‘We never want to have this happen again,’ FDA official testifies about formula shortage | CNN



CNN
 — 

In a rare moment of bipartisan agreement, lawmakers were highly critical of the US Food and Drug Administration’s handling of the infant formula shortage Thursday.

The hearing of the US House Oversight and Accountability Subcommittee on Health Care and Financial Services was one of several Congress has held to better understand what contributed to the recent formula shortage and to understand how to prevent more problems down the road.

Rep. Lisa McClain, R-Michigan, said that the FDA has not been fully forthcoming with Congress and the public.

“Why was the FDA unprepared for the crisis?” she asked in her opening statement.

She said that the agency failed to prioritize food safety. “The FDA has not taken the action needed to prevent a similar crisis from happening again.”

Rep. Katie Porter, D-California, said she agreed with McClain that another shortage could happen, “and that is a deadly serious problem.”

“There is a lot of blame to go around,” Porter added. “It’s clear with today’s witness selection that Republicans want to blame the FDA, and I’ll level with you, I think some of that blame is well-placed. We’ve had two subsequent infant formula recalls in 2023 already, and we’re still seeing that the FDA can make further improvements on internal processes, intervene in issues sooner and follow through with more inspections to prevent further contamination.”

Three major manufacturers in the US control over 90% of the formula market, and that consolidation is a “serious concern” that “contributed significantly to shortages,” according to Dr. Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, who testified Thursday.

A shortage that started in 2021 was exacerbated when the country’s largest infant formula maker, Abbott Nutrition, recalled multiple products in mid-February 2022 and had to pause production at its plant in Sturgis, Michigan, after FDA inspectors found potentially dangerous bacteria.

The plant inspection was tied to an outbreak of Cronobacter sakazakii that had sickened at least four infants and killed two, although investigations did not find a genetic link between bacteria samples from the facility and bacteria found in the water and powder used to mix the formula that the infants had consumed.

Mayne testified that it was difficult to trace the cases and determine how big of a concern the outbreak was. The bacteria is a common pathogen in the environment “but one about which we have limited information.”

The FDA has urged the US Centers for Disease Control and Prevention to make Cronobacter infection a notifiable disease – meaning providers would be required to report cases to local or state public health officials – so public health experts would be able to more quickly determine the source of any contamination.

In addition to the bacteria, an FDA inspection of the Sturgis plant found unsanitary conditions and several violations of food safety rules.

A whistleblower had alerted the FDA to alleged safety lapses at the plant in February 2021, months before Abbott’s formula was recalled. The complaint suggested that the plant lacked proper cleaning practices and that workers falsified records and hid information from inspectors.

Like other FDA leaders who have been called before Congress, Mayne testified that she was not made aware of the complaint right away. She called it “a failure of escalation.”

“I do wish I had been made aware of this particular whistleblower complaint, but just to reiterate, the complaint was acted upon,” Mayne said. However, she noted, it was “less than ideal” how quickly there was an FDA inspection of the plant and how quickly the agency was able to act.

When the whistleblower made the complaint, there was no process within the FDA to escalate it. The process has since changed so that if a complaint meets certain criteria involving vulnerable populations, hospitalizations or deaths, leadership would be immediately informed. If a consumer complaint involves an infant death or hospitalization, it also immediately gets escalated to leadership.

To prevent future shortages, Mayne testified, it won’t just be the FDA that needs to change. The industry should do more to adopt enhanced food safety measures to “deliver the safest possible” infant formula, she said.

The agency would also like better regulations. There have been been two infant formula recalls already in 2023, and in neither case was the manufacturer required to notify the FDA that it had found contamination before the formula left the plant.

The FDA has asked formula makers to inform the agency about positive tests, but such reporting is only voluntary. If it were mandatory, the FDA could know about problems in real time and could take action.

“Our food safety experts, our compliance experts can work with the manufacturers,” Mayne said. In such a collaboration, they could quickly identify what product to focus on to prevent a shortage.

The FDA has taken recent steps to improve. In February, it announced that it is restructuring its food division to be more responsive and that it is creating an office of critical foods. The FDA is also hiring specialized infant formula inspection staff, Mayne said.

The infant formula supply is generally in good shape, she said, but there are still some distribution issues.

The in-stock rate is near 90%, even higher than pre-recall levels. But some rural areas are having a hard time getting all the formula they need.

Formula manufacturers have been producing more than is being purchased week after week to build up supply, Mayne said. The Biden administration has also worked to bring in formula from manufacturers overseas.

But another shortage is not out of the question, particularly if one of the country’s main manufacturers is taken offline for any significant amount of time.

“We never want to have this happen again,” Mayne said.

Lawmakers have proposed significant cuts, about 22%, to the FDA’s budget for 2023. Mayne said that consumers and the industry would be “adversely affected” if the cuts go through.

“Broadly, across the FDA, I can say it would be devastating,” she said, resulting in a loss of 32% of domestic inspections and 22% of foreign inspections. The cuts would also disproportionately affect its food programs, which get much of their funding from the budget, unlike divisions involving drugs that get money from user fees.

“We would be unable to do what I think American consumers expect us to do,” Mayne said.

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FDA advisers vote unanimously in support of over-the-counter birth-control pill | CNN



CNN
 — 

Advisers for the US Food and Drug Administration voted unanimously on Wednesday in support of making the birth-control pill Opill available over-the-counter, saying the benefits outweigh the risks.

Two FDA advisory panels agreed that people would use Opill safely and effectively and said groups such as adolescents and those with limited literacy would be able to take the pill at the same time every day without help from a health care worker.

The advisers were asked to vote on whether people were likely to use the tablet properly so that the benefits would exceed the risks. Seventeen voted yes. Zero voted no or abstained.

Opill manufacturer Perrigo hailed the vote as a “groundbreaking” move for women’s health.

“Perrigo is proud to lead the way in making contraception more accessible to women in the U.S.,” Murray Kessler, Perrigo’s president and CEO, said in a statement. “We are motivated by the millions of people who need easy access to safe and effective contraception.”

The FDA doesn’t have to follow its advisers’ advice, but it often does. It is expected to decide whether to approve the over-the-counter pill this summer.

If it’s approved, this will be the first birth-control pill available over the counter in the United States. Opill is a “mini-pill” that uses only the hormone progestin.

At Wednesday’s meeting, Dr. Margery Gass of the University of Cincinnati College of Medicine thanked the FDA for its consideration of switching Opill to an over-the-counter product.

“I think this represents a landmark in our history of women’s health. Unwanted pregnancies can really derail a woman’s life, and especially an adolescent’s life,” she said.

The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers.

Unwanted pregnancies are a public health issue in the US, where almost half of all pregnancies are unintended, 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.

A recent study showed that it’s become harder for women to access reproductive health care services more broadly – such as routine screenings and birth control – in recent years.

About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017. Nearly 19% reported at least three barriers in 2021, up from 16% in 2017.

Increasing reproductive access for women and adolescents was a resounding theme among the FDA advisers.

“We can take this opportunity to increase access, reduce disparities and, most importantly, increase the reproductive autonomy of the women of our nation,” said Dr. Jolie Haun of the James A. Haley Veterans’ Hospital and the University of Utah.

Dr. Karen Murray, deputy director of the FDA’s Office of Nonprescription Drugs, said the agency understands the importance of “increased access to effective contraception” but hinted that the FDA would need more data from the manufacturer.

