No antibiotics worked, so this woman turned to a natural enemy of bacteria to save her husband’s life | CNN



CNN
 — 

In February 2016, infectious disease epidemiologist Steffanie Strathdee was holding her dying husband’s hand, watching him lose an exhausting fight against a deadly superbug infection.

After months of ups and downs, doctors had just told her that her husband, Tom Patterson, was too racked with bacteria to live.

“I told him, ‘Honey, we’re running out of time. I need to know if you want to live. I don’t even know if you can hear me, but if you can hear me and you want to live, please squeeze my hand.’

“All of a sudden, he squeezed really hard. And I thought, ‘Oh, great!’ And then I’m thinking, ‘Oh, crap! What am I going to do?’”

What she accomplished next could easily be called miraculous. First, Strathdee found an obscure treatment that offered a glimmer of hope — fighting superbugs with phages, viruses created by nature to eat bacteria.

Then she convinced phage scientists around the country to hunt and peck through molecular haystacks of sewage, bogs, ponds, the bilge of boats and other prime breeding grounds for bacteria and their viral opponents. The impossible goal: quickly find the few, exquisitely unique phages capable of fighting a specific strain of antibiotic-resistant bacteria literally eating her husband alive.

Next, the US Food and Drug Administration had to greenlight this unproven cocktail of hope, and scientists had to purify the mixture so that it wouldn’t be deadly.

Yet just three weeks later, Strathdee watched doctors intravenously inject the mixture into her husband’s body — and save his life.

Their story is one of unrelenting perseverance and unbelievable good fortune. It’s a glowing tribute to the immense kindness of strangers. And it’s a story that just might save countless lives from the growing threat of antibiotic-resistant superbugs — maybe even your own.

“It’s estimated that by 2050, 10 million people per year — that’s one person every three seconds — is going to be dying from a superbug infection,” Strathdee told an audience at Life Itself, a 2022 health and wellness event presented in partnership with CNN.

“I’m here to tell you that the enemy of my enemy can be my friend. Viruses can be medicine.”

sanjay pkg vpx

How this ‘perfect predator’ saved his life after nine months in the hospital

During a Thanksgiving cruise on the Nile in 2015, Patterson was suddenly felled by severe stomach cramps. When a clinic in Egypt failed to help his worsening symptoms, Patterson was flown to Germany, where doctors discovered a grapefruit-size abdominal abscess filled with Acinetobacter baumannii, a virulent bacterium resistant to nearly all antibiotics.

Found in the sands of the Middle East, the bacteria were blown into the wounds of American troops hit by roadside bombs during the Iraq War, earning the pathogen the nickname “Iraqibacter.”

“Veterans would get shrapnel in their legs and bodies from IED explosions and were medevaced home to convalesce,” Strathdee told CNN, referring to improvised explosive devices. “Unfortunately, they brought their superbug with them. Sadly, many of them survived the bomb blasts but died from this deadly bacterium.”

Today, Acinetobacter baumannii tops the World Health Organization’s list of dangerous pathogens for which new antibiotics are critically needed.

“It’s something of a bacterial kleptomaniac. It’s really good at stealing antimicrobial resistance genes from other bacteria,” Strathdee said. “I started to realize that my husband was a lot sicker than I thought and that modern medicine had run out of antibiotics to treat him.”

With the bacteria growing unchecked inside him, Patterson was soon medevaced to the couple’s hometown of San Diego, where he was a professor of psychiatry and Strathdee was the associate dean of global health sciences at the University of California, San Diego.

“Tom was on a roller coaster — he’d get better for a few days, and then there would be a deterioration, and he would be very ill,” said Dr. Robert “Chip” Schooley, a leading infectious disease specialist at UC San Diego who was a longtime friend and colleague. As weeks turned into months, “Tom began developing multi-organ failure. He was sick enough that we could lose him any day.”

Patterson's body was systemically infected with a virulent drug-resistant bacteria that also infected troops in the Iraq War, earning the pathogen the nickname

After that reassuring hand squeeze from her husband, Strathdee sprang into action. Scouring the internet, she had already stumbled across a study by a Tbilisi, Georgia, researcher on the use of phages for treatment of drug-resistant bacteria.

A phone call later, Strathdee discovered phage treatment was well established in former Soviet bloc countries but had been discounted long ago as “fringe science” in the West.

“Phages are everywhere. There’s 10 million trillion trillion — that’s 10 to the power of 31 — phages that are thought to be on the planet,” Strathdee said. “They’re in soil, they’re in water, in our oceans and in our bodies, where they are the gatekeepers that keep our bacterial numbers in check. But you have to find the right phage to kill the bacterium that is causing the trouble.”

Buoyed by her newfound knowledge, Strathdee began reaching out to scientists who worked with phages: “I wrote cold emails to total strangers, begging them for help,” she said at Life Itself.

One stranger who quickly answered was Texas A&M University biochemist Ryland Young. He’d been working with phages for over 45 years.

“You know the word persuasive? There’s nobody as persuasive as Steffanie,” said Young, a professor of biochemistry and biophysics who runs the lab at the university’s Center for Phage Technology. “We just dropped everything. No exaggeration, people were literally working 24/7, screening 100 different environmental samples to find just a couple of new phages.”

While the Texas lab burned the midnight oil, Schooley tried to obtain FDA approval for the injection of the phage cocktail into Patterson. Because phage therapy has not undergone clinical trials in the United States, each case of “compassionate use” required a good deal of documentation. It’s a process that can consume precious time.

But the woman who answered the phone at the FDA said, “‘No problem. This is what you need, and we can arrange that,’” Schooley recalled. “And then she tells me she has friends in the Navy that might be able to find some phages for us as well.”

In fact, the US Naval Medical Research Center had banks of phages gathered from seaports around the world. Scientists there began to hunt for a match, “and it wasn’t long before they found a few phages that appeared to be active against the bacterium,” Strathdee said.

Dr. Robert

Back in Texas, Young and his team had also gotten lucky. They found four promising phages that ravaged Patterson’s antibiotic-resistant bacteria in a test tube. Now the hard part began — figuring out how to separate the victorious phages from the soup of bacterial toxins left behind.

“You put one virus particle into a culture, you go home for lunch, and if you’re lucky, you come back to a big shaking, liquid mess of dead bacteria parts among billions and billions of the virus,” Young said. “You want to inject those virus particles into the human bloodstream, but you’re starting with bacterial goo that’s just horrible. You would not want that injected into your body.”

Purifying phage to be given intravenously was a process that no one had yet perfected in the US, Schooley said, “but both the Navy and Texas A&M got busy, and using different approaches figured out how to clean the phages to the point they could be given safely.”

More hurdles: Legal staff at Texas A&M expressed concern about future lawsuits. “I remember the lawyer saying to me, ‘Let me see if I get this straight. You want to send unapproved viruses from this lab to be injected into a person who will probably die.’ And I said, “Yeah, that’s about it,’” Young said.

“But Stephanie literally had speed dial numbers for the chancellor and all the people involved in human experimentation at UC San Diego. After she calls them, they basically called their counterparts at A&M, and suddenly they all began to work together,” Young added.

“It was like the parting of the Red Sea — all the paperwork and hesitation disappeared.”

The purified cocktail from Young’s lab was the first to arrive in San Diego. Strathdee watched as doctors injected the Texas phages into the pus-filled abscesses in Patterson’s abdomen before settling down for the agonizing wait.

“We started with the abscesses because we didn’t know what would happen, and we didn’t want to kill him,” Schooley said. “We didn’t see any negative side effects; in fact, Tom seemed to be stabilizing a bit, so we continued the therapy every two hours.”

Two days later, the Navy cocktail arrived. Those phages were injected into Patterson’s bloodstream to tackle the bacteria that had spread to the rest of his body.

“We believe Tom was the first person to receive intravenous phage therapy to treat a systemic superbug infection in the US,” Strathdee told CNN.

“And three days later, Tom lifted his head off the pillow out of a deep coma and kissed his daughter’s hand. It was just miraculous.”

Patterson awoke from a coma after receiving an intravenous dose of phages tailored to his bacteria.

Today, nearly eight years later, Patterson is happily retired, walking 3 miles a day and gardening. But the long illness took its toll: He was diagnosed with diabetes and is now insulin dependent, with mild heart damage and gastrointestinal issues that affect his diet.

“He isn’t back surfing again, because he can’t feel the bottoms of his feet, and he did get Covid-19 in April that landed him in the hospital because the bottoms of his lungs are essentially dead,” Strathdee said.

“As soon as the infection hit his lungs he couldn’t breathe and I had to rush him to the hospital, so that was scary,” she said. “He remains high risk for Covid but we’re not letting that hold us hostage at home. He says, ‘I want to go back to having as normal life as fast as possible.’”

To prove it, the couple are again traveling the world — they recently returned from a 12-day trip to Argentina.

“We traveled with a friend who is an infectious disease doctor, which gave me peace of mind to know that if anything went sideways, we’d have an expert at hand,” Strathdee said.

