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FDA approves Upadacitinib for Crohn's disease in adults
The U.S. Food and Drug Administration (FDA) has approved Upadacitinib for treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers.
This is the seventh FDA approval for RINVOQ across rheumatology, dermatology, and gastroenterology, where it is now indicated in both ulcerative colitis and Crohn's disease.
"AbbVie recognizes the need for more treatment options for Crohn's disease that can help address both rapid relief of symptoms along with the visible reduction of intestinal lining damage," said Thomas Hudson, M.D., senior vice president of research and development, chief scientific officer, AbbVie. "We're pleased that RINVOQ may provide this relief and is now available to treat Crohn's disease."
Endoscopic Response and Clinical RemissionThe approval is supported by data from two induction studies, U-EXCEED and U-EXCEL, and the U-ENDURE maintenance study.1 Statistical significance was achieved for the co-primary endpoints and key secondary endpoints with RINVOQ 45 mg in the induction studies and RINVOQ 15 mg and 30 mg in the maintenance study compared to placebo.
- Endoscopic response: In the two induction studies, 34% and 46% of patients treated with RINVOQ 45 mg achieved endoscopic response (defined as a decrease of greater than 50% from the baseline Simplified Endoscopic Score for CD [SES-CD] or for patients with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline) at week 12, respectively, compared to 3% and 13% of patients receiving placebo.1 In the maintenance study, 28% and 41% of patients treated with RINVOQ 15 mg and 30 mg achieved endoscopic response at week 52, respectively, compared to 7% of patients receiving placebo.
- Clinical remission: In the two induction studies, 36% and 46% of patients treated with RINVOQ 45 mg achieved clinical remission (defined as a Crohn's Disease Activity Index [CDAI] of less than 150) at 12 weeks, respectively, compared to 18% and 23% of patients receiving placebo. Additionally, in the maintenance trial, 42% and 55% of patients treated with RINVOQ 15 mg and 30 mg achieved clinical remission at 52 weeks, respectively, compared to 14% of patients receiving placebo.1
"Symptoms of moderately to severely active Crohn's disease can be disruptive and uncomfortable for patients, so relief as early as possible is key. Given the progressive nature of the disease, endoscopic response is just as important," said Edward V. Loftus, Jr., M.D., professor of medicine in the division of gastroenterology and hepatology at Mayo Clinic in Rochester, Minnesota and U-EXCEL study investigator.* "Based on the clinical trial results, treatment with RINVOQ shows both early and long-term symptom relief along with evidence of a visible reduction of damage to the intestinal lining caused by excess inflammation."
"I started feeling better within a couple weeks. My symptoms lessened – less cramping, firmer stools, and the bleeding stopped. When I stopped bleeding, I had more energy," said Danielle, who is living with Crohn's disease and received RINVOQ in an open-label treatment arm in one of the clinical trials.
Rapid Clinical Response and Corticosteroid-free Clinical Remission
- Onset of clinical response based on CDAI was observed as early as two weeks in U-EXCEED and U-EXCEL, with a greater proportion of patients achieving clinical response at week 2 in RINVOQ-treated patients compared with placebo.
- This is the first clinical program of an approved moderate-to-severe Crohn's disease treatment to require steroid taper during the induction period, with a corticosteroid taper regimen initiated at week 4. Corticosteroid-free clinical remission (defined as discontinuation of steroid and achievement of clinical remission per CDAI [CDAI less than 150]) among patients on steroid at baseline was achieved at week 12 by more patients treated with RINVOQ in U-EXCEED and U-EXCEL (30% and 40%, respectively) compared to placebo (11% and 13%, respectively). In U-ENDURE, corticosteroid-free remission (defined as no corticosteroids for 90 days prior to week 52 and achievement of clinical remission) was achieved by more patients treated with RINVOQ 15 mg and 30 mg (42% and 53%, respectively) compared to 14% with placebo.
RINVOQ Safety Considerations
- Overall, the safety profile observed in patients with Crohn's disease treated with RINVOQ was consistent with the known safety profile for RINVOQ in other indications.
- RINVOQ may cause serious side effects, including:
- Serious infections. RINVOQ can lower ability to fight infections. Serious infections, some fatal, occurred, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses.
- Increased risk of death in people age 50+ with at least 1 heart disease risk factor.
- Cancer and immune system problems. Increased risk of some cancers, including lymphoma and skin. Current or past smokers have higher risk for lymphoma and lung cancer.
- Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50+ with at least 1 heart disease risk factor, especially in current or past smokers.
- Blood clots, some fatal, in veins of the legs or lungs and arteries. This occurred more often in people 50+ with at least 1 heart disease risk factor.
- Serious allergic reactions. Do not take if allergic to RINVOQ or its ingredients.
- Tears in the stomach or intestines; changes in certain laboratory test results.
2 years 2 months ago
Gastroenterology,Medicine,Gastroenterology News,Medicine News,Top Medical News
Health & Wellness | Toronto Caribbean Newspaper
Will you continue to embrace the false belief of Black people not needing therapy?
BY TRISHA SMITH “I’m not telling any White people my business!” This was my response to my aunt after a year of being in an abusive relationship in my early 20’s. I didn’t know where that response came from, or why I said it, all I knew was that Black people didn’t go to therapy, […]
The post Will you continue to embrace the false belief of Black people not needing therapy? first appeared on Toronto Caribbean Newspaper.
2 years 2 months ago
Spirituality, #LatestPost
AbbVie’s Rinvoq Lands FDA Approval as First Oral Drug for Crohn’s Disease
FDA approval of blockbuster AbbVie drug Rinvoq makes it the first oral therapy for moderately to severely active Crohn’s disease. The regulatory nod is the seventh for the drug, which belongs to a class of therapies called JAK inhibitors.
FDA approval of blockbuster AbbVie drug Rinvoq makes it the first oral therapy for moderately to severely active Crohn’s disease. The regulatory nod is the seventh for the drug, which belongs to a class of therapies called JAK inhibitors.
