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Go to Blogger edit html and find these sentences.Now replace these sentences with your own descriptions.This theme is Bloggerized by Lasantha Bandara - Premiumbloggertemplates.com.
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New data shows that the number of abortions fell by more than 10,000.
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Dana and John Pope had never heard of kratom before their 23-year-old son, Ethan, was found dead on the kitchen floor in his apartment last December with his puppy by his side.
Extracted from the leaves of a tropical tree native to Southeast Asia, kratom is used to make capsules, powders and liquids and is marketed as an aid for pain, anxiety and drug dependence. In Georgia and some other states, it’s often sold at gas stations and smoke shops.
A Georgia Bureau of Investigation autopsy found Ethan Pope died from mitragynine intoxication and had no alcohol or illegal drugs in his system. Mitragynine is a psychoactive compound in kratom, according to the U.S. Food and Drug Administration.
Dana and John Pope have filed a wrongful death lawsuit against about a dozen people, companies and organizations connected to the manufacturing, marketing and sale of kratom.
They don’t know how long their son had been using kratom, but he must have been experiencing adverse effects, Dana Pope said at a news conference Thursday. In his apartment, they found a to-do list with one task that stuck out: Stop taking kratom.
The lawsuit was originally filed in May and an expanded version was filed earlier this week. The lawyers who filed the suit said they want to send a message that kratom is unsafe for human consumption.
“The kratom industry claims that it is a natural, completely safe substance that can lead to greater health and well-being,” lawyer Matt Wetherington said. “However, even if that were true, the kratom that is sold in the United States is ultra-concentrated and is more similar to heroin or other opioids.”
Proponents of kratom say it’s a safe, natural herbal supplement that can help manage pain and ease the effects of opioid withdrawal.
Ethan Pope bought bottles of O.P.M.S. Liquid Kratom in the days before his death. Liquid kratom shots are especially dangerous, “because they are intended to provide consumers with higher concentrations of mitragynine, substantially increasing the risk of overdose and death,” the lawsuit says.
The lawsuit alleges that producers of kratom illegally import it by misclassifying it as an agricultural product and have begun producing, marketing and selling concentrated forms of kratom.
Kratom acts as a stimulant in low doses and a sedative at high doses. It can be addictive and can cause hallucinations, delusions and confusion, according to the U.S. Drug Enforcement Administration.
The FDA has not approved any uses for kratom and “continues to warn consumers not to use any products labeled as containing kratom.” It issued an import alert in 2014 allowing the seizure of kratom as an unapproved drug.
“There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom,” the agency says on its website.
U.S. health officials said in a report released in 2019 that kratom was a cause in 91 overdose deaths in 27 states. While most of those who died had also taken heroin, fentanyl or other drugs, kratom was the only substance detected in seven of the deaths.
Another 2019 study found that calls to U.S. poison control centers about kratom skyrocketed more than 50-fold, from 13 calls in 2011 to 682 calls in 2017.
The defendants in the lawsuit were negligent in their “duty to prevent foreseeable injuries arising from the use of their products,” the lawsuit says. That duty includes making truthful statements about the risks and side effects of kratom and ensuring that the product is consistent in its purity and potency, it states.
Ethan Pope used the kratom products for their intended purpose and the defendants “did not provide adequate warnings and instructions that an ordinary consumer would expect, and the inadequate warnings made the kratom products more dangerous than an ordinary consumer would expect,” the lawsuit says.
Optimized Plant Mediated Solutions, or O.P.M.S., which the lawsuit says manufactured the kratom that Ethan Pope used, is named as a defendant. The company did not immediately respond to a request for comment submitted Thursday via a form on its website.
The lawsuit also alleges that the American Kratom Association, a trade organization, invites consumers to rely on “false, misleading, and materially incomplete medical claims” regarding kratom. It has pushed legislation in numerous states that it says is meant to protect consumers but that actually facilitates the selling of an unpredictable and dangerous drug, said Drew Ashby, a lawyer for the Popes.
“It is unfortunate and disappointing that Georgia is one of the few states in the country that allows this to be sold legally with actual legislation,” Ashby said, referencing a 2019 law that restricted the sale of kratom to people over 18 and implemented labeling requirements that the lawsuit says are not followed.
Daniel Delnero, a lawyer for the association denied the claims against it.
“The American Kratom Association is a consumer advocacy group dedicated to education and responsible use of Kratom. It was improperly added to this lawsuit, and we will vigorously defend the spurious claims against it,” he said in an emailed statement.
The lawsuit asks for damages and seeks a jury trial.
The White House’s top COVID-19 official says he still expects the protection against the Omicron BA.5 variant offered by the new COVID vaccine boosters will be better than their predecessors, despite two studies that appear to question that assumption. In an interview with CBS News, Dr. Ashish Jha also said he does not think another imminent change to the COVID boosters will be needed.
Jha’s comments come after researchers found, in two smaller groups of volunteers, data suggesting that the updated boosters provide only similar but not superior antibody boosts against BA.5, compared to the original vaccine formula.
“I do think that the protection against infection is going to be better than if you were getting the original prototype booster,” Jha told CBS News.
