PAHO/WHO | Pan American Health Organization
Mpox: Organização Mundial da Saúde declara fim da Emergência de Saúde Pública de Importância Internacional
WHO declares end of mpox emergency, calls for sustained efforts for long-term management of the disease
Oscar Reyes
11 May 2023
WHO declares end of mpox emergency, calls for sustained efforts for long-term management of the disease
Oscar Reyes
11 May 2023
2 years 2 months ago
The Crisis Is Officially Ending, but Covid Confusion Lives On
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 formal end May 11 of the national public health emergency for covid-19 will usher in lots of changes in the way Americans get vaccines, treatment, and testing for the coronavirus. It will also change the way some people get their health insurance, with millions likely to lose coverage altogether.
Meanwhile, two FDA advisory committees voted unanimously this week to allow the over-the-counter sale of a specific birth control pill. Advocates of making the pill easier to get say it could remove significant barriers to the use of effective contraception and prevent thousands of unplanned pregnancies every year. The FDA, however, must still formally approve the change, and some of its staff scientists have expressed concerns about whether teenagers and low-literacy adults will be able to follow the directions without the direct involvement of a medical professional.
This week’s panelists are Julie Rovner of KFF Health News, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, Tami Luhby of CNN, and Margot Sanger-Katz of The New York Times.
Panelists
Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico
Tami Luhby
CNN
Margot Sanger-Katz
The New York Times
Among the takeaways from this week’s episode:
- The formal public health emergency may be over, but covid definitely is not. More than 1,000 people in the United States died of the virus between April 19 and April 26, according to the Centers for Disease Control and Prevention. While most Americans have put covid in their rearview mirrors, it remains a risk around the country.
- The Senate Finance Committee held a hearing on “ghost networks,” lists of health professionals distributed by insurance companies who are not taking new patients or are not actually in the insurance company’s network. Ghost networks are a particular problem in mental health care, where few providers take health insurance at all.
- Another trend in the business of health care is primary care practices being bought by hospitals, insurance companies, and even Amazon. This strategy was popular in the 1990s, as health systems sought to “vertically integrate.” But now the larger entities may have other reasons for having their own networks of doctors, including using their patients to create revenue streams.
- Court battles continue over the fate of the abortion pill mifepristone, as a federal appeals court in New Orleans prepares to hear arguments about a lower-court judge’s ruling that would effectively cancel the drug’s approval by the FDA. In West Virginia, the maker of the generic version of the drug is challenging the right of the state to ban medication approved by federal officials. At the same time, a group of independent abortion clinics from various states is suing the FDA to drop restrictions on how mifepristone can be prescribed, joining mostly Democratic-led states seeking to ensure access to the drug.
Plus for “extra credit” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: Slate’s “Not Every Man Will Be as Dumb as Marcus Silva,” by Moira Donegan and Mark Joseph Stern.
Joanne Kenen: The Baltimore Banner’s “Baltimore Isn’t Accessible for People With Disabilities. Fixing It Would Cost Over $650 Million,” by Hallie Miller and Adam Willis.
Tami Luhby: CNN’s “Because of Florida Abortion Laws, She Carried Her Baby to Term Knowing He Would Die,” by Elizabeth Cohen, Carma Hassan, and Amanda Musa.
Margot Sanger-Katz: The New Yorker’s “The Problem With Planned Parenthood,” by Eyal Press.
Also mentioned in this week’s episode:
- CNN’s “Here’s How the End of the Covid-19 Public Health Emergency Affects You,” by Tami Luhby and Alex Leeds Matthews.
- The New York Times’ “Corporate Giants Buy Up Primary Care Practices at Rapid Pace,” by Reed Abelson.
- Vox’s “Independents Back Abortion Rights. They’re Less Sure Democrats Do,” by Rachel M. Cohen.
Click to open the transcript
Transcript: The Crisis Is Officially Ending, but Covid Confusion Lives On
[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 are taping this week on Thursday, May 11, at 10:30 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 Tami Luhby, of CNN.
Tami Luhby: Hello.
Rovner: Margot Sanger Katz, The New York Times.
Sanger-Katz: Good morning.
Rovner: And Joanne Kenen, of the Johns Hopkins Bloomberg School of Public Health and Politico.
Joanne Kenen: Hi, everybody.
Rovner: So the news on the debt ceiling standoff, just so you know, is that there is no news. Congressional leaders and White House officials are meeting again on Friday, and we still expect to not see this settled until the last possible minute. But there was plenty of other health news. We will start with the official end of the U.S. public health emergency for covid. We have talked at some length about the Medicaid unwinding that’s now happening and a potential to end some telehealth service reimbursement. But there’s a lot more that’s going away after May 11. Tami, you’ve been working to compile everything that’s about to change. What are the high points here?
Luhby: Well, there are a lot of changes depending on what type of insurance you have and whether we’re talking about testing, treatment, or vaccines. So I can give you a quick rundown. We wrote a visual story on this today. If you go to CNN.com, you’ll find it on the homepage right now.
Rovner: I will link to it in the show notes for the podcast.
Luhby: Basically, many people will be paying more for treatments and for tests. However, vaccines will generally remain free for almost everyone. And basically, if you look at our story, you’ll see the color-coded guide as to how it may impact you. But basically, testing — at-home tests are no longer guaranteed to be free. So if you’ve been going to your CVS or somewhere else to pick up your eight tests a month, your insurer may opt to continue providing it for free, but I don’t think many will. And then for lab tests, again, it really depends. But if you have Medicaid, all tests will be free through 2024. However, if you have private insurance or Medicare, you will probably have to start paying out-of-pocket for tests that are ordered by your provider. Those deductibles, those pesky deductibles, and copays or coinsurance will start kicking in again. And for treatments, it’s a little bit different again. The cost will vary by treatment if you have Medicare or private insurance. However, Paxlovid and treatments that are purchased by the federal government, such as Paxlovid, will be free as long as supplies last. Now, also, if you’re uninsured, there is a whole different situation. It’ll be somewhat more difficult for them. But there are still options. And, you know, the White House has been working to provide free treatments and vaccines for them.
Rovner: So if you get covid, get it soon.
Luhby: Like today. Right, exactly. Yeah, but with vaccines, even though, again, they’re free as long as the federal supplies last — but because of the Affordable Care Act, the CARES Act, and the Inflation Reduction Act, people with private insurance, Medicare, and Medicaid will actually continue to be able to get free vaccines after the federal supplies run out.
Rovner: After May 11.
Luhby: It’s very confusing.
Rovner: It is very confusing. That’s why you did a whole graphic. Joanne, you wanted to add something.
Kenen: And the confusion is the problem. We have lots of problems, but, like, last week, we talked a little bit about this. You know, are we still in an emergency? We’re not in an emergency the way we were in 2020, 2021, but it’s not gone. We all know it’s much, much better, but it’s not gone. And it could get worse again, particularly if people are confused, if people don’t know how to test, if people don’t know that they can still get things. The four of us are professionals, and, like, Tami’s having to read this complicated color-coded chart — you know, you get this until September 2024, but this goes away in 2023. And, you know, if you have purple insurance, you get this. And if you have purple polka-dotted insurance, you get that. And the lack of clarity is dangerous, because if people don’t get what they’re eligible for because they hear “emergency over, everything — nothing’s free anymore” — we’re already having trouble with uptake. We don’t have enough people getting boosters. People don’t know that they can get Paxlovid and that it’s free and that it works. We are still in this very inadequate response. We’re not in the terrifying emergency of three years ago, but it’s not copacetic. You know, it’s not perfect. And this confusion is really part of what really worries me the most. And the people who are most likely to be hurt are the people who are always most likely to be hurt: the people who are poor, the people who are in underserved communities, the people who are less educated, and it’s disproportionately people in minority communities. We’ve seen this show before, and that’s part of what I worry about — that there’s a data issue that we’ll get to whenever Julie decides to get to it, right?
Rovner: Yeah, I mean, and that’s the thing. With so much of the emergency going away, we’re not really going to know as much as we have before.
Sanger-Katz: In some ways, how you feel about this transition really reflects how you feel about the way that our health care system works in general. You know, what happened for covid is —and I’m oversimplifying a little bit — is we sort of set up a single-payer system just for one disease. So everyone had access to all of the vaccines, everyone had access to all of the tests, everyone had access to all of the treatments basically for free. And we also created this huge expansion of Medicaid coverage by no longer allowing the states to kick people out if they no longer seem to be eligible. So we had the kind of system that I think a lot of people on the left would like to see, not just for one disease but for every disease, where you have kind of more universal coverage and where the cost of obtaining important treatments and prevention is zero to very low. And this is definitely going to be a bumpy transition, but it’s basically a transition to the way our health care system works for every other disease. So if you are someone who had some other kind of infectious disease or a chronic disease like cancer, rheumatoid arthritis, whatever, you’ve been sort of dealing with all of this stuff the whole time — that you have to pay for your drugs; that, you know, that testing is expensive; that it’s confusing where you get things; that, you know, there’s a lot of complexity and hoops you have to jump through; that a lot depends on what kind of insurance you have; that what kind of insurance you can get depends on your income and other demographic characteristics. And so I find this transition to be pretty interesting because it seems like it would be weird for the United States to just forever have one system for this disease and another system for every other disease. And of course, we do have this for people who are experiencing kidney disease: They get Medicare, they get the government system, regardless of whether they would otherwise be eligible for Medicare.
Rovner: We should point out that Congress did that in 1972. They haven’t really done it since.
Kenen: And when it was much more rare than it was today.
Rovner: And when people didn’t live very long with it mostly.
Kenen: We didn’t have as much diabetes either.
Sanger-Katz: But anyway, I just think this transition kind of just gives us a moment to reflect on, How does the system work in general? How do we feel about how the system works in general? Are these things good or bad? And I agree with everything that Joanne said, that the confusion around this is going to have public health impacts as relates to covid. But we have lots of other diseases where we just basically have the standard system, and now we’re going to have the standard system for covid, too.
Kenen: You could have gone to the hospital with the bad pneumonia and needed oxygen, needed a ventilator, and when they tested you, if you had covid, it was all free. And if you had, you know, regular old-fashioned pneumonia, you got a bill. I agree with everything Margot said, but it’s even that silly. You could have had the same symptoms in your same lungs and you had two different health care systems and financing systems. None of us have ever thought anything made sense.
Rovner: Yes, well, I actually —
Kenen: That’s why we have a podcast. Otherwise, you know —
Sanger-Katz: And also the way that the drugs and vaccines were developed was also totally different, right? With the government deeply involved in the technology and development, you know, funding the research, purchasing large quantities of these drugs in bulk in advance. I mean, this is just not the way that our system really works for other diseases. It’s been a very interesting sort of experiment, and I do wonder whether it will be replicated in the future.
