DIRS.INFO The most relevant business & tech news

Surveys indicate that health care is among the top priorities for voters in the November presidential election. Former President Donald Trump has given little detail about his health care vision; his running mate, JD Vance, has suggested deregulation. Each country was graded on five categories: access to care, care process, administrative efficiency, equity and health outcomes. “For far too many people, high-quality medical care is out of reach.”Dr. Adam Gaffney, a critical care physician at the Cambridge Health Alliance in Massachusetts, pointed out that the U.S. differs from the other countries in one critical area: universal health care coverage. Thursday’s report also listed solutions to the country’s health care problems, including lowering the cost of care and expanding access to coverage.

Persons: Kamala Harris, Donald Trump, JD Vance, ” Dr, Joseph Betancourt, David Blumenthal, “, ”, ” Blumenthal, Lawrence Gostin, Gostin, ” Gostin, Dr, Adam Gaffney, ” Gaffney, Reginald Williams II Organizations: U.S, Commonwealth Fund, Affordable, Australia, New, Centers for Disease Control, O’Neill Institute for National, Global Health Law, Georgetown University, United, Cambridge Health Alliance, Fund, International Health Locations: U.S, United States, Australia, Canada, France, Germany, Netherlands, New Zealand, Sweden, Switzerland, United Kingdom, Massachusetts

WASHINGTON — Sen. Bernie Sanders, I-Vt., renewed his criticism of drugmaker Novo Nordisk on Tuesday, claiming that the CEOs of major generic pharmaceutical companies have told him that they can produce and sell its blockbuster diabetes drug Ozempic for less than $100 a month. During Tuesday's roundtable, Sanders said his recent conversations with generic drugmakers revealed that Novo Nordisk's pricing is "nothing less than excess corporate greed." “They have studied the math, and they tell me that they can sell a generic version of Ozempic, the exact same drug that Novo Nordisk is manufacturing, to Americans for less than $100 a month," Sanders said. Sanders’ office declined to say which generic drug companies told him that they could sell Ozempic at a fraction of what Novo Nordisk charges. Novo Nordisk did not immediately respond to a request for comment.

Persons: WASHINGTON — Sen, Bernie Sanders, Sanders, Lars Fruergaard Jorgensen's, Jorgensen, Wegovy, Dale Folwell, Eli Lilly's Organizations: drugmaker Novo Nordisk, Capitol, Novo Nordisk, Health, Education, Labor, Pensions, Wegovy, Nordisk, Yale Locations: U.S, Novo, Denmark, Germany, United Kingdom, North Carolina

Over the last year, a growing number of cinnamon products have been recalled in the U.S. due to high levels of lead. That prompted Consumer Reports to test brands such as Badia, McCormick and Morton & Bassett, along with smaller brands, across 17 mainstream and niche grocery stores. It found high levels of lead in 12 products, with levels reaching 3.5 parts per million. Paras cinnamon powder had the most lead, according to Consumer Reports, containing 3.52 ppm. The FDA has wound down some of its response efforts to its cinnamon applesauce investigation but will continue to monitor other products in stores for high lead levels.

Persons: Food and Drug Administration hasn’t, ”, Laurie Beyranevand, “ I’m, Morton, Bassett, Adam Keating, Keating, ” Beyranevand, there’s Organizations: Consumer, Food and Drug Administration, Center for Agriculture, Food Systems, Vermont Law, Graduate School, FDA, United Nations, Food, Agriculture Organization, Cleveland Clinic, Centers for Disease Control Locations: U.S, McCormick, New York

Ron DeSantis’ administration is once again advising against the mRNA vaccines: this time in the most vulnerable residents. In updated guidance for health care providers released Thursday, the Florida Health Department and state Surgeon General Joseph Ladapo questioned the safety and effectiveness of the mRNA Covid vaccines from Pfizer and Moderna, including for older adults and people with underlying health problems. Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, said the Florida surgeon general's guidance is unnecessarily alarming people about the Covid vaccines. "The mRNA vaccines are remarkably safe," he added. The CDC currently recommends everyone ages 6 months and older get an updated Covid vaccine this fall from any of the three options.