“I guess I’m a bit of a helicopter wife in that sense. Still, we’ve traveled to Costa Rica a couple of times, we’ve been to Africa, and we’re planning to go to Chile in January.”

Patterson’s case was published in the journal Antimicrobial Agents and Chemotherapy in 2017, jump-starting new scientific interest in phage therapy.

“There’s been an explosion of clinical trials that are going on now in phage (science) around the world and there’s phage programs in Canada, the UK, Australia, Belgium, Sweden, Switzerland, India and China has a new one, so it’s really catching on,” Strathdee told CNN.

Some of the work is focused on the interplay between phages and antibiotics — as bacteria battle phages they often shed their outer shell to keep the enemy from docking and gaining access for the kill. When that happens, the bacteria may be suddenly vulnerable to antibiotics again.

“We don’t think phages are ever going to entirely replace antibiotics, but they will be a good adjunct to antibiotics. And in fact, they can even make antibiotics work better,” Strathdee said.

In San Diego, Strathdee and Schooley opened the Center for Innovative Phage Applications and Therapeutics, or IPATH, in 2018, where they treat or counsel patients suffering from multidrug-resistant infections. The center’s success rate is high, with 82% of patients undergoing phage therapy experiencing a clinically successful outcome, according to its website.

Schooley is running a clinical trial using phages to treat patients with cystic fibrosis who constantly battle Pseudomonas aeruginosa, a drug-resistant bacteria that was also responsible for the recent illness and deaths connected to contaminated eye drops manufactured in India.

And a memoir the couple published in 2019 — “The Perfect Predator: A Scientist’s Race to Save Her Husband From a Deadly Superbug” — is also spreading the word about these “perfect predators” to what may soon be the next generation of phage hunters.

VS Phages Sanjay Steffanie

How naturally occurring viruses could help treat superbug infections

“I am getting increasingly contacted by students, some as young as 12,” Strathdee said. “There’s a girl in San Francisco who begged her mother to read this book and now she’s doing a science project on phage-antibiotic synergy, and she’s in eighth grade. That thrills me.”

Strathdee is quick to acknowledge the many people who helped save her husband’s life. But those who were along for the ride told CNN that she and Patterson made the difference.

“I think it was a historical accident that could have only happened to Steffanie and Tom,” Young said. “They were at UC San Diego, which is one of the premier universities in the country. They worked with a brilliant infectious disease doctor who said, ‘Yes,’ to phage therapy when most physicians would’ve said, ‘Hell, no, I won’t do that.’

“And then there is Steffanie’s passion and energy — it’s hard to explain until she’s focused it on you. It was like a spiderweb; she was in the middle and pulled on strings,” Young added. “It was just meant to be because of her, I think.”

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Stem Cells Fast Facts | CNN



CNN
 — 

Here is some background information about stem cells.

Scientists believe that stem cell research can be used to treat medical conditions including Parkinson’s disease, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis and rheumatoid arthritis.

Sources: National Institutes of Health, Mayo Clinic

Stem cell research focuses on embryonic stem cells and adult stem cells.

Stem cells have two characteristics that differentiate them from other types of cells:

– They are unspecialized cells that can replicate themselves through cell division over long periods of time.

– Stem cells can be manipulated, under certain conditions, to become mature cells with special functions, such as the beating cells of the heart muscle or insulin-producing cells of the pancreas.

There are many different types of stem cells, including: pluripotent stem cells and adult stem cells.
Pluripotent stem cells (ex: embryonic stem cells) can give rise to any type of cell in the body. These cells are like blank slates, and they have the potential to turn into any type of cell.
Adult stem cells can give rise to multiple types of cells, but are more limited compared with embryonic stem cells. They are more likely to generate within a particular tissue, organ or physiological system. (Ex: blood-forming stem cells/bone marrow cells, sometimes referred to as multipotent stem cells)

Embryonic stem cells are harvested from four to six-day-old embryos. These embryos are either leftover embryos in fertility clinics or embryos created specifically for harvesting stem cells by therapeutic cloning. Only South Korean scientists claim to have successfully created human embryos via therapeutic cloning and have harvested stem cells from them.

Adult stem cells are already designated for a certain organ or tissue. Some adult stem cells can be coaxed into or be reprogrammed into turning into a different type of specialized cell within the tissue type – for example, a heart stem cell can give rise to a functional heart muscle cell, but it is still unclear whether they can give rise to all different cell types of the body.

The primary role of adult stem cells is to maintain and repair the tissue in which they are found.

Regenerative medicine uses cell-based therapies to treat disease.

Scientists who research stem cells are trying to identify how undifferentiated stem cells become differentiated as serious medical conditions, such as cancer and birth defects, are due to abnormal cell division and differentiation.

Scientists believe stem cells can be used to generate cells and tissues that could be used for cell-based therapies as the need for donated organs and tissues outweighs the supply.

Stem cells, directed to differentiate into specific cell types, offer the possibility of a renewable source of replacement cells and tissues to treat diseases, including Alzheimer’s diseases.

Cloning human embryos for stem cells is very controversial.

The goal of therapeutic cloning research is not to make babies, but to make embryonic stem cells, which can be harvested and used for cell-based therapies.

Using fertilized eggs left over at fertility clinics is also controversial because removing the stem cells destroys them.

Questions of ethics arise because embryos are destroyed as the cells are extracted, such as: When does human life begin? What is the moral status of the human embryo?

1998 – President Bill Clinton requests a National Bioethics Advisory Commission to study the question of stem cell research.

1999 – The National Bioethics Advisory Commission recommends that the government allow federal funds to be used to support research on human embryonic stem cells.

2000 – During his campaign, George W. Bush says he opposes any research that involves the destruction of embryos.

2000 – The National Institutes of Health (NIH) issues guidelines for the use of embryonic stem cells in research, specifying that scientists receiving federal funds can use only extra embryos that would otherwise be discarded. President Clinton approves federal funding for stem cell research but Congress does not fund it.

August 9, 2001 – President Bush announces he will allow federal funding for about 60 existing stem cell lines created before this date.

January 18, 2002 – A panel of experts at the National Academy of Sciences (NAS) recommends a complete ban on human reproductive cloning, but supports so-called therapeutic cloning for medical purposes.

February 27, 2002 – For the second time in two years, the House passes a ban on all cloning of human embryos.

July 11, 2002 – The President’s Council on Bioethics recommends a four-year ban on cloning for medical research to allow time for debate.

February 2005 – South Korean scientist Hwang Woo Suk publishes a study in Science announcing he has successfully created stem cell lines using therapeutic cloning.

December 2005 – Experts from Seoul National University accuse Hwang of faking some of his research. Hwang asks to have his paper withdrawn while his work is being investigated and resigns his post.

January 10, 2006 – An investigative panel from Seoul National University accuses Hwang of faking his research.

July 18, 2006 – The Senate votes 63-37 to loosen President Bush’s limits on federal funding for embryonic stem-cell research.

July 19, 2006 – President Bush vetoes the embryonic stem-cell research bill passed by the Senate (the Stem Cell Research Enhancement Act of 2005), his first veto since taking office.

June 20, 2007 – President Bush vetoes the Stem Cell Research Enhancement Act of 2007.

January 23, 2009 – The FDA approves a request from Geron Corp. to test embryonic stem cells on eight to 10 patients with severe spinal cord injuries. This will be the world’s first test in humans of a therapy derived from human embryonic stem cells. The tests will use stem cells cultured from embryos left over in fertility clinics.

March 9, 2009 – President Barack Obama signs an executive order overturning an order signed by President Bush in August 2001 that barred the NIH from funding research on embryonic stem cells beyond using 60 cell lines that existed at that time.

August 23, 2010 – US District Judge Royce C. Lamberth issues a preliminary injunction that prohibits the federal funding of embryonic stem cell research.

September 9, 2010 – A three-judge panel of the US Court of Appeals for the District of Columbia Circuit grants a request from the Justice Department to lift a temporary injunction that blocked federal funding of stem cell research.

September 28, 2010 – The US Court of Appeals for the DC Circuit lifts an injunction imposed by a federal judge, thereby allowing federally funded embryonic stem-cell research to continue while the Obama Administration appeals the judge’s original ruling against use of public funds in such research.

October 8, 2010 – The first human is injected with cells from human embryonic stem cells in a clinical trial sponsored by Geron Corp.

November 22, 2010 – William Caldwell, CEO of Advanced Cell Technology, tells CNN that the FDA has granted approval for his company to start a clinical trial using cells grown from human embryonic stem cells. The treatment will be for an inherited degenerative eye disease.

April 29, 2011 – The US Court of Appeals for the District of Columbia lifts an injunction, imposed last year, banning the Obama administration from funding embryonic stem-cell research.

May 11, 2011 – Stem cell therapy in sports medicine is spotlighted after New York Yankees pitcher Bartolo Colon is revealed to have had fat and bone marrow stem cells injected into his injured elbow and shoulder while in the Dominican Republic.