Luhby: Right. But it was also clear that this is not the beginning of the pushback. I mean, Congress has not wanted to allocate more money, you know, and there’s been a lot of arguments and conflicts over the whole course of this so-called single-payer system, or this more flexible system. So the U.S.’ approach to health care has been pushing its way in for many months.
Rovner: I naively, at the beginning of the pandemic, when we first did this and when the Republicans all voted for it, it’s like, let’s have the federal government pay the hospitals for whatever care they’re providing and make everything free at point of service to the patient — and I thought, Wow, are we going to get used to this and maybe move on? And I think the answer is exactly the opposite. It’s like, let’s get rid of it as fast as we possibly can.
Kenen: There’s money that the government has put in. I believe it is $5 billion into the next generation of vaccines and treatments, because the vaccine we have has certainly saved many lives. But as we all know, it’s not perfect. You know, it’s preventing death, but not infection. It’s not ending circulation of the disease. So we need something better. This debt ceiling fight, if the people in the government could spend all $5 billion today — like we were joking, if you want to get covid, if you’re going to get covid, get it today — I mean, if they could, they would spend all $5 billion of it today, too, because that could be clawed back. I mean, that’s — it’s going to be part of the coming fight.
Luhby: But the question is, even if they develop it, will anyone take it, or will enough people take it? That’s another issue.
Rovner: Well, since we’re sort of on the subject, I’m going to skip ahead to what I was going to bring up towards the end, which I’m calling “This Week in Our Dysfunctional Health System.”
Kenen: We could call it that way every week.
Rovner: Yes, that’s true. But this is particularly about how our health system doesn’t work. First up is “ghost networks.” Those are where insurers provide lists of health care providers who are not, in fact, available to those patients. A quote “secret shopper survey” by the staff of the Senate Finance Committee found that more than 80% of mental health providers found in insurance directories in 12 plans from six states were unreachable, not accepting new patients, or not actually in network. This is not a new problem. We’ve been hearing about it for years and years. Why does it persist? One would think that you could clean up your provider directory. That would be possible, right?
Kenen: Didn’t they legislate that, though? Didn’t they say a few years ago you have to clean it up? I mean, there are going to be some mistakes because there’s, you know, many, many providers and people will make changes or leave practices or … [unintelligible] … jobs or whatever. But I thought that they had supposedly, theoretically, taken care of this a couple years ago in one of the annual regulations for ACA or something.
Rovner: They supposedly, theoretically, took care of the hospitals reporting their prices in a way that consumers can understand, too. So we’ve discovered in our dysfunctional health care system that Congress passing legislation or HHS [the Department of Health and Human Services] putting out rules doesn’t necessarily make things so.
Kenen: Really?
Rovner: Yeah. I just — this was one that I had thought, Oh, boy, I have a whole file on that from like the 1990s.
Sanger-Katz: It’s a huge problem, though. I mean —
Rovner: Oh, it is.
Sanger-Katz: You know, we have a system where, for large groups of Americans, you are expected to shop for a health insurance plan. If you’re purchasing a marketplace plan for yourself, if you are purchasing a Medicare Advantage plan when you become eligible for Medicare, and in many cases, if you have a choice of employer plans, you know, you’re supposed to pick the plan that’s best for you. And we have a system that tells people that having those kinds of choices is good and maximizes the benefits to people, to be able to pick the best plan. But for a lot of people, being able to have the doctors and hospitals that they use or to have a choice of a wide range of doctors for various problems, including mental health services, is a huge selling point of one plan versus another. And again, you have these ghost networks, when you have this lack of transparency and accuracy of this information, it just causes people to be unable to make those good choices and it undermines the whole system of market competition that underpins all of this policy design. I think you can argue that there are not a million gazillion people who are actually shopping on the basis of this. But I do think that knowing whether your medical providers are covered when you’re choosing a new health care plan is actually something that a lot of people do look into when they are choosing a health insurance plan. And discovering that a doctor that you’ve been seeing for a long time and whose relationship you really value and whose care has been important to you is suddenly dishonestly represented as a part of an insurance plan that you’ve selected is just, you know, it’s a huge disappointment. It causes huge disruptions in people’s care. And I think the other thing that this study highlighted is that health insurance coverage for mental health services continues to be a very large problem. There has been quite a lot of legislation and regulation trying to expand coverage for mental health care. But there are these kind of lingering problems where a lot of mental health care providers simply don’t accept insurance or don’t accept very many patients who have insurance. And so I think that this report did a good job of highlighting that place where I think these problems are even worse than they are with the health care system at large. It’s just very hard to find mental health care providers who will take your insurance.
Rovner: And I would say, when you’re in mental health distress or you have a relative who’s in mental health distress, the last thing you need is to have to call 200 different providers to find one who can help you.
Kenen: A lot of the ones that are taking insurance are these online companies, and the good thing is that they’re taking insurance and that there may be convenience factors for people, although there’s also privacy and other factors on the downside. But there have been reports about, your data is not private, and I have no idea how you find out which company is a good actor in that department and which company is just selling identifiable data. I mean, I think it was The Washington Post that had a story about that a couple of weeks ago. You know, you click in on something — straight to the data broker. So, yeah, you get insurance coverage, but at a different price.
Rovner: Well, overlaid over all of this is consolidation, this time at the primary care level of health care. Margot, your colleague Reed Abelson had a big story this week on primary care practices being bought up by various larger players in the health care industry, including hospitals, insurance companies, pharmacy chains, and even Amazon. These larger entities say this can act as a move towards more coordinated, value-based care, which is what we say we all want. But there’s also the very real possibility that these giant, vertical, mega medical organizations can just start to name their own price. I mean, this is something that the FTC [Federal Trade Commission] in theory could go after but has been kind of loath to and that Congress could go after but has also been kind of loath to.
Sanger-Katz: Yeah, in some ways we’ve seen this movie before. There was a big wave of primary care acquisitions that happened, I think, in the 1990s by hospitals. And the hospitals learned pretty quickly that primary care doctors are kind of a money-losing proposition, and they divested a lot. But I think what Reed documented so nicely is that the entities that are buying primary care now are more diverse and they have different business strategies. So it’s not just hospitals who are sort of trying to get more patients referred to their higher-profit specialists, but it’s also Medicare Advantage insurers who benefit from being able to tell the primary care doctors to diagnose their patients with lots of diseases that generate profits for the plan, and it’s other kinds of groups that see primary care as kind of the front door to other services that can be revenue-generating. And it’s very — it will be very interesting to see what the effects of these will be and whether these will turn out to be good business decisions for these new entities and of course also whether it will turn out to be good for patient care.
Rovner: Yeah, I remember in the 1990s when hospitals were buying up doctor practices, the doctors ended up hating it because they were asked to work much harder, see patients for a shorter period of time, and some of them actually — because they were now on salary rather than being paid for each patient — were cutting back on, you know, in general, on the amount of care they were providing. And that was what I think ended up with a lot of these hospitals divesting. It didn’t work out the way the hospitals hoped it would. But as you point out, Margot, this is completely different, so we will — we will see how this moves on. All right. Let’s go back a little bit. We’re going to talk about abortion in a minute. But first, something that could prevent a lot of unintended pregnancies: On Wednesday, an advisory committee for the Food and Drug Administration — actually two advisory committees — unanimously recommended that the agency approve an over-the-counter birth control pill. This has been a long time coming here in the U.S., even though pills like these are available without prescription in much of Europe and have been for years. But while the FDA usually follows the recommendations of its advisory committees, we know that some FDA scientists have expressed concerns about over-the-counter availability. So what’s the problem with giving women easier access to something that so many depend on?
Kenen: There are trade-offs. And there are — some of the scientists at the FDA are more conservative than others about, What if the woman doesn’t understand how to take the pill properly? Things like that. I mean, obviously, if we go the over-the-counter route, as other countries are doing, there have to be very simple, easy-to-understand explanations in multiple languages. Pharmacists should be able to explain it like, you know, “You have to take it every day, and you have to take it at approximately the same time every day,” and things like that. So, you know, obviously not taking it right doesn’t protect you as much as taking it right. But there are a lot of people who will be able to get it. You know, getting a prescription is not always the easiest thing in the world. Or if you’re lucky, you just click on something and somebody calls your doctor and gets you a refill. But that doesn’t always work and not everybody has access to that, and you have to still see your doctor sometimes for renewals. So if you’re a working person who doesn’t have sick leave and you have to take time off from work every three months to get a refill or you have to hire child care or you have to take three buses — you know, it takes a whole day, and then you sit in a waiting room at a clinic. I mean, our health system is not patient-friendly.
Rovner: I was going to say, to go back to what Tami was talking about earlier — if pills are available over the counter, it’s going to depend on, you know, what your insurance is like, whether you would get it covered.
Kenen: The cost.
Rovner: That’s right. And it could end up being —
Kenen: But I don’t think the FDA is concerned about that.
Rovner: No, they’re not. That’s not their job.
Kenen: The pill is pretty safe, and these are lower-dose ones than the pills that were invented, you know, 50 years ago. These are lower-dose, safer drugs with fewer side effects. But I mean, there’s concern about the rare side effect, there’s concern about people not knowing how to take it, all that kind of stuff. But Julie just mentioned the cost of coverage is a separate issue because under the ACA it’s covered. And if it becomes over the counter, the mechanism for getting that covered is, at this point, unclear.
Sanger-Katz: But we do have a system now where, for a lot of women, obtaining birth control pills depends on being able to get a doctor’s appointment on a regular basis. I think, you know, this is not standard practice, but I do think that there are a lot of OB-GYNs who basically won’t write you for a birth control pill unless you come in on a regular basis to receive other kinds of health screenings. And I think many of them do that with good intentions because they want to make sure that people are getting Pap smears and other kinds of preventive health services. But on the other hand, it does mean that there are a lot of women who, if they don’t have time or they can’t afford to come in for regular doctor’s appointments, lose access to birth control. And I think over-the-counter pills is one way of counteracting that particular problem.
Rovner: And I think that’s exactly why so many of the medical groups are urging this. During the more than a decade-long fight over making the morning-after pill over the counter, the big hang-up was what to do about minors. Even President Obama, a major backer of women’s reproductive health rights, seemed unhappy at the idea of his then-barely teenage daughters being able to get birth control so easily and without notifying either parent. It seems unimaginable that we’re not going to have that same fight here. I mean, literally, we spent six years trying to figure out what age teens could be to safely buy morning-after pills, which are high doses of basically these birth control pills. I’m actually surprised that we haven’t really seen the minor fight yet.