Some of the advisers and FDA scientists expressed concern that some of Perrigo’s data was unreliable due to overreporting of “improbable dosing.”

Murray said the lack of sufficient information from the study poses challenges for approval.

“It would have been a much easier time for the agency if the applicant had submitted a development program and an actual use study that was very easy to interpret and did not have so many challenges. But that was not what happened for us. And so the FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively in the nonprescription setting,” she said. “But I wanted to again emphasize that FDA does realize how very important women’s health is and how important it is to try to increase access to effective contraception for US women.”

Ultimately, the advisers said, they don’t want further studies of Opill to delay the availability of the product in an over-the-counter setting.

“I just wanted to say that the improbable dosing issue is important, and I don’t think it’s been adequately addressed and certainly leads to some uncertainty in the findings. But despite this, I would not recommend another actual use study this time, and I think we can make a decision on the totality of the evidence,” said Kate Curtis of the US Centers for Disease Control and Prevention.

Curtis said she voted yes because “Opill has the potential to have a huge positive public health impact.”

Earlier in the discussion, Dr. Leslie Walker-Harding of the University of Washington and Seattle Children’s Hospital said the pill is just as safe as many other medications available on store shelves.

“The safety profile is so good that we would need to take every other medicine off the market like Benadryl, ibuprofen, Tylenol, which causes deaths and people can get any amount of that without any oversight. And this is extremely safe, much safer than all three of those medications, and incorrect use still doesn’t appear to have problematic issues,” she said.

Dr. Katalin Roth of the George Washington University School of Medicine and Health Sciences also emphasized the safety of the pill over the 50 years it has been approved as a prescription drug in the US.

“The risks to women of an unintended pregnancy are much greater than any of the things we were discussing as risks of putting this pill out out over-the-counter,” she said. “The history of women’s contraception is a struggle for women’s control over their reproduction, and we need to trust women.”

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Bacterial infection linked to recent baby formula shortage may join federal disease watchlist | CNN



CNN
 — 

US health officials may soon ask states to notify them of any cases of infants with serious infections caused by Cronobacter sakazakii, bacteria that can contaminate infant formula.

Cronobacter infections typically strike infants who are less than 2 months old, and they can be fatal or permanently disabling.

In an outbreak that the US Centers for Disease Control and Prevention investigated last year, four babies were sickened, including two who died. All the infants had been fed baby formula manufactured at the same factory in Sturgis, Michigan, triggering an extensive investigation by the US Food and Drug Administration and ultimately stopping production at the facility for months. The shutdown worsened ongoing supply chain issues and threw the country into a nationwide shortage.

Ultimately, the FDA and the CDC could find no genetic links between Cronobacter samples from the facility and the bacteria found in the water and powder used to mix the formula that the infants had consumed.

These infections are thought to be infrequent, but the true burden in the US is unknown because Cronobacter is not currently part of the National Notifiable Diseases Surveillance System, a list of about 120 illnesses given special priority by the CDC because they’ve been deemed to be important to public health.

The Council of State and Territorial Epidemiologists, a nonprofit organization that advocates for effective disease surveillance, identified Cronobacter as a priority area for investigation this year.

A work group was formed in the winter to assess conditions, risks and surveillance processes related to the bacterial infection, and it will present recommendations to advance Cronobacter surveillance in June.

Adding Cronobacter infections to the national watchlist is among the strategies being considered.

“When we look back at large-scale outbreaks over the course of the last year, many of those outbreaks were associated with diseases and conditions that were nationally notifiable, but not all of them,” said Janet Hamilton, executive director of the council – and Cronobacter was one of the exceptions.

“So whenever we have something like that, that prompts the council to determine and assess whether we need to potentially be doing more.”

Adding an illness to the national list can have a sizable impact. After E. coli O157 was added to the notifiable disease list in 1994 and most states required doctors to report cases by 2000, the number of reported outbreaks tripled.

However, it would take quite some time for any changes to take effect.

If the Council of State and Territorial Epidemiologists votes in favor of adding Cronobacter infections to the national list of notifiable diseases, the recommendation will go to the CDC for approval. If the CDC deems an illness to be notifiable, it’s up to state and local governments to adjust their reporting laws and develop processes for doctors to report cases to health departments, which then forward those reports to the CDC.

The soonest that data collection could start is the beginning of 2024, and it would most likely be well into the year, depending on state legislative sessions.

Currently, only two states, Minnesota and Michigan, require doctors to report Cronobacter cases, which may be diagnosed more generically as sepsis or meningitis, conditions that can result from an infection.

“Unless detailed studies are done, the diagnosis as a Cronobacter illness may be missed,” FDA Commissioner Dr. Robert Califf wrote in a blog post last week. “The lack of mandatory reporting significantly hampers the ability to fully understand Cronobacter’s public health impact.”

Dr. Peter Lurie, executive director of the Center for Science in the Public Interest, applauded the potential move.

“I think it’s a necessary step. It is difficult to prevent diseases that you can’t count,” Lurie said.

In addition, Lurie says, manufacturers should be required to notify the FDA when a batch of baby formula tests positive for Cronobacter before it leaves the plant. The FDA has asked manufacturers to tell it about positive tests, but such reporting is voluntary.

Lurie says the FDA should also be doing more sampling and testing for Cronobacter in the environment to get a better understanding of where the bacteria can turn up.

“I think we have a lot to learn there,” he said.

Mitzi Baum, CEO of the group Stop Foodborne Illness, which has been advocating for the change, said she was grateful the Council of State and Territorial Epidemiologists was moving toward a vote on it.

She said greater awareness of the infection was long overdue.

“It’s always prefaced by ‘this is rare,’ but we don’t know how rare it is because it’s not reportable. And there needs to be a lot more education about this pathogen and a lot more research,” Baum said.

Baum said her group is working with the council to create an education campaign to raise awareness of the infection among doctors. The next step, she says, is getting funding.

The council’s Hamilton points out that “simply making something nationally notifiable doesn’t necessarily translate into awareness and recognition on the prevention side. If people don’t have the right set of information and education, by the time we’re doing public health surveillance for it, the disease or infection has already occurred.”

According to the FDA, Cronobacter sakazakii is a common natural pathogen that can enter homes and other spaces on hands, shoes and other contaminated surfaces. It is “especially good at surviving in dry foods,” such as powdered baby formula.

Infections are harmless for most people, but it can be life-threatening for infants, especially those who are born prematurely or with weakened immune systems. It’s particularly important to be sure that parents of high-risk infants know how to keep them safe, Hamilton said.

“Providing good education around how to stop infections is really what leads to the level of change that we would love to see,” she said.

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Covid-19 Pandemic Timeline Fast Facts | CNN



CNN
 — 

Here’s a look at the coronavirus outbreak, declared a worldwide pandemic by the World Health Organization. The coronavirus, called Covid-19 by WHO, originated in China and is the cousin of the SARS virus.

Coronaviruses are a large group of viruses that are common among animals. The viruses can make people sick, usually with a mild to moderate upper respiratory tract illness, similar to a common cold. Coronavirus symptoms include a runny nose, cough, sore throat, possibly a headache and maybe a fever, which can last for a couple of days.

WHO Situation Reports

Coronavirus Map

CNN’s early reporting on the coronavirus

December 31, 2019 – Cases of pneumonia detected in Wuhan, China, are first reported to WHO. During this reported period, the virus is unknown. The cases occur between December 12 and December 29, according to Wuhan Municipal Health.