2 years 2 months ago
BioPharma, Daily, Pharma, Top Story, AbbVie, biopharma nl, Clinical Trials, Crohn's disease, FDA, North Chicago, Rinvoq
PAHO/WHO | Pan American Health Organization
Nueva publicación de la OPS busca apoyar a los países a fortalecer la atención de emergencias para salvar vidas en las carreteras
New PAHO publication aims to help countries strengthen emergency care to save lives on the road
Oscar Reyes
18 May 2023
New PAHO publication aims to help countries strengthen emergency care to save lives on the road
Oscar Reyes
18 May 2023
2 years 2 months ago
FDA approves Rinvoq as first oral therapy for moderate to severe Crohn’s disease
The FDA has approved AbbVie’s Rinvoq as a once-day pill intended for the treatment of adult patients with moderate to severe Crohn’s disease who are intolerant, or have had an inadequate response, to one or more TNF inhibitors.Upadacitinib (Rinvoq, AbbVie)v is now indicated for both Crohn’s disease and ulcerative colitis.
Additionally, this decision marks the drug’s seventh FDA approval across gastroenterology, dermatology and rheumatology.“AbbVie recognizes the need for more treatment options for Crohn’s disease that can help address both rapid relief of
2 years 2 months ago
The Abortion Pill Goes Back to Court
The Host
Julie Rovner
KFF Health News
Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.
The fate of the abortion pill mifepristone remains in jeopardy, as an appellate court panel during a hearing this week sounded sympathetic to a lower court’s ruling that the FDA should not have approved the drug more than two decades ago. No matter how the appeals court rules, the case seems headed for the Supreme Court.
Meanwhile, in the partisan standoff over raising the nation’s debt ceiling, a key sticking point has emerged: whether to add a work requirement to the state-federal Medicaid program. Republicans are adamant about adding one; Democrats point out that, in the few states that have tried them, red tape has resulted in eligible people wrongly losing their health coverage.
This week’s panelists are Julie Rovner of KFF Health News, Sandhya Raman of CQ Roll Call, Rachel Roubein of The Washington Post, and Victoria Knight of Axios.
Panelists
Sandhya Raman
CQ Roll Call
Rachel Roubein
The Washington Post
Victoria Knight
Axios
Among the takeaways from this week’s episode:
- Hopes among abortion rights advocates for continued access to mifepristone dimmed as the three judges on the 5th Circuit Court of Appeals signaled they are skeptical of the FDA’s decades-old approval of the drug and of the Biden administration’s arguments defending it. Lawyers debated whether the Texas doctors challenging the drug had been harmed by it and thus had standing to sue. If the original ruling effectively revoking the drug’s approval is allowed to stand, the case could open the door to future legal challenges to the approval of controversial drugs.
- Two more states in the South are moving to restrict abortion, further cutting access to the procedure in the region. In North Carolina, a new Republican supermajority in the state legislature enabled the passage this week of a new, 12-week ban, as lawmakers in South Carolina consider a six-week ban.
- In Congress, the top Senate Republican said he will not back one senator’s months-long effort to hold up Pentagon nominations over a policy that supports troops and their dependents who must travel to other states to obtain an abortion.
- Envision Healthcare — which spent big in 2019 to fight legislation prohibiting some surprise medical bills — has filed for bankruptcy protection more than a year after the law took effect and cut into its bottom line. But a federal lawsuit from a group of emergency room physicians against Envision may move forward. The lawsuit claims the private equity-backed company is in violation of a California law banning corporate control of medical practices, and it could carry major consequences for the growing number of practices backed by private equity firms across the country.
- Monica Bertagnolli has been nominated to lead the National Institutes of Health. Currently the director of the National Cancer Institute, she will need to be confirmed by the Senate, which hasn’t confirmed an NIH chief since before the passage of the Affordable Care Act in 2010. Meanwhile, Sen. Bernie Sanders’ stewardship of a key health committee is causing delays on even bipartisan efforts.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: The Washington Post’s “A 150-Year-Old Law Could Help Determine the Fate of U.S. Abortion Access,” by Dan Diamond and Ann E. Marimow.
Victoria Knight: The New York Times’ “World Health Organization Warns Against Using Artificial Sweeteners,” by April Rubin.
Rachel Roubein: CBS News’ “Thousands Face Medicaid Whiplash in South Dakota and North Carolina,” by Arielle Zionts of KFF Health News.
Sandhya Raman: CQ Roll Call’s “A Year After Dobbs Leak, Democrats Still See Abortion Driving 2024 Voters,” by Mary Ellen McIntire and Daniela Altimari.
Also mentioned in this week’s episode:
KFF Health News’ “ER Doctors Vow to Pursue Case Against Envision Despite Bankruptcy,” by Bernard J. Wolfson.
click to open the transcript
Transcript: The Abortion Pill Goes Back to Court
KFF Health News’ ‘What the Health?’
Episode Title: The Abortion Pill Goes Back to Court
Episode Number: 298
Published: May 18, 2023
[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]
Julie Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent at KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, May 18, at 10 a.m. As always, news happens fast and things might have changed by the time you hear this. So here we go. We are joined today via video conference by Rachel Roubein of The Washington Post.
Rachel Roubein: Hi. Thanks for having me.
Rovner: Victoria Knight of Axios.
Victoria Knight: Hi. Good morning.
Rovner: And Sandhya Raman of CQ Roll Call.
Sandhya Raman: Hi, and good morning, everyone.
Rovner: Lots and lots of health news this week, so we will dive right in. We’re going to start with abortion because there is so much breaking news on that front. On Wednesday, a three-judge panel of the 5th Circuit Court of Appeals in New Orleans held a hearing on the Biden administration’s appeal of a Texas ruling that the FDA was wrong when it approved the abortion pill mifepristone more than 22 years ago. The panel, which was randomly chosen from an already pretty conservative slate there in the 5th Circuit, appeared to be even more anti-abortion than most of the judges on that bench. So, Sandhya, you listened to this whole thing. What, if anything, did we glean from this hearing?
Raman: I think we gleaned a lot of things and a lot of things I think we have predicted from the start. I think going into this, looking at the various judges’ records, they have ruled on anti-abortion cases in the past in the favor of that. You take that in with a grain of salt. And from watching the arguments, it seemed like they were fairly skeptical of the challenge and FDA’s approval of mifepristone and the subsequent regulations. You could kind of see through the questioning the kinds of things that they were asking and just pretty skeptical of just a lot of the things that were being said by DOJ [the Department of Justice] and by Danco there yesterday. So —
Rovner: Yeah, we should say that the lawyer for the FDA had one sort of round of presentation and questions. And then the lawyer from Danco, the company that makes mifepristone, had another. And they were pretty tough on both of them.