Kenen: I think everyone’s waiting for somebody else to do it first. I mean, like Julie, I wasn’t expecting to hear more about age limitations, and that’ll probably come up when the FDA acts, because I think the advisory committee just wanted to — they were pretty strong saying, “Yeah, make this OTC.”
Sanger-Katz: I also think the politics around emergency contraception are a little bit different because I think that, while physicians understand that those pills are basically just high-dose birth control pills and that they work in just the same way as typical contraception, I think there’s a perception among many members of the public that because you can take them after unprotected sex, that they might be something closer to an abortion. Now, that is not true, but because I think that is a common misperception, it does lead to more discomfort around the availability of those pills, whereas birth control pills — while I think there are some people who object to their wide dissemination and certainly some who are concerned about them in the hands of children, I think they are more broadly accepted in our society.
Rovner: We obviously are going to see, and we’ll probably see fairly soon. We’re expecting, I guess, a decision from the FDA this summer, although with the morning-after pill we expected a decision from FDA that lingered on for many months, in some cases many years.
Kenen: And I think it’s at least hypothetically possible that states will not do what the FDA says. Say the FDA says they can be over the counter with no age limitations. I can see that becoming a fight in conservative states. I mean, I don’t know exactly the mechanism for how that would fall, but I could certainly think that somebody is going to dream up a mechanism so that a 12-year-old can’t get this over the counter.
Rovner: I want to move to abortion because first up is the continuing question over the fate of the abortion pill, which we get to say at this point: not the same as the emergency contraceptive pill, which, as Margot said, is just high-dosage regular birth control pills. Needless to say, that’s the one that we’re having the current court action over. And there was even more action this week, although not from that original case, which will be heard by the Court of Appeals later in this month. In West Virginia, a judge declined to throw out a case brought by GenBioPro. They are the maker of the generic version of mifepristone, the abortion pill. That generic, which accounts for more than half the market, would be rendered unapproved even under the compromise position of the Court of Appeals because it was approved after the 2016 cutoff period. Remember, the Court of Appeals said, We don’t want to cancel the approval, but we want to roll it back to the date when FDA started to loosen the restrictions on it. So, in theory, there would be no generic allowed, but that’s actually not even what the West Virginia lawsuit is about; it’s about challenging the state’s total abortion ban as violating the federal supremacy of the FDA over state laws. Joanne, that’s what sort of you were talking about now with contraceptives, too. And this is the big unanswered question: Can states basically overrule the FDA’s approval and the FDA’s approval for even an age limit?
Kenen: Well, I mean, I’m not saying they can, but I am saying that I don’t know where the question will come down. Go back to the regular birth control; I can certainly see conservative states trying to put age limits on it. And I don’t know how that’ll play out legally. But this is a different issue, and this is why the abortion pill lawsuits are not just about the abortion pill. They’re about drug safety and drug regulation in this country. The FDA is the agency we charge with deciding whether drugs are safe and good for human beings, and not the system of politicians and state legislators in 50 different states replacing their judgment. So obviously, it’s more complicated, because it’s abortion, but one of several bottom lines in this case is who gets to decide: the FDA or state legislature.
Rovner: And right: Do states get to overrule what the federal Food and Drug Administration says? Well, I —
Kenen: Remember, some states have had — you know, California’s had stricter regulations on several health things, you know, and that’s been allowed that you could have higher ceilings for various health — you know, carcinogenics and so forth. But they haven’t fundamentally challenged the authority of the FDA.
Rovner: Yet. Well, since confusion is our theme of the week, also this week a group of independent abortion clinics led by Whole Woman’s Health, which operates in several states, filed suit against the FDA, basically trying to add Virginia, Kansas, and Montana to the other 18 states that sued to force FDA to further reduce the agency’s current restrictions on mifepristone. A federal judge in Washington state ruled — the same day that Texas judge did that mifepristone should have its approval removed — judge in Washington said the drug should become even more easily available. In the real world, though, this is just sowing so much confusion that nobody knows what’s allowed and what isn’t, which I think is kind of the point for opponents, right? They just want to make everybody as confused as possible, if they can’t actually ban it.
Sanger-Katz: I think they actually want to ban it. I mean, I think that’s their primary goal. I’m sure there are some that will settle for confusion as a secondary outcome. I think just this whole mess of cases really highlights what a weird moment we are, where we’re having individual judges and individual jurisdictions making determinations about whether or not the FDA can or can’t approve the safety and efficacy of drugs. You know, as Joanne said, we’ve just had a system in this country since the foundation of the FDA where they are the scientific experts and they make determinations and those determinations affect drug availability and legal status around the country. And this is a very unusual situation where we’re seeing federal courts in different jurisdictions making their own judgments about what the FDA should do. And I think the Texas judge that struck down the approval of mifepristone, at least temporarily, has come in for a lot of criticism. But what the judge in Washington state did is sort of a flavor of the same thing. It’s telling the FDA, you know, how they should do their business. And it’s a weird thing.
Rovner: It is. Well, one last thing this week, since we’re talking about confusion, and the public is definitely confused, according to two different polls that are out this week — on the one hand, a Washington Post-ABC News poll found that a full two-thirds of respondents say mifepristone, the abortion pill, should stay on the market, and more than half say they disagree with the Supreme Court’s overturn of Roe v. Wade, including 70% of independents and more than a third of Republicans. Yet, in focus groups in April, more than a third of independents couldn’t differentiate Democrats’ position on abortion from Republicans’. As reported by Vox, one participant said, quote, “I really haven’t basically heard anything about which party is leaning toward it and which one isn’t.” When pressed, she said, “If I had to guess, I would say Democrat would probably be against it and Republican would probably be for it.” Another participant said she thought that Joe Biden helped get the Supreme Court judges who overturned Roe. We really do live in a bubble, don’t we? I think that was sort of the most mind-blowing thing I’ve read since — all the months since Roe got overturned, that there are people who care about this issue who have no idea where anybody stands.
Sanger-Katz: I think it’s just a truth about our political system that there are a lot of Americans who are what the political scientists call low-information voters. These are people who are just not following the news very closely and not following politics very closely. And they may have a certain set of opinions about issues of the day, but I think it is a big challenge to get those people aware of where candidates stand on issues of concern to them and to get them activated. And it doesn’t really surprise me that independent voters are the ones who seem to be confused about where the parties are, because they’re probably the least plugged into politics generally. And so, for Democrats, it does seem like this lack of information is potentially an opportunity for them, because it seems like when you ask voters what they want on abortion, they want things that are more aligned with Democratic politicians’ preferences than Republicans’. And so it strikes me that perhaps some of those people in the focus group who didn’t know who stood for what, maybe those are gettable voters for the Democratic Party. But I think — you know, we’re about to go into a very heated campaign season, you know, as we go into the presidential primaries and then the general election in which there are going to be a lot of ads, a lot of news coverage. And, you know, I think abortion is very likely to be a prominent issue during the campaigns. And I think it is almost certainly going to be a major goal of the Biden presidential reelection campaign to try to make sure that these people know where Biden stands relative to abortion, because it is an issue that so many voters agree with him on.
Rovner: And it makes you see, I mean, there’s a lot of Republicans who are trying to sort of finesse this issue now and say, you know, “Oh, well, we’re going to restrict it, but we’re not going to ban it,” or, “We have all these exceptions” that are, of course, in practice, you can’t use. Obviously, these are the kinds of voters who might be attracted to that. So we will obviously see this as it goes on.
Kenen: But Julie, do you remember whether they were actually voters? Because I had the same reaction to you: like, of all the things to not be sure of, that one was pretty surprising. But we also know that in places like Kansas where, you know, where there are not that many Democrats, these referenda won. Voters have supported abortion rights in the 2022 elections and in these state referenda. So independents must be voting with the —
Rovner: I was going to say, I think if you’re doing —
Kenen: Something isn’t totally — something is not totally adding up there.
Rovner: If you’re doing a focus group for politics, one presumes that you get voters. So, I mean, I think that was — that was the point of the focus group. But yeah, it’s —
Kenen: Or people who say they’re voters.
Rovner: Or people who say they’re voters. That is a different issue. All right. Well, something not that confusing: Now it’s 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. Tami, why don’t you go first this week?
Luhby: OK. Well, I picked a story from CNN by my colleagues on the health team. It’s titled “Because of Florida Abortion Laws, She Carried Her Baby to Term Knowing He Would Die,” by Elizabeth Cohen, Carma Hassan, and Amanda Musa. And I have to say that when I first read this story, I couldn’t get through it, because it was so upsetting. And then when I selected it as an extra credit, I had to read it in full. But it’s about a family in Florida whose son was born without kidneys. They knew that he was going to die. And it’s about all of the effects from everything from, you know, the mother, Deborah Dorbert, on her physically and emotionally. But it also, you know, talked about the family and, you know, the effect on the marriage and the effect — which was just so upsetting — was on the 4-year-old son, who became very attached. I don’t think they even knew — well, it wasn’t a girl. It was actually a boy. But for some reason, this older son felt that it was a girl and just kept saying, like, “My sister is going to do X, Y, Z.” And, you know, how did the parents break it to him? Because he saw that his mother was, you know, pregnant and getting larger. And, you know, it was just figuring out how to break it to him that no baby was coming home. So the details are heart-wrenching. The quotes in the third paragraph: “‘He gasped for air a couple of times when I held him,’ said Dorbert. ‘I watched my child take his first breath, and I held him as he took his last one.’” So, you know, these are things that, you know — and we just talked about how the states are arguing over what exceptions there should be, if any, you know, and these are the stories that the legislators don’t think about when they pass these laws.
Rovner: I think I said this before because we’ve had a story like this almost every week. This one was particularly wrenching. But I think the one thing that all these stories are doing is helping people understand, particularly men, that there are complications in pregnancy, that they’re not that rare, that, you know, that they sort of throw off and say, “Oh, well, that’s, you know, one in a million,” — It’s not one in a million. It’s like one in a thousand. That’s a lot of people. So I mean, that’s why there are a lot of these stories, because there are a lot of pregnancies that don’t go as expected.
Luhby: Right. And it really shows the chilling effect on doctors because, you know, you would say, “Oh, it’s simple: life of the mother or, you know, life of the fetus” or something like that. That seems pretty straightforward, but it isn’t. And these doctors, in cases where, you know, other cases where it is the life of the mother, which seem, again, very straightforward, the doctors are not willing to do anything because they’re afraid.
Rovner: I know. Joanne.
