- “You always speak about procedures…” VP Jagdeep Dhankhar, LoP Kharge engage in heated argument ANI News
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Tag Archives: procedures
Emergency rule seeks to limit access to certain procedures for transgender Missourians • Missouri Independent – Missouri Independent
- Emergency rule seeks to limit access to certain procedures for transgender Missourians • Missouri Independent Missouri Independent
- Missouri Attorney General Andrew Bailey Promulgates Emergency Regulation Targeting Gender Transition Procedures for Minors Missouri Attorney General’s Office
- Limits on transgender care for Missouri youths begin shortly The Associated Press
- Missouri AG issues emergency order restricting gender-affirming health care The Hill
- Emergency rules limiting transgender care in Missouri set to take effect this month St. Louis Public Radio
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Missouri Senate approves four-year ban on medical procedures for transgender minors • Missouri Independent – Missouri Independent
- Missouri Senate approves four-year ban on medical procedures for transgender minors • Missouri Independent Missouri Independent
- Missouri AG seeks to restrict gender-affirming care for minors CNN
- Rally precedes Senate transgender bill compromise Columbia Missourian
- Editorial: Citing social contagion,’ state attorney general invokes powers he doesn’t have St. Louis Post-Dispatch
- Missouri Democrats once again filibuster ban on medical procedures for transgender minors • Missouri Independent Missouri Independent
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I’m a leg-lengthening surgeon. Most of my clients are men with confidence issues — here’s what the procedure’s like
© Courtesy of Shahab Mahboubian
Dr. Shahab Mahboubian at his facility. Courtesy of Shahab Mahboubian
- Shahab Mahboubian performs 30 to 40 cosmetic limb-lengthening surgeries a year.
- He said the majority of his patients are men who feel passed over in relationships and careers.
- He can add up to 6 inches to a patient’s height and said patients usually leave more confident.
This as-told-to essay is based on a conversation with Shahab Mahboubian, an orthopedic surgeon in his 40s who specializes in limb-lengthening surgeries at his private practice, Height Lengthening, in Burbank, California. It has been edited for length and clarity.
I love what I do. I see my height-lengthening patients as my kids, and I get to watch them grow. After surgery, some of them are actually taller than me — I’m 5-foot-9 — putting them above the national average.
I grew up in LA and got my medical degree from Western University of Health Sciences in Pomona, California. Then I spent six years in New York doing my residency at Long Island’s Peninsula Hospital and completing my limb-lengthening fellowship at the Hospital for Special Surgery. I’ve been practicing for 13 years, including two years at my current office in Burbank, California.
As a child, I loved working with my hands and was always taking things apart and putting them back together
I especially enjoyed working with tools like screwdrivers, hammers, and drills, but the human body especially fascinated me. The only field in medicine that uses all of these tools is orthopedic surgery, so it seemed like the right fit.
I specialized in limb-lengthening surgery specifically because I wanted to do something that was different from everybody else. I also wanted to help a portion of the population that didn’t have access to services that correct deformities and limb-length discrepancies. It’s a difficult field to get into because orthopedic-surgery programs are very competitive, and there aren’t many fellowships or training facilities for limb lengthening, but I found the challenge very gratifying.
In the beginning of my career, I mostly focused on surgeries that correct deformities from prior traumas or birth
Kids sometimes get hurt and end up with leg-length discrepancies. Others are born with leg-length discrepancies or bow-legged and knock-kneed deformities. I had a young lady who came to me with a knock-kneed deformity when she was 16 years old. Seven or eight years later, she came back with her own child who was having orthopedic problems after a car accident. It was very memorable to treat her as a child then have her come back to make sure her own child was OK — fortunately, she was.
Surgery helps patients with these deformities or injuries walk better and participate more fully in activities like sports, but my practice has since evolved. Now the people who reach out to me seem more interested in cosmetic limb-lengthening — or leg surgery to increase height — so that’s the direction that my practice has taken, though I still see a small percentage of patients to correct deformities.
The idea of being taller fascinates people
I get about 20 emails a day asking about limb-lengthening procedures and up to 40 when one of our posts goes viral on TikTok or Instagram. The general population believes that whatever height you grow to is your final height, but that’s not the case — a lengthening procedure provides an opportunity to become taller.
People mostly ask the price of the surgery, how soon they can return to work or get back to playing sports, and how long they’ll be in a wheelchair or using a walker. They want to know how the procedure will affect their lives. We also get some international patients who ask us how to get a visa if they come from elsewhere. We can’t do that for them, but we try to guide them on where to go.
The surgery is quite expensive — it can cost anywhere from $75,000 to $90,000, depending on exactly what the patient wants to do — and insurance does not cover it if it’s cosmetic. People that undergo limb-lengthening surgery are from all walks of life, and many used COVID lockdowns to recover post-surgery.
© Provided by Business Insider
Mahboubian with a patient before and after surgery. Courtesy of Shahab Mahboubian
For the most part, it’s men who want the procedure
Most men who come to me complain that they’re not taken seriously or that they’re made fun of. Plenty of patients say that they don’t get attention from women, while others say they’ve been passed over for career opportunities because of their height.
