
Califf responded that the FDA “acknowledges the public health benefits of increased access to oral contraceptives” and that “the Agency’s decision making is guided by the best available science.”
The FDA advisers are expected to vote Wednesday on whether to recommend that the agency approve Opill going over-the-counter. The agency often follows the recommendations of its advisers but doesn’t always do so.
by tyler | May 9, 2023 | CNN, health
After more than three very long years, it’s finally happening: The Covid-19 pandemic is ending, at least in the formal sense, both in this country and abroad. This moment is not being marked with parades or big parties but rather with the flourishes of two administrative pens. On Friday, the World Health Organization announced that Covid-19 no longer constitutes a Public Health Emergency of International Concern, and this Thursday, the United States is set to end its own public health emergency declaration.
So, what does that mean? Throughout the pandemic, I have written several essays about the United States as if it were my own patient. I think of the end of the public health emergency as my patient finally being discharged from the hospital after a lengthy illness. The hospitalization has been full of setbacks and improvements, stints in the ICU and then back to the general care floor, vital signs bordering on the catastrophic but also triumphs of modern medicine and human ingenuity.
And although it is a very good sign that the patient is getting discharged, it doesn’t mean America (or the world) is entirely out of the woods. There will still be testing, close monitoring and follow-up appointments – all, hopefully, to prevent readmission.
Last week, WHO’s International Health Regulations Emergency Committee met and decided that the Public Health Emergency of International Concern (PHEIC) should end because of declining Covid-19-related hospitalizations and deaths, and high levels of immunity in the population.
The committee “advised that it is time to transition to long-term management of the COVID-19 pandemic,” and WHO Director-General Tedros Adhanom Ghebreyesus concurred.
But like me, WHO plans to keep a close eye on the patient. The agency said that while the level of concern is lower, Covid-19 is still a global threat because the virus continues to evolve and spread.
“While we’re not in the crisis mode, we can’t let our guard down,” said Dr. Maria Van Kerkhove, WHO’s Covid-19 technical lead and head of its program on emerging diseases. She added that the disease and the coronavirus that causes it are “here to stay.”
Long before WHO’s announcement, the US had designated May 11 as the day to end its public health emergency. It may feel like an arbitrary day, but it’s not as random as it seems.
When Covid-19 was declared a US public health emergency on January 31, 2020, the nation was trying to head off the spread of the virus SARS-CoV-2.
The declaration – which has been renewed 13 times, typically in 90-day increments – essentially gave the government wide-ranging flexibility in the fight against the biggest public health crisis in a century. It enabled the government to temporarily implement certain policies and actions.
For example, at the societal level, it allowed for a wider social safety net, the expansion of Medicaid in some states and the ability to prescribe controlled substances via telemedicine. At the individual level, it gave Americans free access to Covid vaccines, tests and treatments. It also permitted the government to keep its finger on the pulse of the pandemic by requiring states and other entities to report data such as test positivity rates, death rates and vaccination numbers.
On February 9, the US Department of Health and Human Services announced that it was extending the PHE one last time and said it would subsequently allow it to expire on May 11. This means an immediate end to some programs and actions; others will wind down more slowly, and some will remain in place.
Another change: The US Centers for Disease Control and Prevention will lose access to some of the data it’s been using to measure the severity of the pandemic and guide its public health recommendations.
“It is the case at the end of the public health emergency, we will have less [of a] window as to the data,” CDC Director Dr. Rochelle Walensky said last week during a Senate committee hearing. “We will lose our percent positivity. We won’t get laboratory reporting. We won’t get case reporting. So we’ll lose some of that.”
But Walensky, who is stepping down at the end of June, reiterated that the CDC is “not changing the steam at which we are working through this resolving this public health emergency.”
The agency, she said, will keep a close eye on this virus around the country, utilizing more novel approaches like genomic sequencing and wastewater testing.
We must remain vigilant. Nobody wants to see the patient readmitted to the hospital.
If you look only at absolute numbers, the decision to end the PHE might make you scratch your head. After all, there were almost 9,900 new hospital admissions related to Covid in the US for the week ending May 1, and there were roughly 1,050 deaths per week at the end of April. Comparatively, when the first PHE declaration was signed at the end of January 2020, there were no deaths reported in the United States (the first US death wouldn’t be tallied until February 29). In fact, it wasn’t until February 10 that deaths worldwide topped 1,000.