Kenen: This is a story from The Baltimore Banner that has a very long title. It’s by Hallie Miller and Adam Willis, and it’s called “Baltimore Isn’t Accessible for People With Disabilities. Fixing It Would Cost Over $650 Million.” Baltimore is not that big a city. $650 million is a lot of curbs and barriers. And there’s also a lot of gun violence in Baltimore. If you drive around Baltimore, and I work there a few days a week, you see lots of people on walkers and scooters and wheelchairs because many of them are survivors of gun violence. And you see them struggling. And there were quotes from people saying they, you know, were afraid walking near the harbor that they would fall in because there wasn’t a path for them. It is not invisible, but we treat it like it’s invisible. And it’s been many years since the Americans with Disabilities Act was passed, and we still don’t have it right. It’s a — this one isn’t confusion like everything else we talked about today. I loved Margot’s phrase about confusion as a secondary outcome. I think you should write a novel with that title. But it’s — this isn’t confusion. This is just not doing the right thing for people who are — we’re just not protecting or valuing.
Rovner: And I’d say for whom there are laws that this should be happening. Margot.
Sanger-Katz: I had another story about abortion. This one was in The New Yorker, called “The Problem With Planned Parenthood,” by Eyal Press. The story sort of looked at Planned Parenthood, you know, which is kind of the largest abortion provider in the country. It’s — I mean, it’s really a network of providers. They have all these affiliates. They’re often seen as being more monolithic than perhaps they are. But this story argued that people who were operating independent abortion clinics, who do represent a lot of the abortion providers in the country as well, have felt that Planned Parenthood has been too cautious legally, too afraid of running afoul of state laws, and so that has led them to be very conservative and also too conservative from the perspective of business, and that there is a view that Planned Parenthood is not serving the role that it could be by expanding into areas where abortion is less available. I thought it was just interesting to hear these criticisms and hoped to understand that the community of abortion providers are, you know, they’re diverse and they have different perspectives on how abortion access should work and what kinds of services should be provided in different settings. And they also view each other as business competition in some cases. I mean, a lot of the complaints in this article had to do with Planned Parenthood opening clinics near to independent clinics and kind of taking away the business from them, making it harder for them to survive and operate. Anyway, I thought it was a very interesting window into these debates, and it did mesh with some of my reporting experience, particularly around the legal cautiousness. I did a story before the Dobbs decision came down from the Supreme Court where Planned Parenthood in several states had just stopped offering abortions even before the court had ruled, because they anticipated that the court would rule and they just didn’t want to make any mistake about running afoul of these laws such that, you know, women were denied care that was still legal in the days leading up to the Supreme Court decision.
Rovner: Yeah, it’s a really good story. Well, my story is kind of tangentially about abortion. It’s from Slate, and it’s called “Not Every Man Will Be as Dumb as Marcus Silva,” by Moira Donegan and Mark Joseph Stern. And it’s about a case from Texas, of course, that we talked about a couple of weeks ago, where an ex-husband is suing two friends of his ex-wife for wrongful death, for helping her get an abortion. Well, now the two friends have filed a countersuit claiming that the ex-husband knew his wife was going to have an abortion beforehand because he found the pill in her purse and he put it back so that he could use the threat of a lawsuit to force her to stay with him. It feels like a soap opera, except it is happening in real life. And my first thought when I read this is that it’s going to make some great episode of “Dateline” or “20/20.” That is our show, as always.
Kenen: Or, not “The Bachelor.”
Rovner: Yeah, but not “The Bachelor.” That is our show. 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. Joanne?
Kenen: @JoanneKenen.
Rovner: Tami.
Luhby: @Luhby.
Rovner: Margot.
Sanger-Katz: @sangerkatz.
Rovner: We will be back in your feed next week, hopefully with a little less confusion. Until then, be healthy.
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2 years 2 months ago
COVID-19, Health Industry, Insurance, Multimedia, Pharmaceuticals, Public Health, Abortion, FDA, Hospitals, KFF Health News' 'What The Health?', Legislation, Podcasts, Women's Health
Trinidad and Tobago among countries with the most cases of hypertension - TT Newsday
- Trinidad and Tobago among countries with the most cases of hypertension TT Newsday
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- Wellness Wednesday: The importance of blood pressure screening FOX54 News Huntsville
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2 years 2 months ago
Trinidad and Tobago among countries with the most cases of hypertension - TT Newsday
- Trinidad and Tobago among countries with the most cases of hypertension TT Newsday
- Wellness Wednesday: The importance of blood pressure screening FOX54 News Huntsville
- Warning: Hypertension is a silent killer! Don’t Be Caught Off Guard – 7 Vital Facts You Need to Know to Protect Your Heart Health!” News24
- View Full Coverage on Google News
2 years 2 months ago
PAHO/WHO | Pan American Health Organization
Improved management of hypertension could save 420,000 lives each year in the Americas, PAHO Director says
Improved management of hypertension could save 420,000 lives each year in the Americas, PAHO Director says
Cristina Mitchell
11 May 2023
Improved management of hypertension could save 420,000 lives each year in the Americas, PAHO Director says
Cristina Mitchell
11 May 2023
2 years 2 months ago
STAT+: Wyden decries ‘astonishingly low’ tax rates for pharma companies as he probes business maneuvers
Thanks to changes in tax law six years ago, several of the largest pharmaceutical companies saw their tax rates fall substantially, but they also reported that most of their profits were shifted offshore in an effort to avoid paying U.S.
taxes, according to a memo by a U.S. Senate Committee.
Specifically, the average effective tax rate for seven of the biggest drugmakers fell by 40% — dropping to 11.6% in 2020, down from 19.6% in 2016. In 2017, a new law was passed that permanently lowered corporate tax rates from 35% to 21%. Meanwhile, many of the largest pharmaceutical companies reported that 75% of their profits came from overseas.
2 years 2 months ago
Pharma, Pharmalot, Congress, finance, Pharmaceuticals, STAT+
Medical News, Health News Latest, Medical News Today - Medical Dialogues |
Provide Security to all Hospitals to avert Violence Against doctors: Kerala HC directs Police
Ernakulam: While considering the matter concerning violence against doctors, a Division bench of Kerala High Court at a special sitting today directed the State Police chief to evolve sufficient and effective protocols regarding the manner in which persons in custody- be that accused or otherwise- are to be presented in hospitals and before medical professionals as part of the criminal justice
system or such other.
Apart from this, the HC Division bench of Justices Devan Ramachandran and Kauser Edappagath has also directed the SPC to place on record necessary requirements and protocols to ensure that effective security is provided in all hospitals so that any further incidents or attacks can be avoided.
"We remind the SPC, as we have already indited above, that it is the fundamental obligation of the police force, headed by him, to ensure that hospitals and the personnel who man them are adequately and sufficiently protected on a day-to-day basis, for the 24 - hour time frame," the bench observed.
The observation from the HC bench has come when yesterday Dr. Vandana Das was brutally stabbed to death with scissors at a government hospital in Kerala's Kollam district allegedly by a prisoner who was brought to the facility for a medical examination by the Police.
Five others, including the policeman, sustained injuries during the incident. The doctor was immediately taken to a private hospital in Kottarakkara, where she died while undergoing treatment. The incident took place at the government taluk hospital in Kottarakkara, police said.
Yesterday, during an urgent hearing of the matter, the Kerala High Court bench had said that the incident was an outcome of police and government failure and the court had sought a report regarding the incident from the State Police Chief who was also asked to be present virtually when was taken up Thursday morning.
Expressing its shock over the matter, the HC division bench comprising Justice Devan Ramachandran and Justice Kauser Edappagath observed, "We are, like any other right thinking citizen, shocked and distraught by the tragic events and feel helpless for not having been able to ensure that Dr.Vandana Das lived a full life. The least we can do is to place on record our deep felt condolences to the family, friends, relatives, classmates and colleagues of Dr.Vandana Das and assure them that her sacrifice will not be forgotten easily."
Yesterday, the bench also issued several directions in connection with the death of Dr. Vandana. Court had directed to preserve the CCTV visuals of the rooms/places of occurrence of the incident. The bench also directed the Judicial First Class Magistrate-I, Kottarakkara to visit the Taluk Hospital, Kottarakkara and conduct an inspection of the scene of incident and report the same to the court.
"Every order that we have passed in this case, as also the provisions of the aforementioned 'Act', shall apply in its full force and warrant to every Intern, House Surgeon, Post Graduate student and other persons engaged in the Health Science Education, without any reservation; and all our orders shall be implemented in its letter and spirit as far as such sections are also concerned. We, however, leave liberty to Sri.S.Kannan – learned Senior Government Pleader, to seek any modification of this particular direction, if needed in future," the bench had also mentioned.
During the case hearing today, the court noted that the directions have been confirmed since the Senior Government Pleader Sri. S. Kannan said that no modifications were necessary especially because Section 2 of the Kerala Healthcare Service Persons and Healthcare Service Institutions (Prevention of Violence and Damage to Property) Act, 2012, covers medical students, interns, house surgeons and every other person involved in the Health Sciences Education.
While the SPC and ADGP explained the matter concerning the death of Dr. Vandana in detail, the HC bench noted that "...we are not concerned about the same, as much as we are to ensure that no further attacks are caused on any Health-care professional in the future."
The bench was informed that the investigation into the death of Vandana Das is going on and accordingly, the Court directed the SPC to ensure that investigation is carried out in her name faithfully, truthfully and diligently. Responding to this, the SPC assured that every step in that regard will be taken.
Meanwhile, the ADGP confirmed that even though there are protocols with respect to the manner in which accused and other persons in custody of the Police are to be presented before medical professionals or in hospitals, they are not up to the mark at the present time and require modification.
At this outset, the bench observed,
"As far as the incident in question is concerned, there can be little doubt that the killing of a young doctor by a person who was in custody of the police — be that as an accused or in any other capacity — points at a systemic failure. The Police Officers above were also ad idem that it is the fundamental duty of any officer to guard a citizen, even at the cost of their own lives. The preliminary information that we have, which is gathered from the statements filed on behalf of SPC and others, is that, for some reason, Vandana Das was alone in the observation room at the particular point of time, which opportunity was seized by the accused to repeatedly stab her. This is a gruesome incident, which, as we have already said in our earlier order, should have never happened."
"Obviously, therefore, protocols will have to be immediately evolved as to the manner in which doctors, healthcare professionals, students, interns, house surgeons and such others are to be protected because, otherwise, the faith in the system will surely erode," it further noted.
Therefore, the bench directed the SPC to evolve sufficient and effective protocols concerning how persons in custody – be that accused or otherwise – are to be presented in hospitals and before medical professionals as part of the criminal justice system or such other.
"...as we have already said in our earlier order, it would be apposite to reflect upon the protocols that are applicable in the case of the production of accused before a learned Magistrate. We must, however, say that even the protocols with respect to learned Magistrates are extremely lacking and it is only a matter of providential grace that we have yet to come across a situation where such an officer is attacked. The Police will have to certainly pull up their socks on a war-footing," further observed the bench.
