The adult who died had a severely compromised immune system based on other health issues, so it's unclear at this point if monkeypox even played a role.
The increase in cases among kids here locally has health officials urging high-risk adults to be careful around them.
Dallas County now has 32,000 doses of the monkeypox vaccine available to combat the outbreak that has now spread to children.
Health officials won't reveal the ages of the three cases among the juvenile patients other than they are under the age of 18.
The health department said it shows that the disease can be contracted through non-sexual contact.
"That's why we ask adults to be very careful around children if you have any symptoms or monkeypox," said Christian Grisales with Dallas County Health and Human Services. "What you need to do immediately is to isolate, get tested and if you get qualify for the vaccinated immediately."
DCHHS said it has no plans to widen the criteria for the vaccine which remains available only to certain categories of men who engage in sex with other men.
"Should you keep your kids home from school? No. Monkeypox is very rarely a fatal disease," said Dr. James Pinckney.
Pinckney, founder and CEO of Diamond Health, said the few cases among children should not be considered a serious concern.
But he said it does mean encouraging good hygiene and close monitoring for symptoms.
"I think what we should do is continue to be cautious, monkeypox has spread to individuals that typically aren't contracting disease," Pinckney said. "When the outbreak first started, it was caused by sexual contact and now we're seeing more and more cases where people have come in direct contact with monkeypox or someone infected with monkeypox and it is spreading in a different manner."
Dallas County currently has 526 confirmed cases, only five of those women.
That's nearly 100 more cases than this time last week but health officials believe the numbers show that the spread is slowing.
Enlarge/ A sign announcing monkeypox vaccination is set up in Tropical Park by Miami-Dade County and Nomi Health on August 15, 2022, in Miami.
A severely immunocompromised adult who tested positive for monkeypox has died in Texas, marking the first US death connected to the global outbreak, state health officials said Tuesday.
For now, health officials are not yet sure if monkeypox was the cause of the person's death. The adult died on August 28 in Harris County, which includes Houston. Harris County officials said in a news release that an autopsy is in process, and the results will be released in the next few weeks.
"Monkeypox is a serious disease, particularly for those with weakened immune systems," John Hellerstedt, commissioner of the Texas Department of State Health Services, said in the release. "We continue to urge people to seek treatment if they have been exposed to monkeypox or have symptoms consistent with the disease."
In a White House press briefing Tuesday afternoon, Jennifer McQuiston, deputy director of CDC's Division of High Consequence Pathogens and Pathology, highlighted the uncertainty around the death and rarity of fatalities from monkeypox in this outbreak.
"It's our understanding this patient also had underlying health conditions and had a number of things going on," McQuiston said. "I think that additional investigation is needed to know what role monkeypox may or may not have played in their death." In the meantime, she emphasized that death "remains very rare" and "we have mitigation efforts in place to prevent monkeypox." These include vaccination, testing, and treatment.
Of the international deaths reported, some have involved people with compromised immune systems, but others have not. A 41-year-old man in Brazil who died with monkeypox reportedly had lymphoma and was immunocompromised. But, two people who died in Spain from monkeypox-associated encephalitis (inflammation of the brain) were not thought to be immunocompromised and were considered previously healthy.
(CNN)Statins are an important tool to prevent major cardiovascular problems, but many patients stop taking them because of side effects, including muscle pain. However, for more than 90% of patients on statins who experience muscle pain, the statin is not the cause of the pain, according to a study published Monday in The Lancet and presented at the European Society of Cardiology Congress in Spain.
"Our results confirm that, in the majority of cases, statin therapy is not likely to be the cause of muscle pain in a person taking statin therapy," said the study, led by authors from Oxford Population Health and the Medical Research Council Population Health Research Unit at the University of Oxford. "This finding is particularly true if the treatment has been well tolerated for a year or more before developing symptoms."
The authors conducted a meta-analysis of 19 randomized double-blind trials of statin regimens versus placebos. All trials had over 1,000 participants and at least two years of follow up. They also looked at four double-blind trials of more and less intense statin regimens.
Study author Colin Baigent, a professor of epidemiology at University of Oxford, said that there have been many non-randomized studies which don't involve any kind of placebo or random allocation to a statin that have produced "really quite extreme" estimates of how much muscle pain statins cause.
"This has put patients off starting statins, or made them stop treatment when they develop muscle pain because they simply look in the paper and they see that statins cause lots and lots of muscle pain and so they stop," Baigent said during a Science Media Center briefing. "We were really trying to deal with that problem."