In medicine, however, numbers and data are important, but trends tell an even richer, more complete story.
Imagine my patient, America, coming into the hospital when they first started feeling ill. Maybe their fever was 101 degrees, their pulse was fast, and they felt some malaise. I noted their vital signs – cases, hospitalizations and deaths – but what I really monitored was the trend. Were those numbers getting better or worse? Had the illness peaked, or was it only just getting started? In early 2020, all those numbers were trending in the wrong direction.
But right now, the trends – in cases, hospitalizations and deaths – are all still high but thankfully moving in the right direction for my patient, our country.
This is also true globally. “For more than a year, the pandemic has been on a downward trend,” WHO’s Tedros said Friday, explaining why the PHEIC declaration was coming to an end. But he said that he would not hesitate to declare a global health emergency again if there is a significant rise in Covid-19 cases or deaths in the future.
To be clear, we have the ability to do much better and bring the numbers down much further before discharging our patient, but that raises a philosophical question, even more than a medical one: What are we willing to tolerate as a society in order to prevent illness and death?
During the past three years, I would often speak with public health and other experts to try to work out exactly when we would move out of the pandemic phase and into the endemic stage of this health emergency. There were few hard answers. Instead, many told me that it came down to the number of Covid deaths we could stomach as a society, in exchange for an end to having our lives disrupted.
At the time, I wrote: “At what point do we as a society throw up our hands and say, ‘We can’t do any better than this,’ so let’s call this level of sickness and death ‘endemic,’ accept the numbers and move on with our lives?”
We seem to have collectively, emotionally reached that point. If the US weekly death rate at the end of April held steady for 52 weeks (or represented the average weekly death rate), we would have about 54,700 deaths per year. This puts Covid on par with a bad influenza season. And remember, when it comes to flu, less than half the adult population in the United States gets a vaccine every year.
Solid medical science in the form of vaccines and effective public health strategies, such as high-quality masks and indoor ventilation, can get us only so far if there isn’t a collective will to use them.
Many of us are ready for this chapter in history to be over, and truth be told, I am well aware that many people already moved on weeks – if not months – ago. But we must also remember that there is a substantial group of Americans who are still very worried about contracting Covid, in particular the older and the sicker.
As you probably know by now, the CDC estimates that the risk of hospitalization for those 75 or older is between 9 and 15 times higher than for those who are 18 to 29, and here in the United States, nearly 25 million people are older than 75. When it comes to our general health, a study published in the journal Clinical Infectious Diseases found that people with asthma had a 1.4 times higher risk of hospitalization than a healthy person, hypertension bumped up the risk to 2.8 times higher, chronic kidney disease to four times higher and severe obesity to 4.4 times higher. Someone with three or more health conditions had a five times higher risk. Forty percent of Americans are obese, and nearly 70% of the country has at least one of the conditions that greatly increases their risk.
Therein lies one of the greatest lessons of the pandemic for my patient, the United States. While we had tremendous resources to combat this pandemic, our collective poor health put us at a tremendous disadvantage. We must do all we can to focus on the basics, because no amount of wealth can buy good health.
For now, however, my patient is taking crucial steps out of the hospital and back into the world. I am elated.
On the discharge papers, I write these parting instructions: Be prudent. Stay at home if you are sick. Talk to your doctor about keeping a course of oral antivirals (like Paxlovid) in your medicine cabinet if you are at higher risk of hospitalization or death. Remember what Dr. Anthony Fauci recently said: “If you are vaccinated and boosted and have available therapy, you are not going to die [of Covid], no matter how old you are.” That should be reassuring to people like my parents, who are now in their early 80s.
And, yes, please use the formal end of the pandemic as a new beginning for yourself personally. Invest in yourself to get into the best possible health to feel better, happier and stronger now, as well as to weather any medical storm in the future.
But most of all, go enjoy all the things that a major emergency or the threat of severe illness wouldn’t let you do. Call if you have any problems.