Observing that "lack of protocols or inefficiency of the same, can never be impelled as a reason to justify another crime", the HC bench directed, for the time being, that every protocol applicable for production of the accused or persons in custody of the Police before the learned Magistrate shall apply in the case of the production of such persons in the hospitals or before the doctors or health care professionals concerned.
Addressing the issue of security in various hospitals and especially those in the Government Sector, the bench observed,
"...we have no doubt that it is the fundamental duty of the SPC to ensure such. In fact, he also agreed to this and submitted that he will place on record necessary requirements and protocols in this regard, including considering whether members of the State Industrial Security Force (SISF) can be deployed for such purposes."
"Of course, we have to give the SPC some time to consider all these aspects and inform us; but, in the meanwhile, we are constrained to ensure that effective security is provided in all hospitals in the manner as is legally possible, so as to avoid any further incidents or attacks. We remind the SPC, as we have already indited above, that it is the fundamental obligation of the police force, headed by him, to ensure that hospitals and the personnel who man them are adequately and sufficiently protected on a day-to-day basis, for the 24 - hour time frame," the bench mentioned in the order.
During the course of the hearing, Advocate Sri.Gopakumaran Nair intervened to say that Government has been assuring that an Ordinance will be brought to amend the 2012 Act appositely. Referring to this, he urged the court to issue direction to the Government to take action in this regard quickly. Further, he prayed to the court to direct Government for considering the appointment of a Special Prosecutor for trial of the case.
Responding to this, the Government counsel submitted that the requests will be considered by the Government with all seriousness and discussions are going on with all stakeholders regarding the concerned Ordinance and prayers will be submitted to the Court by the next date of hearing.
Meanwhile, Dr. Rajeev Joshi submitted that Government has not yet responded to certain IAs and taking note of this, the bench directed the Senior Government Pleader to look into the interim applications and submit the response by the next date of hearing.
Apart from this, the bench also allowed the Kerala University of Health Sciences (KUHS) to submit their suggestions regarding the Ordinance or the amendment before the Government.
Medical Dialogues had earlier reported that recently the State Government of Kerala has informed the High Court that the Government is proposing to amend the Kerala Healthcare Service Persons and Healthcare Service Institutions (Prevention of Violence and Damage to Property) Act 2012.
During the course of hearing of a plea filed by Kerala Private Hospitals Association, the HC bench had referred to the reports of 'routine' attacks on Healthcare personnel and observed that even though Kerala Healthcare Service Act 2012 has provision for strict penalties for assault against healthcare workers, the legal provision was not sufficient to stop the assaults.
Apart from this, taking note of the increasing number of attacks upon doctors, the HC bench had earlier directed the police authorities to ensure that a First Information Report (FIR) gets registered on every incident of violence within one hour. Besides, in a landmark move, the HC bench also decided to directly take cognizance of the complaints regarding violence against doctors, nurses or other healthcare professionals.
To read the HC order, click on the link below:
https://medicaldialogues.in/pdf_upload/kerala-hc-violence-against-doctors-209473.pdf
2 years 2 months ago
Editors pick,State News,News,Health news,Kerala,Hospital & Diagnostics,Doctor News,Medico Legal News
PAHO/WHO | Pan American Health Organization
PAHO brings together experts to review strategies to tackle outbreaks in the Americas
PAHO brings together experts to review strategies to tackle outbreaks in the Americas
Cristina Mitchell
11 May 2023
PAHO brings together experts to review strategies to tackle outbreaks in the Americas
Cristina Mitchell
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2 years 2 months ago
Public Health recognizes gyms should not sell steroids
Santo Domingo.- The Vice Minister of Collective Health, Eladio Pérez, recently emphasized that gyms should not be authorized places to distribute medications, exceptionally anabolic steroids used to enhance muscle mass among young individuals.
Santo Domingo.- The Vice Minister of Collective Health, Eladio Pérez, recently emphasized that gyms should not be authorized places to distribute medications, exceptionally anabolic steroids used to enhance muscle mass among young individuals. Pérez expressed concern about the improper dispensation of medications, comparing it to administering a penicillin injection in a non-medical setting. He clarified that gyms are not subject to the qualifications and oversight of the Vice Ministry of Quality Assurance, suggesting that other ministries may have jurisdiction over these matters. Pérez assured that appropriate measures would be taken to address the situation if necessary, emphasizing the need to regulate the sales of such substances.
Minister of Sports, Francisco Camacho, acknowledged the challenge of intervening in the matter, noting that gyms are private businesses. He stated that the approval of the General Sports Law is required to address the issue effectively. Camacho explained that while the Ministry, the Olympic Committee, and the International Olympic Committee hold responsibilities regarding athletes and can conduct doping tests, they lack jurisdiction over private citizens. He stressed the need for complaints to be filed to initiate regulatory actions.
Pérez called for the regulation of the sales of these substances and emphasized that the Ministry of Public Health’s role is to verify the importation of approved drugs with proper sanitary registration and quality guarantees. He highlighted the passive monitoring conducted to detect specific issues and ensure safe administration in healthcare centers. The vice minister also called for stronger enforcement of the law and increased doping tests in sports.
In response to the situation, the Ministry of Sports has been collaborating with the Ministry of Health to raise awareness among parents about the dangers of steroid use and encourage them to report coaches who promote the use of such substances to their children. Rafael Mena, the Vice President of the Pediatric Society, emphasized the risks associated with indiscriminate use of anabolic steroids, such as liver cancer, hypertension, and muscle and ligament rupture. Mena stressed the importance of increased supervision and penalties for coaches who engage in such practices. He also noted that these substances are essential in medical treatments for asthma and lupus.
Efforts are being made to address the issue through the Doping Law, which aims to regulate and combat the misuse of substances. The focus is on achieving comprehensive regulations and raising awareness to protect the well-being of young athletes and individuals engaging in fitness activities.
2 years 2 months ago
Health
Medical News, Health News Latest, Medical News Today - Medical Dialogues |
COVID vaccine maker Novavax forecasts higher-than-expected revenue
United States: COVID-19 vaccine maker Novavax Inc on Tuesday forecast much higher 2023 revenue than Wall Street expected and announced plans to cut a quarter of its workforce, spurring hopes of a recovery for the cash-strapped biotech, and its shares jumped 40%.
In February, the company raised doubts about its ability to remain in business, due to uncertainty about 2023 revenue, funding from the U.S. government, and pending arbitration with global vaccine alliance Gavi.
Novavax, whose COVID vaccine is its lone marketed product after 35 years in business, is relying on launching an updated COVID shot this fall to match circulating strains and cost cuts to improve its prospects.
The Maryland-based drugmaker on Tuesday also unveiled promising early data for its COVID and flu combination vaccine.
It said it now expects 2023 revenue between $1.4 billion and $1.6 billion, compared with analysts' estimates of $831.6 million, according to Refinitiv data.
Novavax said $800 million of that was from "locked-in" overseas purchase contracts for the COVID shot that it has committed to ship this year.
Jefferies analyst Roger Song said the amount of overseas revenue flagged by the company was a surprise to the market, and the roughly $260 million to $440 million they expect in the U.S. was also encouraging.
"They seemed to be very confident about the U.S. fall campaign," Song said.
Novavax is working to produce an update version of its protein-based vaccine in time for the fall COVID-19 booster season. Protein-based vaccines like Novavax's take longer to produce than the messenger RNA-based versions made by Moderna and Pfizer /BioNTech.
Chief Executive John Jacobs declined to disclose the company's U.S. pricing strategy as the country moves to a commercial marketplace for COVID products from government purchases when the pandemic was designated a public health emergency.
"Obviously, it's a really competitive marketplace. We're coming in as a late follower with two competitors that were entrenched in the U.S. market already," Jacobs said in an interview. "We're assessing what the competitors are doing and we'd rather unveil our cards a little bit later."
The company said it plans to layoff around 20% of its nearly 2,000 full-time employees, close to 400 jobs. The remaining job cuts will be contractors, it said.
Novavax expects the cost cuts to reduce its annual research and commercial expenses by 20% to 25% from last year.
Its cash and equivalents fell to $637 million at quarter-end from $1.3 billion as of Dec. 31.
Novavax posted a first-quarter net loss of $3.41 a share, compared with estimates for a loss of $3.46 a share.
All the COVID vaccine makers are working on COVID-flu combination shots with the aim of expanding and picking up market share in what they hope will be an annual booster market.
Data from a mid-stage trial in adults aged 50 to 80 years showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots, Novavax said.
Read also: Novavax cut USD 50 million in costs, plans to slash more: CEO
2 years 2 months ago
News,Industry,Pharma News,Latest Industry News
PBMs, the brokers who control drug prices, finally get Washington’s attention
For two decades, patients and physicians eagerly awaited a lower-cost version of the world's bestselling drug, Humira, while its maker, AbbVie, fought off potential competitors by building a wall of more than 250 patents around it.
For two decades, patients and physicians eagerly awaited a lower-cost version of the world's bestselling drug, Humira, while its maker, AbbVie, fought off potential competitors by building a wall of more than 250 patents around it.
2 years 2 months ago
PBMs, the Brokers Who Control Drug Prices, Finally Get Washington’s Attention
For two decades, patients and physicians eagerly awaited a lower-cost version of the world’s bestselling drug, Humira, while its maker, AbbVie, fought off potential competitors by building a wall of more than 250 patents around it.
When the first Humira biosimilar — essentially a generic version — finally hit the market in January, it came with an unpleasant surprise. The biosimilar’s maker, Amgen, launched two versions of the drug, which treats a host of conditions including rheumatoid arthritis. They were identical in every way but this: One was priced at about $1,600 for a two-week supply, 55% off Humira’s list price. But the other was priced at around $3,300, only about 5% off. And OptumRx, one of three powerhouse brokers that determine which drugs Americans get, recommended option No. 2: the more expensive version.
As Murdo Gordon, an Amgen executive vice president, explained in an earnings call, the higher price enabled his company to give bigger rebates, or post-sale discounts, to Optum and other intermediaries. Most of that money would be passed on to insurers, and patients, he said. Gordon did not mention that the higher-priced option would leave some patients paying much more out-of-pocket, undermining the whole rationale for generic drugs.
The Optum-Amgen announcements perfectly elucidated why, after years of thundering against drugmakers, Congress and the administration have now focused on regulating the deal-makers known as pharmacy benefit managers, or PBMs. Sen. Bernie Sanders’ health committee grilled a panel of PBM and pharmaceutical executives Wednesday in preparation for a vote on PBM legislation, expected Thursday.