July 27, 2011 – Judge Lamberth dismisses a lawsuit that tried to block funding of stem cell research on human embryos.

February 13, 2012 – Early research published by scientists at Cedars-Sinai Medical Center and Johns Hopkins University shows that a patient’s own stem cells can be used to regenerate heart tissue and help undo damage caused by a heart attack. It is the first instance of therapeutic regeneration.

May 2013 – Scientists make the first embryonic stem cell from human skin cells by reprogramming human skin cells back to their embryonic state, according to a study published in the journal, Cell.

April 2014 – For the first time scientists are able to use cloning technologies to generate stem cells that are genetically matched to adult patients,according to a study published in the journal, Cell Stem Cell.

October 2014 – Researchers say that human embryonic stem cells have restored the sight of several nearly blind patients – and that their latest study shows the cells are safe to use long-term. According to a report published in The Lancet, the researchers transplanted stem cells into 18 patients with severe vision loss as a result of two types of macular degeneration.

May 2, 2018 – The science journal Nature reports that scientists have created a structure like a blastocyst – an early embryo – using mouse stem cells instead of the usual sperm and egg.

June 4, 2018 – The University of California reports that the first in utero stem cell transplant trial has led to the live birth of an infant that had been diagnosed in utero with alpha thalassemia, a blood disorder that is usually fatal for fetuses.

January 13, 2020 – In a study published in the Proceedings of the National Academy of Sciences, researchers announce they have created the world’s first living, self-healing robots using stem cells from frogs. Named xenobots after the African clawed frog (Xenopus laevis), the machines are less than a millimeter (0.04 inches) wide, small enough to travel inside human bodies. Less than two years later, scientists announce that these robots can now reproduce.

February 15, 2022 – A US woman becomes the third known person to go into HIV remission, and the first mixed-race woman, thanks to a transplant of stem cells from umbilical cord blood, according to research presented at a scientific conference on Retroviruses and Opportunistic Infections.

November 7, 2022 – Scientists announce they have transfused lab-made red blood cells grown from stem cells into a human volunteer in a world-first trial that experts say has major potential for people with hard-to-match blood types or conditions such as sickle cell disease.

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HIV/AIDS Fast Facts | CNN



CNN
 — 

Here’s a look at the origins, treatments and global response to HIV and AIDS.

HIV stands for human immunodeficiency virus.

AIDS stands for acquired immunodeficiency syndrome.

HIV/AIDS is spread through sexual contact with an infected person, sharing needles with an infected person, through transfusions of infected blood or through an infected mother.

People infected with HIV go through three stages of infection:

  1. Acute infection, or acute retroviral syndrome, which can produce flu-like symptoms in the first month after infection.
  2. Clinical latency, or asymptomatic HIV infection, in which HIV reproduces at lower levels.
  3. AIDS, in which the amount of CD4 cells fall below 200 cells per cubic millimeter of blood (as opposed to the normal level of 500-1,500).

HIV-1 and HIV-2 can both cause AIDS. HIV-1 is the most common human immunodeficiency virus; HIV-2 is found mostly in western Africa.

Antiretroviral therapy (ART) involves taking a cocktail of HIV medications used to treat the virus. In 1987, Azidothymidine (AZT) became the first FDA-approved drug used to attempt to treat HIV/AIDS.

from UNAIDS:

38.4 million – Number of people living with HIV/AIDS worldwide in 2021.

5.9 million – Approximate number of people living with HIV globally that are unaware of their HIV-positive status in 2021.

160,000 – Newly infected children worldwide in 2021.

1.5 million – New infections worldwide in 2021.

650,000 – Approximate number of AIDS-related deaths worldwide in 2021.

Of the 4,500 new infections each day in 2019, 59% are in sub-Saharan Africa.

40.1 million – Approximate number of AIDS-related deaths worldwide since the start of the epidemic.

Sub-Saharan Africa is comprised of the following countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of the Congo, Ivory Coast, Djibouti, Equatorial Guinea, Eritrea, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Republic of the Congo, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, Sudan, South Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.

1981 The Centers for Disease Control and Prevention (CDC) publish the first reports of men in Los Angeles, New York and San Francisco who were previously healthy and are suffering from rare forms of cancer and pneumonia, accompanied by “opportunistic infections.”

1982 The CDC refer to the disease as AIDS for the first time.

1983 French and American researchers determine that AIDS is caused by HIV.

1985 Blood tests to detect HIV are developed.

December 1, 1988 – First World AIDS Day.

1999 Researchers in the United States find evidence that HIV-1 most likely originated in a population of chimpanzees in West Africa. The virus appears to have been transmitted to people who hunted, butchered and consumed the chimpanzees for food.

January 29, 2003 In his State of the Union speech, US President George W. Bush promises to dramatically increase funding to fight HIV/AIDS in Africa.

May 27, 2003 – Bush signs H.R. 1298, the US Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003, also known as PEPFAR (US President’s Emergency Plan for AIDS Relief), that provides $15 billion over the next five years to fight HIV/AIDS, tuberculosis and malaria abroad, particularly in Africa.

July 30, 2008 H.R. 5501, The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, becomes law and authorizes up to $48 billion to combat global HIV/AIDS, tuberculosis and malaria. Through 2013, PEPFAR plans to work in partnership with host nations to support treatment for at least four million people, prevention of 12 million new infections and care for 12 million people.

October 2011 – In his book, “The Origins of AIDS,” Dr. Jacques Pepin traces the emergence and subsequent development of HIV/AIDS to suggest that initial AIDS outbreaks began earlier than previously believed.

July 24, 2012 – Doctors announce during the 19th International AIDS Conference that Timothy Ray Brown, known as the “Berlin patient,” has been clinically “cured” of HIV. Brown, diagnosed with leukemia, underwent a bone marrow transplant in 2007 using marrow from a donor with an HIV-resistant mutation. He no longer has detectable HIV.

March 3, 2013 Researchers announce that a baby born infected with HIV has been “functionally cured.” The child, born in Mississippi, was given high doses of antiretroviral drugs within 30 hours of being born. A year later, the child now has detectable levels of the virus in her blood, 27 months after being taken off antiretroviral drugs, according to scientists involved with her case.

June 18, 2013 Marking the 10th anniversary of PEPFAR, Secretary of State John Kerry announces that the millionth child has been born HIV-free due to prevention of mother-to-child transmission programs (PMTCT).

March 14, 2014 – The CDC reports on a case of likely female-to-female HIV transmission. Unlike previous announcements of other cases involving female-to-female transmission, this case excludes additional risk factors for HIV transmission.

July 24, 2017 – A 9-year-old child from South Africa is reported to have been in remission for over eight years without treatment, according to Dr. Avy Violari, who spoke at the 9th International AIDS Society Conference on HIV Science in Paris.

November 2018 – According to PEPFAR’s website, they have “supported life-saving antiretroviral treatment (ART) for more than 14.6 million men, women and children” since 2003.

March 5, 2019 – According to a case study published in the journal Nature, a second person has sustained remission from HIV-1. The “London patient” was treated with stem cell transplants from donors with an HIV-resistant mutation. The London patient has been in remission for 18 months since he stopped taking antiretroviral drugs. The study also includes a possible third remission after stem cell transplantation, this person is referred to as the “Düsseldorf patient.”

May 2, 2019 – A study of nearly 1,000 gay male couples, where one partner with HIV took antiretroviral therapy (ART), found no new cases of transmission to the HIV-negative partner during sex without a condom. The landmark, eight-year study, published in the Lancet medical journal shows that the risk of passing on the HIV virus is eliminated with effective drugs treatment.

October 7, 2019 – Governor Gavin Newsom signs a bill making HIV prevention drugs available without a prescription in California starting on January 1, 2020. The medications covered by the new legislation are pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), which both help prevent HIV infections. California becomes the first state in the country to allow pharmacists to provide the drugs without a physician’s prescription.

November 6, 2019 – According to a study published in the Journal of Acquired Immune Deficiency Syndromes, a team of scientists has detected a new strain of HIV. The strain is a part of the Group M version of HIV-1, the same family of virus subtypes to blame for the global HIV pandemic, according to Abbott Laboratories, which conducted the research along with the University of Missouri, Kansas City.

June 15, 2020 – A study is published in the journal JAMA Network Open showing that the life expectancy of people with HIV approaches that of people without the virus, when antiviral therapy is started early in infection. However, disparities still remain in the number of chronic health problems that people with HIV endure.

July 7, 2020 – Scientists presenting at the 23rd International AIDS Conference announce a new study that found an injection of the investigational drug cabotegravir every eight weeks was more effective at preventing HIV than daily oral pills. It is also announced that a Brazilian man might be the first person to experience long-term HIV remission after being treated with only an antiviral drug regimen – not stem cell transplantation.

November 16, 2021 – A new study finds a second patient whose body has seemingly rid itself of HIV. The international team of scientists reports in the Annals of Internal Medicine that the patient, originally from the city of Esperanza, Argentina, showed no evidence of intact HIV in large numbers of her cells, suggesting that she may have naturally achieved what they describe as a “sterilizing cure” of HIV infection. The 30-year-old woman in the new study is only the second patient who has been described as achieving this sterilizing cure without help from stem cell transplantation or other treatment.