The new study says that "even during the first year of a moderate-intensity statin regimen, it is likely to be the cause in only approximately one in 15 patients who report muscle symptoms, rising to approximately one in 10 in those who are taking a more intensive regimen.
"In other words, the statin is not the cause of muscle symptoms in more than 90% of individuals who report such symptoms."
The authors found that in the first year, statin therapy produced a 7% relative increase in muscle pain or weakness, but there was no significant increase after that. The increased risk was already present within the first three months after treatment was assigned.
There were reports of at least one episode of muscle pain or weakness from 27.1% of patients assigned a statin versus 26.6% of those who had a placebo during a median 4.3 year follow up.
In the trials looked at by the authors, they say that statin therapy, during the first year of use, caused approximately 11 additional muscle pain reports per 1,000 patients.
"What we conclude is that there are two things that we need to do as a profession, as a society," Baigent said in the briefing. "The first thing is, we need to do a better job of managing patients who report muscle pain when they are taking a statin, because there's a tendency in patients to end up stopping the statin and that has a detrimental effect on their long term health. And the second thing we need to do is we need to look at the information that is available to patients in package inserts."
He noted that if people were better informed about the real risks of muscle pains, then they might stay on statin therapy for longer.
The study does have some limitations, including considerable heterogeneity in the methods used for muscle symptoms, some adverse event data not being available and most of the studies not excluding participants who may now be categorized as statin intolerant.
In a commentary published alongside the study, Dr. Maciej Banach, a cardiologist at the Medical University of Lodz and Polish Mother's Memorial Hospital Research Institute in Poland, wrote that the possible side effects of statins shouldn't be a consideration when starting treatment.
"It should be strong emphasized that the small risk of muscle symptoms is insignificant in comparison with the highly proven cardiovascular benefits of statins," he wrote.
The US Centers for Disease Control and Prevention says heart disease is the leading cause of death for men, women and those of most racial and ethnic groups in the United States. There is one cardiovascular disease death every 34 seconds in the country.
Last week, the US Preventive Services Task Force announced its latest guidance on the use of statins to prevent a first heart attack or stroke.
The guidelines are more conservative than those put out by other groups, such as the American College of Cardiology. They recommend statins in adults 40 to 75 who have at lease one risk factor of cardiovascular disease and a 10% or high risk of a heart attack in the next 10 years.
According to the American Heart Association, "statins are recommended for most partients and have been directly associated with a reduction in the risk of heart attack and stroke. Statins continue to provide the most effective lipid-lowering treatment in most cases."
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A three-in-one drug combo can help people with a history of heart attacks stay healthy, new research shows. The randomized clinical trial found that people who took the bundled medication, also known as a polypill, went on to experience fewer heart attacks, strokes, or cardiovascular-related deaths than those given standard care. The findings may pave the way for the polypill to become a common heart treatment moving forward.
The basic concept of the polypill has been around for over two decades. Many medical conditions require taking multiple medications, which can be a time-consuming task and added burden for patients. So by taking these individual drugs and putting them into a single pill, the theory goes, you can make it easier for patients to adhere to their treatment. There are already standard treatments for some conditions, such as HIV, that are given as a combination medication. But the original inspiration for the polypill was as a way to improve the treatment of cardiovascular disease. And now, this strategy seems to have passed its biggest test yet with flying colors.
In 2015, the “Secondary prEvention of CardiovascUlar disease in the Elderly”—or SECURE—trial began. It was meant to test out a fixed dose combination of three generic drugs already known to improve heart disease outcomes: aspirin, a common statin known as atorvastatin, and the ACE inhibitor ramipril. The combo drug is manufactured by the pharmaceutical company Ferrer and is approved in the EU and some other countries as Trinomia.
About 2,500 heart attack survivors over the age of 65 were included in the trial, which was sponsored by the EU and conducted in seven European countries. The patients were randomized to either receive Trinomia or standard treatment. They were then tracked over the next five years, with the researchers primarily looking for incidents of cardiovascular-related death, along with nonfatal heart attacks, strokes, and blocked coronary arteries that needed urgent treatment.
Ultimately, 12.7% of patients in the control group experienced at least one of these outcomes, compared to 9.5% of those in the polypill group, amounting to a 24% reduction in risk. When it came to deaths in particular, those who took the polypill were 33% less likely to die than control patients. And other data showed that people on the polypill were more likely to keep taking it as recommended—exactly as hoped. The study’s findings were published Friday in the New England Journal of Medicine.