I wish my patient well. I wish us all well.
by tyler | May 8, 2023 | CNN, health
I’ve worked with middle schoolers, their parents and their schools for 20 years to help kids navigate the always awkward, often painful, sometimes hilarious in hindsight, years of early adolescence.
Most of the social and development stretch marks we gain during adolescence fade to invisibility over time. We stop holding a grudge against the kid who teased us in class for tripping, or we forgive ourselves our bad haircuts, botched friendships and cringy attempts at popularity.
But one growing pain can be dangerously hard to recover from, and ironically, it’s the one that has most to do with our physical growth.
Children are supposed to keep growing in adolescence, and so a child’s changing body during that time should not be cause for concern. Yet it sends adults into a tailspin of fear around weight, health and self-esteem.
Kids have always worried about their changing bodies. With so many changes in such a short period of early puberty, they constantly evaluate themselves against each other to figure out if their body development is normal. “All these guys grew over the summer, but I’m still shorter than all the girls. Is something wrong with me?” “No one else needs a bra, but I do. Why am I so weird?”
But the worry has gotten worse over the past two decades. I’ve seen parents becoming increasingly worried about how their children’s bodies change during early puberty. When I give talks about parenting, I often hear adults express concern and fear about their children starting to gain “too much” weight during early adolescence.
Parents I work with worry that even kids who are physically active, engaged with others, bright and happy might need to lose weight because they are heavier than most of their peers.
Why are parents so focused on weight? In part, I think it’s because our national conversations about body image and disordered eating have reached a frenzy on the topic. Over the past year, two new angles have further complicated this matter for children.
Remember Jimmy Kimmel’s opening monologue at the Oscars making Ozempic and its weight-loss properties a household name? Whether it’s social media or the mainstream press, small bodies and weight loss are valued. It’s clear to young teens I know that celebrities have embraced a new way to shrink their bodies.
Constant messages about being thin and fit are in danger of overexposing kids to health and wellness ideals that are difficult to extract from actual health and wellness.
Compound this with the American Academy of Pediatrics recently changing its guidelines on treating overweight children, and many parents worry even more that saying or doing nothing about their child’s weight is harmful.
The opposite is true. Parents keep their children healthiest when they say nothing about their changing shape. Here’s why.
Other than the first year of life, we experience the most growth during adolescence. Between the ages of 13 and 18, most adolescents double their weight. Yet weight gain remains a sensitive, sometimes scary subject for parents who fear too much weight gain, too quickly.
It helps to understand what’s normal. On average, boys do most of their growing between 12 and 16. During those four years, they might grow an entire foot and gain as much as 50 to 60 pounds. Girls have their biggest growth spurt between 10 and 14. On average, they can gain 10 inches in height and 40 to 50 pounds during that time, according to growth charts from the US Centers for Disease Control and Prevention.
“It’s totally normal for kids to gain weight during puberty,” said Dr. Trish Hutchison, a board-certified pediatrician with 30 years of clinical experience and a spokesperson for the American Academy of Pediatrics, via email. “About 25 percent of growth in height occurs during this time so as youth grow taller, they’re also going to gain weight. Since the age of two or three, children grow an average of about two inches and gain about five pounds a year. But when puberty hits, that usually doubles.”
The American Academy of Pediatrics released a revised set of guidelines for pediatricians in January, which included recommendations of medications and surgery for some children who measure in the obese range.
In contrast, its 2016 guidelines talked about eating disorder prevention and “encouraged pediatricians and parents not to focus on dieting, not to focus on weight, but to focus on health-promoting behaviors,” said Elizabeth Davenport, a registered dietitian in Washington, DC.
“The new guidelines are making weight the focus of health,” she said. “And as we know there are many other measures of health.”
Davenport said she worries that kids could misunderstand their pediatricians’ discussions about weight, internalize incorrect information and turn to disordered eating.
“A kid could certainly interpret that message as not needing to eat as much or there’s something wrong with my body and that leads down a very dangerous path,” she said. “What someone could take away is ‘I need to be on a diet’ and what we know is that dieting increases the risk of developing an eating disorder.”
Many tweens have tried dieting, and many parents have put their kids on diets.