December 20, 2021 – The US Food and Drug Administration announces that it has approved the first injectable medication for pre-exposure prophylaxis (PrEP) to lower the risk of getting HIV through sex.

February 15, 2022 – A US woman becomes the third known person to go into HIV remission, and the first mixed-race woman, thanks to a transplant of stem cells from umbilical cord blood, according to research presented at a conference on Retroviruses and Opportunistic Infections.

December 1, 2022 – An experimental HIV vaccine, called eOD-GT8 60mer, has been found to induce broadly neutralizing antibody precursors among a small group of volunteers in a Phase 1 study. The clinical trial results, published in the journal Science, suggest that a two-dose regimen of the vaccine, given eight weeks apart, can elicit immune responses against the human immunodeficiency virus.

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How psilocybin, the psychedelic in mushrooms, may rewire the brain to ease depression, anxiety and more | CNN



CNN
 — 

Shrooms, Alice, tweezes, mushies, hongos, pizza toppings, magic mushrooms — everyday lingo for psychedelic mushrooms seems to grow with each generation. Yet leading mycologist Paul Stamets believes it’s time for fans of psilocybin mushrooms to leave such childish slang behind.

“Let’s be adults about this. These are no longer ‘shrooms.’ These are no longer party drugs for young people,” Stamets told CNN. “Psilocybin mushrooms are nonaddictive, life-changing substances.”

Small clinical trials have shown that one or two doses of psilocybin, given in a therapeutic setting, can make dramatic and long-lasting changes in people suffering from treatment-resistant major depressive disorder, which typically does not respond to traditional antidepressants.

Based on this research, the US Food and Drug Administration has described psilocybin as a breakthrough medicine, “which is phenomenal,” Stamets said.

Psilocybin, which the intestines convert into psilocin, a chemical with psychoactive properties, is also showing promise in combating cluster headaches, anxiety, anorexia, obsessive-compulsive disorder and various forms of substance abuse.

“The data are strong from depression to PTSD to cluster headaches, which is one of the most painful conditions I’m aware of,” said neurologist Richard Isaacson, director of the Alzheimer’s Prevention Clinic in the Center for Brain Health at Florida Atlantic University.

“I’m excited about the future of psychedelics because of the relatively good safety profile and because these agents can now be studied in rigorous double-blinded clinical trials,” Isaacson said. “Then we can move from anecdotal reports of ‘I tripped on this and felt better’ to ‘Try this and you will be statistically, significantly better.’ “

Classic psychedelics such as psilocybin and LSD enter the brain via the same receptors as serotonin, the body’s “feel good” hormone. Serotonin helps control body functions such as sleep, sexual desire and psychological states such as satisfaction, happiness and optimism.

People with depression or anxiety often have low levels of serotonin, as do people with post-traumatic stress disorder, cluster headaches, anorexia, smoking addiction and substance abuse. Treatment typically involves selective serotonin reuptake inhibitors, or SSRIs, which boost levels of serotonin available to brain cells. Yet it can take weeks for improvement to occur, experts say, if the drugs even work at all.

With psychedelics such as psilocybin and LSD, however, scientists can see changes in brain neuron connectivity in the lab “within 30 minutes,” said pharmacologist Brian Roth, a professor of psychiatry and pharmacology at the University of North Carolina at Chapel Hill.

“One of the most interesting things we’ve learned about the classic psychedelics is that they have a dramatic effect on the way brain systems synchronize, or move and groove together,” said Matthew Johnson, a professor in psychedelics and consciousness at Johns Hopkins Medicine.

“When someone’s on psilocybin, we see an overall increase in connectivity between areas of the brain that don’t normally communicate well,” Johnson said. “You also see the opposite of that – local networks in the brain that normally interact with each other quite a bit suddenly communicate less.”

It creates a “very, very disorganized brain,” ultimately breaking down normal boundaries between the auditory, visual, executive and sense-of-self sections of the mind – thus creating a state of “altered consciousness,” said David Nutt, director of the Neuropsychopharmacology Unit in the Division of Brain Sciences at Imperial College London.

And it’s that disorganization that is ultimately therapeutic, according to Nutt: “Depressed people are continually self-critical, and they keep ruminating, going over and over the same negative, anxious or fearful thoughts.

“Psychedelics disrupt that, which is why people can suddenly see a way out of their depression during the trip,” he added. “Critical thoughts are easier to control, and thinking is more flexible. That’s why the drug is an effective treatment for depression.”

There’s more. Researchers say psychedelic drugs help neurons in the brain sprout new dendrites, which look like branches on a tree, to increase communication between cells.

“These drugs can increase neuronal outgrowth, they can increase this branching of neurons, they can increase synapses. That’s called neuroplasticity,” Nutt said.

That’s different from neurogenesis, which is the development of brand-new brain cells, typically from stem cells in the body. The growth of dendrites helps build and then solidify new circuits in the brain, allowing us to, for example, lay down more positive pathways as we practice gratitude.

“Now our current thinking is this neuronal outgrowth probably doesn’t contribute to the increased connectivity in the brain, but it almost certainly helps people who have insights into their depression while on psilocybin maintain those insights,” Nutt said.

“You shake up the brain, you see things in a more positive way, and then you lay down those positive circuits with the neuroplasticity,” he added. “It’s a double whammy.”

Interestingly, SSRIs also increase neuroplasticity, a fact that science has known for some time. But in a 2022 double-blind phase 2 randomized controlled trial comparing psilocybin to escitalopram, a traditional SSRI, Nutt found the latter didn’t spark the same magic.

“The SSRI did not increase brain connectivity, and it actually did not improve well-being as much as psilocybin,” Nutt said. “Now for the first time you’ve got the brain science lining up with what patients say after a trip: ‘I feel more connected. I can think more freely. I can escape from negative thoughts, and I don’t get trapped in them.’ “

Taking a psychedelic doesn’t work for everyone, Johnson stressed, “but when it works really well it’s like, ‘Oh my god, it’s a cure for PTSD or for depression.’ If people really have changed the way their brain is automatically hardwired to respond to triggers for anxiety, depression, smoking — that’s a real thing.”

How long do results last? In studies where patients were given just one dose of a psychedelic “a couple of people were better eight years later, but for the majority of those with chronic depression it creeps back after four or five months,” Nutt said.

“What we do with those people is unknown,” he added. “One possibility is to give another dose of the psychedelic — we don’t know if that would work or not, but it might. Or we could put them on an SSRI as soon as they’ve got their mood improved and see if that can hold the depression at bay.

“There are all sorts of ways we could try to address that question,” Nutt said, “but we just don’t know the answer yet.”

The mycelium, or rootlike structure, of Lion's mane mushroom is part of the

Stamets, who over the last 40 years has discovered four new species of psychedelic mushrooms and written seven books on the topic, said he believes microdosing is a solution. That’s the practice of taking tiny amounts of a psilocybin mushroom several times a week to maintain brain health and a creative perspective on life.

A typical microdose is 0.1 to 0.3 grams of dried psilocybin mushrooms, as compared with the 25-milligram pill of psilocybin that creates the full-blown psychedelic experience.

Stamets practices microdosing and has focused on a process called “stacking” in which a microdose of mushrooms is taken with additional substances believed to boost the fungi’s benefits. His famous “Stamets Stack” includes niacin, or vitamin B3, and the mycelium, or rootlike structure, of an unusual mushroom called Lion’s mane.

Surveys of microdosers obtained on his website have shown significantly positive benefits from the practice of taking small doses.

“These are self-reported citizen scientists’ projects, and we have now around 14,000 people in our app where you register yourself and report your microdose,” Stamets told an audience at the 2022 Life Itself conference, a health and wellness event presented in partnership with CNN.

“I’m going to say something provocative, but I believe it to my core: Psilocybin makes nicer people,” Stamets told the audience. “Psilocybin will make us more intelligent and better citizens.”

Scientific studies so far have failed to find any benefits from microdosing, leaving many researchers skeptical. “People like being on it, but that doesn’t validate the claims of microdosing,” Johnson said. “People like being on a little bit of cocaine, too.”

Experimental psychologist Harriet de Wit, a professor of psychiatry and behavioral science at the University of Chicago, was excited to study microdosing because it solves a key problem of scientific research in the field – it’s hard to blind people to what they are taking if they begin to trip. Microdosing solves that problem because people don’t feel an effect from the tiny dose.

De Wit specializes in determining whether a drug’s impact is due to the drug or what scientists call the “placebo effect,” a positive expectation that can cause improvement without the drug.

She published a study in 2022 that mimicked real-world microdosing of LSD, except neither the participants nor researchers knew what was in the pills the subjects took.

“We measured all kinds of different behavioral and psychological responses, and the only thing we saw is that LSD at very low doses produced some stimulant-like effects at first, which then faded,” de Wit said.