“Treatment with a polypill containing aspirin, ramipril, and atorvastatin within 6 months after myocardial infarction resulted in a significantly lower risk of major adverse cardiovascular events than usual care,” the authors wrote.
The SECURE trial is the first of its kind to test the polypill for heart attack survivors. Many experts in the field have been waiting for the study’s findings to emerge, and it’s this sort of gold standard data that can lead to the wider acceptance of a novel treatment approach in medicine. Given these results, it’s likely that more countries will decide to approve Trinomia. (Notably, the U.S. has not approved Trinomia, though it has approved other polypills.) So the drug may very well someday become a new standard of care for survivors at risk of future heart complications.
“The SECURE study findings suggest that the polypill could become an integral element of strategies to prevent recurrent cardiovascular events in patients who have had a heart attack. By simplifying treatment and improving adherence, this approach has the potential to reduce the risk of recurrent cardiovascular disease and death on a global scale,” said senior study author Valentin Fuster, the physician-in-chief at Mount Sinai Hospital in New York as well as the general director of the Spanish National Center for Cardiovascular Research, in a statement released by Mount Sinai.
New Covid-19 booster shots are expected to be authorized this week by the FDA.
Photo: Constanza Hevia H. for The Wall Street Journal
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 PfizerInc. and its partner BioNTech SE, and ModernaInc.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.”
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Although thousands of Americans have tested positive for monkeypox since the outbreak began, this past spring, only a handful of pediatric monkeypox cases have been identified across the U.S.
Across the country, at least 18 children in 10 states have now tested positive for monkeypox, according to state and local health officials, and little is known about most of these cases, due to concerns over patient privacy.
One of these cases has been identified in King County, Washington, where local officials recently confirmed that an infant in their community had tested positive for the monkeypox virus.
The child has been hospitalized and receiving treatment for the virus in recent days after being exposed to monkeypox through an infected family member, officials said. The child did not become infected in a school, child care, or other public setting.
Officials from Seattle Children's Hospital confirmed to ABC News that their teams are currently caring for the infected baby, who is under the age of 1.
Dr. Danielle Zerr, medical director of infection prevention at Seattle Children's Hospital, told ABC News that although the infant is still hospitalized, the patient is doing better, and officials are currently creating a discharge plan. The patient has been in the hospital for several days, according to Zerr.
A colorized transmission electron micrograph shows monkeypox particles (red) found within an infected cell (blue), cultured in the laboratory that was captured and color-enhanced at the NIAID Integrated Research Facility in Fort Detrick, Md.
NIAID via AP
A concerning rash prompted the parents to initially seek care for the infant, she said.
"The main thing that the patient was experiencing was the rash and complications of the rash, so, concern of super infection of the rash. Those were really the reasons that the patient came into the hospital," Zerr said.
"The rash can be quite pronounced in many patients, especially as it evolves over time. And I think that sort of a rash on a child is going to raise people's antennae, and lead a parent to seek care," she added.
In addition to "supportive care" to ensure the patient is hydrated and well-cared for, the hospital has been treating the young patient with TPOXX, a Food and Drug Administration-approved treatment for smallpox, that has been made available for children under special expanded access protocols.
"Once we had the confirmed test result, we started that antiviral for the patient and it did really seem like there was some improvement in the days following starting the antiviral," Zerr said. "The rash has shown some improvement with treatment. So that's a great sign, and [the] patient seems to maybe be feeling a little bit better."
The hospital, and local public health authorities, have been working to roll out contact tracing to determine whether any staff, patients or families have been exposed to the virus. A hospital representative also told ABC News, in a statement, that "appropriate isolation" has been "instituted" for some staff. Anyone who may have been exposed will be contacted.
Individuals who have been exposed to the positive case will also be offered the monkeypox vaccine, Zerr said.
Earlier this month, in an effort to protect the youngest Americans, the FDA issued an emergency use authorization that allows children under 18 who are at high risk of monkeypox to be vaccinated.
In July, the Centers for Disease Control and Prevention warned in a health alert that there is some preliminary evidence to suggest children younger than 8 years old could develop more severe illness, if infected with monkeypox.
Zerr noted that it is understandable that given the news of the emergence of pediatric monkeypox cases, parents may feel anxious. However, she stressed that at this time, it is still quite rare for children to contract the virus, and it is unlikely the children will become infected in settings like schools, as most transmission is occurring between close contact.