“Some current statistics show that 51% of 10-year-old girls have tried a diet and 37% of parents admit to having placed their child on a diet,” Hutchison said in an email, adding that dieting could be a concern with the new American Academy of Pediatrics guidelines.
“There is evidence that having conversations about obesity can facilitate effective treatment, but the family’s wishes should strongly direct when these conversations should occur,” Hutchison said. “The psychological impact may be more damaging than the physical health risks.”
It’s not that weight isn’t important. “For kids and teens, we need to know what their weight is,” Davenport said. “We are not, as dietitians, against kids being weighed because it is a measure to see how they’re growing. If there’s anything outstanding on an adolescent’s growth curve, that means we want to take a look at what’s going on. But we don’t need to discuss weight in front of them.”
In other words, weight is data. It may or may not indicate something needs addressing. The biggest concern, according to Davenport, is when a child isn’t gaining weight. That’s a red flag something unhealthy is going on.
“Obesity is no longer a disease caused by energy in/energy out,” Hutchison said. “It is much more complex and other factors like genetics, physiological, socioeconomic, and environmental contributors play a role.”
It’s important for parents and caregivers to know that “the presence of obesity or overweight is NOT an indication of poor parenting,” she said. “And it’s not the child or adolescent’s fault.”
It’s also key to note, Hutchison said, that the new American Academy of Pediatrics guidelines, which are only recommendations, are not for parents. They are part of a 100-page document that provides information to health care providers with clinical practice guidelines for the evaluation and treatment of children and adolescents who are overweight or obese. Medications and surgery are discussed in only four pages of the document.
Parents need to work on their own weight bias, but they also need to protect their children from providers who don’t know how to communicate with their patients about weight.
“Working in the field of eating disorder treatment for over 20 years, I sadly can’t tell you the number of clients who’ve come in and part of the trigger for their eating disorder was hearing from a medical provider that there was an issue or a concern of some sort with their weight,” Davenport said.
Hutchison said doctors and other health providers need to do better.
“We all have a lot of work to do when it comes to conversations about weight,” Hutchison said. “We need to approach each child with respect and without (judgment) because we don’t want kids to ever think there is something wrong with their body.”
The right approach, according to American Academy of Pediatrics training, is to ask parents questions that don’t use the word “weight.” One example Hutchison offered: “What concerns, if any, do you have about your child’s growth and health?”
Working sensitively, Hutchison said she feels doctors can have a positive impact on kids who need or want guidance toward health-promoting behaviors.
Davenport and her business partner in Sunny Side Up Nutrition, with input from the Carolina Resource Center for Eating Disorders, have gotten more specific. They have created a resource called Navigating Pediatric Care to give parents steps they can take to ask health care providers to discuss weight only with them — not with children.
“Pediatricians are supposed to ask permission to be able to discuss weight in front of children,” Davenport said. “It’s a parent’s right to ask this and advocate for their child.”
Davenport advises parents to call ahead and schedule an appointment to discuss weight before bringing in a child for a visit. She also suggests calling or emailing ahead with your wishes, though she admits it may be less effective in a busy setting. She said to print out a small card to hand to the nurse and physician at the appointment. You can also say in front of the child, “We prefer not to discuss weight in front of my child.”
by tyler | May 5, 2023 | CNN, health
When the US public health emergency ends May 11, the US Centers for Disease Control and Prevention will have to change some of the ways it tracks Covid-19 in the United States, but the agency says it won’t lose its sightlines on the infection as it continues to be part of American life.
On Thursday, for the first time in three years, the CDC will stop posting a national count of Covid-19 cases. The agency’s color-coded maps of county-level transmission and disease burden will be retired, the CDC will no longer track variants down to the state level, and it will update its genomic surveillance estimates every two weeks instead of weekly.
“Though our data going forward will be different, they will continue to provide timely insights for CDC, for local health officials, as well as for the public to understand Covid-19 dynamics,” CDC Principal Deputy Director Dr. Nirav Shah said.
“In short, we will still be able to tell that it’s snowing, even though we’re no longer counting every snowflake.”
Instead of following Covid-19 cases, the agency will track the burden and spread of disease primarily through hospitalizations and deaths.