When I talk to these same patients after height-lengthening surgery, they feel like they’re on the same playing field with everyone else. They’re happier, they have a lot more confidence, and they feel like they’re able to conquer a lot more than before.
I would say 80% to 85% of my cosmetic limb-lengthening patients are men, and 15% to 20% are women. A lot of our patients are entrepreneurs, in the military, or work in tech. I’ve performed height-lengthening surgery on individuals ranging from 16 to 65 years old. I’ve had twins, siblings, and even a father and son who’ve undergone the procedure.
All of them are unique in their own ways. Some have gained as little as four centimeters, while others have gained up to 16 centimeters, or about six inches.
I’ve had a few transgender men as patients
As they transition, some patients want to have more masculine features, including being taller.
One of my patients was very hesitant to tell me about their transition — I guess because of bad experiences they’d had with other physicians for things they wanted to do, including gender-affirmation surgery. I figured it out, based on anatomy and X-rays, and told them the best thing to do is be honest. Once I gained their trust and let them know that their experience is nothing abnormal, they felt a lot more comfortable with me.
Like most other cosmetic surgeries, I don’t think an additional psychiatric evaluation is necessary before getting the procedure, unless the patient is seeing a psychiatrist or feels they need one.
I turn away some people, either because they don’t have enough muscle flexibility or because they have unrealistic goals
As we lengthen the bone, the surrounding soft tissue, such as the muscles, tendons, veins, arteries, and nerves, will also lengthen. Hence, the more flexibility a person has, the easier it will be to lengthen the bone against the surrounding soft tissues. As long as a person is healthy and active, and doesn’t have any bone disease, they should be fit for the surgery.
There are some people who want to be a foot taller and I’m like, “That’s not going to happen.” The maximum amount I can add to someone’s height for cosmetic reasons is about 6 inches in two separate surgeries at least three or four weeks apart. For most patients undergoing one surgery, the max we can add is just over three inches.
We do the surgery through a minimally invasive process
We make small incisions, and then we put in guidewires and use X-rays to make sure everything is being placed accurately on the bone. Then we surgically cut the bone and put a rod — also known as a Precice nail — that’s about 10 to 13 inches long and one-third to half-an-inch wide into the middle of the bone, where the marrow is. Then we put in screws to stabilize the nail.
After surgery, we start the lengthening process using a magnetic machine that communicates with the nail, or rod, that’s now inside the bone. The machine turns tiny gears that are inside the nail to lengthen the space between the segments of the bone, 1 millimeter at a time. When we lengthen really slowly over time, the patient’s body creates new bone and it fills in the gaps. It’s amazing, right?
© Courtesy of Shahab Mahboubian
Mahboubian standing with a patient before and after two surgeries. Courtesy of Shahab Mahboubian
All my patients leave one millimeter taller because we test the nail during surgery to make sure it’s functioning properly. A patient will typically spend two to three days in the hospital to recover, then lengthen their legs at home by about 1 millimeter a day. It’s actually fairly painless because it’s such a small amount at a time.
If a patient’s job requires them to sit for long periods of time, they can get back to work as soon as two weeks. It takes anywhere from six to eight months to a year to do activities that require being on your feet, such as labor-intensive work and competitive sports.
My caseload was on the higher end during 2020. Now, it’s about the same as it was in 2019.
In a year, I do anywhere from 30 to 40 cases. When everyone was dealing with COVID-19 at home and not doing things, it was a good time to have the surgery and recover.
An orthopedic surgeon can make $250,000 to $2 million a year. Some make more than that, but it really depends on how business-minded you are and what other things — like investing or getting involved with orthopedic products — you’re doing outside of seeing patients.
Doctors in all specialties are not making what they did 20 years ago. Insurance reimbursements keep getting lower every year as expenses get higher. It’s a challenge for everybody. You’ve got to be smart and have some business sense to make a good living.
Every day that I wake up and go to work, I feel like it’s a new opportunity for me to do good and help people.
When a patient comes in for a limb-lengthening consultation, I talk to them about why they want to get it done
We discuss whether their goals are achievable and which surgery would be best for them — either working on the femur bones in the high parts of the legs or the tibias and fibulas in the lower part of the legs. Then I make the proper measurements for the implants and make sure the patient’s fully ready for their surgery.
Before surgery, I meet the patient at the hospital, say hello, then get them pumped up and ready to go for the procedures. Before surgery, one of my favorite traditions is to play the song “Ten Feet Tall” by Afrojack on my phone as we’re walking to the OR suite. It always gets them pumped up for their surgery.
Though I’ve done limb-lengthening surgeries hundreds of times, I still get a little nervous. But when I actually start the surgery, all of that goes away.
Every job has its stresses, and mine is no different
There are times when we run into some difficulty, such as blood clots or compartment syndrome, which is when a patient bleeds a lot into the muscle. This problem can damage muscles and nearby nerves. I’ve also had a couple of patients who didn’t grow good bone during their lengthening, but after making several adjustments to the lengthening rate — and even using stem cells — we were able to help the bone grow nice and strong.