Raman: Yeah, and I thought it was interesting because when we were listening to the arguments, the DOJ lawyer and the Danco lawyer were kind of arguing a lot of the time just that there shouldn’t be standing, that there isn’t necessarily proof in any of the filings that any of the doctors that that were suing have really had harm due to the FDA’s role. It was kind of down the road. I think one thing that Harrington, the judge for the DOJ, had said, that was the FDA approving a drug does not mean that anyone has to prescribe it, it does not mean anyone has to take it, that the fact that if you were treating someone after the fact, that’s a few steps down the line. And so that was kind of like a messaging thing that they were doing kind of over and over again. And then when we got to the Alliance Defending Freedom, which is representing the conservative doctors, Erin Hawley had said, you know, they are affected both physically and she said emotionally, which was interesting, kind of looking at that. And so it’ll depend on how the judges rule. I think that there were definitely some signs throughout the arguments about this not being as unprecedented and that the FDA is not untouchable in terms of the courts weighing in on regulation.
Rovner: If you were just listening to it, you didn’t sort of know all of this. And remember, these were two Trump-appointed judges and a George W. Bush-appointed judge who has a history of ruling in favor of anti-abortion efforts. But they were saying that, “Well, people sue the FDA all the time. You know, what’s the difference here?” Well, the difference here is nobody has ever sued the FDA saying that they were wrong to approve something 20 years ago. Nobody’s ever tried to get a drug taken off the market that way. There’s obviously lots of litigation against the FDA for the way it does some of its thing. I mean, it’s often little things and then people sue each other with the FDA caught in the middle — drugmakers and lots of patent suits. I was surprised that the appeals court judges took issue with what everybody I think acknowledges is a correct claim that this is unprecedented and this could open the door to other challenges to other drugs for any reason — you know, someone doesn’t like them. I mean, these doctors are not saying that they’ve prescribed this drug and women have taken it and had bad reactions. They’re saying that possibly, if someone takes it and has a bad reaction, that they would have to treat that person and that that would harm their conscience, even though, as the lawyers made it clear, no one has ever forced these doctors to take care of anyone against their conscience because there are already laws that protect against that. So it was very roundabout in a lot of ways.
Raman: I think one thing that they had mentioned was that, you know, some of the cases cited in the filings were, you know, someone had taken an imported version of a mifepristone, not the one that Danco made, and then someone else had been recommended not to take the drug but still took the drug and then had side effects related to that. But there is another thing that kind of stuck out to me, was when Judge [James] Ho had asked would the FDA adhere to whatever the final court decision was? And that was a little striking to me. And then the FDA had said, you know, we will. And they cited that they had signed an affidavit last year saying that they’re going to agree to whatever the final decision is. But there were a lot of parts of the case that were just very unusual compared to the other cases that I have watched on this or any other part of health care, I think.
Rovner: Although in fairness to the judges, I mean, there was — a lot of legal experts were saying that the FDA does have enforcement authority to determine what it’s going to enforce and what it isn’t. And Justice [Samuel] Alito, when he actually challenged the Supreme Court’s stay of the original ruling — Justice Alito questioned about whether FDA would even follow if this drug was deemed unapproved. So that’s at least been coming up as a discussion. Let’s move on because it could be weeks or even months before we hear back from this panel, and we will obviously keep watching it. There’s been plenty of action in the states, too, this week — not that surprising because it’s May and lots of state legislatures are wrapping up their sessions for the year. But we should point out that particularly North and South Carolina are acting on abortion because they’ve been two of the last states in the South where abortion had remained both legal and pretty much broadly available. That’s changing as of this week, though, isn’t it?
Roubein: That’s changing in North Carolina, for sure, after this week. The Republicans there have supermajorities as of April; a Democrat in the House switched to the Republican Party. And what they did there is they overrode a veto from Democratic Gov. Roy Cooper. And this new bill, which the main provisions go into effect July 1, will restrict abortions at 12 weeks in pregnancy. And now in South Carolina, it’s still a little bit to be determined. The House passed a bill last night which would restrict abortions after fetal cardiac activity’s detected — roughly six weeks. Now they’re sending that bill back to the Senate, which had already passed it. But they made some changes. And it’s not clear whether some of the Republican female senators who oppose a near-total ban will be in favor of these changes. So that one’s a bit up in the air.
Rovner: And obviously, the 12 weeks in North Carolina is going to be important because there are a lot of women coming from other states now to North Carolina and clinics are getting backed up. It is a time thing for women to sort of be able to get themselves together, often get child care, get time off from a job, have to find a hotel in most cases, and go to another state. So it’s going to turn out to be an issue.
Roubein: I think one of the provisions abortion rights groups are pointing to there is, because this is a 12-week ban, so roughly 90% of abortions are allowed to continue, but what Democrats really pointed out was that the bill requires an in-person visit 72 hours before obtaining an abortion. So that could kind of restrict people, as you mentioned, Julie, from being able to take that time and come in from out of state in North Carolina, which has become a destination for abortions.
Rovner: All right. Well, I want to circle back to something that’s been going on for a while in the U.S. Senate. We talked about it back in March. Alabama Republican Sen. Tommy Tuberville is single-handedly holding up many military promotions to protest a Biden administration policy that allows members of the military in states with abortion bans both time off and travel funds to obtain an abortion in another state. Defense Secretary Lloyd Austin says that this — the delayed promotions — is starting to impact the nation’s readiness. Is there any resolution to this in sight? It’s now been going on for, what, a month and a half.
Raman: I think that, you know, we’re getting somewhat closer to it, but it’s hard to tell. I mean, we’ve had Mitch McConnell say that he’s not supporting what Tuberville is doing with the blockade of military nominations, so that could be a little bit more pressure compared to anyone else in the caucus putting that pressure. But I think the other thing that had come up is that there had been a report this week that the administration was going to delay on deciding if Space Force Command was going to move from Colorado to Alabama because of Tuberville. And so I think that, if that is the case — two different pressure points — there might be movement. But it’s been happening for a long time. We’ve had hundreds of nominees delayed. And I think the pushback has not necessarily been fully partisan. Even before we had McConnell speak out, we’ve had other members of — Republican senators kind of say, you know, this is maybe not the best move to do this, so —
Rovner: I mean, given how important Republicans take the military, I get why he’s doing this. It’s a pressure point because it’s a DOD [Department of Defense] policy. But still, it looks funny for a Republican to be holding up something that’s really important to the military.