Persons: Ron DeSantis ’, Joseph Ladapo, Nature Cardiovascular Research , Paul Offit, Offit, They’re, Isaac Bogoch, ”, Boguch, Ladapo Organizations: Florida Health Department, Pfizer, Moderna, Nature Cardiovascular Research, Children’s Hospital of Philadelphia, Food and Drug Administration, United States, University of Toronto, CDC, Emergency Locations: Florida, U.S

The Centers for Disease Control and Prevention said Thursday it has yet to identify “a clear source” of infection in a Missouri patient who tested positive for the bird flu virus despite no known contact with poultry or dairy cows. Since March, there have been 13 bird flu infections in poultry and dairy workers amid an outbreak of H5N1 spreading rapidly in dairy cows across 200 dairy herds in 14 states, according to the CDC. The patient was hospitalized, officials believe, not because of the infection but because of the patient’s underlying medical conditions. They’re also asking about the type and source of meat and dairy the patient consumed, including any raw dairy. No bird flu infections in dairy cattle have been reported in Missouri, state health officials said in a release Friday.

Persons: Nirav Shah, wasn’t, They’re, Shah, ” Shah, Demetre Daskalakis, ” Organizations: Disease Control, Prevention, CDC, ”, CDC’s National Center Locations: Missouri

After eight years of threatening to repeal the Affordable Care Act, more commonly known as Obamacare, former President Donald Trump still doesn’t have a comprehensive plan to replace it. People in the U.S. pay roughly twice as much for health care than any other nation on earth. But is it feasible to create a new health care law that reduces the escalating costs? “Right now, Obamacare is the status quo in health care,” said Larry Levitt, executive vice president of health policy at KFF, a nonprofit group that researches health policy issues. Harris has committed to extending the subsidies; Trump has remained silent.

Persons: Donald Trump, ”, John A . Graves, “, Kamala Harris, Trump, ” Trump, —, Larry Levitt, ” Levitt, Graves, Gerard Anderson, ” Graves, Jill Horwitz, David Sanders, “ We’ve, we’ve, ” Horwitz, Horwitz, Harris, Levitt, “ Trump, that’s Organizations: Trump, Vanderbilt University School of Medicine, U.S . Department of, Treasury, Congressional, “ Republicans, ACA, Republicans, Republican, Committee, House Republicans, Johns Hopkins University Bloomberg School of Public Health, Budget, Affordable, Law, Medicine, UCLA School of Law Locations: United States

The rate of weight loss with the experimental pill, called amycretin, appears to be more rapid than what’s seen for other drugs. “It’s roughly double the weight loss rate seen with current GLP-1 agonists and approaching procedural or surgical-level outcomes,” said Dr. Christopher McGowan, a gastroenterologist who runs a weight loss clinic in North Carolina. McGowan said that while the weight loss was significant, he still has concerns about how fast people lost weight. “While losing weight is seemingly the end goal, how that weight is lost matters,” he said. Spratt said she would like to know how much of the weight loss came from fat compared with muscle.

Persons: “, ”, Christopher McGowan, ” Dr, Susan Spratt, Spratt, haven’t, Martin Lange, Lange, McGowan, ” McGowan Organizations: Novo Nordisk, European Association for, Diabetes, Population Health Management, Duke Health Locations: Novo, Spain, North Carolina, semaglutide, Wegovy, It’s

The findings bring the phenomenon — and the controversy — of the latest new and powerful weight loss drugs to the youngest age group yet. The new trial looked at liraglutide, the active ingredient used in two of Novo Nordisk’s older GLP-1 drugs: Saxenda, a weight loss drug, and Victoza, a diabetes drug. So instead of looking at overall weight loss like in adult studies, they decided to focus more on BMI, which takes into account both weight and height. A spokesperson for Novo Nordisk said that it has submitted an application to the Food and Drug Administration to expand the approval of liraglutide for weight loss in children ages 6 to 11. Is 6 too young for a weight loss drug?

Persons: Roy Kim, “, ” Kim, Claudia Fox, Fox, Eli Lilly, ”, liraglutide, ” Fox, Sarah Armstrong, ” Armstrong, comorbidities, it’s, ” Wegovy, Zepbound, Shauna Levy, ” Levy Organizations: New England, of Medicine, Novo Nordisk, Cleveland Clinic, Centers for Disease Control, University of Minnesota, BMI, Food and Drug Administration, American Academy of Pediatrics, Duke University, Tulane Bariatric Center Locations: liraglutide, Ozempic, Ohio, U.S, New Orleans

A person in Missouri has been infected with bird flu, the Centers for Disease Control and Prevention said Friday. The adult, who didn't have known contact with poultry or dairy cows, was hospitalized on Aug. 22 and has recovered. At least 196 herds of dairy cows in 14 states have confirmed outbreaks of the H5 influenza virus, according to the CDC. There has been no evidence that H5N1 — the H5 virus spreading in dairy cows — has been spreading from person to person. The Missouri State Public Health Laboratory was sent a sample from the patient, Missouri health officials said in the release.