The placebo effect is powerful, she added, which might explain why the few additional studies done on it have also failed to find any positive results.

“I suspect microdosing may have an effect on mood, and over time it might build up resilience or improve well-being,” Nutt said. “But I don’t think it will rapidly fragment depression like macrodosing and going on a trip.”

Obviously, not all hallucinogenic experiences are positive, so nearly every study on psychedelic drugs has included therapists trained to intercede if a trip turns bad and to maximize the outcome if the trip is good.

“This is about allowing someone access into deeper access into their own mental processes, with hopefully greater insight,” Johnson said. “While others might disagree, it does seem very clear that you need therapy to maximize the benefits.”

There are also side effects from psychedelics that go beyond a bad trip. LSD, mescaline and DMT, which is the active ingredient in ayahuasca tea, can increase blood pressure, heart rate, and body temperature, according to the National Institute on Drug Abuse. Ayahuasca tea can also induce vomiting. LSD can cause tremors, numbness and weakness, while the use of mescaline can lead to uncoordinated movements. People hunting for psychedelic mushrooms can easily mistake a toxic species for one with psilocybin, “leading to unintentional, fatal poisoning.”

Another issue: Not everyone is a candidate for psychedelic treatment. It won’t work on people currently on SSRIs — the receptors in their brains are already flooded with serotonin. People diagnosed with bipolar disorder or schizophrenia, or who have a family history of psychosis are always screened out of clinical trials, said Frederick Barrett, associate director of the Center for Psychedelic and Consciousness Research at Johns Hopkins.

“If you have a vulnerability to psychosis, it could be that exposing you to a psychedelic could unmask that psychosis or could lead to a psychotic event,” Barnes said.

Then there are the thousands of people with mental health concerns who will never agree to undergo a psychedelic trip. For those people, scientists such as Roth are attempting to find an alternative approach. He and his team recently identified the mechanisms by which psychedelics bond to the brain’s serotonin receptors and are using the knowledge to identify new compounds.

“Our hope is that we can use this information to ultimately make drugs that mimic the benefits of psychedelic drugs without the psychedelic experience,” Roth said.

“What if we could give people who are depressed or suffer from PTSD or anxiety or obsessive-compulsive disorder a medication, and they could wake up the next day and be fine without any side effects? That would be transformative.”

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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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New study suggests Black women should be screened earlier for breast cancer | CNN



CNN
 — 

A new study on breast cancer deaths raises questions around whether Black women should screen at earlier ages.

An international team of researchers wrote in the study, published Wednesday in the journal JAMA Network Open, that clinical trials may be warranted to investigate whether screening guidelines should recommend Black women start screening at younger ages, around 42 instead of 50.

The US Preventive Services Task Force – a group of independent medical experts whose recommendations help guide doctors’ decisions – recommends biennial screening for women starting at age 50. The Task Force says that a decision to start screening prior to 50 “should be an individual one.” Many medical groups, including the American Cancer Society and Mayo Clinic, already emphasize that women have the option to start screening with a mammogram every year starting at age 40.

Even though Black women have a 4% lower incidence rate of breast cancer than White women, they have a 40% higher breast cancer death rate.

“The take-home message for US clinicians and health policy makers is simple. Clinicians and radiologists should consider race and ethnicity when determining the age at which breast cancer screening should begin,” Dr. Mahdi Fallah, an author of the new study and leader of Risk Adapted Cancer Prevention Group at the German Cancer Research Center in Heidelberg, Germany, said in an email.

“Also, health policy makers can consider a risk-adapted approach to breast cancer screening to address racial disparities in breast cancer mortality, especially the mortality before the recommended age of population screening,” said Fallah, who is also a visiting professor at Lund University in Sweden and an adjunct professor at the University of Bern in Switzerland.

Breast cancer screenings are typically performed using a mammogram, which is an X-ray picture taken of the breast that doctors examine to look for early signs of breast cancer developing.

“Guidelines for screening actually already do recommend basing a woman’s time to initiate screening on the risk of developing cancer, though race and ethnicity have not been traditional factors that go into these decisions,” Dr. Rachel Freedman, a breast oncologist at Dana-Farber Cancer Institute, who was not involved in the new study, said in an email.

The American Cancer Society currently recommends that all women consider mammogram screenings for breast cancer risk starting at the age of 40 – and for women 45 to 54, it’s recommended to get mammograms every year. Those 55 and older can switch to screening every other year if they choose.

But “we are in the process of updating our breast cancer screening guidelines, and we are examining the scientific literature for how screening guidelines could differ for women in different racial and ethnic groups, and by other risk factors, in a way that would reduce disparities based on risk and disparities in outcome,” Robert Smith, senior vice president for cancer screening at the American Cancer Society, who was not involved in the new study, said in an email. “We are examining these issues closely.”

The American Cancer Society’s recommendations appear to align with the findings in the new study, as the research highlights how screening guidelines should not be a “one-size-fits-all policy,” but rather help guide conversations that patients and their doctors have together.

“We, here at the American Cancer Society, strongly recommend that all women consider a screening mammogram from the age of 40 onwards, and that means having a discussion with their doctor,” said Dr. Arif Kamal, the American Cancer Society’s chief patient officer, who was not involved in the new study.

“The authors highlight that age 50 can be a little late,” Kamal said about the study’s findings on when to begin breast cancer screening. “We are in agreement with that, particularly for women who may be at slightly higher risk.”

The researchers – from China, Germany, Sweden, Switzerland and Norway – analyzed data on 415,277 women in the United States who died of breast cancer in 2011 to 2020. That data on invasive breast cancer mortality rates came from the National Center for Health Statistics and was analyzed with the National Cancer Institute’s SEER statistical software.

When the researchers examined the data by race, ethnicity and age, they found that the rate of breast cancer deaths among women in their 40s was 27 deaths per 100,000 person-years for Black women compared with 15 deaths per 100,000 in White women and 11 deaths per 100,000 in American Indian, Alaska Native, Hispanic and Asian or Pacific Islander women.

“When the breast cancer mortality rate for Black women in their 40s is 27 deaths per 100,000 person-years, this means 27 out of every 100,000 Black women aged 40-49 in the US die of breast cancer during one year of follow-up. In other words, 0.027% of Black women aged 40-49 die of breast cancer each year,” Fallah said in the email.

In general, for women in the United States, their average risk of dying from breast cancer in the decade after they turn 50, from age 50 to 59, is 0.329%, according to the study.

“However, this risk level is reached at different ages for women from different racial/ethnic groups,” Fallah said. “Black women tend to reach this risk level of 0.329% earlier, at age 42. White women tend to reach it at age 51, American Indian or Alaska Native and Hispanic women at age 57 years, and Asian or Pacific Islander women later, at age 61.”

So, the researchers determined that when recommending breast cancer screening at age 50 for women, Black women should start at age 42.

Yet “the authors didn’t have any information on whether the women included in this study actually had mammographic screening and at what age. For example, it is possible that many women in this study actually had screening during ages 40-49,” Freedman, of the Dana-Farber Cancer Institute, said in her email.

“This study confirms that the age of breast cancer-mortality is younger for Black women, but it doesn’t confirm why and if screening is even the main reason. We have no information about the types of cancers women developed and what treatment they had either, both of which impact mortality from breast cancer,” she said.

The harm of starting mammograms at a younger age is that it raises the risk of a false positive screening result – leading to unnecessary subsequent tests and emotional stress.

But the researchers wrote in their study that “the added risk of false positives from earlier screenings may be balanced by the benefits” linked with earlier breast cancer detection.

They also wrote that health policy makers should pursue equity, not just equality, when it comes to breast cancer screening as a tool to help reduce breast cancer death rates.

Equality in the context of breast cancer screening “means that everyone is screened from the same age regardless of risk level. On the other hand, equity or risk-adapted screening means that everyone is provided screening according to their individual risk level,” the researchers wrote. “We believe that a fair and risk-adapted screening program may also be associated with optimized resource allocation.”

The new study is “timely and relevant,” given the overall higher mortality rate for breast cancer in Black women and that Black women are more likely to be diagnosed at a younger age compared with other ethnic groups, Dr. Kathie-Ann Joseph, surgical oncologist at NYU Langone’s Perlmutter Cancer Center and professor of surgery and population health at the NYU Grossman School of Medicine, said in an email.

“While some may argue that earlier screening may lead to increased recalls and unnecessary biopsies, women get recalled for additional imaging about 10% of the time and biopsies are needed in 1-2% of cases, which is quite low,” said Joseph, who was not involved in the new study.

“This has to be compared to the lives saved from earlier screening mammography,” she said. “I would also like to point out that while we certainly want to prevent deaths, earlier screening can have other benefits by allowing women of all racial and ethnic groups to have less extensive surgery and less chemotherapy which impacts quality of life.”

Breast cancer is the most common cancer among women in the United States, except for skin cancers. This year, it is estimated that about 43,700 women will die from the disease, according to the American Cancer Society, and Black women have the highest death rate from breast cancer.