The move to stop posting a national case count is largely symbolic. The number of Covid-19 cases known to public health officials has long been undercounted. The percent of detected cases has only fallen further as people have turned to rapid home testing for a diagnosis. At some points in the pandemic, experts estimated that the true number of cases was more than 14 times higher than official counts.
Other metrics that people are used to seeing on the CDC’s Covid Data Tracker are also going to go away. As CNN previously reported, the CDC will stop publishing detailed, color-coded Covid-19 Transmission Levels and Covid-19 Community Level maps that have been tied to recommendations about when to wear masks, when it’s a good idea for people to test to prevent the spread of disease and when to avoid large indoor public gatherings.
When the public health emergency ends, more states are expected to stop reporting Covid-19 cases to CDC. Iowa, for example, has already stopped. So the CDC says it won’t be feasible to maintain a national count or update its maps.
Future recommendations for precautions like masking will instead be tied to hospitalization levels.
Covid-19 will retain its designation as a nationally notifiable disease, but that’s just a recommendation, says Dr. Brendan Jackson, who leads the CDC’s Covid-19 response. It doesn’t carry any authority for required reporting. When the public health emergency ends, it will be a state-by-state decision whether to share those numbers, Jackson said Thursday.
The CDC says it will still publish the case counts it gets from states, but that will be in a different section of its website, and the numbers won’t be totaled.
Some experts say they’re disappointed to see that the CDC will have to go back to an older, fragmented system of having to ask states to share data.
“We’re kind of reverting back to a system where the CDC kind of independently negotiates all these data sharing agreements with the states and they make it more voluntary,” said Beth Blauer, associate vice provost for public sector innovation at Johns Hopkins University.
“I think having the states do this all independently doesn’t make a ton of sense because it doesn’t help us understand, in the aggregate, the impact that disease is having on our communities,” Blauer said.
She also said it will be very difficult to scale this system back up should another large, immediate public health threat emerge.
Starting next week, vaccination counts will become discretionary. Jackson said that most, but not all, of the 64 jurisdictions that report to the CDC have signed data use agreements to share their vaccine administration numbers. They may not share as much as they have in the past about who is getting vaccinated or do it as frequently, which may limit the nation’s ability to spot widespread racial, ethnic or socioeconomic disparities for future vaccination campaigns. Starting in June, the CDC says, it will update its vaccination data on a monthly basis.
Laboratories will no longer be required to send testing data to the CDC, which will hamper the ability to understand test positivity rates, a metric that, early in the pandemic, helped public health officials know whether they were doing enough testing or if transmission in a community was going up or down. Positivity rates were used in the transmission maps but also for the CDC’s tracking of variants.
The CDC will still get some lab testing data from another system called the National Respiratory and Enteric Virus Surveillance System, a network of about 450 labs that help it track illnesses like influenza and respiratory syncytial virus, or RSV.
Variant tracking will continue, but the CDC will have to adjust some of the metrics it uses to model variant proportions. State-level estimates of variant proportions with go away, but regional levels will remain. Those will be updated twice a month going forward instead of weekly, as they are now.
The way the CDC will collect data on deaths will change, too. Instead of scraping numbers from state website and getting direct reports from states, which counted deaths based on the date they were reported, the CDC will switch to a national system that counts deaths based on death certificate data. The agency says this system has become much more timely and will be a more stable way to count Covid-19 deaths going forward. It will also add a new metric to its death reporting: the percentage of all deaths reported that week that are caused by Covid-19.
Hospitals will still have to report Covid-19 data through April 2024, but they won’t track as many metrics or submit that information as frequently. Hospitals have shared information daily through most of the pandemic, but now that reporting will be weekly.
Hospitalizations and deaths are known as lagging indicators because they increase only after people have gotten sick. Studies released Friday from CDC epidemiologists show that hospitalizations may not lag behind cases as much as we once thought they did.
The new studies, published in the CDC’s Morbidity and Mortality Weekly Report, show that Covid-19 hospitalizations lagged one day behind increases in reported cases and four days behind increases in emergency room visits.
The research also shows that the new system the CDC will be using to track deaths will show trends 13 days earlier than data collected from states, the system that’s being discontinued.