Persons: William Schaffner, Schaffner Organizations: Centers for Disease Control, Prevention, CDC, Vanderbilt University Medical Center, Missouri State Public Health Laboratory Locations: Missouri, U.S, Nashville , Tennessee

Harris hasn’t yet released many details about her strategy to wipe out medical debt, but policy experts say a newly implemented medical debt relief program from North Carolina could offer a roadmap. Roy Cooper announced that nearly 100 hospitals in the state had signed on to participate in the Medical Debt Relief Incentive Program, which he said will incentivize hospitals to eliminate $4 billion in medical debt for 2 million low- and middle-income patients over the next two years. At a campaign event last week in Raleigh, North Carolina, Harris thanked Cooper for canceling medical debt in his state, and Cooper introduced Harris at the convention Thursday. Hospitals will get additional federal funds if they forgive existing debt and move to prevent future medical debt. “I see medical debt as the most salient example of a health care system which isn’t working,” he said.

Persons: Kamala Harris, Harris, Harris hasn’t, Roy Cooper, Cooper, Neale Mahoney, “, ” Mahoney, ”, Adam Gaffney, Larry Levitt, Levitt, —, Mahoney, Harris ’, ” Levitt, Will, aren’t, Ciara Zachary, Zachary, it’s, Barack Obama, ” Zachary Organizations: Democratic, Convention, North Carolina Gov, Debt Relief, Stanford University, White, National Economic Council, Cambridge Health Alliance, Consumer Financial, White House, North Carolina Department of Health, Human Services, Medicaid, UNC Gillings School of Global Public Health, Medicare, Services, Republican, Affordable Locations: United States, Chicago, U.S, KFF, North Carolina, Raleigh , North Carolina, “ North Carolina, Massachusetts, —

The shots will be important, however, as the U.S. heads into the fall and winter, when cases usually rise again. Vaccine experts select the Covid strain in the spring for a vaccination campaign in the fall. Last fall, when CDC data showed a rise in hospitalizations, some doctors criticized the FDA for waiting too long to roll out the updated Covid vaccines. Has the FDA considered changing the fall vaccine rollout schedule, now early September? Link-Gelles highlighted the challenges in determining the optimal timing for administering the Covid vaccines.

Persons: Will, ”, John Moore, Akiko Iwasaki, Covid —, CDC epidemiologist Ruth Link, that’s, Isaac Bogoch, “, Ofer Levy, Levy, ” Levy, it’s, ” Weill Cornell's Moore, “ I’m, what’s, ” Moore Organizations: Weill Cornell Medical College, “, Centers for Disease Control, Food and Drug Administration, Yale University, FDA, CDC, NBC, University of Toronto, Precision, Boston Children’s Hospital Locations: U.S, hospitalizations

If approved, it would have been the first new treatment for PTSD in more than two decades. Lykos Therapeutics had asked the FDA to approve the drug as part of a treatment regimen, given alongside talk therapy. Lykos Therapeutics had asked the FDA to approve the drug as part of a treatment regimen, given alongside talk therapy. Lykos added that the agency expressed concerns similar to those raised during the advisory committee meeting in June. Davis Institute for Psychedelics and Neurotherapeutics, said he doesn’t think the FDA decision will hinder the development of psychedelics for mental health disorders, including PTSD.

Persons: “, ”, Holly Fernandez Lynch, Lykos, Amy Emerson, Sarah Silbiger, David Olson, Olson, ” Olson, Brian Barnett, ” Barnett, Joe Biden, Biden, Robert Califf, ” Lynch, psychedelics, David Rind Organizations: Drug Administration, Therapeutics, FDA, Lykos Therapeutics, University of Pennsylvania, Davis Institute for Psychedelics, Cleveland Clinic, Clinical Locations: U.S, White Oak, Md, Ohio

The Food and Drug Administration’s “hands-off approach” to food additives, including those found in ultraprocessed foods and energy drinks, may allow unsafe ingredients to enter the nation’s food supply, according to the authors of an editorial published Thursday. While food manufacturers can request an FDA review of new ingredients before they are added to products — and they sometimes do — they are not required to do so. From 1990 to 2010, an estimated 1,000 substances were labeled GRAS by manufacturers and were used without notifying the agency, Pomeranz said, citing earlier research. Since then, she added, there have likely been many more ingredients added to the nation’s food supply without the FDA’s oversight. “We have no idea how many substances are in the food supply based on this self-GRAS mechanism,” Pomeranz said.