Raman: Earlier this year, I think it was last month, you know, the Senate had done their procedural vote on a Tuberville resolution on something that was kind of similar, when they had the VA [Department of Veterans Affairs] rule that allows them to provide abortions for, you know, the Hyde exceptions, so rape, incest, life of the mother. And, you know, that didn’t pass on a procedural vote. So maybe something like that could be, like, a bargaining point. But it would require Democrats to say, “Yes, we do want to vote on this.” And I think that the last comments that Tuberville had even said were that, you know, “Until this policy is gone, I don’t want to waiver.” So it might not be a solution, but it could be something.
Rovner: Well, speaking of things that are proving difficult to resolve, let’s talk about the debt ceiling talks. As of today, Thursday, there’s no agreement yet, although President Biden is going to cut his overseas trip short after Treasury Secretary Janet Yellen warned that the so-called x-date, when the Treasury can no longer pay its bills, could really happen as soon as June 1. One of the big sticking points appears to be work requirements for programs aimed at low-income Americans, which Republicans are demanding and Democrats are resisting. Welfare, now called Temporary Aid to Needy Families, already has work requirements, as does SNAP [Supplemental Nutrition Assistance Program], the current name for food stamps, which leaves Medicaid, which has been a particular sticking point over the last few years. I guess we were all right back in February when Biden and the Republicans seemed to take Medicare and Social Security off the table, and we all predicted the fight would come down to Medicaid. So here we are, yes?
Knight: Yep, we’re at Medicaid. But it does seem like we’re really going back and forth on it. I think the sentiment at first was kind of that this would be the first thing to fall out of a potential deal between Democrats and Republicans because Democrats are really opposed to this. But I don’t know. This week, President Biden made some comments that were a little confusing. It kind of made it sound like he was potentially open to the idea. And then the White House kind of walked that back this week and sent some press releases out that were like, We don’t want to touch Medicaid. And then I believe it was sometime yesterday, on Wednesday, the president said, “Maybe, but nothing of consequence,” when talking about work requirements. And Congress is leaving today. So I think it’s kind of still up in the air, but the door still seems to be open, I guess is kind of the takeaway.
Rovner: There seems to be some concern from Democrats on Capitol Hill that President Biden may give too much away in trying to avoid a debt default. I mean, he’s already sort of after, you know, “We will not negotiate on the debt ceiling, we will not negotiate on the debt ceiling” — I mean, the administration says they’re negotiating on the budget, but they’re negotiating on the debt ceiling, right?
Knight: Yeah. I mean, and it seems that President Biden, the administration, may be open to budget caps as well or cutting spending. And that was kind of something that it seemed like Democrats at first were not open to doing at all. I talked to some appropriators this week, and they’re pretty upset about — Democratic appropriators — they’re pretty upset because they want the debt ceiling and appropriations to be a separate process, and they’re being tied together right now. Yeah, I think they’re somewhat concerned with how the president is negotiating right now.
Rovner: Well, it’s May 18. There’s been no talk yet of a temporary — although I assume at some point we’re going to say, let’s just extend this out a few days, and let’s extend it out a few more days, and we’ll extend it out a few more days. So obviously, we will watch this space. So the mifepristone case is not the only judicial news this week. In that other case out of Texas, challenging the preventive health services part to the Affordable Care Act, the 5th Circuit Court of Appeals — lots of news out of New Orleans this week — temporarily stayed the ruling by Judge Reed O’Connor that the ACA unconstitutionally deputized the U.S. Preventive Health Services Task Force from deciding which preventive services should be provided without copays. Long sentence. I hope it makes sense. Reed O’Connor, of course, being the judge who tried unsuccessfully to declare the entire ACA unconstitutional in 2018. What happens now in this case? Nothing changes until it gets resolved, right?
Roubein: Right. Right now I think that just through that, this means that insurers will be required to continue covering services recommended by the U.S. Preventive Services Task Force without cost sharing in care.
Rovner: And that includes PrEP for HIV, which is what’s really at issue with these doctors who are suing the FDA — or actually I guess they’re suing HHS [the Department of Health and Human Services] in general — saying that they don’t want to be required to provide these drugs.
Roubein: Yeah, it does include PrEP.
Rovner: So that will continue. I imagine that will also find its way to the Supreme Court. Finally, in not really judicial but court-related news, Envision, the private equity-backed physician staffing firm, filed for Chapter 11 bankruptcy this week, presumably because the emergency room physician practices it owns can no longer send patients most surprise medical bills. ER bills were among the most common types of surprise bills, when patients would specifically take their emergency to an in-network hospital, only to find that the doctors in the emergency room were all out of network. Is this one small step towards taking some of the profit motive out of health care? I don’t see anybody, like, shedding a lot of tears for Envision declaring bankruptcy here.
Raman: I think the second part, that the lawsuit by the ER doctors against Envision, despite them filing for bankruptcy, is going forward is interesting, and it seems unusual to me, because they’re not asking for monetary damages, but they want, like, a legal finding that the way that the company’s business structure — ownership of the staffing groups — is illegal, and if, like, winning that would ban the practice in the state of California. And so I think if you’re looking at it in terms of, like, things that would happen over the course of time, policywise, that could be something interesting to kind of watch there.
Roubein: I just wanted to hearken back real quick to, like, 2019. In the middle of the surprise billing debate, Envision and another major doctor staffing firm spent significant sums of money to try and sway the surprise billing legislation that the House and the Senate were hashing out.
Rovner: Yeah, they made CNN and MSNBC very rich with their ads.
Roubein: Millions of them.