Even though Black women are 40% more likely than White women to die from the disease, Kamal of the American Cancer Society said that the disparity in deaths is not a result of Black women not following the current mammogram guidelines.

Rather, implicit bias in medicine plays a role.

“In the United States, across the country, there are not differences in mammogram screening rates among Black women and White women. In fact, across the entire country, the number is about 75%. We see about 3 in 4 women – Black, White, Hispanic, and Asian – are on time with their mammograms,” Kamal said.

Yet there are multiple timepoints after a patient is diagnosed with breast cancer where they may not receive the same quality of care or access to care as their peers.

“For example, Black women are less likely to be offered enrollment in a clinical trial. That is not because of a stated difference in interest. In fact, the enrollment rate in clinical trials is equal among Black women and White women, if they’re asked,” Kamal said.

“What we have to understand is where the implicit and systemic biases held by patients and their caregivers and their families may exist – those that are held within health systems and even policies and practices that impede everyone having fair and just access to high quality health care,” he said.

Additionally, Black women have nearly a three-fold increased risk of triple-negative breast cancers. Those particular type of cancers tend to be more common in women younger than 40, grow faster than other types of invasive breast cancer and have fewer treatment options.

Black women also tend to have denser breast tissue than White women. Having dense tissue in the breast can make it more difficult for radiologists to identify breast cancer on a mammogram, and women with dense breast tissue have a higher risk of breast cancer.

But such biological differences among women represent just a small part of a much larger discussion around racial disparities in breast cancer, Kamal said.

“There are systemic issues, access to care issues that really go beyond biology,” he said. “The reality is cancer affects everybody and it does not discriminate. Where the discrimination sometimes occurs is after the diagnosis, and that’s really what we need to focus on.”

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‘Big step forward’: New lab tests may accelerate Parkinson’s diagnosis and research | CNN



CNN
 — 

A lab test that can tell doctors if someone has Parkinson’s disease is a long-sought goal of researchers.

Doctors currently diagnose the progressive condition by looking for telltale physical symptoms: tremors, a halting gait, stiffness or trouble balancing. About 90,000 Americans are diagnosed on the basis of these symptoms each year, according to a recent study.

These signs can be subtle at first, and it can be difficult to discriminate Parkinson’s from other disorders until the disease is more advanced and affects more of the brain.

The lack of a lab test that can pick up the disease in its early stages has also stymied the search for new treatments. Studying a group of people with the same movement symptoms could mean inadvertently including those whose condition could be caused by something else.

It also means people are usually studied when the disease process is well under way. Many therapies work best when they’re given at the first sign of symptoms, or even before.

All this may soon change, thanks to new tests that are able to detect traces of a key protein that misfolds and gums up specific areas of the brain, called alpha-synuclein.

One test, SYNTap, which looks for seeds of this misfolded protein in spinal fluid, was just vetted in the Parkinson’s Progression Marker’s Initiative, a large study undertaken by the Michael J. Fox Foundation. Several companies are developing versions of this type of test.

It joins another test called Syn-One, which detects traces of the protein in skin. Syn-One has been available since 2019 and is being studied with funding from the National Institutes of Health.

When they return positive results, the new tests don’t diagnose Parkinson’s disease but rather point to a group of disorders caused by abnormal clumping of the alpha-synuclein protein. Those include dementia with Lewy bodies and multiple system atrophy, a rare disorder that causes damage to several areas of the brain. Parkinson’s is the most common of these disorders.

Parkinson’s affects the nervous system and, in addition to movement-related symptoms, can cause problems such as depression, anxiety, cognitive impairment, trouble sleeping, hallucinations and loss of smell. It’s not fatal, but it can have serious complications. The exact cause is largely unknown.

The tests usher in “a bit of a new chapter for us in Parkinson’s disease, where we can really focus on biology,” said Dr. Kathleen Poston, a professor of neurology and neurological sciences at Stanford University, who participated in a study of the SYNTap test.

“I think that will very hasten our engagement and clinical trials and, I hope, allow us to have more successful therapeutic clinical trials in in the next five years,” Poston said.

The test is available to doctors, but it had not been shown to be reliable in a large clinical trial.

In a study published Wednesday in the journal Lancet Neurology, the SYNTap test proved to be accurate when given to 1,100 participants, including people with Parkinson’s, people with genetic or clinical risk factors who had not been diagnosed, and healthy controls. Overall, the test correctly identified people with Parkinson’s disease 88% of the time and correctly ruled it out 96% of the time.

“It shows that this method is fairly accurate for detecting Parkinson’s disease, even in patients who do not yet have symptoms,” said Dr. Andrew Ko, a neurosurgeon at the University of Washington School of Medicine who was not involved in the research. “This is a big step forward showing that this type of test is accurate.”

The test was most accurate in people without any known genetic risks for Parkinson’s disease, who also had loss of their sense of smell. In this group, the test correctly detected the disease 99% of the time. If they didn’t have a loss of smell, the accuracy dropped to 78%.

In people with the most common genetic risk, a mutation in their LRRK2 gene, the test correctly flagged Parkinson’s only about 67% of the time.

That means the test is very good at ruling out Parkinson’s, but it will miss some people who actually do have it.

“If you had this test and it was ‘normal’ or negative … it doesn’t mean you don’t have Parkinson’s disease,” said Dr. Kelly Mills, a neurologist and director of the Movement Disorders Division at Johns Hopkins University, who was not involved in the research.

For the time being, that means the test itself won’t be so helpful to individual patients.

“I think it’s a big deal for research, which is going to be a huge deal for patients,” Mills said.

The study’s authors agree.

“Right now, the test has sort of only a modest utility in routine clinical care,” said study author Dr. Andrew Siderowf, a neurologist at the University of Pennsylvania’s Perlman School of Medicine.

Parkinson’s treatment is based on relieving symptoms, and all the test can do is to help a doctor refine a diagnosis. It won’t change how a patient is treated, but it might bring some people peace of mind that their diagnosis is correct, Siderowf said.

It’s also a very invasive test that requires a painful procedure called a spinal tap, although researchers hope to soon translate their results to other kind of biological samples, such as blood or saliva, that would be easier to collect.

One of the most promising results of the study was in people who had early changes that are known to be strongly tied to the development of Parkinson’s disease. In 18 people who had lost their sense of smell, the test detected alpha-synuclein in 16. In another group of 33 people with REM sleep behavior disorder, which makes people kick, punch or hit in their sleep as they act out their dreams, the test detected alpha-synuclein in 28.

Because this group was so small, the researchers say, those tests will have to be repeated to learn whether it can detect the disease before movement is impaired.

But that is the goal, according to the study’s funders at the Michael J. Fox Foundation, who believe that this test will revolutionize research.

“We have a really robust current pipeline of therapeutics that are looking to interfere with the the biology and the disease,” said Deborah Brooks, CEO of the foundation. “We will continue at a rapid and aggressive pace,” she said.

Brooks said that when they learned the results of the SYNTap tests, she flew out to see actor and philanthropist Fox, who was vacationing with his family, to tell him personally. Fox has been living with Parkinson’s since 1991.

Together, they called one of the foundation’s scientists, Dr. Todd Sherer, a neuroscientist who is also the foundation’s chief mission officer.

“I said, ‘so, you know, Todd’s calling in, but he’s gonna tell you all the details. I’m just gonna give you the headline: We’ve had a breakthrough,’ ” Brooks said.

Fox and Sherer had been searching for a biomarker for the condition for over a decade.

When Sherer finished his presentation, Brooks said, Fox leaned over, picked up the laptop and kissed him on the head.

“This is awesome,” he said.

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Most men with prostate cancer can avoid or delay harsh treatments, long-term study confirms | CNN



CNN
 — 

Most men who are diagnosed with prostate cancer can delay or avoid harsh treatments without harming their chances of survival, according to new results from a long-running study in the United Kingdom.

Men in the study who partnered with their doctors to keep a close eye on their low- to intermediate-risk prostate tumors – a strategy called surveillance or active monitoring – slashed their risk of the life-altering complications such as incontinence and erectile dysfunction that can follow aggressive treatment for the disease, but they were no more likely to die of their cancers than men who had surgery to remove their prostate or who were treated with hormone blockers and radiation.

“The good news is that if you’re diagnosed with prostate cancer, don’t panic, and take your time to make a decision” about how to proceed, said lead study author Dr. Freddie Hamdy, professor of surgery and urology at the University of Oxford.

Other experts who were not involved in the research agreed that the study was reassuring for men who are diagnosed with prostate cancer and their doctors.

“When men are carefully evaluated and their risk assessed, you can delay or avoid treatment without missing the chance to cure in a large fraction of patients,” said Dr. Bruce Trock, a professor of urology, epidemiology and oncology at Johns Hopkins University.

The findings do not apply to men who have prostate cancers that are scored through testing to be high-risk and high-grade. These aggressive cancers, which account for about 15% of all prostate cancer diagnoses, still need prompt treatment, Hamdy said.