The three biggest PBMs — OptumRx, CVS Caremark, and Express Scripts — control about 80% of prescription drug sales in America and are the most profitable parts of the health conglomerates in which they’re nestled. CVS Health, the fourth-largest U.S. corporation by revenue on Fortune’s list, owns CVS Caremark and the insurer Aetna; UnitedHealth Group, a close fifth, owns Optum; and Cigna, ranking 12th, owns Express Scripts. While serving as middlemen among drugmakers, insurers, and pharmacies, the three corporations also own the highest-grossing specialty drug and mail-order pharmacies.
“John D. Rockefeller would be happy to be alive today,” said David Balto, a former Federal Trade Commission attorney who represents clients suing PBMs. “He could own a PBM and monopolize economic power in ways he never imagined.”
Drug manufacturers claim that exorbitant PBM demands for rebates force them to set high list prices to earn a profit. Independent pharmacists say PBMs are driving them out of business. Physicians blame them for unpredictable, clinically invalid prescribing decisions. And patients complain that PBMs’ choices drain their pocketbooks.
With PBMs driving prices, competition has had the opposite effect from what economic theory predicted Medicare patients would spend out-of-pocket on drugs, one large study showed. Over a five-year period, patients were paying 50% more for branded drugs that had competitors than for those that didn’t.
All this makes the PBMs ripe targets for politicians of both parties. Yet the complexity and obscurity of their role in the drug marketplace have skeptics wondering whether legislation advancing in the House and Senate will actually help patients or lower prices at the pharmacy counter.
“We may try to make things better and actually make things worse,” Sen. Rand Paul (R-Ky.) said at Wednesday’s hearing.
The PBMs pass along most of their rebates to health plans, which will bear a larger share of patient drug costs in coming years under Medicare changes that are part of the 2022 Inflation Reduction Act. It’s likely that pressure on insurers will be passed along to PBMs and result in even more aggressive limits on physician prescription decisions, said Troyen Brennan, an adjunct Harvard University professor who was chief medical officer for CVS Health from 2008 to 2022.
Several congressional bills target drug company rebates to PBMs and what’s known as “spread pricing” — the extra money PBMs collect from insurers over what they pay pharmacies for drugs.
But those aren’t the big PBM revenue sources anymore, Brennan said. PBMs today mostly make money by owning mail-order and specialty pharmacies and from the government’s 340B program, created to help hospitals that treat a disproportionately elderly and poor population. Medicare requires drugmakers to provide big discounts to participating hospitals and the growing rosters of affiliated physician groups they own, and some of those discounts end up with PBMs.
Employers and the federal government decide where most of the rebate money goes, PBM leaders testified Wednesday — and health plans decide what out-of-pocket costs their covered members will pay.
In other words, drug companies blame PBMs for high drug counter prices, PBMs blame insurers, and insurers blame the drug companies, all part of a health care system that hinges on an unspoken bargain: Make life comfortable for some — mostly the upper and middle classes — at the expense of lower-income and poorly insured people who get what they get.
PBMs’ extraction of money from patients in the name of “copayments” at the pharmacy counter “reintroduces medical underwriting” that was stripped away by the Affordable Care Act, Craig Garthwaite, a health care researcher at Northwestern’s Kellogg School of Management, told a Senate panel last year. Insurers can no longer pick and choose whom to insure, as they could before the landmark 2010 health law. But they are finding ways to make the sickest pay.
“People with expensive conditions are paying more for insurance so healthy people can pay less,” he said.
PBMs Evolve From Minnows to Whales
In 1967, a year before the first PBM was founded, spending on prescription drugs outside of a hospital in the U.S. totaled around $3.3 billion, compared with more than $600 billion in net payments last year. By 2005, when Medicare expanded to include coverage of outpatient drugs, government and private insurers depended on PBMs’ negotiating power to keep rising drug prices in check.
The Federal Trade Commission and Justice Department allowed the largest PBMs to gobble up competitors and merge with insurers during the Bush and Obama administrations on the grounds that bolstering their powers might rein in prices. The FTC fought state investigations of anti-competitive behavior, saying that pressure on PBMs would benefit consumers.
The FTC under President Joe Biden has switched course, at least partly because of the arrival of Chair Lina Khan, a vigorous proponent of antitrust policy who launched an investigation of the PBMs last June.
It came partly at the request of independent pharmacists, who rely on PBM reimbursements for the drugs they purchase and provide consumers. Thousands of pharmacists complained to the FTC that PBMs force them to accept unfairly low reimbursements — then slam them with opaque rules requiring them to pay back some of the money months later. Pharmacists returned $12.6 billion to PBMs in 2021, according to a recent Medicare Payment Advisory Commission report.
During a recent week, said Ashley Seyfarth, who owns Kare Drug in Aztec, New Mexico, a PBM reclaimed money from one prescription because the paperwork was faxed. It clawed back cash from another sale because Kare had kept the drug on the shelf an extra day, beyond the PBM’s time limit, to accommodate a patient delayed getting to the store.
And her reimbursements are “beyond low,” Seyfarth said. She laughed when asked whether contract terms with the PBMs were negotiable. “You aren’t negotiating anything,” she said. “It’s take it or leave it.”
PBMs “have the right to audit whether contract terms are agreed to,” Angela Banks, vice president of policy at the Pharmaceutical Care Management Association, the PBM trade group, said at a recent conference. “A lot of the complaints about PBMs come from two parties from whom we are extracting money: manufacturers and pharmacists.”
PBM pricing decisions are often murky. According to a recent study, in 2018 Medicare spent $2.6 billion more through PBMs for a year’s worth of 184 generic drugs than they would have cost at Costco. Doctors and hospitals find PBM formularies baffling, with dozens of variations depending on a patient’s health plan.
When Philadelphia-area internist Amy Davis writes a prescription, she has no idea what the pharmacy will bill her patients, she said, or whether a PBM has decided the drug needs prior authorization. Sometimes she doesn’t find out until a patient returns months later saying they skipped the drug because it was too expensive.
“We physicians are completely in the dark,” she said. “And it’s designed that way.”
The PBMs’ growing use of proprietary pharmacies, including mail-order operations, can interfere with the care of patients like Jasmine St. Clair, a 45-year-old restaurant manager and mother of six in Mount Juliet, Tennessee.
In October 2021, St. Clair’s treatment for a rare, non-smoking-related lung cancer was delayed three weeks after PBM giant Express Scripts insisted her prescription be filled by Accredo, the mail-order pharmacy it owns.
In the meantime, her fatigue and lower-back and neck pain became so bad “I couldn’t pick up my daughter, who was 2,” St. Clair said. “And I was really getting scared.”
After St. Clair started the four-pills-twice-a-day regimen, her tumor rapidly shrank. But in January, her husband’s insurance changed and the medications didn’t arrive on time. When she called Accredo to see what was wrong, “they said, ‘You owe $8,000. Would you like to pay by card?’”
The pharmacy attached to her oncology practice straightened out the payment issue and ensured her continued use of the drug, St. Clair said. Her oncologist, Johnetta Blakely, said these are daily occurrences in her practice.
“The problem with the PBMs and the specialty pharmacies they own is that they are so complicated and intertwined it’s hard to figure out what the heck they are doing,” Blakely said. “All this bureaucratic stuff is a distraction and takes away from things I could be doing, like asking Jasmine about her kids.”
What’s the Remedy?
Bipartisan House and Senate bills would require PBMs to reimburse pharmacies serving Medicaid patients based on an authorized price list, rather than using standards that allegedly allow PBMs to lowball pharmacies. The Congressional Budget Office has estimated the bills would save the federal government $1 billion over 10 years. Another Senate bill would require PBMs to report more of their earnings to the FTC, and would ban deceptive and unfair fees.
But PBMs have shown themselves adept at finding ways around regulation. A federal rule scheduled to take effect next year would curtail PBM “clawbacks” on independent pharmacies. But PBM contracts sent out to pharmacies in recent weeks get around that by lowering reimbursement fees and putting a percentage of their payments to pharmacies into a kind of escrow, said Douglas Hoey, CEO of the National Community Pharmacists Association.
When the Trump administration considered banning brand-name drug rebates in 2017, PBMs set up companies in Ireland and Switzerland to take over the negotiations and purchases. Doing so offered a tax advantage and allowed the PBMs to avoid scrutiny of the quantity and nature of those deals. Recently, Express Scripts set up another company to purchase generic drugs, in the Cayman Islands.
And PBMs appear adept at moving money from one pocket to another. “Yesterday’s rebates are today’s fees and potentially tomorrow’s something else,” said John O’Brien, CEO of the pharmaceutical industry-funded research group, the National Pharmaceutical Council.
Every arrangement that PBMs make with manufacturers, employers, and insurers is secret and proprietary, said Barak Richman, a Duke University Law School professor. This makes it nearly impossible to examine what kind of deals PBMs are making.
Antitrust law could be brought to bear on the PBMs, Richman said. And the Biden administration has shown an eagerness to possibly reverse mergers that have increased PBM clout. The Justice Department has taken similar steps.
But federal officials will have to move fast to slow the PBMs. Insurers that don’t have PBMs as part of their business have been shrinking in recent years because of the growing clout and buying power of the companies.
“I predict that any health insurer that doesn’t have a PBM is going to disappear in 10 years,” said Neeraj Sood, a professor at the University of Southern California Sol Price School of Public Policy. “Otherwise, there is no way to compete with the big three.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
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2 years 2 months ago
Health Care Costs, Health Industry, Pharmaceuticals, Biden Administration, Drug Costs, Legislation, New Mexico, Pennsylvania, Prescription Drugs, Tennessee, U.S. Congress
New AI tool helps doctors streamline documentation and focus on patients
Doctors in the U.S. spend an average of 1.84 hours per day completing electronic notes outside their regular work hours, recent studies have shown — and 57% of them said documentation takes away from the time they can spend with patients.
Aiming to change that, Nuance — a Microsoft-owned artificial intelligence company in Massachusetts — has created an AI tool for physicians called DAX Express, which streamlines the note-taking process.
At Cooper University Health Care in New Jersey, doctors who are already using the tool have reported improved patient outcomes, greater efficiency and reduced costs.
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"For our physicians who use DAX more than half the time, they have seen a 43% reduction of the time they spend writing notes and an overall 21% reduction in the amount of time they spend in the electronic medical record," said Dr. Anthony Mazzarelli, the CEO of Cooper, which employs 150 physicians.
He is also an emergency physician.
Peter Durlach, chief strategy officer of Nuance, compares the tool to a "co-pilot" for physicians.
"DAX lets clinicians fully focus on caring for patients instead of manually filling in data entry screens," he told Fox News Digital.
"This technology helps improve the patient experience and the quality of care, while also making it so that clinicians no longer need to spend hours of their own time completing documentation."
DAX Express is powered by GPT-4, the latest version of AI chatbot technology from OpenAI.