As an orthopedic surgeon, I’m constantly dealing with patients who come into the office upset and in pain, and my job is to make them feel better. I’m like their coach or cheerleader when they’re down on themselves. People talk about this surgery so much — it’s all over social media and forums. After I do these surgeries, I want my patients to be happy and encourage others to trust me and get good results.
© Courtesy of Shahab Mahboubian
Mahboubian with a patient before and after surgery. Courtesy of Shahab Mahboubian
When cosmetic surgeries started to gain popularity, people criticized it. The same is true for height-lengthening procedures.
There will always be people who have their opinions about changing what God has given us. But as more people realize that this surgery exists and as it becomes more popular, the level of criticism will decrease. There are colleagues who may bad-mouth you, but as long as they do good work, doctors, for the most part, have respect for one another.
In general, people see you for how you treat them, but you can’t make everybody happy. There will always be people who have complications or continue to have pain despite a perfect surgery. So you have to be able to relate to patients as well as peers.
It’s definitely not easy to do what I do. I have my own practice with my own staff, and sometimes it’s very difficult to balance patient care and business aspects. But as I get older and become more experienced, I think I’m able to handle those stresses better. In the end, you have to treat people with respect and always maintain open lines of communication.
Are you a surgeon or healthcare worker with a story to tell? Email mlogan@insider.com.
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Oscars to review ‘campaign procedures’ after Andrea Riseborough backlash | Oscars 2023
The film academy has announced a review of “campaign procedures” in the wake of a backlash to this year’s Oscar nominations.
The British actor Andrea Riseborough gained a surprise best actress nod for her role in indie To Leslie after a grassroots campaign backed by A-listers including Kate Winslet, Jane Fonda, Charlize Theron, Gwyneth Paltrow and Amy Adams.
While the academy doesn’t mention Riseborough or the actors involved in the last-minute campaign, the statement alludes to questions that have arisen since this week’s announcement.
“It is the Academy’s goal to ensure that the awards competition is conducted in a fair and ethical manner, and we are committed to ensuring an inclusive awards process,” the statement reads. “We are conducting a review of the campaign procedures around this year’s nominees, to ensure that no guidelines were violated, and to inform us whether changes to the guidelines may be needed in a new era of social media and digital communication. We have confidence in the integrity of our nomination and voting procedures, and support genuine grassroots campaigns for outstanding performances.”
Riseborough’s inclusion in the category led to surprise from many prognosticators given the film’s low profile during the awards season. Her film To Leslie made only $27,000 on its release last October and while she was nominated for an Independent Spirit award, she was not picked by either the Golden Globes or Screen Actors Guild.
According to the Los Angeles Times, the film’s director, Michael Morris, and his wife, actor Mary McCormack “contacted nearly every one” of their famous friends asking them to watch the film and spread the word about it on social media. Support soon followed with Theron hosting a screening back in November, Winslet leading a Q&A and online posts appearing from others, including Edward Norton and Susan Sarandon. Many posts also included similar wording, referring to the film as “a small film with a giant heart”.
Riseborough told Deadline that she was “astounded” by the nomination. “It was so hard to believe it might ever happen because we really hadn’t been in the running for anything else,” she said. “Even though we had a lot of support, the idea it might actually happen seemed so far away.” Winslet also said it was “hard-won” and “deeply deserved”.
Sources claim to Variety that the academy has been “inundated” with calls and emails about the nomination but no formal complaint has been filed. The academy is set to meet on Tuesday and reportedly this will be on the agenda.
Riseborough is included in the category alongside Cate Blanchett, Ana de Armas, Michelle Williams and Michelle Yeoh.
Pig’s Heart Took Longer to Generate a Beat in Transplant Patient
A genetically modified pig heart transplanted into a severely ill person took longer to generate a heartbeat than those of typical pig or human hearts, research showed, another potential challenge for doctors aiming to conduct clinical trials of pig-organ transplants.
Doctors took daily electrocardiograms of
David Bennett,
a 57-year-old handyman and father of two who received a gene-edited pig heart in an experimental surgery at the University of Maryland Medical Center in Baltimore in January. Mr. Bennett died in March from heart failure, but doctors still aren’t sure why the pig heart thickened and lost its pumping ability.
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Doctors involved in the groundbreaking surgery have been studying data from Mr. Bennett’s case, which is being closely watched in the wider transplant community. Researchers reported in May that a common pig virus was detected in the pig heart transplanted into Mr. Bennett. They said there is no evidence the virus infected Mr. Bennett, but its presence in the pig heart could have caused inflammation that contributed to the cascade of events that led to his death from heart failure.
Researchers analyzed Mr. Bennett’s EKG data as part of efforts to understand his decline after the transplant, direct future research and determine a possible path toward opening clinical trials. Widely used tests that measure electrical signals that cause the heart to beat, EKGs can help diagnose heart attacks, irregular heart rhythms and other possible abnormalities.
Researchers reported unexpected findings in two aspects of Mr. Bennett’s EKG data: the time it takes electricity to travel from the top to the bottom chamber of the heart and across the bottom chambers, which pumps blood through the heart, and the time it takes the lower chambers of the heart to go through a full electrical cycle, which is associated with a heartbeat.