Jha said he was not surprised about the new study results and praised the two scientists — Dan Barouch of Harvard Medical School and David Ho of Columbia University — who led each of the research teams behind the preliminary findings.
However, he predicted that the “well-controlled trials” with “larger samples” now underway from vaccine makers could yield more favorable results about the boosters’ performance.
The studies did turn up higher antibody responses after the updated booster, Jha said, even if they were too small to be statistically significant.
“I expect we’re going to see at least that size benefit, probably bigger, in the Pfizer and Moderna studies,” Jha said.
Jha’s comments are in line with expectations previously voiced by federal health officials from across the Biden administration, who have argued for months that the updated boosters being rolled out this fall would outperform the original formulations.
The new boosters are known as “bivalent” because they include both a component targeting the original “prototype” strain and another aimed at the BA.4 and BA.5 variants.
Early data from animals tested with the new shots had been promising. Previous versions targeting other strains trialed on humans also suggested a bivalent formulation would also offer at least an “incremental” improvement, health authorities concluded.
And with new strains on the rise in the U.S. and around the world, officials hoped the new vaccines would do better at fending off a feared winter surge of the virus.
“The one I am paying most close attention to in the United States is BQ.1.1, which is a BA.5 derivative, and based on all of the things that we understand about immunology, your protection against BQ.1.1 is going to be significantly better after a BA.5 bivalent [booster],” said Jha.
But this week, two studies seemed to upend those expectations.
“There was no significant difference in neutralization of any SARS-CoV-2 variant tested between individuals who received a fourth monovalent vaccine and those who received a fourth dose of a bivalent vaccine,” concluded one study, which has yet to be peer-reviewed, posted by the team led by Ho.
Scientists drew blood from people roughly a month after they had gotten the new shot and tested their antibody responses against
“pseudoviruses” — essentially mock-ups of different variants, including BA.5.
Barouch’s team performed a similar experiment against BA.5. They turned up only “a modest and nonsignificant” improvement from the updated boosters in their study, which has also yet to be peer-reviewed.
“If that very small difference holds up in a much larger study, then a much larger study might actually say that’s a statistically significant difference. The question is, is it clinically relevant? And I don’t believe that that level of difference is clinically relevant,” Barouch said in an interview.
Barouch said a phenomenon called immune imprinting may turn out to be the culprit for the disappointing immune response to the updated booster.
Immune imprinting, also known as “original antigenic sin,” refers to the theory that the initial exposure people had to an earlier strain of the virus — either from infection or vaccination — may hinder the ability of the body to produce antibodies to new strains.
Both the vaccine companies and health officials had previously downplayed the hurdle this phenomenon might pose to the new shots.
Barouch acknowledged there was a possibility that responses against BA.5 could improve after more weeks following the updated booster, but cautioned that we have seen antibodies decline in the months after previous mRNA COVID shots.
His team also measured another part of the immune response from T cells. Those were “not substantially” boosted by additional shots from either the bivalent or original formulations.
“We all talk about antibodies, the focus has been on antibodies, but there’s two sides to the immune system: antibodies and T cells. And we believe that both are important for protection against severe disease,” said Barouch.
The new studies come as the Biden administration is preparing for key decisions about the country’s COVID-19 vaccine supply.
Millions of doses of the original monovalent vaccine, which is still being used for primary series shots, are due to expire over the coming months. Boosters also still need to be greenlighted for the youngest age group: children down to 6 months old.
The federal government’s supply of the updated boosters is on pace to run out next year as a result of a stalled COVID funding request on Capitol Hill, which will prompt a shift to the private market.
FDA and CDC officials have said that they expect to decide over the winter whether and how to update the vaccine regimen for the future.
Those decisions will rest, in part, on how the updated shots perform.
“We will have our BA.4/5 data by year end and ours will be statistically powered,” Moderna spokesperson Chris Ridley said in an email.
Ridley also pointed to results from a previous bivalent formulation by Moderna targeted at the BA.1 variant, which was published in The New England Journal of Medicine a few weeks ago.
Pfizer and their German partner BioNTech announced finding “positive early data” from their updated shots earlier this month. Pfizer spokesperson Steve Danehy said they expect to “have additional data in coming weeks” on the shots.
“We’re going to want to make policy decisions based on more definitive, larger studies, which are coming soon,” Jha said.
An 80-year-old doctor is set to run his 45th Marine Corps Marathon, only missing the race twice since first competing in 1977. Dr. Glenn Geelhoed has run more than 170 marathons on all seven continents, but his true passion is saving lives through his nonprofit, Mission to Heal.
Mission to Heal brings medical supplies and training to the most remote corners of the world.
“We have done what we can to help not just to heal the folk that we see immediately by cutting and sewing, but by teaching those skills such that it continues beyond us,” Geelhoed told CBS News.
He said that his medical missions are inspired by his runs.
“The marathon is a good metaphor because it takes discipline, it takes effort, and it takes a commitment,” he said. “That’s what health care is.”
Asked how much longer he plans on running these punishing races, Geelhoed told CBS News, “Until the next one. And the next one and the one after that.”
The side effect, a buildup of fluid in the brain, led to the death of one of the children and presents a grave setback for a class of personalized medicine.
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