Dr. Danielle Zerr, medical director of infection prevention at Seattle Children's Hospital, speaks to ABC News on Aug. 26. 2022 about a child getting monkeypox.
ABC News
"I think the thing that we focus on is that they've so far been very few pediatric cases," Zerr said. "It does generally require closer contact, so it's not the kind of illness that is likely to be transmitted in school settings... It's very, very low risk to kids who are going about their usual activities like attending school and other activities like that."
Should a child be exposed to monkeypox, Zerr advised that parents stay in contact with their child's pediatrician and be on the lookout for any suspicious rashes.
"If you know your child's been exposed to a confirmed case of monkey pox, then you do really want to be keeping a very close eye on them," Zerr said. "I think that that would be a reasonable strategy to keep your kid at home if they develop new signs and symptoms of illness. And then, if they develop a rash, especially a pustular rash, connect with your child's primary care provider.
Thus far, the majority of cases in the current monkeypox outbreak have been detected in gay, bisexual or other men who have sex with men. However, health officials have repeatedly stressed that anyone can contract the virus, and although the risk of monkeypox remains low among young children and adolescents, they too can test positive if they have been exposed.
Across the globe, more than 47,000 cases of monkeypox have now been reported, including 17,400 cases in the U.S. -- the most of any country, according to the CDC.
Monkeypox primarily spreads through prolonged skin-to-skin contact with infected people's lesions or bodily fluids, according to the CDC. The virus can also spread through bedding and towels contaminated by infected lesions.
In addition to lesions, which can appear like pimples or blisters, the most common symptoms associated with monkeypox are swollen lymph nodes, fever, headache, fatigue and muscle aches.
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The patients turning up at clinics often have a range of symptoms that are not typical of the infection. Some of the infected seem to have no symptoms at all.
Early in the monkeypox outbreak, a man in his 20s arrived at an emergency department in Northern California, tiny blisters on his lips, hands and back. Within 12 hours, doctors diagnosed him with monkeypox.
That’s where their certainty ended. The patient did not have fever, aches, weakness, pain or other symptoms typical of the disease. He did not know when or how he had become infected. He had not had sexual contact with anyone for months, he said, and had not touched — as far as he knew — anyone with pox, as the lesions are called, or other symptoms.
At the onset of the outbreak, scientists thought they knew when and how the monkeypox virus was spread, what the disease looked like and who was most vulnerable. The 44,000 cases identified worldwide have upended many of those expectations.
Monkeypox patients have turned up with what looked like mosquito bites, pimples or ingrown hairs, not the large pustules usually associated with the infection. Some did not even have visible lesions but felt excruciating pain when swallowing, urinating or emptying their bowels.
Some had headaches or depression, confusion and seizures. Others had severe eye infections or inflammation of the heart muscle. At least three of the six deaths reported so far were linked to encephalitis, an inflammation of the brain.
“We really are seeing a very, very wide range of presentation,” said Dr. Boghuma Titanji, an infectious disease physician at a clinic in Atlanta that serves people living with H.I.V.
Scientists now know that the monkeypox virus lurks in saliva, semen and other bodily fluids, sometimes for weeks after recovery. The virus has always been known to spread through close contact, but many researchers suspect the infection may also be transmitted through sex itself.
The California patient had virus in his throat, but no respiratory symptoms, and in his rectum, but without pain or pox. The case underscores other research suggesting that the virus may be spread even by people with atypical or asymptomatic infections, said Dr. Abraar Karan, who diagnosed the patient and published a recent case report.
In another study, also published this month, anal swabs of 200 men without symptoms turned up 13 who were positive for monkeypox. Only two of them later developed symptoms.
“It’s no longer correct to say it can’t be transmitted asymptomatically,” said Dr. Chloe Orkin, an infectious disease physician at Queen Mary University of London. “I think that it means that our working model of how it’s spread is incorrect.”
Early in the outbreak, the C.D.C. said that “people who do not have monkeypox symptoms cannot spread the virus to others.” The agency changed that phrasing on July 29 to say that “scientists are still researching” the possibility of asymptomatic transmission.
In a statement to The New York Times, an agency spokeswoman acknowledged recent evidence that asymptomatic cases were possible but said that it was still uncertain whether people without symptoms could spread the virus and that more research was needed.
When the first few dozen cases of monkeypox emerged in Europe, spreading of the virus through sexual contact and genital lesions came as a surprise to many scientists. But it shouldn’t have.
Those cases were the first reported in Nigeria in 40 years, and the World Health Organization helped the country “mount the local response, with the goal to control spread,” said Fadela Chaib, a spokeswoman for the organization.