For others, however, the study adds to a growing body of evidence showing that surveillance of prostate cancers is often the right thing to do.

“What I take away from this is the safety of doing active monitoring in patients,” said Dr. Samuel Haywood, a urologic oncologist at the Cleveland Clinic in Ohio, who reviewed the study, but was not involved in the research.

Results from the study were presented on Saturday at the European Association of Urology annual conference in Milan, Italy. Two studies on the data were also published in the New England Journal of Medicine and a companion journal, NEJM Evidence.

Prostate cancer is the second most common cancer in men in the United States, behind non-melanoma skin cancers. About 11% – or 1 in 9 – American men will be diagnosed with prostate cancer in their lifetime, and overall, about 2.5% – or 1 in 41 – will die from it, according to the National Cancer Institute. About $10 billion is spent treating prostate cancer in the US each year.

Most prostate cancers grow very slowly. It typically takes at least 10 years for a tumor confined to the prostate to cause significant symptoms.

The study, which has been running for more than two decades, confirms what many doctors and researchers have come to realize in the interim: The majority of prostate cancers picked up by blood tests that measure levels of a protein called prostate-specific antigen, or PSA, will not harm men during their lifetimes and don’t require treatment.

Dr. Oliver Sartor, medical director of the Tulane Cancer Center, said men should understand that a lot has changed over time, and doctors have refined their approach to diagnosis since the study began in 1999.

“I wanted to make clear that the way these patients are screened and biopsied and randomized is very, very different than how these same patients might be screened, biopsied and randomized today,” said Sartor, who wrote an editorial on the study but was not involved in the research.

He says the men included in the study were in the earliest stages of their cancer and were mostly low-risk.

Now, he says, doctors have more tools, including MRI imaging and genetic tests that can help guide treatment and minimize overdiagnosis.

The study authors say that to assuage concerns that their results might not be relevant to people today, they re-evaluated their patients using modern methods for grading prostate cancers. By those standards, about one-third of their patients would have intermediate or high-risk disease, something that didn’t change the conclusions.

When the study began in 1999, routine PSA screening for men was the norm. Many doctors encouraged annual PSA tests for their male patients over age 50.

PSA tests are sensitive but not specific. Cancer can raise PSA levels, but so can things like infections, sexual activity and even riding a bicycle. Elevated PSA tests require more evaluation, which can include imaging and biopsies to determine the cause. Most of the time, all that followup just isn’t worth it.

“It is generally thought that only about 30% of the individuals with an elevated PSA will actually have cancer, and of those that do have cancer, the majority don’t need to be treated,” Sartor said.

Over the years, studies and modeling have shown that using regular PSA tests to screen for prostate cancer can do more harm than good.

By some estimates, as many as 84% of men with prostate cancer identified through routine screening do not benefit from having their cancers detected because their cancer would not be fatal before they died of other causes.

Other studies have estimated about 1 to 2 in every five men diagnosed with prostate cancer is overtreated. The harms of overtreatment for prostate cancer are well-documented and include incontinence, erectile dysfunction and loss of sexual potency, as well as anxiety and depression.

In 2012, the influential US Preventive Services Task Force advised healthy men not to get PSA tests as part of their regular checkups, saying the harms of screening outweighed its benefits.

Now, the task force opts for a more individualized approach, saying men between the ages of 55 and 69 should make the decision to undergo periodic PSA testing after carefully weighing the risks and benefits with their doctor. They recommend against PSA-based screening for men over the age of 70.

The American Cancer Society endorses much the same approach, recommending that men at average risk have a conversation with their doctor about the risks and benefits beginning at age 50.

The trial has been following more than 1,600 men who were diagnosed with prostate cancer in the UK between 1999 and 2009. All the men had cancers that had not metastasized, or spread to other parts of their bodies.

When they joined, the men were randomly assigned to one of three groups: active monitoring or using regular blood tests to keep an eye on their PSA levels; radiotherapy, which used hormone-blockers and radiation to shrink tumors; and prostatectomy, or surgery to remove the prostate.

Men who were assigned monitoring could change groups during the study if their cancers progressed to the point that they needed more aggressive treatment.

Most of the men have been followed for around 15 years now, and for the most recent data analysis, researchers were able get follow-up information on 98% of the participants.

By 2020, 45 men – about 3% of the participants – had died of prostate cancer. There were no significant differences in prostate cancer deaths between the three groups.

Men in the active monitoring group were more likely to have their cancer progress and more likely to have it spread compared with the other groups. About 9% of men in the active monitoring group saw their cancer metastasize, compared with 5% in the two other groups.

Trock points out that even though it didn’t affect their overall survival, a spreading cancer isn’t an insignificant outcome. It can be painful and may require aggressive treatments to manage at that stage.

Active surveillance did have important benefits over surgery or radiation.

As they followed the men over 12 years, the researchers found that 1 in 4 to 1 in 5 of those who had prostate surgery needed to wear at least one pad a day to guard against urine leaks. That rate was twice as high as the other groups, said Dr. Jenny Donovan of the University of Bristol, who led the study on patient-reported outcomes after treatment.

Sexual function was affected, too. It’s natural for sexual function to decline in men with age, so by the end of the study, nearly all the men reported low sexual function, but their patterns of decline were different depending on their prostate cancer treatment, she said.

“The men who have surgery have low sexual function early on, and that continues. The men in the radiotherapy group see their sexual function drop, then have some recovery, but then their sexual function declines, and the active monitoring group declines slowly over time,” Donovan said.

Donovan said that when she presents her data to doctors, they point out how much has changed since the study started.

“Some people would say, ‘OK, yeah, but we’ve got all these new technologies now, new treatments,’ ” she said, such as intensity-modulated radiation therapy, brachytherapy and robot-assisted prostate surgeries, “but actually, other studies have shown that the effects on these functional outcomes are very similar to the effects that we see our study,” she said.

Both Donovan and Hamby feel the study’s conclusions still merit careful consideration by men and their doctors as they weigh treatment decisions.

“What we hope that clinicians will do is use these figures that we’ve produced in these papers and share them with the men so that newly diagnosed men with localized prostate cancer can really assess those tradeoffs,” Donovan said.

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Elite athletes with genetic heart disease can safely return to play with diagnosis and treatment, early study suggests | CNN



CNN
 — 

In a new study, most elite athletes with a diagnosed genetic heart disease did not experience serious or fatal symptoms of their condition, such as sudden cardiac death. The research suggests it can be “feasible” and “safe” for athletes to continue to participate in their sport.

Among a sample of 76 elite athletes with a genetic heart disease who had competed or are still competing in either Division I university or professional sports, 73 out of the 76 did not experience a cardiac event triggered by their disease during the study period, according to researchers behind a late-breaking clinical trial presented Monday at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology.

Among those elite athletes with a genetic heart disease, 40 of them – 52% – were asymptomatic, the study abstract finds.

Over the years, researchers have become more aware of alarming reports about elite athletes experiencing heart problems, or even suddenly collapsing during games.

“For athletes with genetic heart conditions, and I would add non-athletes, the tragedies occur when we don’t know of their condition,” said Dr. Michael Ackerman, a genetic cardiologist at Mayo Clinic in Rochester, Minnesota, who was a senior author of the new research. “When we know of their condition, and we assess the risk carefully and we treat it well, these athletes and non-athletes, they can expect to live and thrive despite their condition.”

The new research has not yet been published in a peer-reviewed journal, but the findings suggest that many athletes with a genetic heart disease can decide with their health care professionals on whether to continue competing in their sport and how to do so safely, instead of being automatically disqualified due to their health conditions.

“In sports, historically, we’ve been paternalistic and de-emphasize patient preference and risk tolerance, but we know that athletes come from all walks of life. They are intelligent and when there’s scientific uncertainty, their values should be incorporated in medical decision-making,” Dr. J. Sawalla Guseh, cardiologist at Massachusetts General Hospital, who was not involved in the new study, said during Monday’s scientific session.

“Shared decision-making when done well can have very favorable outcomes,” he said.

Elite basketball, hockey, soccer and football players, were among the 76 athletes included in the new study, conducted by researchers at Mayo Clinic and other institutions in the United States. They wrote in their study abstract that this is the first study to their knowledge describing the experience of athletes competing at the NCAA Division I level or in professional sports with a known genetic heart disease that puts them at risk of sudden cardiac death.

The athletes in the study were cleared for return-to-play at either a NCAA Division I school or at the professional level. They were studied over an average of seven years, and all had been diagnosed with a genetic heart disease in the past 20 years, being treated at either Mayo Clinic, Morristown Medical Center, Massachusetts General Hospital or Atrium Health Sports Cardiology Center.

“Only three of them had a breakthrough cardiac event, which means after they were diagnosed and treated, they were still having an event,” said Katherine Martinez, an undergraduate student at Loyola University in Baltimore, who helped conduct the research as an intern in the Mayo Clinic’s Windland Smith Rice Sudden Death Genomics Laboratory.