The surfaces of pig cells contain a sugar molecule that triggers the human immune system to attack the organs. Scientists are using the gene editing tool Crispr to overcome this obstacle.
Here’s one approach:
…and then insert the edited DNA into a pig egg cell whose nucleus has been removed. The egg cell is then transferred to the uterus of a sow. The sow gives birth to pigs whose cells—including those in their organs— contain the edited genes.
Crispr acts like scissors cutting DNA at a specific place
scientists edit troublesome genes in pig DNA…
…and sometimes add human genes…
ORGAN OPTIONS
Researchers are trying various techniques that might allow transplantation of gene-edited pig hearts, kidneys and livers into humans. Recent studies on pig organ transplantation in baboons and people have focused mainly on hearts and kidneys.
HEART TO HEART
Pig and human hearts have similarities—but also some differences.
Pigs can be bred to have hearts of similar size as human hearts.
Pig and human hearts each have four pumping chambers—two small ones known as atria and two large ones known as ventricles.
The wall of tissue separating the ventricles is thicker in pig hearts than in human hearts.
Pig and human hearts each are attached to a large artery known as the aorta as well as to a large vein known as the vena cava.
A pig’s inferior (lower) vena cava joins a pig heart’s right atrium at an angle. The vein is longer in pigs than in humans.
EASING ORGAN REJECTION
The surfaces of pig cells contain a sugar molecule that triggers the human immune system to attack the organs. Scientists are using the gene editing tool Crispr to overcome this obstacle. Here’s one approach:
Crispr acts like scissors cutting DNA at a specific place.
Scientists edit troublesome genes in pig DNA…
…and sometimes add human genes…
…and then insert the edited DNA into a pig egg cell whose nucleus has been removed. The egg cell is then transferred to the uterus of a sow. The sow gives birth to pigs whose cells—including those in their organs—contain the edited genes.
ORGAN OPTIONS
Researchers are trying various techniques that might allow transplantation of gene-edited pig
hearts, kidneys and livers into humans. Recent studies on pig organ transplantation in baboons and people have focused mainly on hearts and kidneys.
HEART TO HEART
Pig and human hearts have similarities—but also some differences.
Pigs can be bred to have hearts of similar size as human hearts.
Pig and human hearts each have four pumping chambers—two small ones known as atria and two large ones known as ventricles.
The wall of tissue separating the ventricles is thicker in pig hearts than in human hearts.
Pig and human hearts each are attached to a large artery known as the aorta as well as to a large vein known as the vena cava.
A pig’s inferior (lower) vena cava joins a pig heart’s right atrium at an angle. The vein is longer in pigs than in humans.
EASING ORGAN REJECTION
The surfaces of pig cells contain a sugar molecule that triggers the human immune system to attack the organs. Scientists are using the gene editing tool Crispr to overcome this obstacle. Here’s one approach:
Crispr acts like scissors cutting DNA at a specific place.
Scientists edit troublesome genes in pig DNA…
…and sometimes add human genes…
…and then insert the edited DNA into a pig egg cell whose nucleus has been removed. The egg cell is then transferred to the uterus of a sow. The sow gives birth to pigs whose cells— including those in their organs—contain the edited genes.
ORGAN OPTIONS
Researchers are trying various techniques that might allow transplantation of gene-edited pig
hearts, kidneys and livers into humans. Recent studies on pig organ transplantation in baboons and people have focused mainly on hearts and kidneys.
HEART TO HEART
Pig and human hearts have similarities—but also some differences.
Pigs can be bred to have hearts of similar size as human hearts.
Pig and human hearts each have four pumping chambers—two small ones known as atria and two large ones known as ventricles.
The wall of tissue separating the ventricles is thicker in pig hearts than in human hearts.
Pig and human hearts each are attached to a large artery known as the aorta as well as to a large vein known as the vena cava.
A pig’s inferior (lower) vena cava joins a pig heart’s right atrium at an angle. The vein is longer in pigs than in humans.
The time intervals are typically shorter in pig hearts that are in pigs. But they took longer in the gene-modified pig heart inside a human. The time for the electricity to travel through the heart’s electrical system and generate a heartbeat also took longer than what is typical for human hearts, said
Timm Dickfeld,
a professor of medicine and director of electrophysiology research at the University of Maryland Medical Center, who was the leader of the EKG study.
What that might mean in the future for doctors caring for patients with gene-modified pig heart transplants is uncertain, said
Paul Wang,
director of the Stanford Cardiac Arrhythmia Service and a professor of medicine and bioengineering at Stanford University, who examined the data but wasn’t involved in the study.
“It has only been done once,” Dr. Wang said. “It needs to be done many more times for us to understand what these differences mean.”
The EKG data haven’t been published or undergone an outside vetting process. They are being presented by the Maryland team at an American Heart Association annual meeting starting Nov. 5. The Maryland team said they are studying the significance of the findings and hope to gather more data in future studies.
The fact that the electrical signals traveled through Mr. Bennett’s heart more slowly than expected “did not appear to be associated with a pathological outcome,” said
Bartley Griffith,
co-director of the cardiac xenotransplantation program at the University of Maryland School of Medicine, who performed Mr. Bennett’s transplant surgery.