But the unusual symptoms of the patients went unnoticed. “If what is happening in Europe and the global North had not happened, I don’t think that paper would be discussed,” said Dr. Dimie Ogoina, who led a study describing the cases.
“We have this disease that’s more than 50 years old, and there’s a lot of things we still don’t know — and that’s because the condition has been largely restricted to Africa,” he said.
In late May, Dr. Orkin contacted several international colleagues to put together what turned out to be the largest study of monkeypox. Hundreds of physicians from 16 countries eventually contributed information about the cases they were seeing.
They changed the reporting forms as the disease came into sharper focus, adding the possibility of a single pox, lesions in the throat or rectum, and medical complications — features that were “not included in international case definitions of monkeypox,” Dr. Orkin said.
The resulting analysis of 528 patients was published in The New England Journal of Medicine on July 21. A few days later, Dr. Orkin alerted several national health agencies, knowing the findings should alter the case definitions that doctors consult when diagnosing patients.
Suzie Howell for The New York Times
Britain’s Health Security Agency and the European Centers for Disease Control both replied the same day. Britain added some of the new symptoms to its monkeypox case definition three days later. The European agency invited Dr. Orkin to present her findings.
In an interview in late July, Dr. Orkin reflected that during pandemics, public health agencies are considered the experts, and officials educate doctors on the disease and its treatment. Yet it’s clinicians who see the symptoms firsthand.
“It seems to me that consulting with clinicians in the field may have been helpful,” she said. National health agencies have been slow to understand the virus’s many manifestations in the current outbreak, she added.
Dr. Orkin is president of the Medical Women’s Federation, past president of the British H.I.V. Association and a governing council member of the International AIDS Society. “I’ve got a loud voice,” she said, “and I’m still finding it difficult to get a response.”
Senior members of the W.H.O. responded to Dr. Orkin on Aug. 2, asking to discuss the cases that she and her colleagues had described. The C.D.C. did not reply to Dr. Orkin but added rectal pain and bleeding, along with other new symptoms, to its guidance to clinicians on Aug. 5.
The new C.D.C. definition mentions lesions in the mouth but does not describe the range or importance of pox in the mouth, eyes and urethra. In its statement, the agency said it was aware of Dr. Orkin’s findings and had begun studies “that will help us better understand the range and importance of lesions at these and other bodily sites.”
Based on reports that the virus persists in semen for weeks, Britain recommended that men who recover from monkeypox use condoms for 12 weeks after infection, a tacit acknowledgment that this may be a transmission route.
The C.D.C. has not gone along, saying that “researchers are working with our partners to learn if, and how frequently, the virus is being spread through contact with semen.”
The agency should advise men to wear condoms for a few weeks, as Britain has, Dr. Karan said. “We do not know how long people can transmit through semen,” he said. “I think they should communicate that clearly.”
For patients, outdated case definitions and guidance can have serious implications. Cameron French, 30, was exposed to the virus on July 6. Two weeks later, he developed a sore throat, head and body aches, painful urination and three bumps — on his face, a thigh and an elbow.
Yet on his first visit to a clinic, on July 25, his doctor did not connect the symptoms. She told him the bump on his thigh was an ingrown hair and tested him for a urinary tract infection.
He went back three days later. This time, the doctor agreed to test him for monkeypox. After he tested positive, he had to push once again, this time to get the antiviral tecovirimat.
Mr. French said he was most frustrated by the lack of guidance on how to distinguish a potential new pox from a pimple so he could end his monthlong isolation. “That’s been a big ambiguous question mark,” he said. “That’s been hard.”
The mysterious illness that has sickened and killed dozens of dogs across Michigan has been identified by state officials as canine parvovirus.
The announcement from the Michigan Department of Agriculture and Rural Development comes after one animal shelter in Ostego County reported at least 30 animals falling victim to the illness, despite testing negative for it.
Canine parvovirus spreads through fecal matter and includes symptoms such tiredness, loss of appetite and diarrhea.
The disease primarily affects elderly canines and dogs below the age of 2. (iStock)
"Canine parvovirus is a severe and highly contagious disease in dogs, but the Michigan Department of Agriculture and Rural Development and veterinary professionals have extensive experience with this virus," State Veterinarian Nora Wineland said in a statement.