With case levels low across most of the country, the need for these kinds of insights has gone away, or scientists have found other ways to get the information, such as testing of wastewater, which begins to increase about a week before testing data reflects an uptick in spread. Wastewater testing is available in some places, but not all areas have this capability.
The CDC will also maintain traveler surveillance, testing wastewater on airplanes in an effort to spot new incoming threats.
The CDC will also maintain what it calls sentinel systems: smaller, but nationally representative networks of hospitals and laboratories that will feed in more detailed data. This is much the same way the agency tracks patterns in other respiratory diseases, such as the flu and RSV. The CDC says recent investments in these sentinel systems will help it maintain eyes on Covid-19.
Instead, it will be using hospitalizations and emergency room visits as the primary ways it tracks Covid-19 and as the basis for its recommendations. When hospitalization rates in an area are high, for example, it will be recommending that people wear masks, said Jackson.
CDC Director Dr. Rochelle Walensky acknowledged some of these data changes in a Senate committee hearing this week, although she emphasized that the CDC was not “changing the steam” of its work on Covid-19.
“As the public health emergency is set to end next week, I do want to just reiterate that we at CDC are not changing the steam at which we are working through resolving this public health emergency,” Walensky said at a hearing of the Senate Committee on Health Education, Labor and Pensions.
“It is the case at the end of the public health emergency, we will have less window as to the data,” she said. “We won’t get laboratory reporting. We won’t get case reporting. So we’ll lose some of that.”
by tyler | May 5, 2023 | CNN, health
After a spate of student illnesses prompted the temporary closure of a Detroit school, the district says two students were diagnosed with the bacterial illness Haemophilus influenzae.
Two students at Marcus Garvey Academy were diagnosed with H. flu, Chrystal Wilson, assistant superintendent of communications with the Detroit Public Schools Community District, said Friday.
The pre-K through eighth-grade school closed this week after “a number of students” in the lower grades became ill. Wilson said that fewer than 25 of the school’s 310 students were sick.
The school will reopen Monday, she said.
Earlier this week, she said, the school “experienced an unusually high rate of flu-like symptoms including student fevers, and vomiting, namely at the early grade levels.”
The closure also followed the death last week of a kindergartener who attended Marcus Garvey Academy, the school district said in a statement.
The student’s cause of death is pending, the Wayne County Medical Examiner’s Office said Friday.
“The student came to school with flu-like symptoms,” Wilson said.
Haemophilus influenzae, or H. flu, is a disease caused by bacteria that can lead to illnesses such as ear infections and bronchitis or more serious bloodstream infections, the US Centers for Disease Control and Prevention says. It is not the same as illness caused by influenza viruses.
“These bacteria live in people’s nose and throat, and usually cause no harm. However, the bacteria can sometimes move to other parts of the body and cause infection,” the CDC says.
The bacteria spreads through airborne particles and typically infects children under 5 or adults 65 and up.
Vaccines for Haemophilus influenzae type B (Hib) are recommended for children starting at 2 months old, according to the CDC, but they do not protect against other types of H. flu.
The Detroit Health Department said in a statement Wednesday that it is working with the school district to monitor the illnesses and reminded the public that vaccines are available.
“The Detroit Health Department offers vaccinations to children and adults to protect against many childhood diseases,” it said. “Vaccinations are also available at pediatric centers and primary care providers.”
by tyler | May 4, 2023 | CNN, health
For three years now, the expansion of telehealth has made care more accessible for many people, especially those in rural areas. Patients have been able to receive prescriptions from providers without seeing them in person. But that may change come May 11 when the federal government is set to end the Covid-19 public health emergency declaration that made this convenience possible.
Before the pandemic, medical practitioners were subject to the conditions of the Ryan Haight Act, which required at least one in-person examination before prescribing a controlled medicine, said Dr. Shabana Khan, chair of the American Psychiatric Association’s Committee on Telepsychiatry.
“There are seven exceptions, and one of them is a public health emergency declared by the secretary of (health and human services), which is what we’ve had for the past three years,” Khan said. “It was immensely helpful … and allowed many Americans to get their medical care without having to come in person, so we could treat patients completely remotely.”