Dr. Griffith added that if Mr. Bennett had survived longer and the time intervals became even slower, a pacemaker might eventually have become necessary.
Researchers have tried for decades to develop the transplantation of organs between different species, or xenotransplantation, to address a chronic shortage of organs. More than 3,500 people are on the waiting list in the U.S. for a heart transplant, according to a 2022 update from the American Heart Association.
Megan Sykes,
director of the Columbia Center for Translational Immunology in New York, said that although pigs are similar to humans in organ size and physiology, the EKG data illustrate that there are differences that may only emerge after doing transplants into humans.
“We have reached the point where we need human studies as well as animal studies,” Dr. Sykes said.
The Maryland team and other groups have met with the Food and Drug Administration recently to discuss how to start small clinical trials of genetically modified pig organs. The FDA has requested additional data from the Maryland team in baboons, said
Muhammad Mohiuddin,
the scientific program director of cardiac xenotransplantation at the University of Maryland School of Medicine. Dr. Mohiuddin said they plan to gather additional EKG data as part of the research.
Write to Amy Dockser Marcus at amy.marcus@wsj.com
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Monkeypox Outbreak Leaves Risks, Questions in Its Wake
As a global outbreak of monkeypox loses steam, disease researchers said they need a better understanding of how the virus spreads, and how well vaccination protects against it to predict whether it could come roaring back.
A global outbreak that gained momentum in May spread the virus much farther than it had been found previously. The virus might have reached new animal hosts, increasing the risk of future outbreaks, said epidemiologists and infectious-disease specialists. The extent to which vaccination has protected the most at-risk people from catching monkeypox is unknown.
“We can’t get lulled into this sense that monkeypox has disappeared,” said Jason Kindrachuk, an assistant professor at the University of Manitoba with a focus on emerging viruses.
Case numbers have been steadily declining since early August. Daily reported cases in the U.S. have fallen to around 40, from a peak of around 440. In Ontario, once a hot spot, health officials in the Canadian province said they are considering whether to declare the outbreak over.
The slowdown is attributed to a combination of a buildup of immunity and behavioral change, disease researchers said. The exact role each played hasn’t been determined. “They are working together in many cases,” said
David Heymann,
professor of infectious-disease epidemiology at the London School of Hygiene and Tropical Medicine.
Dozens of countries bet that Jynneos, a vaccine made by Denmark’s
Bavarian Nordic
A/S that had sat in stockpiles as a biodefense against a possible reintroduction of smallpox, could curb the spread of monkeypox, which is part of the same virus family. Studies on smallpox vaccines in Africa had found that they were around 85% effective at preventing monkeypox, but no such studies had been undertaken with Jynneos.
Early evidence from Jynneos’s use during the outbreak suggests the bet paid off. A recent study from the Centers for Disease Control and Prevention found that among men ages 18 to 49 in the U.S. who were eligible for Jynneos, case rates among the unvaccinated were 14 times higher than for those who had received at least one dose at least two weeks earlier. As of Oct. 18, around 647,400 people in the U.S. had received at least one dose of Jynneos, according to the CDC.
Immunity doesn’t fully explain the drop in cases, disease experts said. In the U.K., new cases started to fall before a vaccination campaign gained momentum, said Jake Dunning, senior researcher at the University of Oxford’s Pandemic Sciences Institute.
Early evidence indicates that use of the Jynneos vaccine has helped contain monkeypox.
Photo:
patrick t. fallon/Agence France-Presse/Getty Images
“Vaccine probably helped to bring things down and keep it as one curve, rather than more of a roller coaster,” he said.
Also driving down cases, disease experts said, was a reduction in sexual contact by men at the highest risk of catching monkeypox. In an August survey of around 800 men who have sex with men in the U.S., around half reported taking at least one measure in response to the monkeypox outbreak to limit their number of sexual contacts. Those measures included reducing one-time sexual encounters and cutting down the number of sex partners. A U.K. report published in September found that rates of two sexually transmitted diseases that also disproportionately affect men who have sex with men fell in August, suggesting that behavior change contributed to the decline in monkeypox.
Uncertainty regarding the precise roles played by immunity and behavior change mean that it is impossible to predict the trajectory of the virus, disease experts said. “If there’s a significant proportion that is attributed to behavior change, if that behavior change is not sustainable, will we see increases again?” said Anne Rimoin, professor of epidemiology at the University of California, Los Angeles, who has been researching monkeypox in the Democratic Republic of Congo for many years.
Even if the virus fades in some places, it is likely to be reintroduced through international travel because it is present in so many countries, said Emma Thomson, a professor of infectious disease at the University of Glasgow.
It hasn’t been determined whether the virus made its way into any new animal populations during the global outbreak. While monkeypox is mainly associated with forest-dwelling rodents in western and central Africa, it has been detected in other animals. An Italian greyhound in Paris caught monkeypox in June, likely from one of its owners, according to a case report in the Lancet.
“More human infections may arise because of that,” Geoffrey Smith, an expert on poxviruses at the University of Cambridge, said of potential animal reservoirs.