January 1, 2020 – Chinese health authorities close the Huanan Seafood Wholesale Market after it is discovered that wild animals sold there may be the source of the virus.

January 5, 2020 – China announces that the unknown pneumonia cases in Wuhan are not SARS or MERS. In a statement, the Wuhan Municipal Health Commission says a retrospective probe into the outbreak has been initiated.

January 7, 2020 – Chinese authorities confirm that they have identified the virus as a novel coronavirus, initially named 2019-nCoV by WHO.

January 11, 2020 – The Wuhan Municipal Health Commission announces the first death caused by the coronavirus. A 61-year-old man, exposed to the virus at the seafood market, died on January 9 after respiratory failure caused by severe pneumonia.

January 17, 2020 – Chinese health officials confirm that a second person has died in China. The United States responds to the outbreak by implementing screenings for symptoms at airports in San Francisco, New York and Los Angeles.

January 20, 2020 – China reports 139 new cases of the sickness, including a third death. On the same day, WHO’s first situation report confirms cases in Japan, South Korea and Thailand.

January 20, 2020 – The National Institutes of Health announces that it is working on a vaccine against the coronavirus. “The NIH is in the process of taking the first steps towards the development of a vaccine,” says Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases.

January 21, 2020 – Officials in Washington state confirm the first case on US soil.

January 23, 2020 – At an emergency committee, WHO says that the coronavirus does not yet constitute a public health emergency of international concern.

January 23, 2020 – The Beijing Culture and Tourism Bureau cancels all large-scale Lunar New Year celebrations in an effort to contain the growing spread of coronavirus. On the same day, Chinese authorities enforce a partial lockdown of transport in and out of Wuhan. Authorities in the nearby cities of Huanggang and Ezhou Huanggang announce a series of similar measures.

January 28, 2020 – Chinese President Xi Jinping meets with WHO Director General Tedros Adhanom in Beijing. At the meeting, Xi and WHO agree to send a team of international experts, including US Centers for Disease Control and Prevention staff, to China to investigate the coronavirus outbreak.

January 29, 2020 – The White House announces the formation of a new task force that will help monitor and contain the spread of the virus, and ensure Americans have accurate and up-to-date health and travel information, it says.

January 30, 2020 – The United States reports its first confirmed case of person-to-person transmission of the coronavirus. On the same day, WHO determines that the outbreak constitutes a Public Health Emergency of International Concern (PHEIC).

January 31, 2020 – The Donald Trump administration announces it will deny entry to foreign nationals who have traveled in China in the last 14 days.

February 2, 2020 – A man in the Philippines dies from the coronavirus – the first time a death has been reported outside mainland China since the outbreak began.

February 3, 2020 – China’s Foreign Ministry accuses the US government of inappropriately reacting to the outbreak and spreading fear by enforcing travel restrictions.

February 4, 2020 – The Japanese Health Ministry announces that ten people aboard the Diamond Princess cruise ship moored in Yokohama Bay are confirmed to have the coronavirus. The ship, which is carrying more than 3,700 people, is placed under quarantine scheduled to end on February 19.

February 6, 2020 – First Covid-19 death in the United States: A person in California’s Santa Clara County dies of coronavirus, but the link is not confirmed until April 21.

February 7, 2020 – Li Wenliang, a Wuhan doctor who was targeted by police for trying to sound the alarm on a “SARS-like” virus in December, dies of the coronavirus. Following news of Li’s death, the topics “Wuhan government owes Dr. Li Wenliang an apology,” and “We want freedom of speech,” trend on China’s Twitter-like platform, Weibo, before disappearing from the heavily censored platform.

February 8, 2020 – The US Embassy in Beijing confirms that a 60-year-old US national died in Wuhan on February 6, marking the first confirmed death of a foreigner.

February 10, 2020 – Xi inspects efforts to contain the coronavirus in Beijing, the first time he has appeared on the front lines of the fight against the outbreak. On the same day, a team of international experts from WHO arrive in China to assist with containing the coronavirus outbreak.

February 10, 2020 – The Anthem of the Seas, a Royal Caribbean cruise ship, sets sail from Bayonne, New Jersey, after a coronavirus scare had kept it docked and its passengers waiting for days.

February 11, 2020 – WHO names the coronavirus Covid-19.

February 13, 2020 – China’s state-run Xinhua News Agency announces that Shanghai mayor Ying Yong will be replacing Jiang Chaoliang amid the outbreak. Wuhan Communist Party chief Ma Guoqiang has also been replaced by Wang Zhonglin, party chief of Jinan city in Shandong province, according to Xinhua.

February 14, 2020 – A Chinese tourist who tested positive for the virus dies in France, becoming the first person to die in the outbreak in Europe. On the same day, Egypt announces its first case of coronavirus, marking the first case in Africa.

February 15, 2020 – The official Communist Party journal Qiushi publishes the transcript of a speech made on February 3 by Xi in which he “issued requirements for the prevention and control of the new coronavirus” on January 7, revealing Xi knew about and was directing the response to the virus on almost two weeks before he commented on it publicly.

February 17, 2020 – A second person in California’s Santa Clara County dies of coronavirus, but the link is not confirmed until April 21.

February 18, 2020 – Xi says in a phone call with British Prime Minister Boris Johnson that China’s measures to prevent and control the epidemic “are achieving visible progress,” according to state news Xinhua.

February 21, 2020 – The CDC changes criteria for counting confirmed cases of novel coronavirus in the United States and begins tracking two separate and distinct groups: those repatriated by the US Department of State and those identified by the US public health network.

February 25, 2020 – The NIH announces that a clinical trial to evaluate the safety and effectiveness of the antiviral drug remdesivir in adults diagnosed with coronavirus has started at the University of Nebraska Medical Center in Omaha. The first participant is an American who was evacuated from the Diamond Princess cruise ship docked in Japan.

February 25, 2020 – In an effort to contain the largest outbreak in Europe, Italy’s Lombardy region press office issues a list of towns and villages that are in complete lockdown. Around 100,000 people are affected by the travel restrictions.

February 26, 2020 – CDC officials say that a California patient being treated for novel coronavirus is the first US case of unknown origin. The patient, who didn’t have any relevant travel history nor exposure to another known patient, is the first possible US case of “community spread.”

February 26, 2020 – Trump places Vice President Mike Pence in charge of the US government response to the novel coronavirus, amid growing criticism of the White House’s handling of the outbreak.

February 29, 2020 – A patient dies of coronavirus in Washington state. For almost two months, this is considered the first death due to the virus in the United States, until autopsy results announced April 21 reveal two earlier deaths in California.

March 3, 2020 – The Federal Reserve slashes interest rates by half a percentage point in an attempt to give the US economy a jolt in the face of concerns about the coronavirus outbreak. It is the first unscheduled, emergency rate cut since 2008, and it also marks the biggest one-time cut since then.

March 3, 2020 – Officials announce that Iran will temporarily release 54,000 people from prisons and deploy hundreds of thousands of health workers as officials announced a slew of measures to contain the world’s deadliest coronavirus outbreak outside China. It is also announced that 23 members of Iran’s parliament tested positive for the virus.

March 4, 2020 – The CDC formally removes earlier restrictions that limited coronavirus testing of the general public to people in the hospital, unless they had close contact with confirmed coronavirus cases. According to the CDC, clinicians should now “use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested.”