The tool automatically and securely creates clinical notes, with the patient’s consent, that are immediately available for the doctor to review after each patient visit.
"The phone sits between the doctor and the patient," Mazzarelli explained during an on-camera interview with Fox News Digital. "It incorporates not just what the doctor says, but also what the patient says. And then it uses AI to write the note."
He added, "It's a huge step up from just dictating notes."
Next, the note is sent to the doctor, who can make any necessary changes before approving it. The doctor can then share the file with the patient for transparency.
"It’s like a physician’s assistant that thinks really fast," Mazzarelli said. "The physician is still responsible for making sure the note correctly reflects the conversation."
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The tool gives doctors evidence-based support for the decisions they make, right in the palm of their hand, he added.
"This is, to me, the next evolution," Mazzarelli said. "It’s not that we just want a faster horse and buggy — we want the car."
The more obvious benefits of DAX are removing the administrative burden from physicians and reducing burnout, but the benefits extend to the patient as well, Mazzarelli said.
The doctor is able to directly interact with the patient and look the person in the eye without the distraction of note-taking, he said.
This aligns with Cooper University Health Care’s philosophy of practicing "compassion science," which emphasizes a clear understanding of what patients are experiencing.
"If you can really connect with patients, whether you're a nurse or a doctor or anybody in health care, it improves patient outcomes and lowers overall costs," Mazzarelli said.
"That's good for not just patients, but for the whole health care system."
Because the physician has to sign off on each AI-created medical note, Mazzarelli believes Nuance’s AI tool presents a low risk.
"It's the same risk as if you had an intern or an administrative assistant write something for you and you put it out in the world and didn't look at it," he said.
"If you’re depending on AI and not thinking of it as an assistant and you just let it make all the decisions — then you certainly could have a problem there."
Nuance’s Durlach believes that administrative functions — note-taking, coding and billing — should be the first place to implement AI because they require a lot of manual work and the cost of making a mistake does not impact patient health.
"As a Microsoft company, our goal is to develop and deploy AI that will have a beneficial impact and earn trust from society," Durlach told Fox News Digital.
"We are committed to creating responsible AI by design."
In developing its tech, Nuance focuses on a core set of principles: fairness, reliability and safety, privacy and security, inclusiveness, transparency and accountability.
"In an industry where certain types of mistakes can have serious consequences, health care organizations must be particularly mindful of choosing safe and proven AI solutions," Durlach said.
In the past, medical technology has actually increased the number of administrative tasks, Mazzarelli said — but he believes AI has the potential to dramatically streamline the doctor-patient experience.
"I am very optimistic about the application of generative AI to improve medical care," the doctor said.
"I think it's going to help doctors and patients have better relationships. And I think if used correctly, it's going to be among the best advances we've had."
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As medicine continues to become more complex, Mazzarelli said, there is a greater need for decision support.
"As personalized medicine becomes more and more the way of the future, we need assistance to make sure we can use it correctly," he added.
"AI is clearly already here, and I'm even more optimistic about the ways it can assist in the future."
2 years 2 months ago
Health, artificial-intelligence, medical-tech, chatgpt, health-care, lifestyle, Massachusetts
Do YOU have a bromance? Scientists reveal how men express their feelings
Conventional wisdom says friendships between men are cold and less nurturing. But researchers say, 'Men demonstrate closeness less obviously, in coded ways'
Conventional wisdom says friendships between men are cold and less nurturing. But researchers say, 'Men demonstrate closeness less obviously, in coded ways'
2 years 2 months ago
Marihuana legal es más potente que nunca pero no está bien regulada
La marihuana y otros productos que contienen THC, el principal ingrediente psicoactivo de la planta, se han vuelto más potentes y peligrosos a medida que la legalización los ha vuelto más accesibles.
Décadas atrás, el contenido de THC de la hierba solía ser inferior al 1,5%. Hoy, algunos productos tienen más de un 90%.
La marihuana y otros productos que contienen THC, el principal ingrediente psicoactivo de la planta, se han vuelto más potentes y peligrosos a medida que la legalización los ha vuelto más accesibles.
Décadas atrás, el contenido de THC de la hierba solía ser inferior al 1,5%. Hoy, algunos productos tienen más de un 90%.
La euforia de antaño ha dado paso a algo más alarmante. Cientos de miles de personas llegan a salas de emergencias por crisis relacionadas con la marihuana, y millones sufren trastornos psicológicos vinculados al consumo de cannabis, según investigaciones federales.
Pero los organismos reguladores no están a la altura.
En los estados que permiten la venta y el consumo de la marihuana y sus derivados, la protección al consumidor no es consistente.
“En muchos estados, los productos tienen una etiqueta de advertencia y poco más por parte de las entidades reguladoras”, dijo Cassin Coleman, vicepresidente del comité de asesoramiento científico de la Asociación Nacional de la Industria del Cannabis.
En general, el gobierno federal no ha intervenido. Sigue prohibiendo la marihuana como sustancia catalogada en la Lista 1 —como droga sin uso médico aceptado y con un alto riesgo de abuso— en virtud de la Ley de Sustancias Controladas (CSA). Pero en lo que respecta a la venta de cannabis, que muchos estados han legalizado, no regula características como la pureza o la potencia.
La Administración de Drogas y Alimentos (FDA) “básicamente se ha cruzado de brazos y no ha cumplido con su deber de proteger la salud pública”, afirmó Eric Lindblom, de la Facultad de Derecho de la Universidad de Georgetown que anteriormente trabajó en el Centro para Productos del Tabaco de la FDA.
La marihuana se ha transformado profundamente desde que generaciones de estadounidenses la usaron por primera vez.
El cannabis se cultiva para suministrar dosis mucho más altas de THC. En 1980, el contenido de THC de la marihuana confiscada era inferior al 1,5%. Hoy en día, muchas variedades de flores de cannabis —la materia vegetal que se puede fumar en un porro— tienen más de un 30% de THC.
Recientemente, en un dispensario de California el menú incluía una variedad con un 41% de THC.
La legalización también ha abierto la puerta a productos que se extraen de la marihuana pero que no siquiera parecidos: concentrados de THC aceitosos, cerosos o cristalinos que se calientan e inhalan mediante el vapeo o el dab, utilizando dispositivos parecidos a un soplete.
Los concentrados actuales pueden tener más de un 90% de THC. Algunos se anuncian como THC casi puro.
Pocos personifican la expansión de la marihuana de forma tan clara como John Boehner, ex presidente de la Cámara de Representantes de Estados Unidos. El republicano de Ohio se opuso durante mucho tiempo a la marihuana y, en 2011, se declaró “inalterablemente contrario” a su legalización.
Ahora forma parte del consejo directivo de Acreage Holdings, un productor de derivados de la marihuana.
Y Acreage Holdings ilustra la evolución del sector. Su marca Superflux comercializa un producto para vapear —”resina pura en un formato cómodo e instantáneo”— y concentrados como “budder”, “sugar”, “shatter” y “wax”. La empresa anuncia su concentrado de “THCa cristalino” como “lo último en potencia”.
Según el Instituto Nacional sobre el Abuso de Drogas, las concentraciones más elevadas entrañan mayores riesgos. “Los riesgos de dependencia física y adicción aumentan con la exposición a altas concentraciones de THC, y las dosis más altas de THC tienen más probabilidades de producir ansiedad, agitación, paranoia y psicosis”, se explica en su sitio web.
En 2021, 16,3 millones de personas en Estados Unidos —el 5,8% de las personas de 12 años en adelante— habían sufrido un trastorno por consumo de marihuana en el último año, según una encuesta publicada en enero por el Departamento de Salud y Servicios Humanos (HHS).
Esta cifra es muy superior a la suma de los trastornos por consumo de cocaína, heroína, metanfetamina, estimulantes de venta bajo receta, como Adderall, o analgésicos recetados, como fentanilo y OxyContin.
Otras drogas son más peligrosas que la marihuana, y la mayoría de las personas afectadas por su consumo padecieron un caso leve. Pero aproximadamente 1 de cada 7 —más de 2,6 millones de personas— padecieron un caso grave, según la encuesta federal.
La mayoría de los médicos equiparan el término “trastorno grave por consumo de sustancias” con la adicción, señaló Wilson Compton, subdirector del Instituto Nacional sobre el Abuso de Drogas.
El trastorno por consumo de cannabis “puede ser devastador”, afirmó Smita Das, psiquiatra de Stanford y presidenta de un consejo sobre adicciones de la Asociación Americana de Psiquiatría.
Das dijo que ha visto vidas destrozadas por el cannabis: personas de éxito que han perdido familias y trabajos. “Se encuentran en una situación en la que no saben cómo han llegado, porque sólo era un porro, sólo era cannabis, y no se suponía que el cannabis les creara adicción”, explicó Das.
Entre los diagnósticos médicos atribuidos a la marihuana figuran la “dependencia del cannabis con trastorno psicótico con delirios” y el síndrome de hiperémesis cannabinoide, una forma de vómito persistente.
Se estima que unas 800,000 personas realizaron visitas a emergencias relacionadas con la marihuana en 2021, según un estudio del gobierno publicado en diciembre de 2022.
Derecho a desintoxicación.
Un padre de Colorado pensó que era cuestión de tiempo para que el cannabis matara a su hijo.
En la primavera de 2021, el adolescente pasó un semáforo en rojo, chocó contra otro auto —resultando heridos él y el otro conductor— y huyó del lugar, según recordó el padre en una entrevista.
En los restos del accidente, el padre encontró porros, envases vacíos de un concentrado de THC de alta potencia conocido como “wax” y un vaporizador de THC.
En el teléfono móvil de su hijo descubrió mensajes de texto y decenas de referencias al “dabbing” y a la hierba. El adolescente dijo que había estado fumando antes del accidente y que intentó suicidarse.
Semanas después, la policía ordenó su ingreso involuntario en un hospital para una evaluación psiquiátrica. Según un informe policial, creía que lo perseguían francotiradores de un cártel de drogas.
El médico que evaluó al adolescente le diagnosticó “abuso de cannabis”.
“Deja de consumir dabs o wax, ya que pueden volverte extremadamente paranoico”, escribió el médico. “Vete directamente al programa de desintoxicación que elijas”.
Según el relato del padre, en los dos últimos años el adolescente sufrió varias retenciones involuntarias, docenas de encuentros con la policía, repetidos encarcelamientos y una serie de estadías en centros de tratamiento hospitalario.
A veces parecía fuera de la realidad, y enviaba mensajes de texto diciendo que Dios le hablaba y le daba superpoderes.
Los daños también fueron económicos. Los reclamos al seguro médico por su tratamiento ascendieron a casi $600,000 y los gastos de la familia llegaron a casi $40,000 hasta febrero.