Rovner: In the ’90s, I covered, you know, this whole corporate practice of medicine thing because I think it’s every state has a law that says that corporations can’t practice medicine; only licensed health professionals can practice medicine. So I’ve always wondered about, you know, what this lawsuit is about anyway. How are these companies actually getting away with doing this? And the answer is maybe they’re not or maybe they won’t. It’s going to be interesting. There’s now so much profit motive and private equity in health care because there’s a lot of money to be made that it’s, I think somebody is actually starting to, you know, call on it. We will definitely see how this plays out. We may not have a “This Week in Private Equity” anymore. Well, let us go back to Capitol Hill, where we finally have a nominee to head the National Institutes of Health, current National Cancer Institute chief Monica Bertagnolli, who is also, ironically, a cancer patient at the moment, although her prognosis is very good, we are told. There hasn’t been a confirmed head of the NIH since Francis Collins stepped down at the end of 2021. Congress hasn’t had to confirm a new head of the NIH since before the passage of the Affordable Care Act. I imagine that Dr. Bertagnolli is going to have to navigate some pretty choppy confirmation waters, even in a Senate where Democrats are nominally in the majority, right?
Knight: Yeah, I spent some time talking to HELP [Health, Education, Labor and Pensions] Committee Republicans last week and this week, and they definitely have some things they want to see out of a new NIH director. They’re definitely concerned about gain-of-function research, potential funding of that type of research, which is supposed to, hypothetically, make viruses more virulent. So several of them said, you know, “We don’t want to see the agency funding that kind of research,” or, “We want restrictions around that kind of research.” They also are concerned with the agency giving a grant to an organization called EcoHealth, which was supposed to have done research in Wuhan that was around gain-of-function-type things. And I think they also, in general, are just concerned with how the NIH and the CDC [Centers for Disease Control and Prevention] responded to the covid pandemic, and they aren’t happy with some of the decisions they made, what they felt like were mandate — top-down mandates. And so I do think we will see, if we actually get a HELP confirmation hearing any time soon, we’ll see — I think it’s going to be pretty contentious possibly. And as you referenced, I kind of looked into this when I was writing my story, and there really has not been a contentious hearing in a long time. Francis Collins went through a unanimous voice vote when he was confirmed. And then the two previous NIH directors, they kind of sailed through their HELP confirmation hearings. And if you think about it, Francis Collins also has served under both Republican and Democratic presidents. And I wonder if we are coming to a point where that won’t happen anymore with NIH directors.
Rovner: Back when I first started covering the NIH, it was contentious because they were talking about fetal tissue research and stem cell research and stuff that was really controversial. But then Newt Gingrich, when he became speaker of the House, declared that, you know, he wanted the 21st century to be, you know, the century of biomedicine. And he vowed to double the funding for the NIH, which the Republicans did, you know, with the Democrats’ help. So NIH has been this sacred cow, if you will, bipartisanly for at least two decades. And now it’s sort of coming back to being a little bit controversial again. In talking about the debt ceiling and possible budget cuts, I mean, NIH has usually been spared from those. But I’m guessing that if there’s budget caps, NIH is going to be included in those places where we’re going to cut the budget, right?
Knight: Yeah, absolutely. I have been talking to a Republican House appropriator over the NIH. Robert Aderholt told me that, yes, they expect a cut in their budget because Defense and NIH, Labor, HHS are usually the biggest bills. And he told me Defense probably isn’t getting cut very much, so we’re expecting to get cut. So obviously, you know, it’s a messaging bill in the House, but I think the expectation is that they’re going to propose that. The Senate seemed pretty set on keeping NIH funding what it was. They had an NIH appropriations hearing recently. So, I mean, there’s going to be some difference between those two chambers. But I think it does seem likely, especially with all the debt ceiling stuff, that cuts are possible.
Rovner: So that’s NIH. In the meantime, now we have an opening at the CDC because Rochelle Walensky announced her resignation. Have we heard any inklings about who wants to step into that very hot seat?
Roubein: I can point to some reporting from my colleagues at the Post, Dan Diamond and Lena H. Sun. At the time, the day that Walensky announced that she’d be stepping down June 30, they had wrote that White House officials had, you know, been preparing for a little while for a potential departure and had begun gauging interest in the position. And some people that Dan and Lena named that the administration had approached is former New York City Health Commissioner Dave A. Chokshi, former North Carolina Health Secretary Mandy Cohen, and the California health state secretary. Now, we don’t know ultimately what the White House, President Biden, is going to do. I do think it’s worth pointing out that the new CDC director won’t have to be Senate-confirmed; that was passed in the big sweeping government funding bill, that a CDC director would need to be confirmed, but starting January 20, 2025. So, you know, sounds like something, you know, Democrats might have been interested in doing, kind of pushing that out. So, yeah.
Rovner: The CDC is, you know, sort of the one big Department of Health and Human Services job that does not come up for Senate confirmation. Obviously, that is being changed, but it’s not being changed yet. Well, both of these confirmations, mostly the NIH one at this point, comes up before the Senate HELP Committee, Victoria, as you pointed out. Chairman Bernie Sanders there is having — what shall we call them? — some growing pains as chairman of a committee with a heavy legislative workload. What’s the latest here? He’s still kind of working on getting some of these bipartisan bills through, isn’t he?
Knight: Yeah, there is a little bit of a snafu at a recent HELP Committee hearing where Ranking Member Bill Cassidy was not happy that Sen. Sanders was bringing up some amendments that he wasn’t aware of or that they had kind of agreed to table at some point and then he brought them back up during a hearing or during a markup, and so they ended up having to delay the markup itself and do it the next week. And these were bipartisan bills. So it was really just a process issue; it wasn’t so much the subject of the bills. And they kind of worked it out and were able to pass the bills out of the committee, or most of the bills out of the committee, the next week after that happened. So I think that Sen. Sanders is figuring out how to run the HELP Committee. What I’ve kind of heard is that he is somewhat more interested in labor issues than health, and so his focus is not maybe as much on health. And I think you can see that sometimes. Also, when you talk to Sen. Sanders, he’s very much a big-picture guy and isn’t so much in the process weeds often, whereas Sen. Cassidy loves the process.
Rovner: So we’re noticing.
Knight: Yeah, Sen. Cassidy loves the process. So they’re an interesting duo, I think.