March 8, 2020 – Italian Prime Minister Giuseppe Conte signs a decree placing travel restrictions on the entire Lombardy region and 14 other provinces, restricting the movements of more than 10 million people in the northern part of the country.

March 9, 2020 – Conte announces that the whole country of Italy is on lockdown.

March 11, 2020 – WHO declares the novel coronavirus outbreak to be a pandemic. WHO says the outbreak is the first pandemic caused by a coronavirus. In an Oval Office address, Trump announces that he is restricting travel from Europe to the United States for 30 days in an attempt to slow the spread of coronavirus. The ban, which applies to the 26 countries in the Schengen Area, applies only to foreign nationals and not American citizens and permanent residents who’d be screened before entering the country.

March 13, 2020 – Trump declares a national emergency to free up $50 billion in federal resources to combat coronavirus.

March 18, 2020 – Trump signs into law a coronavirus relief package that includes provisions for free testing for Covid-19 and paid emergency leave.

March 19, 2020 – At a news conference, officials from China’s National Health Commission report no new locally transmitted coronavirus cases for the first time since the pandemic began.

March 23, 2020 – United Nations Secretary-General António Guterres calls for an immediate global ceasefire amid the pandemic to fight “the common enemy.”

March 24, 2020 – Japan’s Prime Minister Shinzo Abe and International Olympic Committee (IOC) president Thomas Bach agree to postpone the Olympics until 2021 amid the outbreak.

March 25, 2020 – The White House and Senate leaders reach an agreement on a $2 trillion stimulus deal to offset the economic damage of coronavirus, producing one of the most expensive and far-reaching measures in the history of Congress.

March 27, 2020 – Trump signs the stimulus package into law.

April 2, 2020 – According to the Department of Labor, 6.6 million US workers file for their first week of unemployment benefits in the week ending March 28, the highest number of initial claims in history. Globally, the total number of coronavirus cases surpasses 1 million, according to Johns Hopkins University’s tally.

April 3, 2020 – Trump says his administration is now recommending Americans wear “non-medical cloth” face coverings, a reversal of previous guidance that suggested masks were unnecessary for people who weren’t sick.

April 8, 2020 – China reopens Wuhan after a 76-day lockdown.

April 14, 2020 – Trump announces he is halting funding to WHO while a review is conducted, saying the review will cover WHO’s “role in severely mismanaging and covering up the spread of coronavirus.”

April 20, 2020 – Chilean health officials announce that Chile will begin issuing the world’s first digital immunity cards to people who have recovered from coronavirus, saying the cards will help identify individuals who no longer pose a health risk to others.

April 21, 2020 – California’s Santa Clara County announces autopsy results that show two Californians died of novel coronavirus in early and mid-February – up to three weeks before the previously known first US death from the virus.

April 28, 2020 – The United States passes one million confirmed cases of the virus, according to Johns Hopkins.

May 1, 2020 – The US Food and Drug Administration issues an emergency-use authorization for remdesivir in hospitalized patients with severe Covid-19. FDA Commissioner Stephen Hahn says remdesivir is the first authorized therapy drug for Covid-19.

May 4, 2020 – During a virtual pledging conference co-hosted by the European Union, world leaders pledge a total of $8 billion for the development and deployment of diagnostics, treatments and vaccines against the novel coronavirus.

May 11, 2020 – Trump and his administration announce that the federal government is sending $11 billion to states to expand coronavirus testing capabilities. The relief package signed on April 24 includes $25 billion for testing, with $11 billion for states, localities, territories and tribes.

May 13, 2020 – Dr. Mike Ryan, executive director of WHO’s health emergencies program, warns that the coronavirus may never go away and may just join the mix of viruses that kill people around the world every year.

May 19, 2020 – WHO agrees to hold an inquiry into the global response to the coronavirus pandemic. WHO member states adopt the proposal with no objections during the World Health Assembly meeting, after the European Union and Australia led calls for an investigation.

May 23, 2020 – China reports no new symptomatic coronavirus cases, the first time since the beginning of the outbreak in December.

May 27, 2020 – Data collected by Johns Hopkins University reports that the coronavirus has killed more than 100,000 people across the US, meaning that an average of almost 900 Americans died each day since the first known coronavirus-related death was reported nearly four months earlier.

June 2, 2020 – Wuhan’s Health Commission announces that it has completed coronavirus tests on 9.9 million of its residents with no new confirmed cases found.

June 8, 2020 – New Zealand Prime Minister Jacinda Ardern announces that almost all coronavirus restrictions in New Zealand will be lifted after the country reported no active cases.

June 11, 2020 – The United States passes 2 million confirmed cases of the virus, according to Johns Hopkins.

June 16, 2020 – University of Oxford scientists leading the Recovery Trial, a large UK-based trial investigating potential Covid-19 treatments, announce that a low-dose regimen of dexamethasone for 10 days was found to reduce the risk of death by a third among hospitalized patients requiring ventilation in the trial.

June 20, 2020 – The NIH announces that it has halted a clinical trial evaluating the safety and effectiveness of drug hydroxychloroquine as a treatment for the coronavirus. “A data and safety monitoring board met late Friday and determined that while there was no harm, the study drug was very unlikely to be beneficial to hospitalized patients with Covid-19,” the NIH says in a statement.

June 26, 2020 – During a virtual media briefing, WHO announces that it plans to deliver about 2 billion doses of a coronavirus vaccine to people across the globe. One billion of those doses will be purchased for low- and middle-income countries, according to WHO.

July 1, 2020 – The European Union announces it will allow travelers from 14 countries outside the bloc to visit EU countries, months after it shut its external borders in response to the pandemic. The list does not include the US, which doesn’t meet the criteria set by the EU for it to be considered a “safe country.”

July 6, 2020 – In an open letter published in the journal Clinical Infectious Diseases, 239 scientists from around the world urge WHO and other health agencies to be more forthright in explaining the potential airborne transmission of coronavirus. In the letter, scientists write that studies “have demonstrated beyond any reasonable doubt that viruses are released during exhalation, talking, and coughing in microdroplets small enough to remain aloft in air and pose a risk of exposure at distances beyond 1 to 2 meters (yards) from an infected individual.”

July 7, 2020 – The Trump administration notifies Congress and the United Nations that the United States is formally withdrawing from WHO. The withdrawal goes into effect on July 6, 2021.

July 21, 2020 – European leaders agree to create a €750 billion ($858 billion) recovery fund to rebuild EU economies ravaged by the coronavirus.

July 27, 2020 – A vaccine being developed by the Vaccine Research Center at the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, in partnership with the biotechnology company Moderna, enters Phase 3 testing. The trial is expected to enroll about 30,000 adult volunteers and evaluates the safety of the vaccine and whether it can prevent symptomatic Covid-19 after two doses, among other outcomes.

August 11, 2020 – In a live teleconference, Russian President Vladimir Putin announces that Russia has approved a coronavirus vaccine for public use before completion of Phase 3 trials, which usually precedes approval. The vaccine, which is named Sputnik-V, is developed by the Moscow-based Gamaleya Institute with funding from the Russian Direct Investment Fund (RDIF).

August 15, 2020 – Russia begins production on Sputnik-V, according to Russian state news agency TASS.

August 23, 2020 – The FDA issues an emergency use authorization for the use of convalescent plasma to treat Covid-19. It is made using the blood of people who have recovered from coronavirus infections.