Persons: ”, Jennifer Pomeranz, “, Pomeranz, ” Pomeranz, Xaq, ” Frohlich, Richard Mattes, ” Mattes, “ It’s Organizations: American, of Public Health, FDA, European Union, NYU School of Global Public Health, Auburn University, Purdue University Locations: India, Japan, GRAS, Alabama, Indiana

☆ Fungal infections are becoming more common. Why isn't there a vaccine?
▼ + stars: | 2023-02-10 | by ( Berkeley Lovelace Jr. | ) www.cnbc.com time to read: +4 min

Ritesh Shukla | Getty ImagesFungal infections are becoming more common in the United States, but unlike illnesses caused by bacteria or viruses, there's no vaccine to protect against a fungal threat. Fungi cause a wide range of illnesses in people, from irritating athlete's foot to life-threatening bloodstream infections. In the U.S., fungal infections are responsible for more than 75,000 hospitalizations and nearly 9 million outpatient visits each year, according to the Centers for Disease Control and Prevention. Despite the growing threat, there are currently no licensed vaccines — in the U.S. or abroad — to prevent fungal infections. Fatal fungal infectionsNorris said that the ultimate goal would be to develop a single vaccine that protects against all fungal infections.

They have soared in popularity over the last year, in part from social media attention and billionaires like Elon Musk touting the drugs’ weight loss effects. Ozempic is not approved for weight loss, but doctors sometimes prescribe it off-label for that purpose. Harper took Ozempic off-label for weight loss from May until November (she paused while moving to Washington state but plans to start again). For Yazeed, weight loss was not the reason she went on Ozempic, nor was it a goal. He hasn't experienced side effects or weight loss from Ozempic, he said, but he recognizes that isn't true for everyone.

A provision in the Inflation Reduction Act that allows Medicare to negotiate prices on the costliest prescription drugs each year will likely save the U.S. billions of dollars — as long as the drug industry doesn't interfere, according to a study published Friday in JAMA Health Forum. They identified 40 drugs that would have been selected by Medicare for drug pricing negotiation under the Inflation Reduction Act's provision. The researchers simulated negotiated prices by using a so-called ceiling price, which is at least 25% off the average price drug manufacturers charge to nongovernment entities, like private health insurance providers. The researchers found that the Medicare drug negotiation provision would have saved the U.S. $26.5 billion, or 5% of all drug spending, during those three years. It plans to release a list of the first 10 drugs it will target for drug pricing negotiation by September.

The Food and Drug Administration on Friday proposed easing blood donation guidelines for gay and bisexual men. Under current rules, the FDA allows donations from gay and bisexual men if they haven't had sex with another man for three months. In a draft proposal posted to the agency's website, the FDA said the new rules would allow anyone to donate blood — regardless of gender or sexual orientation — as long as they haven't engaged in certain sexual behaviors in the last three months. Blood donors who report having a new sexual partner or more than one sexual partner would be asked about their sexual activity over the last three months under the new guidelines. The FDA will not reach a final decision immediately.

An advisory committee to the Food and Drug Administration on Thursday raised doubts about shifting toward a yearly Covid booster for most adults and children, saying too many questions about the virus still remain unanswered. The FDA convened its Vaccine and Related Biology Products Advisory Committee to discuss how the Covid vaccines may change moving forward. On Monday, the agency published briefing documents proposing annual Covid shots that target the latest variants of the virus — an approach similar to the yearly flu shot. Some committee members said they would prefer to make multiple yearly meetings on the Covid vaccines the norm. In a unanimous vote, the committee recommended using the bivalent formula in all Covid vaccines moving forward, not just for booster shots.