Rovner: Yeah, I mean, I was interested that this week, you know, Sen. Sanders was among those there reintroducing the “Medicare for All” bill that obviously has no future in the immediate future. But at the same time, community health centers are up for reauthorization this year. And that has always been a pet issue, even when he was House member, you know, Rep. Sanders. This is one of the issues that I know he cares a lot about. And now he’s in charge of making sure that it gets reauthorized. So he’s got sort of these competing big-picture stuff and, not smaller, but smaller than the big-picture stuff that he really cares about. I’ll be curious to see what he’s able to do on that front. I assume there’s no word on that yet, even though the authorization ends Sept. 30, right?
Raman: The sense that I’ve gotten from talking to folks is that community health centers is higher up the totem pole than some of the other issues on the must-pass list. I mean, we still have to deal with the debt ceiling and everything related there. But I think that there has been a little bit more progress then. I mean, this week, at least in the House, Energy and Commerce had marked up their bill that had community health center funding in there. So I think there’s a little bit more push on that end because they’re, you know, fairly bipartisan, have seen interest across the board on that. So I think that they are making some progress there. It’s just that there’s so many other factors right now, and that makes it pretty tricky.
Rovner: The ironic thing about Congress — it’s summertime when everybody else sort of kicks back. — that’s when Congress kicks into gear. So a lot, I imagine, is going to happen in June and July. All right. That is this week’s news. Now it is time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Victoria, why don’t you go first this week?
Knight: Sure. My extra credit this week is called “World Health Organization Warns Against Using Artificial Sweeteners.” It was published in The New York Times. Basically, the WHO said this week that artificial sweeteners aren’t effective in reducing body fat and could actually increase the risk of Type 2 diabetes and cardiovascular diseases. They looked at the available evidence, and it’s just a set of guidelines that they’re issuing. It’s not binding to anything. You know, every country can kind of make their own decision based on this. But I think it was an interesting marker. If you look at the influx of all these artificial sweeteners over time that have kind of become a mainstream part of our diet, they’re available in a bunch of different things that you can get at the store, and people often turn to them when they’re trying to reduce sugar. And now this large body is saying they may actually worsen your health, not help you, and not even reduce fat. So I think that was just kind of interesting. The FDA did not respond to The New York Times’ request for the story, so I’m not sure their stance on this, but just something to note.
Rovner: I was interested that the WHO did that. It seemed sort of very not WHO-ish, but also interesting. Sandhya, why don’t you go next.
Raman: All right, so my extra credit this week is called “A Year After Dobbs Leak, Democrats Still See Abortion Driving 2024 Voters.” And it’s from my colleagues “What the Health?” alum Mary Ellen McIntire and Daniela Altimari. And they take a look at how Democrats are kind of seeing how abortion messaging isn’t fading a year after — almost — the Dobbs decision, are kind of doubling down on focusing on that. President Biden and Vice President Harris were both at the EMILYs List gala this week honoring Nancy Pelosi. And it also comes amid a lot of the state action we talked about earlier of a lot of abortion bans going into place. And so they have a good look at that that you can read.
Rovner: Rachel.
Roubein: My extra credit is called “Thousands Face Medicaid Whiplash in South Dakota and North Carolina,” by Arielle Zionts from KFF Health News. And she takes a look at the unwinding of keeping people on the Medicaid program, particularly in South Dakota and North Carolina, where the dynamic is really interesting, because both states have recently passed Medicaid expansion. So officials are kind of going through the Medicaid rolls beforehand. So some people who could be eligible soon may be getting kicked off, only to need to reapply, or officials need to tell them that they can reapply. So I thought it was a really interesting look on how this is playing out.
Rovner: Yeah, it is. I mean, talk about head-explodingly confusing for people; it’s like, “You’re not eligible now, but you will be in three weeks. So just kind of sit tight and don’t go to the doctor for the next couple of weeks,” basically where they are. Well, my story is from The Washington Post, and it’s called “A 150-Year-Old Law Could Help Determine the Fate of U.S. Abortion Access,” by Dan Diamond and Ann Marimow. And it’s about the Comstock Act, which we have talked about before. It’s a Reconstruction-era law pushed through Congress by an anti-vice crusader, Anthony Comstock, who I learned this week was not actually a member of Congress. He was just an interested party. The law purports to ban the mailing of all sorts of lewd and lascivious items, including those intended to be used for abortion. Abortion opponents are trying to resurrect the law, which has never been formally repealed. But it turns out that Comstock wasn’t actually all that anti-abortion. In a newly resurrected interview that Comstock did with Harper’s Weekly in 1915, he said he never intended for the law to interfere with the practice of medicine by licensed doctors, including for abortion. Quote, “A reputable doctor may tell his patient, in his office what is necessary, and a druggist may sell on a doctor’s written prescription drugs which he would not be allowed to sell otherwise.” That’s how Comstock is quoted as saying. Um, wow. It’s just another weird twist in an already very twisty story. But let’s keep track of the Comstock Law going forward. All right. That is our show for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us too. Special thanks, as always, to our ever-patient producer, Francis Ying. Also as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me. I’m still there. I’m at @jrovner. Sandhya?
Raman: @SandhyaWrites.
Rovner: Rachel.
Roubein: @rachel_roubein.
Rovner: Victoria.
Knight: @victoriaregisk.
Rovner: We will be back in your feed next week. Until then, be healthy.
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2 years 2 months ago
Courts, Health Industry, Medicaid, Medicare, Multimedia, Public Health, States, Abortion, Biden Administration, KFF Health News' 'What The Health?', North Carolina, Podcasts, South Carolina, U.S. Congress, Women's Health
Skin cancer is seen more frequently in the Dominican Republic
Santo Domingo.- The rising rates of skin cancer in the country can be attributed to several factors, including inadequate skin care, delayed intervention, and the failure to use sunscreen. This year alone, the Dominican Dermatological Institute (IDCP) has received 605 consultations resulting in diagnoses of cancerous skin lesions.
Santo Domingo.- The rising rates of skin cancer in the country can be attributed to several factors, including inadequate skin care, delayed intervention, and the failure to use sunscreen. This year alone, the Dominican Dermatological Institute (IDCP) has received 605 consultations resulting in diagnoses of cancerous skin lesions. This number is alarmingly close to the previous year’s report, which documented 1,168 cases of cancer detection.