August 27, 2020 – The CDC notifies public health officials around the United States to prepare to distribute a potential coronavirus vaccine as soon as late October. In the documents, posted by The New York Times, the CDC provides planning scenarios to help states prepare and advises on who should get vaccinated first – healthcare professionals, essential workers, national security “populations” and long-term care facility residents and staff.

September 4, 2020 – The first peer-reviewed results of Phase 1 and Phase 2 clinical trials of Russia’s Covid-19 vaccine are published in the medical journal The Lancet. The results “have a good safety profile” and the vaccine induced antibody responses in all participants, The Lancet says.

October 2, 2020 – Trump announces that he and first lady Melania Trump have tested positive for Covid-19. He spends three nights at Walter Reed National Military Medical Center receiving treatment before returning to the White House.

October 12, 2020 – Drugmaker Johnson & Johnson announces it has paused the advanced clinical trial of its experimental coronavirus vaccine because of an unexplained illness in one of the volunteers.”Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians,” the company said in a statement. ENSEMBLE is the name of the study. The trial resumes later in the month.

December 10, 2020 – Vaccine advisers to the FDA vote to recommend the agency grant emergency use authorization to Pfizer and BioNTech’s coronavirus vaccine.

December 14, 2020 – US officials announce the first doses of the FDA authorized Pfizer vaccine have been delivered to all 50 states, the District of Columbia and Puerto Rico.

December 18, 2020 – The FDA authorizes a second coronavirus vaccine made by Moderna for emergency use. “The emergency use authorization allows the vaccine to be distributed in the U.S. for use in individuals 18 years and older,” the FDA said in a tweet.

January 14, 2021 – The WHO team tasked with investigating the origins of the outbreak in Wuhan arrive in China.

January 20, 2021 – Newly elected US President Joe Biden halts the United States’ withdrawal from WHO.

February 22, 2021 – The death toll from Covid-19 exceeds 500,000 in the United States.

February 27, 2021 – The FDA grants emergency use authorization to Johnson & Johnson’s Covid-19 vaccine, the first single dose Covid-19 vaccine available in the US.

March 30, 2021 – According to a 120-page report from WHO, the novel coronavirus that causes Covid-19 probably spread to people through an animal, and probably started spreading among humans no more than a month or two before it was noticed in December of 2019. The report says a scenario where it spread via an intermediate animal host, possibly a wild animal captured and then raised on a farm, is “very likely.”

April 17, 2021 – The global tally of deaths from Covid-19 surpasses 3 million, according to data compiled by Johns Hopkins.

August 3, 2021 – According to figures published by the CDC, the more contagious Delta variant accounts for an estimated 93.4% of coronavirus circulating in the United States during the last two weeks of July. The figures show a rapid increase over the past two months, up from around 3% in the two weeks ending May 22.

August 12, 2021 – The FDA authorizes an additional Covid-19 vaccine dose for certain immunocompromised people.

August 23, 2021 – The FDA grants full approval to the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older, making it the first coronavirus vaccine approved by the FDA.

September 24, 2021 CDC Director Dr. Rochelle Walensky diverges from the agency’s independent vaccine advisers to recommend boosters for a broader group of people – those ages 18 to 64 who are at increased risk of Covid-19 because of their workplaces or institutional settings – in addition to older adults, long-term care facility residents and some people with underlying health conditions.

November 2, 2021 – Walensky says she is endorsing a recommendation to vaccinate children ages 5-11 against Covid-19, clearing the way for immediate vaccination of the youngest age group yet in the US.

November 19, 2021 – The FDA authorizes boosters of the Pfizer/BioNTech and Moderna Covid-19 vaccines for all adults. The same day, the CDC also endorses boosters for all adults.

December 16, 2021 – The CDC changes its recommendations for Covid-19 vaccines to make clear that shots made by Moderna and Pfizer/BioNTech are preferred over Johnson & Johnson’s vaccine.

December 22, 2021 – The FDA authorizes Pfizer’s antiviral pill, Paxlovid, to treat Covid-19, the first antiviral Covid-19 pill authorized in the United States for ill people to take at home, before they get sick enough to be hospitalized. The following day, the FDA authorizes Merck’s antiviral pill, molnupiravir.

December 27, 2021 The CDC shortens the recommended times that people should isolate when they’ve tested positive for Covid-19 from 10 days to five days if they don’t have symptoms – and if they wear a mask around others for at least five more days. The CDC also shortens the recommended time for people to quarantine if they are exposed to the virus to a similar five days if they are vaccinated.

January 31, 2022 – The FDA grants full approval to Moderna’s Covid-19 vaccine for those ages 18 and older. This is the second coronavirus vaccine given full approval by the FDA.

March 29, 2022 – The FDA authorizes a second booster of the Pfizer/BioNTech and Moderna Covid-19 vaccines for adults 50 and older. That same day, the CDC also endorses a second booster for the same age group.

April 25, 2022 – The FDA expands approval of the drug remdesivir to treat patients as young as 28 days and weighing about seven pounds.

May 17, 2022 – The FDA authorizes a booster dose of Pfizer/BioNTech’s Covid-19 vaccine for children ages 5 to 11 at least five months after completion of the primary vaccine series. On May 19, the CDC also endorses a booster dose for the same age group.

June 18, 2022 – The CDC recommends Covid-19 vaccines for children as young as 6 months.

August 31, 2022 – The FDA authorizes updated Covid-19 vaccine booster shots from Moderna and Pfizer. Both are bivalent vaccines that combine the companies’ original vaccine with one that targets the BA.4 and BA.5 Omicron sublineages. The CDC signs off on the updated booster shots the following day.

May 5, 2023 – The WHO says Covid-19 is no longer a global health emergency.



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The way the US government tracks Covid-19 is about to change | CNN



CNN
 — 

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.”

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US government is testing avian flu vaccines for birds, but ending the historic outbreak isn’t that simple | CNN



CNN
 — 

The United States is facing what some experts are calling “a new era for bird flu.”

Since January 2022, the country has been battling the biggest outbreak yet of highly pathogenic avian influenza in wildlife. The virus is a major threat to commercial and backyard flocks, and it has started to show up in hundreds of mammals, including a handful of pet cats.

The risk to humans is low; there has been only one human case of this virus in the US since the outbreak began, according to the US Centers for Disease Control and Prevention, and nine cases globally, mostly among people who work with birds. The CDC says there are trials underway of vaccines that could be used to protect humans in case the virus changes and becomes more of a threat.

Separately, the US Department of Agriculture, the US National Poultry Research Center and labs at a handful of American universities have been experimenting with vaccine candidates to be used in birds.

The USDA’s Agriculture Research Service started trials of four vaccine candidates for animals in April and expects to have initial data on a single-dose vaccine available this month. A two-dose vaccine challenge study – in which animals are exposed to the virus to see how well the vaccine works – should produce results in June.

If the animal vaccines look to be protective, the USDA’s next step would be to work with manufacturers on whether it would be feasible to use them.

One manufacturer, Zoetis, announced April 5 the development of a vaccine geared toward currently circulating virus strains. The company says it would take about a year to get to the distribution stage in the US.

Vaccines are already available in other countries, including China, Egypt, Indonesia, Italy, Mexico and Vietnam, and some nations are vaccinating their commercial flocks.

However, in the United States, not all poultry experts are ready to use a vaccine, even if one becomes available – at least, not yet. Instead, their focus remains on eradicating the virus.