☆ Updated Covid boosters cut the infection risk from XBB.1.5 subvariant by half, CDC finds
▼ + stars: | 2023-01-25 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +4 min

The updated Covid boosters reduce the risk of Covid infection from the predominant omicron subvariant by nearly half, according to early data published Wednesday by the Centers for Disease Control and Prevention. The findings are “quite reassuring,” Dr. Brendan Jackson, the head of the CDC’s Covid response, said on a call with reporters Wednesday. As of last Wednesday, only about 15% of people in the U.S. had received an updated booster, according to CDC data. People who were vaccinated but had not received the updated booster were compared to those who got the updated booster in the previous two to three months. People who got the updated boosters are probably "much more likely to wear masks indoors or restrain their travel or not go to indoor restaurants," he said.

Researchers saw similar declines in cognitive performance when people replaced vigorous exercise with six minutes of light physical activity or seven minutes of sleeping. But the opposite was also seen to be true: Exercising instead of sitting boosted cognitive performance. Replacing sitting or lying down with nine minutes of vigorous exercise was linked to a more than 1% boost in cognition scores, the study found. "Physical activity is linked to a whole host of benefits, and so you really want to promote as much regular physical activity as possible," said Biswas, who wasn't involved with the research. Mitchell, the study author, noted that light activity is still preferable to sitting.

☆ FDA proposes simplifying the Covid vaccine schedule, making it similar to the flu shot
▼ + stars: | 2023-01-23 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +3 min

Food and Drug Administration advisers will meet Thursday to discuss simplifying the Covid vaccination schedule, allowing most people to get the currently available booster, regardless of how many doses they had received before that. The FDA is proposing skipping over that primary series, meaning that most unvaccinated individuals could go ahead and get the latest booster shot if they decided to get a Covid vaccine. The FDA’s proposal, experts say, would greatly simplify the Covid vaccination schedule in the United States — aligning it more closely with the annual flu shot. In another similarity to the flu shot, the FDA is considering whether the Covid vaccine should be updated at least once a year, based on what strains are in circulation. Dr. Anna Durbin, a vaccine researcher at Johns Hopkins University in Baltimore, said simplifying the Covid vaccine schedule makes sense.

☆ What happens when you stop taking a weight loss drug? Many people gain the weight back.
▼ + stars: | 2023-01-19 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +4 min

She didn't find success until her doctor prescribed Wegovy, a weight loss drug, in August 2021. But it all stopped in February, when Bayandor's health insurance denied her coverage, forcing her to stop taking the medication. Artemis BayandorBayandor's experience isn't uncommon: Widespread shortages of Wegovy, a popular weight loss aid, have forced some people in the U.S. to stop taking it, leading them to gain some — or all — of their weight back. "When you're at that max weight loss, your body's hunger hormones are the highest," she said. In May, an unrelated thyroid issue landed her in the hospital and forced her to stop taking Wegovy.

A newly approved Alzheimer's drug will be available to patients in the coming days, according to its maker, the Japanese pharmaceutical company Eisai. While Leqembi offers hope to patients and their families, experts say that there are still some key unanswered questions about the drug, including about its safety and effectiveness. Besides questions about who will benefit the most, there are also questions about how long the drug will benefit patients. About 17% of the Leqembi group experienced brain bleeds, compared with 9% in the placebo group. The reports of brain bleeding and brain swelling "may only be the tip of the iceberg," he said.

☆ People with diabetes struggle to find Ozempic as it soars in popularity as a weight loss aid
▼ + stars: | 2023-01-12 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +5 min

For the past two years, she's managed the condition using a drug called Ozempic, which helps people with diabetes keep blood sugar levels in check. "It's been very frustrating," Largent-Phillips, of Florida, said of the shortage, adding that her blood sugar levels have been fluctuating as she's had to change medications. If the body doesn't use it well, that sugar stays in the blood, resulting in high blood sugar levels. His wife, Gerilynn, who is a nurse, said his blood sugar levels have gone back up since being off Ozempic. Largent-Phillips, of Florida — who has been documenting her experience on TikTok — said that for now, she has to be vigilant about monitoring her blood sugar levels.

A key adviser to the Food and Drug Administration's vaccine panel is questioning whether more Covid booster shots are necessary for healthy, younger people. The FDA later backed the vaccine panel, authorizing a new formulation of the booster shots. “The people who are talking about why young people need it are missing the point,” he said, referring to the booster. Levy, the director of the Precision Vaccines Program at Boston Children’s Hospital, continues to encourage Covid boosters for everyone who is eligible. Relatively few people in the U.S. have had updated boosters.

Search resuls for: "Berkeley Lovelace Jr"

25 mentions found