"We have a highly effective vaccine available to help protect dogs from the virus. Dogs that are not fully vaccinated against this virus are the most at risk," she continued. "Dog owners across Michigan must work closely with their veterinarians to ensure their dogs are appropriately vaccinated and given timely boosters to keep their pets safe and healthy."
Michigan officials say a "highly effective" vaccine is available to help protect dogs from canine parvovirus. (iStock)
Michigan State University Veterinary Diagnostic Laboratory director Kim Dodd described the situation as "complex because although the dogs displayed clinical signs suggestive of parvovirus, they consistently test negative by point-of-care tests performed in clinics and shelters.
"While those tests are valuable in the clinical setting, they are not as sensitive as the diagnostic tests we can perform here in the laboratory," she added. "We continue to further characterize the virus in hopes of better understanding why those animals were testing negative on screening tests."
The canine parvovirus does not affect other pets, Michigan officials said. (iStock)
But Michigan officials also stressed that "Canine parvovirus is NOT contagious to people or other species of domestic animals."
Fox News' Andrea Vacchiano contributed to this report.
Patients given a combination “polypill” after a heart attack were more likely to stick to their regimens, researchers reported.
Heart disease kills more people than any other condition, but despite advances in treatment and prevention, patients often do not stick to their medication regimens. Now researchers may have found a solution: a so-called polypill that combines three drugs needed to prevent cardiovascular trouble.
In what is apparently the largest and longest randomized controlled trial of this approach, patients who were prescribed a polypill within six months of a heart attack were more likely to keep taking their drugs and had significantly fewer cardiovascular events, compared with those receiving the usual assortment of pills.
The participants also experienced one-third fewer cardiovascular deaths, although their overall risk of death from all causes was not significantly changed.
The study of more than two thousand heart patients, who were followed for three years, was published Friday morning in The New England Journal of Medicine, as the findings were presented at the European Society of Cardiology Congress in Barcelona.
The study is the culmination of 15 years of work by researchers led by Dr. Valentin Fuster, director of Mount Sinai Heart at Mount Sinai Hospital in New York City, and general director of the National Center for Cardiovascular Research in Spain.
“Combination pills are easier for the physician and for the patient, and the data are pretty clear — it translates into a benefit,” said Dr. Thomas J. Wang, chair of the department of internal medicine at UT Southwestern Medical Center, who was not involved in the research but wrote an editorial accompanying the study.
“It’s easier to take one pill versus multiple pills, and it’s easier to take them once a day than multiple times a day.”
The availability of a polypill also appears to nudge physicians to write prescriptions more in line with practice guidelines, Dr. Wang added: “Under ordinary circumstances, physicians often under-prescribe medications that should be given.”
The polypill combines a blood-pressure medication, a cholesterol-lowering drug and aspirin, which helps prevent blood clots. The idea was first floated two decades ago in a more radical form: Advocates proposed giving a daily polypill to everyone once they turned 55, saying it would slash cardiovascular events globally by 80 percent.
That notion was roundly criticized and quickly laid to rest. But the benefits of a polypill for patients at risk of heart problems have been tested in numerous studies since. Polypills are already available to treat other medical conditions, such as H.I.V. and hepatitis C, Dr. Wang noted.
The polypill used in the study has not been approved by the Food and Drug Administration and is not available to patients in the United States right now. Dr. Fuster said the results of the new trial would be submitted to the agency shortly in an effort to obtain approval.
He called the results of the new study “striking,” and said the benefit of the polypill for prevention rivaled that of low-dose aspirin, which is now routinely prescribed to people who have already had a heart attack or other cardiovascular event.
And since participants became even more likely to keep taking the polypill over time, he said, “The potential results could be even better with more follow-up.” Several studies have shown that only about half of patients, or even less, take all their medications as instructed.
The new study, a randomized controlled clinical trial, enrolled just under 2,500 patients at 113 sites in Spain, Italy, France, Germany, Poland, the Czech Republic and Hungary.
All enrollees had survived a heart attack within the previous six months. They were either older than 75, or at least 65 with other health conditions like diabetes or kidney disease. Overall, about 80 percent had high blood pressure, nearly 60 percent had diabetes, and over half had a history of smoking.
Almost all of the patients were white, and fewer than one-third were women. A vast majority were not high school graduates.
Half of the trial participants received the polypill, while the other half received usual care. There were several types of polypills, and treatment was tailored to individual patients.
All of the polypills contained 100 milligrams of aspirin, but doctors could choose between three doses of ramipril, a blood pressure drug, and between two doses of atorvastatin, a cholesterol-lowering medication.