En las entrevistas para este artículo, el padre habló bajo condición de anonimato para no perjudicar la recuperación de su hijo.
Está convencido de que la enfermedad mental de su hijo fue el resultado del consumo de drogas. Dijo que los síntomas remitían cuando su hijo dejaba de consumir THC y volvían cuando usaba de nuevo.
Su hijo tiene ahora 20 años, ha dejado la marihuana y le va bien, dijo el padre, y añadió: "No me cabe la menor duda de que el consumo de cannabis fue lo que le causó la psicosis, los delirios y la paranoia".
Regulación estatal desigual
Ahora, el uso médico de la marihuana es legal en 40 estados y el Distrito de Columbia, y el uso recreativo o para adultos es legal en 22 estados más el Distrito de Columbia, según MJBizDaily, una publicación especializada.
Al principio de la pandemia de covid-19, mientras gran parte de Estados Unidos cerró sus negocios, los dispensarios de marihuana siguieron abiertos. Muchos estados los declararon negocios esenciales.
Pero sólo dos estados que permiten el uso para adultos, Vermont y Connecticut, han puesto límites al contenido de THC —30% para la flor de cannabis y 60% para los concentrados de THC— y eximen de los límites a los cartuchos precargados, dijo Gillian Schauer de la Asociación de Reguladores de Cannabis, un grupo de reguladores estatales.
Algunos estados limitan el número de onzas o gramos que los consumidores pueden comprar. Sin embargo, incluso un poco de marihuana puede equivaler a mucho THC, apuntó Rosalie Liccardo Pacula, profesora de políticas de salud, economía y derecho en la Universidad del Sur de California.
Algunos estados sólo permiten el uso médico de productos con bajo contenido de THC; por ejemplo, en Texas, las sustancias que no contienen más de un 0,5% de THC en peso. Y algunos estados exigen etiquetas de advertencia. En Nueva Jersey, los productos de cannabis con más de un 40% de THC deben declarar: "Este es un producto de alta potencia y puede aumentar el riesgo de psicosis".
La normativa sobre marihuana de Colorado tiene más de 500 páginas. Sin embargo, se enfatizan los límites de las protecciones al consumidor: "Este producto se ha producido sin supervisión reglamentaria en materia de salud, seguridad o eficacia".
Determinar las normas adecuadas puede no ser sencillo. Por ejemplo, las etiquetas de advertencia podrían proteger a la industria de la marihuana de su responsabilidad, al igual que hicieron con las empresas tabacaleras durante años. Poner un tope a la potencia podría limitar las opciones de las personas que toman dosis elevadas para aliviar problemas médicos.
En general, en el ámbito estatal, la industria del cannabis ha frenado los esfuerzos reguladores argumentando que unas normas onerosas dificultarían la competencia entre las empresas legítimas y las ilícitas, explicó Pacula.
Pacula y otros investigadores han pedido al gobierno federal que intervenga.
Meses después de terminar su mandato como comisionado de la FDA, Scott Gottlieb hizo un llamamiento similar.
Al quejarse de que los estados habían llegado "muy lejos mientras el gobierno federal permanecía al margen", Gottlieb pidió "un esquema nacional uniforme para el THC que proteja a los consumidores."
Eso fue en 2019 y poco ha cambiado desde entonces.
¿Dónde está la FDA?
La FDA supervisa los alimentos, los medicamentos recetados, los de venta libre y los dispositivos médicos. Regula el tabaco, la nicotina y los vapes de nicotina. Supervisa las etiquetas de advertencia del tabaco. En interés de la salud y la seguridad públicas, también regula los productos botánicos, productos médicos que pueden incluir material vegetal.
Sin embargo, cuando se trata de la marihuana para fumar, los concentrados de THC derivados del cannabis que se vapean o dabean y los comestibles infundidos con THC, la FDA parece estar muy al margen.
La marihuana medicinal que se vende en los dispensarios no está aprobada por la FDA. La agencia no ha avalado su seguridad o eficacia ni ha determinado la dosis adecuada. No inspecciona las instalaciones donde se producen los productos ni evalúa el control de calidad.
La agencia sí invita a los fabricantes a someter los productos del cannabis a ensayos clínicos y a su proceso de aprobación de medicamentos.
El sitio web de la FDA señala que el THC es el ingrediente activo de dos medicamentos aprobados por la FDA para el tratamiento del cáncer. Aparentemente, sólo por eso la sustancia está bajo la jurisdicción de la FDA.
La FDA tiene "todo el poder que necesita para regular de forma mucho más eficaz los productos de cannabis legalizados por los estados", afirmó Lindblom, ex funcionario de la agencia.
Al menos públicamente, la FDA no le ha prestado atención a los concentrados de THC derivados del cannabis o la hierba fumada en porros, sino más bien en otras sustancias: una variante del THC derivada del cáñamo, que el gobierno federal ha legalizado, y un derivado diferente del cannabis llamado cannabidiol o CBD, que se ha comercializado como terapéutico.
"La FDA se ha comprometido a vigilar el mercado, identificar los productos de cannabis que plantean riesgos y actuar, dentro de nuestras competencias, para proteger al público", declaró Courtney Rhodes, vocera de la FDA.
"Muchos, la mayoría de los productos con THC se ajustan a la definición de marihuana, que es una sustancia controlada. La Drug Enforcement Administration (DEA) regula la marihuana en virtud de la Ley de Sustancias Controladas (CSA). Le remitimos a la DEA para preguntas sobre la regulación y aplicación de las disposiciones de la CSA", escribió Rhodes en un correo electrónico.
La DEA, dependiente del Departamento de Justicia, no respondió a las preguntas formuladas para este artículo.
En cuanto al Congreso, quizá su medida más importante haya sido limitar la aplicación de la prohibición federal.
"Hasta ahora, la respuesta federal a las acciones estatales para legalizar la marihuana ha consistido, sobre todo, en permitir que los estados apliquen sus propias leyes sobre la droga", señaló un informe de 2022 del Servicio de Investigación del Congreso.
En octubre, el presidente Joe Biden ordenó al secretario de Salud y Servicios Humanos y al fiscal general que revisaran la postura del gobierno federal respecto a la marihuana: si debería seguir clasificada entre las sustancias más peligrosas y estrictamente controladas.
En diciembre, Biden firmó un proyecto de ley que ampliaba la investigación sobre la marihuana y obligaba a las agencias federales a estudiar sus efectos. La ley dice que las agencias tienen un año para publicar sus conclusiones.
Algunos defensores de la marihuana dicen que el gobierno federal podría desempeñar un papel más constructivo.
"La NORML no opina que el cannabis sea inocuo, sino que la mejor forma de mitigar sus riesgos potenciales es mediante la legalización, la regulación y la educación pública", afirmó Paul Armentano, subdirector del grupo antes conocido como Organización Nacional para la Reforma de las Leyes sobre la Marihuana (NORML).
"Los productos tienen que someterse a pruebas de pureza y potencia", añadió, y "el gobierno federal podría ejercer cierta supervisión en la concesión de licencias a los laboratorios que prueban esos productos".
Mientras tanto, según Coleman, asesor de la Asociación Nacional de la Industria del Cannabis, los estados se quedan "teniendo que actuar como si fueran USDA + FDA + DEA, todo al mismo tiempo".
¿Y dónde deja eso a los consumidores? Algunos, como Wendy E., jubilada en sus 60 años, luchan contra los efectos de la marihuana.
Wendy, que habló con la condición de que no se revelara su nombre, empezó a fumar marihuana en la secundaria en los años 70 y la convirtió en su estilo de vida durante décadas.
Luego, cuando su estado la legalizó, la compró en dispensarios "y enseguida me di cuenta de que la potencia era mucho mayor que la que yo había consumido tradicionalmente", contó. "Parecía haber aumentado de manera exponencial".
En 2020, explicó, la marihuana legal —mucho más fuerte que la hierba ilícita de su juventud— la llevó a obsesionarse con el suicidio.
Antes, la mujer que se define como "hippie de la madre tierra" encontraba camaradería pasando un porro con sus amigos. Ahora asiste a reuniones de Marihuana Anónimos, con otras personas que se recuperan de esta adicción.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
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2 years 3 months ago
Health Industry, Mental Health, Noticias En Español, Colorado, Connecticut, FDA, Latinos, Legislation, marijuana, New Jersey, Substance Misuse, texas, Vermont
Chest Wearable Provides Key Heart Measurements
Researchers at the University of Texas at Austin have developed a new chest wearable that can obtain both electrocardiogram and seismocardiogram data from the underlying heart. While basic ECG can be monitored via smart watches, no other wearable combines it with seismocardiography, which would conventionally be obtained by listening to the heart using a stethoscope. Pairing both measurements into one device allows clinicians to get a more complete picture of cardiac health, while freeing patients to go about their daily activities wearing an unobtrusive wearable.
Wearables are changing how we monitor patients and obtain clinical data, replacing the inconvenient medical appointments and bulky electronics of the past. Simply applying a wearable to the skin could let patients go about their daily business while providing valuable health data that could reveal a health problem and prompt early treatment.
“Most heart conditions are not very obvious. The damage is being done in the background and we don’t even know it,” said Nanshu Lu, a researcher involved in the study. “If we can have continuous, mobile monitoring at home, then we can do early diagnosis and treatment, and if that can be done, 80% of heart disease can be prevented.”
This latest offering is a flexible “e-tattoo” that conforms to the skin of the chest and which can provide continuous cardiac monitoring for at least 24 hours, although the penny-sized battery can last up to 40 hours and can be swapped out by the patient if required. The flexible patch weighs just 2.5 grams and can wirelessly transmit the cardiac data.
The wearable can obtain two types of cardiac data, electrical and mechanical, which together provide a more complete picture of heart health. These are electrocardiography and seismocardiography data. The latter type of data is acoustic, is generated by the heart valves, and is typically heard as the characteristic “lub dub” sound through a stethoscope.
“Those two measurements, electrical and mechanical, together can provide a much more comprehensive and complete picture of what’s happening with the heart,” said Lu. “There are many more heart characteristics that could be extracted out of the two synchronously measured signals in a noninvasive manner.”
Study in journal Advanced Electronic Materials: A Chest-Conformable, Wireless Electro-Mechanical E-Tattoo for Measuring Multiple Cardiac Time Intervals
2 years 3 months ago
Cardiology, ECG, electrocardiography, seismocardiography, UTAustin
Lupus is a mysterious, brutal disease. Here’s how you can join the fight against it - CNN
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Natural remedies for urinary tract infection
A URINARY tract infection (UTI) occurs when bacteria get into your urinary tract – kidneys, bladder, or urethra. The role of the urinary tract is to make and store urine. The bladder stores urine until it is emptied by urinating through the urethra...
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