“The administration and HHS has put out a notice that they don’t intend to renew it any further,” Khan said, “so the federal public health emergency is going to be expiring May 11.”
Returning to pre-pandemic rules means people who were prescribed controlled medications via telehealth — such as stimulant medications for attention-deficit/hyperactivity disorder, benzodiazepines for anxiety, or medications for opioid use disorder, sleep or pain — will need one in-person medical examination to continue these prescriptions or start new ones.
The US Drug Enforcement Administration’s website has a general list of controlled substances, and an exhaustive list can be found here.
Patients will still be able to get prescriptions for non-controlled medications, such as antibiotics or birth control, via telehealth. The pre-pandemic rules also wouldn’t affect telehealth care by a practitioner who has already conducted an in-person examination of a patient.
To establish some flexibility in the telehealth framework moving forward, Khan said, the DEA has put forth proposals (PDF) that would allow telehealth practitioners to prescribe one 30-day supply of buprenorphine — a medication for opioid use disorder — or Schedule III-V non-narcotic controlled medications without doing an in-person examination first. A patient would have to do an in-person exam before the second prescription of either type of medication, according to those proposals.
But there’s no guarantee that will happen — public comment on the proposals was open through March; since then, the DEA has been considering comments before drafting final regulations.
“It is really important to start planning now,” Khan said. “For many medicines, it can be a risk to abruptly stop treatment.”
People who are on medications for opioid use disorder, ADHD or anxiety and don’t get an in-person exam between May 11 and the next time they need a prescription refill could experience withdrawal requiring a trip to the hospital, or negative effects on health, relationships, employment or academics, she added.
Here’s what else you should know about the changes and steps you should take, according to Khan.
This conversation has been lightly edited and condensed for clarity.
CNN: How should people prepare to ensure their prescription routine isn’t disrupted?
Khan: It’s important for patients who may be prescribed one of these types of medicines by a telemedicine physician or other practitioner to reach out to that practitioner to discuss this issue and make sure that they have a plan. And if it’s feasible to see that telemedicine physician in person, schedule that as soon as possible.
CNN: What if you can’t see your telehealth provider in person?
Khan: Let’s say a telemedicine physician practices completely remotely — then the patient would discuss with them what next steps would be.
In the proposed rule, the qualifying telemedicine referral may allow a patient to be seen by a local DEA-registered practitioner. So, for example, perhaps their primary care doctor or pediatrician — if they are DEA-registered — might be able to go through the qualifying telemedicine referral process so that they can see them in person and continue to be prescribed the medicine. Or patients can contact their health insurance provider to get a list of local referrals.
CNN: Are there any drawbacks to seeing general physicians or pediatricians for controlled medication prescriptions?
Khan: Some may say they aren’t going to prescribe certain medications, like psychiatric medications. Some may say they are comfortable with it, and some may say they will prescribe for a short period of time until you connect with a specialist. So there is variability.
CNN: Would the patient have to continue seeing the referral provider after that first in-person appointment?
Khan: In terms of what’s required at the federal level, if a patient has that one in-person exam with a provider through that qualifying telemedicine referral process, they wouldn’t necessarily have to see that provider again unless that’s part of their treatment plan that’s discussed.
With the qualifying telemedicine referral in the proposed rule, the way it’s written, it doesn’t necessarily have to be the referral practitioner prescribing the medicine; they just need to do the in-person exam. The referral practitioner can refer the patient back to the telemedicine doctor, who can prescribe the medicine.
The other factor that’s significant here is we discussed all the proposed rules and the status at the federal level, but there’s also the state level. States also have rules around controlled medicine prescribing, and they may not always align with federal law. Let’s say the DEA puts out their final rule, and there’s some flexibility — some states might adopt the older Ryan Haight Act language from the federal level, so they might actually be stricter than what we’ll be seeing at the federal level. When federal and state laws don’t align, providers generally have to follow whatever is stricter.
CNN: Will patients need to see their provider in person every time they need a prescription refill?
Khan: The DEA has indicated that the absolute requirement at the federal level is one in-person examination. Beyond that, it would be left to the discretion of whoever the patient is seeing.