In 2003, around 50 people in the U.S. caught monkeypox from pet prairie dogs that had contracted the virus after sharing caging and bedding with small animals imported from western Africa. None of those cases went on to infect other people.
The global outbreak has prompted fresh calls for more research. A U.K. government-backed science funding group this week provided 2 million pounds, the equivalent of $2.2 million, for monkeypox research to 25 scientists spanning 12 universities. The researchers said their work would include detailed genomic sequencing, studies into the immune response to vaccination, developing new therapies and investigating the potential for animals to spread monkeypox.
Scientists said they want more research into monkeypox in central Africa, where a more-severe strain of the virus known as clade I circulates, to reduce transmission in countries there and to lower the risk of its sparking a more widespread outbreak. Dr. Dunning said that a global outbreak arising from the milder clade II virus raised the possibility that it could happen with clade I.
“That would be even more concerning,” he said.
Write to Denise Roland at denise.roland@wsj.com
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
Biden Administration Pares Back Covid Fight as Funding Push Falls Short
The Biden administration has stopped paying to mail out free Covid-19 tests and expects to end free vaccines for Americans after Congress dropped billions of dollars for such efforts from a government funding bill last month.
People familiar with the matter said the administration’s Covid-19 task force will remain in place ahead of an expected uptick in cases in the coming winter months. But the team will shift focus from emergency response to longer-term issues, such as boosting domestic manufacturing of personal protective equipment, researching long Covid and supporting genomic sequencing to identify variants, the people said.
The shift means that health insurers and employers will likely pay for Covid-19 vaccines, drugs and tests, as they do for most medical products and services.
The administration on Tuesday released updates to the national biodefense strategy that it said would strengthen surveillance for risky pathogens and preparedness for future outbreaks or biowarfare attacks. Some of the planning is under way, officials said, and other aspects are dependent on $88 billion in funding for pandemic preparedness and biodefense the administration has requested from Congress.
Changes in the administration’s pandemic strategy come as Covid-19 cases are climbing in Europe, which is often a precursor to rising case numbers in the U.S. And the arsenal of available treatments for people infected with Covid-19 has dipped as mutations allow variants to evade them.
The White House had sought $22.4 billion from Congress for more Covid tests, vaccines and treatments.
Photo:
Kyle Mazza/Zuma Press
“Just because we’ve ended the emergency phase of the pandemic doesn’t mean Covid is over,” said
Eric Topol,
executive vice president of Scripps Research, a medical-research facility.
After the coronavirus hit, the federal government funded development of some Covid-19 vaccines and took control of the purchase and distribution of the shots, tests and other products to guarantee sufficient supplies and make sure they went where needed.
Federal officials planned to relinquish their control to the private sector after the emergency subsided.
Eli Lilly
& Co. said in August it planned to start selling its Covid-19 antibody drug after federal supplies ran out and without new appropriations from Congress.
The federal government has also wound down its program of providing free Covid-19 tests to people who ordered them online, though it is still distributing free tests in other locations, such as long-term-care facilities and rural health clinics.
The issue is tricky for the Biden administration. President Biden had campaigned on a promise to get the pandemic under control, and the White House has sought to show progress in combating the virus. Yet many Americans have stopped masking and taking other precautions, which administration officials worry will put them at risk if a new wave emerges during the winter.
The administration had sought $22.4 billion for the Covid-19 response from Congress, and it recently extended the pandemic’s status as a public-health emergency. The White House said the money was needed to pay for more tests, vaccines—including development of new, next-generation vaccines—and treatments.
The money wasn’t included in a must-pass government-funding bill last month.
To build support for new funding, Biden administration officials have been warning about the risks to people if cases surge in the cold-weather months and there aren’t sufficient supplies of Covid-19 products because the federal government lacks the money to buy them.
“We are going into this fall and winter without adequate tests because of congressional inaction,”
Ashish Jha,
the White House Covid-19 coordinator, said recently. “You can’t fight a deadly virus without resources.”
Republicans, who opposed including the Covid funds in the spending bill, said there had not been a thorough accounting of how pandemic-relief funds had been spent. Congress had allocated about $4.6 trillion as of August, according to USASpending.gov, which tracks federal-spending information.
“You have been given astonishing amounts of money,” Sen.
Richard Burr
(R., N.C.) said at a recent congressional hearing.
Without a new appropriation, funds for the federal government to buy and supply Covid-19 vaccines are expected to run out by early next year. The administration now is looking into ways to guarantee that about 30 million uninsured people can access future boosters, treatments and vaccines. Foundations, companies and other groups have paid for non-pandemic medicines for some people who don’t have insurance.
The administration is also in talks with various stakeholders such as vaccine makers about how to transition from the government procuring vaccines to more traditional models, such as insurance coverage of shots or treatments.
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The administration is also figuring out how to move forward with efforts to develop a more durable, next-generation Covid-19 vaccine without the boost in funds. Without a vaccine that blocks both infection and transmission, the virus has been able to continue mutating to evade immunity. Members of the White House Covid-19 task force have said a nasal vaccine could be more effective because it targets immune responses where the virus first enters the body, though developing such a shot poses scientific challenges.