Adherence to medication was higher among the polypill users, and increased over time, the researchers found. At six months, 70.6 percent of the polypill group were sticking to their regimens, compared with 62.7 percent of those taking usual assortment of pills.
At 24 months, about three-quarters of the patients were still taking a polypill, compared with 63.2 percent of the patients taking the usual pills.
Over three years, 12.7 percent of the patients taking an assortment of pills experienced another heart attack or stroke, or died of a cardiac event or needed urgent treatment to open a blocked artery, compared with 9.5 percent of patients taking a polypill, for a relative reduction in risk of 24 percent.
There was no difference between the two groups in overall mortality, however, as the reduction in cardiovascular deaths in the polypill group was offset by deaths from other causes.
Asked why the polypill was effective, and why adherence to medication was so poor, Dr. Fuster said, “People forget when there are a number of pills to be taken, they don’t take all of them or they take none.”
Although most patients stick to treatment in the immediate aftermath of a heart attack, adherence drops off after the first few months, he said.
The polypill may be less expensive to produce and distribute than a series of different pills. The findings may help make cardiovascular prevention therapy more accessible, especially to individuals in low-income and middle-income countries.
Although the patient cohort in the European study was very homogeneous, other studies have looked at polypill use in minority and underserved populations.
Dr. Wang led a study of a polypill prescribed for primary prevention of cardiovascular disease in a low-income, mostly Black group of adults in Alabama. Adherence was very high, and the participants saw greater decreases in cholesterol and blood pressure than those receiving medications in their usual form.
A review of eight studies that included over 25,000 patients, also led by Dr. Wang, found significantly improved adherence to drug regimens with a polypill and significant reductions in cardiovascular risk factors.
Overall mortality declined among patients assigned to take polypills, as did serious cardiac events, particularly among those who were at low risk to begin with and had no previous heart disease.
The deadly virus affecting dozens of dogs in Northern Michigan has been discovered, and we want to make sure pet parents have all the latest information on the mysterious illness that has puzzled experts for weeks.
State agricultural officials have determined the illness is parvovirus, a highly contagious and often fatal disease that causes acute gastrointestinal illness and is usually found in unvaccinated puppies.
Symptoms include bloody diarrhea and poop, vomiting, and lack of energy.
So far, most of the dogs affected have been under the age of 2, and all of the dogs didn’t have a history of complete vaccination, according to experts.
To find out how pet parents in the area can protect their dogs, and what that has to do with vaccinations, we spoke to Dr. Hilary Jones, veterinarian and chief veterinary officer at DodoVet, for her insight on parvovirus.
What to know about the deadly dog virus in Michigan
Parvovirus is passed from dog to dog, so to keep dogs safe, vaccination is critical.
Pet parents in the area should make sure their dogs have been given one of the core vaccines, DHPP, which covers distemper, parvo, parainfluenza and adenovirus.
“Fully vaccinated means that puppies have completed the three series of shots that are often given at 8, 12 and 16 weeks,” Dr. Jones told The Dodo. “Adult dogs get vaccinated every one to three years for DHPP.”
While the best way to protect against this new suspected parvovirus strain is to make sure your dog is up to date on his vaccines, Dr. Jones has a few more suggestions for pet parents:
Avoid high-traffic areas like parks, dog parks, ponds and lakes.
Don’t let your dog drink from communal water bowls.
If your pet is not fully vaccinated, avoid interactions with other dogs.
Make sure you clean up after your dog, as feces can help spread the disease.
Also monitor your dog for GI signs like vomiting or diarrhea, or changes in energy and appetite (and if you see these signs, reach out to your vet immediately).
“Canine parvovirus is a severe and highly contagious disease in dogs, and veterinary professionals have extensive experience with this virus," State Veterinarian Nora Wineland told The Detroit News. “We have a highly effective vaccine available to help protect dogs from the virus. Dogs that are not fully vaccinated against this virus are the most at risk. ... Protecting Michigan’s dogs is a team effort.”
If you live in Michigan or a surrounding state and suspect your dog is suffering from any parvovirus symptoms (bloody diarrhea and poop, vomiting and lack of energy) it’s best to contact your vet immediately. We hope this situation clears up quickly, and we’ll keep you up to date on all the latest information as we learn more about this deadly virus.
The World Health Organization (WHO) has revealed that there have been a number of confirmed breakthrough cases of monkeypox—cases that occur despite vaccination.
“The vaccines are thought to be approximately 85% effective in preventing monkeypox,” WHO said.