As of April 26, the CDC says, nearly 58.8 million poultry have been affected by avian flu since January 2022. The virus has been detected in at least 6,737 wild birds, and the number is likely to be much higher. There have been poultry outbreaks in 47 states.

Although this is the worst outbreak in history, improved biosecurity measures have vastly reduced the number of cases in the commercial sector, according to the USDA. When the outbreak began in early 2022, there were 51 detections among commercial poultry. In March 2023, there were only seven.

The USDA says close surveillance work among its Animal and Plant Health Inspection Service (APHIS) and state and industry partners led to the reduction in cases.

Generally, there ares two ways of confronting this kind of highly infectious disease in poultry, according to Rodrigo Gallardo, a professor in poultry medicine and a specialist in avian virology at the University of California, Davis.

“One of them is through vaccination action. And then the other one is through eradication,” he said.

In the United States, the latter is the approach for now, Gallardo said.

If farmers detect even a single case in a flock, they will put down the birds right away.

“The virus keeps replicating and amplifying if the birds are alive, so the only way of stopping the replication and limiting the dissemination is by depopulation,” Gallardo said.

Tom Super, the senior vice president for communications for the National Chicken Council, the national trade association for the US broiler chicken industry, said in an email to CNN that although it supports the ongoing discussions about a vaccination program, “currently we support the eradication policy of APHIS and believe that right now this is the best approach at eliminating [bird flu] in the U.S.”

The US Poultry and Egg Association said it’s “certainly a topic of discussion,” but the organization doesn’t have a position on implementing a vaccination program.

A vaccination program comes with several complications, Gallardo said. Vaccinated birds would be protected, but with this highly infectious disease, they still could shed some virus that could infect unprotected birds.

“So vaccination, in that case, creates amplification if it is not done right,” Gallardo said.

Plus, it’s difficult to detect the disease in vaccinated birds. Birds that are vaccinated don’t always show signs if they’re sick, so it would be hard to know what birds to keep separate from the others. Tests also have a hard time telling the difference between antibodies generated by vaccination and antibodies from an infection.

“If you’re not able to diagnose it, it might spread more than what it would do if you are able to diagnose it and eradicate it,” Gallardo said.

Countries that have chosen the vaccination route see more endemic strains develop, meaning the virus is never really totally wiped out.

“This is a very variable virus, and if you don’t update the vaccine that you’re applying to meet the change in the virus, then you won’t be able to completely protect the birds. Partial protection means more birds will be spreading the virus,” Gallardo said.

A vaccine has never been used against highly pathogenic avian influenza in the US, according to the USDA. The agency created a vaccine after an outbreak in 2014 and 2015, but that involved a different strain, so it wouldn’t work on the latest version of the virus.

The logistics of a vaccine like this are difficult, said Dr. Yuko Sato, an associate professor in the College of Veterinary Medicine at Iowa State University.

“You have to make sure that the new vaccine will protect against this current virus and hope that it doesn’t mutate or change so that the vaccine will continue to be protective,” Sato said.

“The vaccine is not a silver bullet. This is not going to prevent infection of the birds, so in order to have an exit strategy as the country, you would have to make sure that if you vaccinate, if you still have positive birds, you have to be able to make sure that you could stamp out the virus. Otherwise, we’ll never be looking at eradicating the virus from the United States.”

Another concern: Birds are a big business in the US.

The US has the largest poultry industry in the world, with 294,000 poultry farms. The market size for chicken and turkey meat production alone for 2023 is projected to generate $57.8 billion, according to market analysis firm IbisWorld.

Bird flu has hurt business in the US, but it could do so in a bigger way if the nation vaccinates poultry, according to the National Chicken Council.

“The National Chicken Council does not support the use of a vaccine for [bird flu] for a variety of reasons – the primary one being trade. Most countries, including the US, do not recognize countries that vaccinate as free of [bird flu] due to concerns that vaccines can mask the presence of the disease. Therefore, they do not accept exports from countries that do vaccinate,” Super wrote in his email.

The US broiler industry is the second largest exporter of chicken in the world. It exports about 18% of the chicken meat produced in the United States, valued at more than $5 billion annually.

“If we start vaccinating for [bird flu] in the U.S., the broiler industry will lose our ability to export which will have a significant impact on the industry – while costing billions and billions of dollars to the U.S. economy every year,” Super said.

With the way the disease is spreading, scientists would also probably have to vaccinate wildlife – which is nearly impossible.

Of the birds affected in this outbreak, about 76% are commercial egg-laying hens, 17% are turkeys, and only 5% are broilers, the chickens used for meat, Super said. The rest of the cases have been among ducks, backyard chickens and game birds.

“So the U.S. poultry sector that least needs a vaccine would have the most to risk from using one,” he said.

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Getting prescription meds via telehealth might change soon. Here’s how to prepare | CNN

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CNN
 — 

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.

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New approach gets newborns with opioid withdrawal out of the hospital sooner and with less medication | CNN



CNN
 — 

Rates of neonatal abstinence syndrome surged in recent years, but a newer approach to caring for newborn babies exposed to opioids during pregnancy gets them out of the hospital sooner and with less medication, according to a study published on Sunday in the New England Journal of Medicine.

Newborns in opioid withdrawal may experience upset stomach, inconsolable crying, seizures and extreme discomfort. The study looked at the impacts of the Eat, Sleep, Console care approach on 1,300 infants at 26 US hospitals, and compared them with the current standard for caring for infants exposed to opioids.

Eat, Sleep, Console encourages involvement from parents, and prioritizes care that doesn’t involve medication, such as swaddling, skin-to-skin contact and breastfeeding. The usual approach involves a nurse measuring a baby’s withdrawal symptoms – such as their level of irritability, pitch of crying, fever or tremors – before providing treatment such as methadone or morphine.

“Compared to usual care, use of the Eat, Sleep, Console care approach substantially decreased time until infants with neonatal opioid withdrawal syndrome were medically ready for discharge, without increasing specified adverse outcomes,” the researchers wrote in the study.

The infants assessed with the Eat, Sleep, Console care method were discharged after eight days on average, compared with almost 15 days for the infants who were cared for by the standard approach, the researchers said. Additionally, infants in the Eat, Sleep, Console care group were 63% less likely to receive opioid medication – 19.5% received medication compared with 52% in the group receiving usual care.

The current approach to usual care “is a very comprehensive and nurse-led way of assessing the infant, whereas the Eat, Sleep, Console approach involves the mom in the way that you assess the infant, and allows the mom to take part in trying to soothe the infants and see if the infant is able to be soothed or is able to eat or is able to sleep,” according to Rebecca Baker, the director of the NIH HEAL Initiative, which provides grants to researchers studying ways to alleviate the country’s opioid health crisis.

“So, in that way, it’s a little bit more functional, like looking at the abilities of the infants versus how severely the infant is affected.”

Assessment results determine whether a baby should receive medication to control withdrawal symptoms, Baker said.

“So even with Eat, Sleep, Console, some infants that were exposed to a lot of opioids during a mother’s pregnancy, they’ll still need medication-based treatment for withdrawal. It’s just fewer of them need it and when they need it, they need less medication to manage the withdrawal symptoms,” she said.

The Eat, Sleep, Console method was developed about eight years ago, and some hospitals have already implemented it. But Baker said the study’s findings could change how more hospitals practice caring for infants with neonatal abstinence syndrome, which primarily occurs in infants who were exposed to opioids while in utero.