Luisa Gonzalez, the head of the center’s Surgical Units, highlighted the increase in the incidence of skin cancer and attributed it to various factors such as environmental pollution, dietary habits, and lifestyle changes. These factors have collectively contributed to a higher prevalence of skin cancer among the population.
Out of the 600-plus consultations received, 111 patients required surgical procedures for skin cancer treatment. This number is significantly higher compared to the previous year when 400 patients underwent surgery, indicating an increasing trend.
The IDCP plans to conduct a national awareness campaign called “Choose to Take Care of Yourself” from the 25th of this month to June 25th. The campaign aims to raise awareness about skin cancer prevention. The medical professionals at the dermatological institute emphasized that the incidence of malignant melanoma in the Dominican Republic differs from the global trend.
Contrary to global statistics, it was observed that women in the Dominican Republic are more proactive in seeking early medical attention for any changing or emerging skin lesions. This may be due to better education and awareness among women compared to men.
Previously, the institute received visits from 30 patients with advanced malignant melanoma in a year, but last year alone, the number increased to 170 patients.
Specialists emphasize the importance of early detection of malignant melanoma, as each case of skin cancer is unique. The institutional focus has always been on raising awareness, as timely prevention measures can significantly reduce the impact of the disease.
Early diagnosis and biopsy are crucial in determining the appropriate course of treatment, as different types of skin cancer exhibit varying behaviors. The Dominican Dermatological Institute follows a protocol for skin cancer patients, including triage, evaluation, surgery, and post-operative follow-ups at regular intervals over several years. This comprehensive approach aims to ensure optimal care and monitoring for patients.
2 years 2 months ago
Health
The Best Bread For Gut Health, According to a Gastroenterologist - EatingWell
- The Best Bread For Gut Health, According to a Gastroenterologist EatingWell
- Fermentation, digestive enzymes and other gut health hacks TODAY
- Why good gut health is essential for wellness during winter months IOL
- For good gut health, you must avoid these six food items The Indian Express
- All diseases begin in the gut | Health Jamaica Gleaner
- View Full Coverage on Google News
2 years 2 months ago
The Best Bread For Gut Health, According to a Gastroenterologist - EatingWell
- The Best Bread For Gut Health, According to a Gastroenterologist EatingWell
- Fermentation, digestive enzymes and other gut health hacks TODAY
- Why good gut health is essential for wellness during winter months IOL
- For good gut health, you must avoid these six food items The Indian Express
- All diseases begin in the gut | Health Jamaica Gleaner
2 years 2 months ago
Fermentation, digestive enzymes and other gut health hacks - TODAY
- Fermentation, digestive enzymes and other gut health hacks TODAY
- The Best Bread For Gut Health, According to a Gastroenterologist EatingWell
- Why good gut health is essential for wellness during winter months IOL
- For good gut health, you must avoid these six food items The Indian Express
- All diseases begin in the gut | Health Jamaica Gleaner
2 years 2 months ago
World Hypertension Day: 17 May 2023
The objective of this year’s theme is to raise awareness, promote hypertension detection and encourage citizens of all countries to prevent and control this silent killer
View the full post World Hypertension Day: 17 May 2023 on NOW Grenada.
The objective of this year’s theme is to raise awareness, promote hypertension detection and encourage citizens of all countries to prevent and control this silent killer
View the full post World Hypertension Day: 17 May 2023 on NOW Grenada.
2 years 2 months ago
Health, PRESS RELEASE, caribbean public health agency, carpha, high blood pressure, joy st john, world hypertension day
Medical News, Health News Latest, Medical News Today - Medical Dialogues |
AstraZeneca to leave leading US drug lobby group
London: AstraZeneca has decided to leave the main US drug lobby group, the Pharmaceutical Research and Manufacturers of America (PhRMA), and pursue other ways of engaging in advocacy at the state and federal level, the company said.
AstraZeneca decided not to continue its membership after a recent assessment of whether it was "the most productive and effective use of (company) resources," a spokesperson for the British drugmaker said in an emailed statement.The news, first reported by Politico, marks the trade body's third major departure in six months. AstraZeneca's exit follows those of AbbVie, maker of blockbuster arthritis drug Humira, and Teva, a leading manufacturer of generic drugs.Read also: AbbVie to exit leading US drug industry trade groupAstraZeneca will redirect the funds previously used on its PhRMA membership to continue U.S. advocacy efforts with state and federal policymakers, the statement read.PhRMA did not respond immediately to an emailed request for comment outside business hours.The U.S. is the largest national market for all big pharma companies. Drugmakers suffered a rare defeat last year in failing to stop the Inflation Reduction Act, which allows the government to negotiate prices on certain drugs.
2 years 2 months ago
News,Industry,Pharma News,Latest Industry News
Huawei WATCH series supports high blood sugar risk assessment
RICHARD YU, the chief executive officer at the Consumer BG at Huawei, has announced that “Huawei WATCH 4 series will be the first to support high blood sugar risk assessment research”. The Huawei WATCH 4 series will debut at Huawei’s new product...
RICHARD YU, the chief executive officer at the Consumer BG at Huawei, has announced that “Huawei WATCH 4 series will be the first to support high blood sugar risk assessment research”. The Huawei WATCH 4 series will debut at Huawei’s new product...
2 years 2 months ago
All diseases begin in the gut
THE GUT is a powerhouse within the body as it converts food into energy, delivers valuable nutrients into the bloodstream, manages waste and protects against disease. In fact, the gut is an intrinsic link to our overall health and wellness. Each of...
THE GUT is a powerhouse within the body as it converts food into energy, delivers valuable nutrients into the bloodstream, manages waste and protects against disease. In fact, the gut is an intrinsic link to our overall health and wellness. Each of...
2 years 2 months ago
AstraZeneca is third member to leave PhRMA in five months
WASHINGTON — AstraZeneca has decided to leave the brand drug lobbying powerhouse PhRMA halfway through the year, the organization said.
The exit is the group’s third in five months, as AbbVie exited PhRMA in December and Teva Pharmaceuticals left in February.
2 years 2 months ago
Pharma, Politics, Advocacy, biotechnology, Congress, drug pricing, life sciences, Pharmaceuticals, policy
AI defines ‘ideal body type’ per social media – here’s what it looks like
Artificial intelligence has its own idea of what the perfect human body should look like.