Infectious disease experts weigh-in on ways to protect yourself from the virus.
Breakthrough cases of monkeypox are now a reality. And while there is a vaccine for the virus, it turns out it’s not as effective as you might think.
The World Health Organization (WHO) has revealed a number of breakthrough cases of monkeypox after preliminary reports detail the efficacy of the vaccine. In a press briefing, Rosamund Lewis, M.D., C.M., WHO’s technical lead for monkeypox, discussed reports of breakthrough cases in people who received a preventative vaccine following exposure to the virus.
“We have known from the beginning that this vaccine would not be a silver bullet, that it would not meet all the expectations that are being put on it and that we don’t have firm efficacy data or effectiveness data in this context,” said Dr. Lewis. She continued to explain that what we are beginning to see is that some cases are being reported, perhaps as breakthrough cases, either following post-exposure vaccination, which is meant to reduce disease severity or following preventive vaccination, which is meant to reduce infection.
“We don’t yet have any randomized control trials specifically on that but the fact that we’re beginning to see some breakthrough cases is also really important information because it tells us that the vaccine is not 100% effective in any given circumstance, whether preventive or post-exposure.” Dr. Lewis added that we cannot expect 100% efficacy at the moment based on this emerging information.
Dr. Lewis reiterated that what we’re seeing are breakthrough cases and that every person who wishes to lower their own level of risk has many interventions at their disposal, which include vaccination where available, avoiding activities where they may be at risk, reducing their number of sexual partners, avoiding group sex or casual sex, and, specifically, when a vaccine is administered, waiting until that vaccine has the time to produce a maximum immune response.
“In the case of [monkeypox] vaccine, this is two weeks after the second dose…People do need to wait until the vaccine can generate a maximum immune response but we don’t yet know what the effectiveness will be overall,” reminds Dr. Lewis.
How effective is the monkeypox vaccine?
“The vaccines are thought to be approximately 85% effective in preventing monkeypox,” says Richard Watkins, M.D., an infectious disease specialist and professor of medicine at the Northeast Ohio Medical University.
According to the CDC, when properly administered before an exposure, vaccines are effective at protecting people against monkeypox. ACAM2000 and JYNNEOSTM (also known as Imvamune or Imvanex) are the two currently licensed vaccines in the United States to prevent smallpox, which are also being used to prevent monkeypox.
The CDC explains that past data from Africa suggests that the smallpox vaccine is at least 85% effective in preventing monkeypox.
Should I be worried about breakthrough monkeypox cases?
There still isn’t enough information to understand how often these breakthrough infections are occurring post-vaccination. But, the efficacy of the vaccines is an indicator that breakthrough cases will happen.
“There needs to be rigorous analysis of data to make sure enough time has elapsed for the vaccine to be expected to be protective,” says Amesh Adalja, M.D., senior scholar at Johns Hopkins Center for Health Security. He adds that many of the breakthrough cases “might’ve occurred in individuals who only received a single dose of the vaccine, which is going to be less efficacious than that approved two-dose regimen.”
Dr. Watkins reminds us that “no vaccine is 100% effective, so breakthrough cases from monkeypox are to be expected.” With that being said, he assures that breakthrough cases are uncommon. That said, the monkeypox outbreak is ongoing and how many people will develop breakthrough cases is difficult to predict.
How can I best protect myself against monkeypox?
There are basically two things that you can do to best avoid contracting the virus: avoid close contact with infected persons and get vaccinated.
“Vaccination remains the best means of protection against monkeypox for those in the at-risk group,” says Dr. Adalja.
Dr. Watkins also strongly recommends avoiding close contact with someone infected with monkeypox. “Those infected need to isolate until the rash is gone and a new layer of skin has formed.”
The bottom line
While we are starting to see some breakthrough cases of monkeypox, the vaccine is still highly effective at preventing severe disease and infection. If you belong to an at-risk group or you believe that you have been exposed to someone infected with monkeypox, consult your doctor right away to see if the vaccine is right for you.
This article is accurate as of press time. However, some of the information may have changed since it was last updated. While we aim to keep all of our stories up to date, please visit online resources provided by theCDCandWHOto stay informed on the latest news. Always talk to your doctor for professional medical advice.
Madeleine, Prevention’s assistant editor, has a history with health writing from her experience as an editorial assistant at WebMD, and from her personal research at university. She graduated from the University of Michigan with a degree in biopsychology, cognition, and neuroscience—and she helps strategize for success across Prevention’s social media platforms.