Fainting was the most common event, and one athlete received a shock with an implantable cardioverter defibrillator, or ICD. None of the athletes died.

“The majority of these athletes went on to continue their career with no events at all,” Martinez said. But most of the athletes in the study – 55 of them, or 72% – were initially disqualified from competing by their primary provider or institution after their diagnosis. Most ultimately opted to return to play with no restrictions after undergoing comprehensive clinical evaluations and talking with their doctors.

While each sports league has its own set of rules, historically, some people diagnosed with a genetic heart disease that puts them at an increased risk for sudden cardiac death have been restricted from competitive sports, the researchers wrote in their study abstract.

“Just because you were given this diagnosis, doesn’t mean that your life, your career, the future that you see for yourself is over, but taking a second opinion from an expert who knows what they’re doing and is comfortable with shared decision-making is the next step,” said Martinez, who worked on the new research alongside her father, Dr. Matthew Martinez, director of Atlantic Health System Sports Cardiology at Morristown Medical Center and an author of the new research.

Regarding the new study, “the take-home message is, if you have one of these findings, seek out an expert who’s going to help you identify a safe exercise plan for you and determine what level you can continue to safely participate in,” he said. “This is the next best step – the next evolution – of how we manage athletes with genetic heart disease.”

Leaving their sport due to a genetic heart disease can be “very destructive” for athletes who have devoted their lives to excelling in competitions, said Dr. Lior Jankelson, director of the Inherited Arrhythmia Program at NYU Langone Heart in New York, who was not involved in the new research.

Yet he added that these athletes still need to consult with their doctors and be watched closely because some genetic diseases could be more likely to cause a serious cardiac event than others.

The new study highlights that “the majority of athletes with genetic heart disease could probably – after careful, meticulous expert risk-stratification and care strategy – participate in sports,” Jankelson said. “But at the same time, this is exactly the reason why these patients should be cared only in high-expertise genetic cardiology clinics, because there are other conditions that are genetic, that could respond very adversely to sports, and have a much higher risk profile of developing an arrhythmia during intense activity.”

Separately, the NCAA Sports Science Institute notes on its website, “Though many student-athletes with heart conditions can live active lives and not experience health-related problems, sudden fatality from a heart condition remains the leading medical cause of death in college athletes.”

For athletes with a genetic heart disease, their symptoms and their family history of cardiac events should be considered when determining their risks, said Dr. Jayne Morgan, a cardiologist with Piedmont Healthcare in Atlanta, who was not involved in the new research.

“Certainly, there is concern with elite athletes competing and whether or not they are being screened appropriately,” Morgan said. But she added that the new research offers “some understanding” to the mental health implications for athletes with a genetic heart disease who may be required to step away from a competitive sport that they love.

“This study, I think, begins to go a long way in identifying that we may not need to pull the trigger so quickly and have athletes step away from something that they love,” Morgan said.

The new study is “timely” given the recent national attention on athletes and their risk of sudden cardiac death, Dr. Deepak Bhatt, director of Mount Sinai Heart in New York City, who was not involved in the research, said in an email.

“These are some of the best data showing that the risk of return to play may not be as high as we fear,” Bhatt said about the new research.

“Some caveats include that the majority of these athletes were not symptomatic and about a third had an implantable defibrillator,” he added. “Any decision to return to the athletic field should be made after a careful discussion of the potential risks, including ones that are hard to quantify. Input from experts in genetic cardiology and sports cardiology can be very helpful in these cases.”

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Stem cell therapy may reduce risk of heart attack and stroke in certain heart failure patients, study shows | CNN



CNN
 — 

Cell therapy, involving adult stem cells from bone marrow, has been shown to reduce the risk of heart attack and stroke in severe heart failure patients, according to a new study.

A single administration of adult stem cells directly into an inflamed heart, through a catheter, could result in a long-term 58% reduced risk of heart attack or stroke among heart failure patients with reduced ejection fraction, meaning they have a weakened heart muscle, suggests the study, published Monday in the Journal of the American College of Cardiology.

The study is being called the largest clinical trial of cell therapy to date in patients with heart failure, a serious condition that occurs when the heart can’t pump enough blood to meet the body’s needs.

“We followed these patients during several years – three years – and what we found was that their hearts got stronger. We found a very significant reduction in heart attack and stroke, especially in the patient that we measured in their blood that they had more inflammation going on,” said the study’s lead author Dr. Emerson Perin, a practicing cardiologist and medical director at The Texas Heart Institute in Houston.

“That effect, it was there across everyone, but for the patient that had inflammation, it was even more significant,” Perin said. “And there also is evidence that we had a reduction in cardiovascular deaths.”

The therapy involves injecting mesenchymal precursor cells into the heart. These particular stem cells have anti-inflammatory properties, which could improve outcomes in heart failure patients since elevated inflammation is a hallmark feature of chronic heart failure.

More than 6 million adults in the United States have chronic heart failure, and most are treated with drugs that address the symptoms of the condition. The patients included in the new study were all taking medications for heart failure, and the new research suggests that cell therapy can be beneficial when used in conjunction with heart failure drugs.

“You can imagine, we keep everybody going and doing better with the medicine. And now we have a treatment that actually addresses the cause and quiets everything down. So, this line of investigation really has a great future and I can see that, with a confirmatory trial, we can bring this kind of treatment into the mainstream,” Perin said.

“We can treat heart failure differently,” he said. “We have a new weapon against heart failure and this study really opens the door and leads the way for us to be able to get there.”

The new study – sponsored by Australian biotechnology company Mesoblast – included 565 heart failure patients with a weakened heart muscle, ages 18 to 80. The patients were screened between 2014 and 2019 and randomly assigned to either receive the cell therapy or a placebo procedure at 51 study sites across North America.

The patients who received the cell therapy were delivered about 150 million stem cells to the heart through a catheter. The cells came from the bone marrow of three healthy young adult donors.

The researchers, from The Texas Heart Institute and other various institutions in the United States, Canada and Australia, then monitored each patient for heart-related events or life-threatening arrhythmias.

Compared with the patients who received a sham procedure, those treated with the stem cell therapy showed a small but statistically significant strengthening of the muscle of the heart’s left pumping chamber within a year.

The researchers also found that the cell therapy decreased the risk of heart attack or stroke by 58% overall.

“This is a long-term effect, lasting an average of 30 months. So that’s why we’re so excited about it,” Perin said.

Among patients with high inflammation in their bodies, the combined reduced risk of heart attack or stroke was even greater, at 75%, the researchers found.

“These cells directly address inflammation,” Perin said.

“They have little receptors for these inflammatory substances – some of them are called interleukins, and there’s other kinds,” he said. “When you put them into an inflamed heart, it activates the cells and the cells go, ‘Wow, we need to respond. This house is on fire. We need to put out the fire.’ And so they then secrete various anti-inflammatories.”

The researchers wrote in their study that their findings should be considered as “hypothesis generating,” in that they show this cell therapy concept could work, but clinical trials would be needed to specifically confirm the effects of these stem cells on heart attack, stroke and other events. It is still unclear for how long the effects of the stem cell therapy last beyond 30 months and whether patients will need more stem cell injections in the future.

Overall, there were no major differences between the adverse events reported among the patients who received the cell therapy compared with those in the control group, and the researchers reported no major safety concerns.

“We’ve made an enormous step to be able to harness the real power of adult stem cells to treating the heart,” Perin said. “This trial really is a signal of a new era.”

For more than a decade, scientists have been studying potential stem cell therapies for heart failure patients – but more research is needed to determine whether this treatment approach could reduce the amount of hospitalizations, urgent care events or complications among patients with heart failure.

The new study didn’t find that, said cardiologist Dr. Nieca Goldberg, medical director of Atria New York City and clinical associate professor of medicine at NYU Grossman School of Medicine, who was not involved in the latest study.

What the new study did find is that “there may be a population of people that could benefit from the stem cell therapy, particularly people who have inflammation,” Goldberg said.

“It’s actually an interesting therapy, an interesting thing to consider, once more research substantiates its benefit. Because in heart failure, there’s multiple things going on and, particularly for the inflammatory component, this could be an interesting treatment,” she said. “It might have some role in heart failure patients with inflammation.”

The therapy’s effects on heart attack or stroke risks “were positive,” Dr. Brett Victor, a cardiologist at the Cardiology Consultants of Philadelphia, who was not involved in the study, said in an email.

“Specifically, patients who received the stem cell therapy were less likely to have a heart attack or stroke over the next 2.5 years, especially among those who were found to have a high degree of systemic inflammation as measured by a laboratory test,” Victor said in the email, adding that this represents how heart failure has a significant inflammatory component.

Those “positive signals” likely will be evaluated more in subsequent studies, Victor said.

“Current therapies for heart failure including lifestyle modifications, a growing list of excellent medications, and device therapies will continue to be the standard of care for treatment in the near-term,” he said. “I suspect that this trial will continue to move the field forward in studying cardiac cell therapy as we continue to look for ways to not just treat, but actually find a cure for this disease.”

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