Anthony Fauci,
the president’s chief medical adviser, said the National Institutes of Health is giving grants totaling more than $60 million over three years to academic institutions for development of a broad coronavirus vaccine. But more funding will be necessary to finish that work, said Dr. Fauci, who leads the NIH’s National Institute of Allergy and Infectious Diseases.
Some public-health leaders and federal officials say the U.S. is falling behind countries such as China, which has introduced a vaccine that is inhaled through the nose and mouth.
“It’s a national-security risk,” said
Jennifer Nuzzo,
a professor of epidemiology and director of the pandemic center at the Brown University School of Public Health in Rhode Island. “Other countries have looked at how the U.S. is struggling.”
—Michael R. Gordon contributed to this article.
Write to Stephanie Armour at Stephanie.Armour@wsj.com
Corrections & Amplifications
The White House wants to show progress in combating the coronavirus. An earlier version of this article incorrectly said the White House wants to show progress in combating the vaccine. (Corrected on Oct. 18)
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Latest Covid Boosters Are Set to Roll Out Before Human Testing Is Completed
The Food and Drug Administration is expected to authorize new Covid-19 booster shots this week without a staple of its normal decision-making process: data from a study showing whether the shots were safe and worked in humans.
Instead, the agency plans to assess the shots using data from other sources such as research in mice, the profiles of the original vaccines and the performance of earlier iterations of boosters targeting older forms of Omicron.
“Real world evidence from the current mRNA Covid-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe,” FDA Commissioner
Robert Califf
said in a recent tweet. The FDA pointed to Dr. Califf’s tweets when asked for comment.
Clearance of the doses, without data from human testing known as clinical trials, is similar to the approach the FDA takes with flu shots, which are updated annually to keep up with mutating flu viruses.
Some vaccine experts have urged the agency to wait before clearing the new Covid-19 booster doses.
Photo:
EMILY ELCONIN/REUTERS
The approach has raised concerns, however, among some vaccine experts who have urged the agency to wait.
“I’m uncomfortable that we would move forward—that we would give millions or tens of millions of doses to people—based on mouse data,” said
Paul Offit,
an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
The comparison with flu vaccines isn’t sound, Dr. Offit said, because flu viruses mutate so rapidly that shots from one year don’t offer protection for the next, while currently available Covid-19 shots continue to keep people out of the hospital.
In addition to evaluating the boosters without clinical-trial data, the FDA won’t convene another element from its earlier Covid-19 vaccine reviews: a meeting of advisers who make recommendations whether the agency should authorize a shot.
Retooled Covid-19 boosters are similar to the original shots, including Moderna’s Covid-19 vaccines, seen last year, but have been customized to fight the latest variants.
Photo:
andrew caballero-reynolds/Agence France-Presse/Getty Images
The FDA scrapped the meeting, Dr. Califf said in his tweets on the subject, because the committee discussed the matter in June, and the agency doesn’t have new questions warranting its input.
The Covid-19 vaccines available in the U.S., which were first authorized for use in December 2020, haven’t been modified until now, though the virus they were designed to target has evolved.
The shots held up well against earlier strains, researchers found, but weren’t as effective against the newest Omicron subvariants like BA.5.
In planning for a fall booster campaign, federal health authorities in late June directed
Pfizer Inc.
and its partner
BioNTech SE,
and
Moderna Inc.
to update their shots to target BA.5, an Omicron subvariant called BA.4 and the original strain of the virus.
“We’ve validated the process several times over and continue to produce safe and effective vaccines against Covid-19,” a Pfizer spokeswoman said. Moderna said all current data indicates its shots are safe and effective.
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Human trials for Moderna’s vaccine targeting the subvariants have started, and for the Pfizer-BioNTech vaccine are expected to start this month, the companies have said. Results won’t be available, however, before the U.S. government’s planned fall booster campaign.
“If we waited for clinical-trial results, thank you very much, we’d get them in the spring. It takes time to do clinical trials,” said
William Schaffner,
professor of medicine at Vanderbilt University Medical Center and a nonvoting liaison to the Centers for Disease Control and Prevention committee that will decide whether to recommend the shots, should the FDA sign off. “This is just an updating of the previous vaccine that we used.”
The retooled shots are similar to the original shots, but customized to fight the latest variants, much like keys that are nearly identical but have slightly different ridges and valleys, said
John Grabenstein,
director of scientific communications for Immunize.org, a nonprofit that seeks to boost immunization rates.
The similarities make it very reasonable for regulators to weigh the overwhelmingly safe track record of the original series when considering the new shots, he said.
The FDA has reviewed test results from a shot that Moderna modified to target an early version of Omicron as well as the ancestral strain of the coronavirus. The study found the shot generated a significant amount of antibodies in humans compared with the company’s currently available booster shot. That shot is now approved in the U.K.
The agency also looked at human data from Pfizer and BioNTech finding that their experimental shots, updated to target an earlier form of Omicron, also boosted antibody levels significantly. The companies have submitted one of those shots to the U.K., EU and Canada for authorization, Pfizer has said.
Such findings give the FDA confidence that the newest modified shots will also work well, said a person familiar with the agency’s deliberations.