Artificial intelligence has its own idea of what the perfect human body should look like.
A new study by The Bulimia Project, a Brooklyn, New York-based website that publishes content and research related to eating disorders, investigated how AI perceived the "ideal" body based on social media data.
The results, produced by AI-generated imaging tools such as Dall-E 2, Stable Diffusion and Midjourney, showed widely "unrealistic" body structures, as reported in a discussion of the findings on The Bulimia Project's website.
Forty percent of the overall images depicted "unrealistic" body types of muscular men and women — 37% for women and 43% for men — according to the study.
For women, the AI-generated images seemed to have a bias toward blonde hair, brown eyes and olive-toned skin.
More than half (53%) of all images of women generated to depict the "ideal body type" included olive skin.
For men, the AI-generated images showed a bias toward brown hair, brown eyes and olive skin.
Sixty-seven percent of all images for men with the "ideal body type" included brown hair and 63% had olive skin.
Additionally, 47% of the images for men included facial hair.
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The Bulimia Project extracted its results by approaching the various AI systems with two prompts.
The first prompt — "the ‘perfect’ female body according to social medial in 2023" — generated a variety of female body types but showed an obvious preference for slimmer women with toned muscles.
The second prompt — "the ‘perfect’ male body, according to social medial in 2023" — did the same, coming up with images of men with perfectly toned abs.
"Smaller women appeared in nearly all the images created by Dall-E 2, Stable Diffusion and Midjourney, but the latter came up with the most unrealistic representations of the female body," the study revealed.
"The same can be said for the male physiques it generated, all of which look like photoshopped versions of bodybuilders."
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The study broadened the scope beyond social media, prompting the AI tools to generate images of "the ‘perfect’ woman in 2023" and "the ‘perfect’ man in 2023."
The results showed more diversity in skin, hair and eye color as well as ethnicity, although the images still depicted conventionally "fit" individuals.
The study compared how the social media-inspired images were much more sexualized and "unsettling," in terms of disproportionate body parts, than the AI-inspired renderings.
"Considering that social media uses algorithms based on which content gets the most lingering eyes, it’s easy to guess why AI’s renderings would come out more sexualized," the study concluded.
"But we can only assume that the reason AI came up with so many oddly shaped versions of the physiques it found on social media is that these platforms promote unrealistic body types to begin with."
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In the age of filters on photo apps such as Snapchat and Instagram, "no one can reasonably achieve the physical standards set by social media," the study noted.
The Bulimia Project study was launched in response to the jarring impact of social media on children’s mental health, which could be a source of body image issues, according to the study.
The idealization of body types on social media has an undeniable effect on adults as well, experts say.
James Campigotto, a Deerfield, Florida-based data journalist who worked on The Bulimia Project's study, told Fox News Digital in an interview that this study was designed to explore the biases and potential dangers of AI.
Campigotto noted that some of the results were considered "unrealistic" in terms of body type by straying "far away" from what is "obtainable" by the average person.
"This could [negatively impact] individuals' body images," he said.
"You could be someone who's doing all the right things, eating properly and exercising constantly … and still not achieving these very outlandish images, which can be very disheartening and impactful on someone's self-image," he added.
Campigotto said he was most surprised by the lack of diversity in the social media-inspired renderings.
TEENS ARE TURNING TO SNAPCHAT'S 'MY AI' FOR MENTAL HEALTH SUPPORT — WHICH DOCTORS WARN AGAINST
Most of the male images showed chiseled abs and "Superman-like" physiques, he said — which he believes could be linked to a lack of conversation surrounding male body positivity.
"I think men are struggling with this idea just as much, if not the same, as women — this idea of body image [and] what it is to have a body you’re proud of," he said.
AI expert Joe Toscano, founder of the data technology company Mach 9 in Omaha, Nebraska, told Fox News Digital the study findings are "not surprising," since the internet is "all about what gets clicked on the most."
"These systems are not making decisions based on ‘thinking,'" he said in a statement. "They're making these decisions based on what's already out there and indicators that are coded into the system to determine what is ‘best.’"
As AI poses a potential threat to self-esteem and body image, Campigotto said the study also revealed biases present within artificial intelligence, warning users to "take everything with a grain of salt."
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"Keep in mind that everything that's being generated is being influenced by a certain perspective and a certain bias," he said.
Taking social media influencers as an example, Campigotto explained they are a "minority group" who should not be representative of an overall image.
Instead, he said, "try to compare yourself to the version of yourself from yesterday and less toward everything going on around you," he said.
"Adjust your perspective to just focus on yourself."
Toscano of Mach 9 added that a certain kind of AI usage will only "accelerate levels of mental illness and body shame."
"I used to compare myself to my peers locally, but now kids are comparing themselves to the things that trend the most on the internet, meaning instead of comparing yourself to one in 1,000 people or even 10,000 people, you're comparing yourself with the ‘best’ in the world — making those standards even more unattainable," he said.
"In addition to that, there's no way to tell what's been rendered or not nowadays," Toscano said.
"There's no way to tell who's had plastic surgery or not nowadays."
2 years 2 months ago
Health, lifestyle, mental-health, artificial-intelligence, tech, Fitness, fitness-and-wellbeing
Vector Control Division: Fogging Schedule
“The fogging operation is in response to complaints of mosquito infestation in those areas”
View the full post Vector Control Division: Fogging Schedule on NOW Grenada.
“The fogging operation is in response to complaints of mosquito infestation in those areas”
View the full post Vector Control Division: Fogging Schedule on NOW Grenada.
2 years 2 months ago
Environment, Health, PRESS RELEASE, dengue fever, fogging, gis, Ministry of Health, vector control division
Dengue outbreak in Grenada – 8 hospitalised
“The situation is very, very serious, and we need to take heed and do all that’s necessary to prevent a major outbreak”
View the full post Dengue outbreak in Grenada – 8 hospitalised on NOW Grenada.
“The situation is very, very serious, and we need to take heed and do all that’s necessary to prevent a major outbreak”
View the full post Dengue outbreak in Grenada – 8 hospitalised on NOW Grenada.
2 years 2 months ago
Community, Environment, Health, dengue fever, kelville frederick, linda straker, mosquito, shawn charles