“The rise of really powerful fentanyl, the synthetic opioid, means that if a mother has used drugs during pregnancy, the baby will be exposed to more powerful drugs, which likely has an effect. We haven’t had a chance to study it in detail yet, but it will affect how they feel when they’re born and separated from the mom,” Baker said.

Findings from the study, which were presented at the PAS 2023 Meeting on Sunday, could have a big impact on hospitals by freeing up bed space in the neonatal intensive care unit and boosting morale among nurses at risk of burnout.

“We trained over 5,000 nurses as part of the study. They felt really empowered to help the mom care for the infant to help the infant recover, and so I think from a morale perspective, that’s incredibly important and valuable,” Baker said. “And as you know, nurses are facing really severe staffing shortages and morale challenges so having this tool available to them where they are kind of able to do something positive in the life of the infant and the connection with the mom is really important.”

The researchers are currently following up with a subgroup of the infants from the study for up to two years to see how they grow and develop.

“One of the things that we want to be really sure of is that there are no negative consequences associated with taking less medication, so we’ll be looking for that,” Baker said.

The United States has seen an explosion in the number of infants born with neonatal abstinence syndrome in recent years, swelling by about 82% between 2010 and 2017, according to the US Centers for Disease Control and Prevention. The number of maternal opioid-related diagnoses is also on the rise, increasing by 131% during that same time frame.

Nearly 60 infants are diagnosed with NAS each day, based on data from the U.S. Agency for Healthcare Research and Quality in 2020.

The United States’ opioid epidemic has been expanding in recent years and opioid deaths are the leading cause of accidental death in the US.

More than a million people have died of drug overdoses – mostly opioids – in the two decades since the US Centers for Disease Control and Prevention began collecting that data. Deaths from opioid overdoses rose more than 17% in just one year, from about 69,000 in 2020 to about 81,020 in 2021, the CDC found.

Most are among adults, but children are also dying, largely after ingesting synthetic opioids such as fentanyl. Between 1999 and 2016, nearly 9,000 children and adolescents died of opioid poisoning, with the highest annual rates among adolescents 15 to 19, the CDC found.

Opioid use during pregnancy has been linked to maternal mortality and risk of overdose for the mother, according to the CDC, while infants risk preterm birth, low birthweight, breathing problems and feeding problems.

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Doctors watching for more cases after mysterious cluster of brain infections strikes kids in southern Nevada | CNN



CNN
 — 

Disease detectives with the US Centers for Disease Control and Prevention are investigating a cluster of rare and serious brain abscesses in kids in and around Las Vegas, Nevada, and doctors from other parts of the country say they may be seeing a rise in cases, too.

In 2022, the number of brain abscesses in kids tripled in Nevada, rising from an average of four to five a year to 18.

“In my 20 years’ experience, I’ve never seen anything like it,” said Dr. Taryn Bragg, an associate professor at the University of Utah who treated the cases.

Pediatric neurosurgeons like Bragg are rare. She is the only one for the entire state of Nevada, and because she treated all the cases, she was the first to notice the pattern and to alert local public health officials.

“After March of 2022, there was just a huge increase,” in brain abscesses, Bragg said. “I was seeing large numbers of cases and that’s unusual.”

“And the similarities in terms of the presentation of cases was striking,” Bragg said.

In almost every case, kids would get a common childhood complaint, such as an earache or a sinus infection, with a headache and fever, but within about a week, Bragg says, it would become clear that something more serious was going on.

After a presentation on the Nevada cases the Epidemic Intelligence Service Conference on Thursday, doctors from other parts of the country said they are seeing similar increases in brain abscesses in kids.

“We’re just impressed by the number of these that we’re seeing right now,” said Dr. Sunil Sood, a pediatric infectious disease specialist at Northwell Health, a health system in New York. He estimates they are seeing at least twice as many as usual, though they haven’t done a formal count. He urged the CDC to continue investigating and work to get the word out.

Brain abscesses are not, by themselves, reportable conditions, meaning doctors aren’t required to alert public health departments when they have these cases.

They typically only come to the attention of public health officials when doctors notice increases and reach out.

Brain abscesses are pus-filled pockets of infection that spread to the brain. They can cause seizures, visual disturbances, or changes in vision, speech, coordination or balance. The earliest symptoms are headaches and a fever that comes and goes. Abscesses often require several surgeries to treat, and kids may spend weeks or even months in the hospital recovering after they have one.

In the Clark County cluster, roughly three-quarters of the cases were in boys, and most were around age 12.

Dr. Jessica Penney is the CDC Epidemic Intelligence Service officer, or “disease detective,” assigned to Southern Nevada Health District, the health department that investigated the cases. She presented her investigation of the Clark County cluster at the CDC’s annual Epidemic Intelligence Service conference on Thursday.

Penney says as they tried to figure out what was driving the increase, they looked at a slew of factors – travel, a history of Covid-19 infection, underlying health, any common activities or exposures – and they didn’t find anything that linked the cases.

Then, she says they decided to look back in time, looking for brain abscess cases in children under 18 all the way back to 2015.

“I felt like that helped us get a better sense of what might be contributing to it,” Penney said in an interview with CNN.

From 2015 to 2020, Penney says the number of cases of brain abscesses in Clark County was pretty stable at around four a year. In 2020, the number of brain abscesses in kids dipped, probably because of measures like social distancing, school closures, and masking – things that shut down the spread of all kinds of respiratory infections, not just Covid-19. In 2021, as restrictions began to lift, the number of these events returned back to normal levels, and then in 2022, a big spike.

“So the thoughts are, you know, maybe in that period where kids didn’t have these exposures, you’re not building the immunity that you would typically get previously, you know with these viral infections,” Penney said. “And so maybe on the other end when we you had these exposures without that immunity from the years prior, we saw a higher number of infections.”

This is a theory called the immunity debt. Doctors have recently seen unusual increases in a number of serious childhood infections, such as invasive group A strep. Some think that during the years of the pandemic, because children weren’t exposed to the number of viruses and bacteria they might normally encounter, it left their immune systems less able to fight off infections.

Sood said he’s not sold on the theory that there’s some kind of immunity debt at work. Instead, he thinks Covid-19 temporarily displaced other infections for a while, essentially crowding others out. Now, as Covid-19 cases have fallen, he thinks other childhood infections are roaring back – he points to unprecedented surge in RSV cases last fall and winter as an example.

Sood says brain abscesses normally follow a very small percentage of sinus infections and inner ear infections in kids. Because they are seeing more of those infections now, the number of brain abscesses has increased proportionally, too.

If immunity debt or a higher burden of infections were to blame, it stands to reason that brain abscesses might have increased in other places, too.

Last year, the CDC worked with the Children’s Hospital Association to find and count brain abscesses in kids, to see if there was any sort of national spike. Data collected through May 2022 did not detect any kind of widespread increase, according to a study published in the Morbidity and Mortality Weekly Report last fall.

But Bragg thinks the data cutoff for the study may have been too early. She says spring 2022 was when she saw cases in her area really take off. She says the CDC is continuing to collect information on brain abscesses and evaluate local and national trends.

About a third of the brain abscesses in the Clark County cluster were caused by a type of bacteria called Streptococcus intermedius that normally hangs out harmlessly in the nose and mouth, where our immune system keeps it in check. But when it gets into places it shouldn’t be, like the blood or brain, it can cause problems.

That can happen after dental work, for example, or when someone has an underlying health condition that weakens their immunity, like diabetes.