“As we know from prior experience, strain changes can be made without affecting safety,” Dr. Califf said in a tweet.
Dr. Offit, however, said he would like to wait for clinical-trial data showing the shots are effective before asking people to take them.
“If you have some evidence that this is likely to be of value, sure,” he said. “But if you don’t have evidence, and you know that the current vaccine does offer protection against severe disease, I don’t think it’s fair to ask people to take risks.”
—Jared S. Hopkins contributed to this article.
Write to Liz Essley Whyte at liz.whyte@wsj.com
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Am I Protected Against Polio? Here’s What to Know About the Vaccine
The detection of poliovirus in wastewater has prompted some Americans to ask one question: Am I protected?
The answer for most people is yes. Most Americans have been inoculated against polio, and the vaccines provide strong protection, according to the Centers for Disease Control and Prevention and scientific research.
If you got vaccinated between the early 1960s and 2000, you would have gotten the OPV, or oral poliovirus vaccine, administered in a little paper cup, on a sugar cube or by drops in your mouth. If you are younger than 22, you would have gotten the Inactivated Poliovirus Vaccine, or IPV, four doses administered in shots in the arm or leg.
If you are unsure about your status, you might need to do some sleuthing. Check with previous family doctors, high-school and college health departments, or consult childhood documents such as baby books or camp or school forms. You might also be able to check with your state’s health department. Some states have registries or immunization information systems that include adults’ vaccination records.
The poliovirus can cause flulike symptoms, such as fever and nausea, as well as more serious cases that affect the brain and spinal cord. Here’s what doctors and health officials say you need to know about protecting yourself and your family
Are my children protected against polio? What’s the polio vaccine schedule?
Most children in the U.S. have been vaccinated against polio as part of routine childhood immunizations. Children now normally get a dose of the polio vaccine when they are 2 months old, 4 months old and then between 6 months and 18 months. Children should get a fourth dose when they are 4 to 6 years old. Nationally, 94% of kindergartners are fully vaccinated, according to the CDC.
If you don’t have immunization records and aren’t sure whether your child is fully vaccinated, consult your pediatrician, your child’s school or their college. You might also be able to get a copy of your child’s vaccination record through your state’s health department or immunization registry.
How old is the polio vaccine?
The vaccine has changed several times over the years. The first effective vaccine, introduced in the U.S. in the 1950s and administered as a shot, was supplanted in the 1960s by oral vaccines that contained weakened live poliovirus. That gave way in 2000 to an injectable vaccine that doesn’t contain the live virus, to eliminate cases of the virus inadvertently transmitted by exposure to the feces of a person vaccinated with the live virus. Oral vaccines containing the live virus are still used in some countries.
Polio vaccines being administered at a high school in Needham, Mass., in 1962.
Photo:
Dick Fallon/The Boston Globe/Getty Images
How effective are the vaccines? Does the polio vaccine last a lifetime?
The IPV protects against severe disease caused by poliovirus in 99% of those who have received three of the four recommended shots and 90% of those who have gotten two shots, according to the CDC.
The fourth dose of the vaccine given to children between the ages of 4 and 6 is a booster designed to maintain their long-term immunity to polio, according to the American Academy of Pediatrics.
A study published in the journal BMC Public Health in 2016 found antibodies in 83% to 97% of more than 4,000 U.S. study subjects who were between the ages of 6 and 49. The variation depended on the type of vaccine they had received. Antibodies were found in 86% to 96% of the oldest study subjects, those ages 40 to 49, indicating that protective antibodies last for decades.
Do adults need a booster for the polio vaccine?
For most people, childhood inoculations should provide sufficient protection. The CDC recommends an extra booster shot for people who are at increased risk of being exposed to the virus, such as lab and healthcare workers who might come into contact with polio patients or contaminated specimens, and travelers planning trips to high-risk areas abroad.
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A spokeswoman for the CDC says the agency will continue to monitor the situation and provide timely updates if the risk to the general public changes.
Widespread additional booster shots aren’t necessary because of the nature of the virus and population immunity, says Jesse Hackell, chairman of the American Academy of Pediatrics committee on practice and ambulatory medicine.
“The poliovirus isn’t like Covid-19. It doesn’t mutate rapidly. It is relatively stable. It’s not likely we will see many infections in vaccinated people,” he says.
Do my children need to get revaccinated?
You don’t need to worry about revaccinating your kids if you’re sure they have been fully vaccinated. However, if you’re not certain and can’t find your child’s vaccination records, your child should be considered susceptible to the disease and get vaccinated or revaccinated, according to the CDC. Children who haven’t started their polio vaccines or who have gotten behind on their shots should start or catch up as soon as possible, health officials say.
Do I need to be revaccinated?
If you aren’t sure whether you’ve been vaccinated, the CDC says to act as if you weren’t. Unvaccinated adults should get three doses of IPV—the first dose at any time, a second dose two months later and a third dose six to 12 months after that. Adults who have had only one or two doses of the vaccine may not be sufficiently protected and should get the remaining one or two doses.
Write to Betsy Morris at betsy.morris@wsj.com
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