That wasn’t the case with the kids in the Clark County cluster, however.

“These are healthy children. With no prior significant medical history that would make them more prone…there wasn’t any known immunosuppression or anything like that,” Bragg says.

Like the cases in Clark County, Sood says most of the kids they are seeing are older, in grade school and middle school. He says until kids reach this age, their sinus cavities are underdeveloped, and haven’t yet grown to their full size. This may make them particularly vulnerable to infection. He thinks these small spaces may become filled with pus and burst. When that happens over the eyebrow, or behind the ear, where the barrier between the brain and sinuses is thinner, the infection can travel to the brain.

Sood says the signs of a sinus infection in kids can be subtle and parents don’t always know what to watch for. If a child gets a cold or stuffy nose and then the next day wakes up with a red and swollen eye, or an eye that’s swollen shut, it’s a good idea to seek medical attention. They may also complain of a headache and point to the spot above their eyebrow as the location of the pain.

Bragg says so far, in 2023, she’s treated two more kids with brain abscesses, but the pace of new cases seems to be slowing down – at least she hopes that’s the case.

Some of the children she treated needed multiple brain and head and neck surgeries to clear their infections.

Sood says in his hospital, doctors have a patient who has been there for two to three months and had five surgeries, although he says she was an extreme case.

Penney says the CDC continues to watch the situation closely.

“We’re going to continue to monitor throughout the year working very closely with our community partners to see you know what, what happens down in Southern Nevada,” she said.

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US cigarette smoking rate falls to historic low, but e-cigarette use keeps climbing | CNN



CNN
 — 

The percentage of adults who smoked cigarettes in the United States fell to a historic low last year, the US Centers for Disease Control and Prevention found. However, e-cigarettes are becoming even more popular.

About 11% of adults told the CDC last year that they were current cigarette smokers, according to the latest preliminary data from the National Health Interview Survey, a biannual survey that provides general information about health-related topics. The survey includes responses from 27,000 people age 18 and older. In 2020 and 2021, about 12.5% of adults said they smoked cigarettes.

This is a significant drop from when surveys like these started. Surveys of Americans in the 1940s found that about half of all adults said they smoked cigarettes. Rates began to decline in the 1960s, and more recently, in 2016, 15.5% of adults said they smoked cigarettes.

Recent studies have shown some groups are still at higher risk. While the latest CDC survey doesn’t capture this level of detail, cigarette smoking rates among some communities – including Native Americans, Alaska Natives and members of the LGBTQ community remain “alarmingly high” according to the 2023 State of Tobacco Control report from the American Lung Association.

The general drop in cigarette smoking among adults should have a positive impact on public health.

Cigarette smoking is still the leading cause of preventable death and disability in the US. So many people have died from smoking, the CDC finds, that more than 10 times as many US citizens have died prematurely from cigarette smoking than have died in all the wars fought by the US.

Smokers are 90% of the lung cancer cases in the United States, but smoking can also cause someone to have a stroke, coronary heart disease, and COPD, as well as other cancers including bladder, colon, kidney, liver, stomach and other cancers. People who live with smokers also are at a greater risk of death, because of secondhand smoke.

This latest survey does not capture why fewer people smoked cigarettes, but the number has been on the decline since the 1960s, after the US surgeon general released the first report on smoking and health that concluded that smoking causes serious health problems.

Experts credit a variety of efforts for the decline in cigarette smoking – anti-smoking campaigns, programs that educate children about the danger of smoking, laws that severely restrict where people could smoke and where cigarette companies could advertise, as well as better access to smoking cessation programs and higher taxes that make cigarettes expensive.

However, Congress hasn’t raised federal tobacco taxes in 14 years. The federal cigarette tax remains $1.01 per pack, and taxes vary for other tobacco products. No state increased its cigarette taxes in 2022.

The pandemic may also have had an influence. Smokers were much more vulnerable to the severe consequences of Covid-19 and that gave some people the extra motivation they needed to quit – and may have given doctors the extra motivation they needed to help them too, according to Dr. Panagis Galiatsatos, a volunteer medical spokesperson with the American Lung Association. At some level, the pandemic also made the medical establishment easier to access.

“The pandemic, I think, really allowed physicians time they never probably had in the past to conduct these telemedicine visits that were appropriate just for smoking cessation strategies, helping them help patients quit and stay quit,” said Galiatsatos, who is a pulmonary and critical care medicine physician and is director of the Tobacco Treatment Clinic with Johns Hopkins Medicine.

Galiatsatos points to the US Surgeon General report released during the Trump administration, just prior to the start of the pandemic. The report detailed that of the patients they have now that smoke, the few that are left are going to be the most resistant to quitting. Then-Surgeon General Jerome Adams’ report encouraged more doctors to help their patients quit. The report found that 40% of smokers are not routinely told by their doctors to stop.

Still, the culture has changed. Smoking is much less socially acceptable in some cultures in the US.

E-cigarette use, though, seems to be more socially acceptable, especially among younger people studies show, and that may explain why those numbers are up.

The current survey found that e-cigarette use rose to nearly 6% last year, that’s up from about 4.9% the year before.

Some argue that e-cigarettes are a good substitute for regular cigarettes, and in some countries they are even promoted as a smoking cessation devices, but the CDC says that “e-cigarettes are not safe for youth, young adults, and pregnant women, as well as adults who do not currently use tobacco products.”

A BMJ study published in February found that people who used e-cigarettes to quit smoking found them to be less helpful than more traditional smoking cessation aids.

The US Food and Drug Administration says there is not enough evidence to support claims that these products are effective tools to help people quit smoking. None are approved for this purpose. The FDA says there are no safe tobacco products, including e-cigarettes, vapes, and other electronic nicotine delivery systems.

“I always hold no stigma or judgment when anyone wants to smoke a traditional cigarette or use electronic cigarettes, but as a lung doctor, I will always promote only air to come into the lungs,” said Galiatsatos. “From my standpoint, I think we should still have a public health mindset around e-cigarette usage because for some individuals, they’re going to have health consequences from this product.”

He said people may choose to vape instead of smoke cigarettes, but clinicians should be prepared to help this population if they do want to quit.

E-cigarettes can, though, produce a number of chemicals that are not good for human health, including acrolein, acetaldehyde, and formaldehyde. Studies show these chemicals are known as aldehydes and can cause lung and heart disease, according to the American Lung Association.

Among teens, nicotine exposure can harm the developing brain, according to the US surgeon general.

E-cigarettes are much more popular than cigarettes among teens, so the adult e-cigarette user numbers will likely continue to grow.

About 14% of high school students said they used e-cigarettes, and 2% of high school students smoked cigarettes last year, according to separate CDC data.

The rate of kids that use e-cigarettesis high, the American Academy of Pediatrics says.

Specifically, in 2022, nearly 5% of middle school and about 17% of high school students reported some form of current tobacco use, according to CDC data from an earlier survey. In 2021, about 11% of middle schoolers and 34% of high schoolers said they had ever tried tobacco.

These “try rates” are important because most adult smokers started at young ages, according to the CDC.

The AAP continues to encourage pediatricians to screen for tobacco use as part of a child’s regular checkup. A talk about tobacco should start no later than age 11 or 12, the report says.

For adult smokers, the CDC encourages encourages people to call 1-800-QUIT-NOW where people can get free confidential coaching. The government also offers free online resources and even text programs that can help people quit.

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